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Senate panel will grill WaMu regulators
Friday, April 9, 2010, 10:57am PDT
by Kirsten Grind
http://www.bizjournals.com/seattle/stories/2010/04/05/daily46.html?surround=lfn
The congressional committee that will question former Washington Mutual executives April 13 in Washington, D.C., has also scheduled a hearing examining the actions of the Seattle bank’s federal regulators, according to information released Friday.
The Senate Permanent Subcommittee on Investigations will question the Federal Deposit Insurance Corp. (FDIC) and the Office of Thrift Supervision (OTS) about WaMu’s oversight and the events leading up to its Sept. 25, 2008, seizure and sale to JPMorgan Chase.
A witness list for the hearing, scheduled for 9:30 a.m. Eastern (6:30 a.m. Pacific) on April 16, will be released on April 12, according to the subcommittee.
The hearing will follow the April 13 session, in which the committee will take testimony from top Washington Mutual executives. That hearing is scheduled to begin 9:30 a.m. Eastern (6:30 a.m. Pacific).
In a statement released Friday, Sen. Carl Levin, D-Michigan, chairman of the Senate subcommittee, said the goals of the panel are to construct a public record of facts about what happened, to inform ongoing legislative debate about financial reform and “to provide a foundation for building better defenses to protect Main Street from the excesses of Wall Street.”
“The recent financial crisis was not a natural disaster; it was a man-made economic assault. People did it. Extreme greed was the driving force. And it will happen again unless we change the rules,” Levin said in the statement.
The Puget Sound Business Journal will be covering the hearings live in Washington, DC next week.
Senate panel will grill WaMu regulators
Friday, April 9, 2010, 10:57am PDT
by Kirsten Grind
http://www.bizjournals.com/seattle/stories/2010/04/05/daily46.html?surround=lfn
The congressional committee that will question former Washington Mutual executives April 13 in Washington, D.C., has also scheduled a hearing examining the actions of the Seattle bank’s federal regulators, according to information released Friday.
The Senate Permanent Subcommittee on Investigations will question the Federal Deposit Insurance Corp. (FDIC) and the Office of Thrift Supervision (OTS) about WaMu’s oversight and the events leading up to its Sept. 25, 2008, seizure and sale to JPMorgan Chase.
A witness list for the hearing, scheduled for 9:30 a.m. Eastern (6:30 a.m. Pacific) on April 16, will be released on April 12, according to the subcommittee.
The hearing will follow the April 13 session, in which the committee will take testimony from top Washington Mutual executives. That hearing is scheduled to begin 9:30 a.m. Eastern (6:30 a.m. Pacific).
In a statement released Friday, Sen. Carl Levin, D-Michigan, chairman of the Senate subcommittee, said the goals of the panel are to construct a public record of facts about what happened, to inform ongoing legislative debate about financial reform and “to provide a foundation for building better defenses to protect Main Street from the excesses of Wall Street.”
“The recent financial crisis was not a natural disaster; it was a man-made economic assault. People did it. Extreme greed was the driving force. And it will happen again unless we change the rules,” Levin said in the statement.
The Puget Sound Business Journal will be covering the hearings live in Washington, DC next week.
Inovio Biomedical Awarded Grant from Pennsylvania Department of Health for Hepatitis C Virus DNA Vaccine Research
Date : 04/09/2010 @ 6:00AM
Source : Business Wire
Stock : Inovio Biomedical Corporation (INO)
http://ih.advfn.com/p.php?pid=nmona&article=42313624&symbol=INO
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that the company and its collaborators from Drexel University, Cheyney University, and the University of Pennsylvania have received a $2.8 million grant to develop a DNA vaccine to treat hepatitis C virus (HCV).
The grant will fund pre-clinical studies to test the safety and effect on the immune system of Inovio’s novel vaccines designed to treat persons who are chronically infected with hepatitis C virus and have not responded to currently available therapies. Persons with chronic HCV infection face an increased risk of developing hepatocellular cancer, a difficult-to-treat cancer with a poor prognosis.
“HCV is a major global health problem, with over 170 million people infected worldwide. As a global leader in therapeutic cancer vaccine development, we are pleased to receive this grant support from the state. We are equally thrilled to work with such a stellar group of collaborators to develop a new generation of therapeutic vaccines for HCV,” stated Dr. J. Joseph Kim, President and CEO.
"These grants will support research on ways to improve the prevention and treatment of critical health problems facing Pennsylvanians," said Pennsylvania Secretary of Health Everette James. "This announcement also reaffirms Pennsylvania's continued commitment to use tobacco settlement dollars to improve the health of its citizens."
These competitive grants focus on specific research priorities established by the Health Research Advisory Committee. These grants are awarded as part of the Commonwealth Universal Research Enhancement Program (CURE), which supports clinical, health services and biomedical research.
More information on the use of tobacco settlement funds can be found at www.health.state.pa.us/cure.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on the design, development, and delivery of a new generation of vaccines, called DNA vaccines, to prevent and treat cancers and infectious diseases. The company’s SynCon™ technology enables the design of “universal” vaccines capable of protecting against multiple – including newly emergent, unknown – strains of pathogens such as influenza. Inovio’s proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to safely and significantly increase gene expression and immune responses. Inovio’s clinical programs include HPV/cervical cancer (therapeutic), avian flu, and HIV vaccines. Inovio is developing its universal and avian influenza vaccines in collaboration with scientists from the University of Pennsylvania, the National Microbiology Laboratory of the Public Health Agency of Canada, and the NIH’s Vaccine Research Center. Other partners and collaborators include Merck, Tripep, University of Southampton, National Cancer Institute, and HIV Vaccines Trial Network. More information is available at www.inovio.com.
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management’s current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Inovio is providing this information as of the date of this press release, and expressly disclaims any duty to update information contained in this press release.
Forward-looking statements in this press release include, without limitation, express and implied statements relating to Inovio’s business, plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and pre-clinical and clinical studies. Actual events or results may differ from the expectations set forth herein as a result of a number of risks, uncertainties and other factors, including but not limited to: Inovio has a history of losses; all of Inovio’s potential human products are in research and development phases; no revenues have been generated from the sale of any such products, nor are any such revenues expected for at least the next several years; Inovio’s product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that pre-clinical and clinical results may not be indicative of results achievable in other trials or for other indications, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that Inovio’s electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; all product candidates that Inovio advances to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization; the availability of funding; the ability to manufacture vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop; whether Inovio’s proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare proposals. Readers are also referred to Inovio’s Annual Report on Form 10-K for the year ended December 31, 2009 and other regulatory filings filed with the Securities and Exchange Commission which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
EMCORE
http://ih.advfn.com/p.php?pid=nmona&article=42316327&symbol=EMKR
EMCORE Announces New openGear 3Gbps HD Broadcast Video Signal Transport Platform
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EMCORE will be displaying these new products at the NABSHOW, April 12-15, 2010 at the Las Vegas Convention Center, Las Vegas, Nevada at Booth C10039 in the Central Hall.
*
"EMCORE's openGear product line is a complete solution for transmitting 3G HD-SDI broadcast video over long or short distances on a single wavelength.
*
EMCORE is currently completing development of two more openGear products for DVI/VGA transport and 3Gbps HD-SDI Video Conversion/Embedding/Transport applications.
EMCORE Announces New openGear 3Gbps HD Broadcast Video Signal Transport Platform
Date : 04/09/2010 @ 8:25AM
Source : MarketWire
Stock : EMCORE (EMKR)
http://ih.advfn.com/p.php?pid=nmona&article=42316327&symbol=EMKR
ALBUQUERQUE, NM -- (Marketwire)
04/09/10
EMCORE Corporation (NASDAQ: EMKR), a leading provider of compound semiconductor-based components, subsystems and systems for the fiber optics and solar power markets, announced today the launch of a new video transport platform based on the popular openGear format of terminal equipment. The openGear products transport SMPTE compliant 3 Gbps HD-SDI (1080p) video signals over fiber optic cables for distances up to 60km. This addition to EMCORE's existing video transport product portfolio complements the Company's flagship Optiva® Video/Audio/Data Transport Platform with a new emphasis on the Broadcast and Professional Audio/Visual markets.
"EMCORE's openGear product line is a complete solution for transmitting 3G HD-SDI broadcast video over long or short distances on a single wavelength. Major broadcasters are in the process of migrating both fixed production and mobile O/B facilities to 3Gbps HD-SDI transport equipment, so that the best quality 1080p high-definition video can be used throughout the entire production and post-production process," said Henok Tafese, Director of Business Development for EMCORE Fiber Optics. "Our fiber products are superior in quality, durability and performance. We believe the addition of the new openGear fiber product family will directly address the requirements of broadcasters for fiber optic video transport solutions."
OpenGear products are offered in the openGear insert card form factor. The cards fit easily into an openGear 2RU 19" rack mount enclosure that provides both power and remote monitoring/management capabilities through the openGear DashBoard? management software. OpenGear 3GHD insert cards are compatible with standard Optiva 3GHD cards as well as the new Micro OPTICAM-3GHD transceiver units, offering the most flexibility when choosing a fiber optic video transport solution. EMCORE is currently completing development of two more openGear products for DVI/VGA transport and 3Gbps HD-SDI Video Conversion/Embedding/Transport applications.
EMCORE will be displaying these new products at the NABSHOW, April 12-15, 2010 at the Las Vegas Convention Center, Las Vegas, Nevada at Booth C10039 in the Central Hall. For more information and a FREE exhibit pass, please visit www.opticomm.com.
About EMCORE:
EMCORE Corporation is a leading provider of compound semiconductor-based components and subsystems for the broadband, fiber optic, satellite and terrestrial solar power markets. EMCORE's Fiber Optics segment offers optical components, subsystems, and systems that enable the transmission of video, voice, and data over high-capacity fiber optic cables for high-speed data and telecommunications, cable television (CATV), and fiber-to-the-premises (FTTP) networks. EMCORE's Solar Photovoltaics segment provides solar products for satellite and terrestrial applications. For space and satellite applications, EMCORE offers high-efficiency compound semiconductor-based gallium arsenide (GaAs) solar cells, covered interconnect cells, and fully integrated solar panels. For terrestrial applications, EMCORE offers concentrating photovoltaic (CPV) systems for utility scale solar applications as well as offering its high-efficiency GaAs solar cells and CPV components for use in solar power concentrator systems. For specific information about our company, our products, or the markets we serve, please visit our websites at www.emcore.com and www.opticomm.com.
Safe Harbor:
Statements in this press release that are not historical facts, and the assumptions underlying such statements, constitute "forward- looking statements" and assumptions underlying "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and involve a number of risks and uncertainties, including (a) the failure of the products mentioned (i) to perform as expected without material defects, (ii) to be manufactured at acceptable volumes, yields, and cost, and (iii) to be successful under field conditions, (b) the failure of the products to be selected by prospective customers for large-scale deployment and (c) the ability of the Company's customers to achieve their own business goals and objectives. Readers should also review the risk factors set forth in EMCORE's Annual Report on Form 10-K for the fiscal year ended September 30, 2009. These forward-looking statements are made as of the date hereof, and EMCORE does not assume any obligation to update these statements.
NexMed Announces Expansion of Its Bio-Quant Subsidiary Facilities
Date : 04/09/2010 @ 9:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=42317233&symbol=NEXM
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that it has expanded its San Diego facilities to accommodate an increase in demand for its pre-clinical research services. Bio-Quant now has approximately 28,000 sq. ft of modern, state-of-the-art laboratory, vivarium and office space.
Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “Our Bio-Quant business has experienced continuous growth during the past five years, including an increase of over 20% in revenues in 2009, alone. This has been achieved, in part, through a prior diversification of our service capabilities and entrance into new geographical markets. The ongoing expansion of our facilities is in response to the rising demand for the specialized services that we offer.”
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company. For example, and without limitation, there can be no assurance that the Company will be able to continue growing its CRO business.
EMCORE Announces New openGear 3Gbps HD Broadcast Video Signal Transport Platform
Date : 04/09/2010 @ 8:25AM
Source : MarketWire
Stock : EMCORE (EMKR)
http://ih.advfn.com/p.php?pid=nmona&article=42316327&symbol=EMKR
ALBUQUERQUE, NM -- (Marketwire)
04/09/10
EMCORE Corporation (NASDAQ: EMKR), a leading provider of compound semiconductor-based components, subsystems and systems for the fiber optics and solar power markets, announced today the launch of a new video transport platform based on the popular openGear format of terminal equipment. The openGear products transport SMPTE compliant 3 Gbps HD-SDI (1080p) video signals over fiber optic cables for distances up to 60km. This addition to EMCORE's existing video transport product portfolio complements the Company's flagship Optiva® Video/Audio/Data Transport Platform with a new emphasis on the Broadcast and Professional Audio/Visual markets.
"EMCORE's openGear product line is a complete solution for transmitting 3G HD-SDI broadcast video over long or short distances on a single wavelength. Major broadcasters are in the process of migrating both fixed production and mobile O/B facilities to 3Gbps HD-SDI transport equipment, so that the best quality 1080p high-definition video can be used throughout the entire production and post-production process," said Henok Tafese, Director of Business Development for EMCORE Fiber Optics. "Our fiber products are superior in quality, durability and performance. We believe the addition of the new openGear fiber product family will directly address the requirements of broadcasters for fiber optic video transport solutions."
OpenGear products are offered in the openGear insert card form factor. The cards fit easily into an openGear 2RU 19" rack mount enclosure that provides both power and remote monitoring/management capabilities through the openGear DashBoard? management software. OpenGear 3GHD insert cards are compatible with standard Optiva 3GHD cards as well as the new Micro OPTICAM-3GHD transceiver units, offering the most flexibility when choosing a fiber optic video transport solution. EMCORE is currently completing development of two more openGear products for DVI/VGA transport and 3Gbps HD-SDI Video Conversion/Embedding/Transport applications.
EMCORE will be displaying these new products at the NABSHOW, April 12-15, 2010 at the Las Vegas Convention Center, Las Vegas, Nevada at Booth C10039 in the Central Hall. For more information and a FREE exhibit pass, please visit www.opticomm.com.
About EMCORE:
EMCORE Corporation is a leading provider of compound semiconductor-based components and subsystems for the broadband, fiber optic, satellite and terrestrial solar power markets. EMCORE's Fiber Optics segment offers optical components, subsystems, and systems that enable the transmission of video, voice, and data over high-capacity fiber optic cables for high-speed data and telecommunications, cable television (CATV), and fiber-to-the-premises (FTTP) networks. EMCORE's Solar Photovoltaics segment provides solar products for satellite and terrestrial applications. For space and satellite applications, EMCORE offers high-efficiency compound semiconductor-based gallium arsenide (GaAs) solar cells, covered interconnect cells, and fully integrated solar panels. For terrestrial applications, EMCORE offers concentrating photovoltaic (CPV) systems for utility scale solar applications as well as offering its high-efficiency GaAs solar cells and CPV components for use in solar power concentrator systems. For specific information about our company, our products, or the markets we serve, please visit our websites at www.emcore.com and www.opticomm.com.
Safe Harbor:
Statements in this press release that are not historical facts, and the assumptions underlying such statements, constitute "forward- looking statements" and assumptions underlying "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and involve a number of risks and uncertainties, including (a) the failure of the products mentioned (i) to perform as expected without material defects, (ii) to be manufactured at acceptable volumes, yields, and cost, and (iii) to be successful under field conditions, (b) the failure of the products to be selected by prospective customers for large-scale deployment and (c) the ability of the Company's customers to achieve their own business goals and objectives. Readers should also review the risk factors set forth in EMCORE's Annual Report on Form 10-K for the fiscal year ended September 30, 2009. These forward-looking statements are made as of the date hereof, and EMCORE does not assume any obligation to update these statements.
Delta Oil & Gas, Inc. Commences Production on 4 Wells at its Oklahoma Prospect
Date : 04/08/2010 @ 1:13PM
Source : Business Wire
Stock : Delta Oil and Gas, Inc. (DLTA)
http://ih.advfn.com/p.php?pid=nmona&cb=1270747477&article=42305550&symbol=NB^DLTA
Delta Oil and Gas, Inc. (OTC:BB – DLTA) is pleased to report that the company has received stabilized flow rates for the first and second wells drilled and completed at its Oklahoma prospect.
After the initial period of production, the flow rates on the first and second wells have stabilized at approximately 400 barrels of oil per day combined with some associated natural gas. This confirms our initial conclusion that we have identified a significant new oil discovery in this area.
Electric logs also indicate the potential for numerous additional high potential pay zones above this tested zone, including one that is known to have flowed oil and gas to the surface during earlier drill stem testing.
The 3rd and 4th wells in this 4 well drilling program have also been drilled, completed and are undergoing further testing for commercially viable quantities of hydrocarbons. Electric logs indicate that the drilling of these wells may have intersected up to nine separate pay zones. The initial indications are that on the fourth well, two significant pay zones were intersected which total approximately 34 feet of hydrocarbon pay. In addition, there may be several other smaller pay zones.
Because of the success of this drilling program, there may be the potential for one or more offset wells in which Delta would participate. Delta owns a 5% working interest in the wells covered by this drilling program and has fully paid the costs associated with this program.
About Delta Oil and Gas
Delta Oil is an exploration company focused on developing North American oil and natural gas reserves. Delta Oil’s current focus is on the exploration of its land portfolio comprised of working interests in acreage in King City, California; Southern Saskatchewan, Canada; and South Central, Oklahoma. As a result of its acquisition of a controlling interest in The Stallion Group, a Nevada corporation, it expanded its property interests to include acreage in the North Sacramento Valley, California.
On behalf of the Board of Directors,
DOUGLAS N. BOLEN, President
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Delta Oil’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended December 31, 2008 and the quarterly reports on Form 10-Q filed subsequently. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Delta Oil & Gas, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Late-stage study begins for cancer drug perifosine
Keryx, AEterna Zentaris announce trial start for cancer drug perifosine
Thursday April 8, 2010, 11:44 am
http://finance.yahoo.com/news/Latestage-study-begins-for-apf-4197808351.html?x=0&.v=1
NEW YORK (AP) -- A late-state clinical trial has started for the potential colorectal cancer treatment perifosine, according to a statement Thursday from Keryx Biopharmaceuticals Inc. and AEterna Zentaris Inc.
Keryx, which is based in New York, said the study is expected to be completed in the second half of 2011 and will involve 430 patients with refractory advanced colorectal cancer. Enrollment will take 12 to 14 months.
Keryx and AEterna Zentaris, a Canadian company, are partnering on perifosine in North America. AEterna Zentaris has the rights to the drug in the rest of the world excluding South Korea.
The companies said earlier this week the Food and Drug Administration gave perifosine a "fast track" designation, which allows for a faster review of a potential treatment intended for a serious or life-threatening disease.
In December, perifosine received a fast-track review designation as a potential treatment for multiple myeloma.
Perifosine also has orphan drug status, which is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Refractory Advanced Colorectal Cancer
Date : 04/08/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42299718&symbol=KERX
Phase 3 X-PECT Trial (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) being conducted pursuant to Special Protocol Assessment with Food and Drug Administration
PR Newswire
NEW YORK, April 8
NEW YORK, April 8 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer.
The Phase 3 trial, entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) or panitumumab (Vectibix®). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint for this study is overall survival, with secondary endpoints including overall response rate, progression-free survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration. Perifosine has also been granted Fast Track designation for the treatment of refractory advanced colorectal cancer.
Dr. Johanna Bendell, Director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, will lead the Phase 3 investigational team that includes Dr. Cathy Eng, Associate Medical Director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas.
Approximately 40 to 50 U.S. sites will participate in the study. Enrollment is expected to take approximately 12 to 14 months, with study completion expected in the second half of 2011.
Dr. Bendell stated, "We have now enrolled the first few patients on the Phase 3 X-PECT trial, which provides an important clinical trial option for patients with refractory advanced colorectal cancer. The randomized Phase 2 data showed promising activity of perifosine plus capecitabine compared to placebo plus capecitabine. I believe the X-PECT trial will soon provide us an answer as to the role of perifosine in the treatment of patients with refractory colorectal cancer."
Ron Bentsur, CEO of Keryx Biopharmaceuticals, commented: "Keryx is committed to developing perifosine as a treatment that will provide meaningful therapeutic value for patients living with refractory advanced colorectal cancer. The Phase 2 trial conducted in this setting provides strong rationale for the benefit of the perifosine/capecitabine combination in the treatment of advanced refractory colorectal cancer and we are extremely excited to initiate this Phase 3 registration trial, pursuant to our SPA, with the goal of potentially having the drug on the market for this indication by mid-2012. We would like to thank Dr. Bendell, Dr. Eng and the team of colorectal investigators for the rapid initiation of this study and their invaluable guidance."
Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
PHASE 3 TRIAL DESIGN:
The Phase 3 X-PECT (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda®) vs. placebo + capecitabine in approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) or panitumumab (Vectibix®). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. The median overall survival for the X-PECT study's targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in overall survival, with an assumed median overall survival for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with advanced colorectal cancer. Currently, there are seven approved drugs for patients with advanced colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda®), irinotecan (Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®), cetuximab (Erbitux®), and panitumumab (Vectibix®). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Bevacizumab, a VEGF monoclonal antibody, is commonly administered with chemotherapy. Typically, patients who fail 5-FU, oxaliplatin, irinotecan, and bevacizumab-containing therapies, and who have wild-type KRAS status receive EGFR monoclonal antibody therapy with either cetuximab or panitumumab. Once patients progress on these agents, there are no further standard treatment options.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.
Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both multiple myeloma and refractory advanced colorectal cancer, and in Phase 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 trials will not coincide with the data analyses from the Phase 1 and Phase 2 clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director – Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Refractory Advanced Colorectal Cancer
Date : 04/08/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42299718&symbol=KERX
Phase 3 X-PECT Trial (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) being conducted pursuant to Special Protocol Assessment with Food and Drug Administration
PR Newswire
NEW YORK, April 8
NEW YORK, April 8 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer.
The Phase 3 trial, entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) or panitumumab (Vectibix®). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint for this study is overall survival, with secondary endpoints including overall response rate, progression-free survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration. Perifosine has also been granted Fast Track designation for the treatment of refractory advanced colorectal cancer.
Dr. Johanna Bendell, Director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, will lead the Phase 3 investigational team that includes Dr. Cathy Eng, Associate Medical Director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas.
Approximately 40 to 50 U.S. sites will participate in the study. Enrollment is expected to take approximately 12 to 14 months, with study completion expected in the second half of 2011.
Dr. Bendell stated, "We have now enrolled the first few patients on the Phase 3 X-PECT trial, which provides an important clinical trial option for patients with refractory advanced colorectal cancer. The randomized Phase 2 data showed promising activity of perifosine plus capecitabine compared to placebo plus capecitabine. I believe the X-PECT trial will soon provide us an answer as to the role of perifosine in the treatment of patients with refractory colorectal cancer."
Ron Bentsur, CEO of Keryx Biopharmaceuticals, commented: "Keryx is committed to developing perifosine as a treatment that will provide meaningful therapeutic value for patients living with refractory advanced colorectal cancer. The Phase 2 trial conducted in this setting provides strong rationale for the benefit of the perifosine/capecitabine combination in the treatment of advanced refractory colorectal cancer and we are extremely excited to initiate this Phase 3 registration trial, pursuant to our SPA, with the goal of potentially having the drug on the market for this indication by mid-2012. We would like to thank Dr. Bendell, Dr. Eng and the team of colorectal investigators for the rapid initiation of this study and their invaluable guidance."
Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
PHASE 3 TRIAL DESIGN:
The Phase 3 X-PECT (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda®) vs. placebo + capecitabine in approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) or panitumumab (Vectibix®). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. The median overall survival for the X-PECT study's targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in overall survival, with an assumed median overall survival for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with advanced colorectal cancer. Currently, there are seven approved drugs for patients with advanced colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda®), irinotecan (Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®), cetuximab (Erbitux®), and panitumumab (Vectibix®). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Bevacizumab, a VEGF monoclonal antibody, is commonly administered with chemotherapy. Typically, patients who fail 5-FU, oxaliplatin, irinotecan, and bevacizumab-containing therapies, and who have wild-type KRAS status receive EGFR monoclonal antibody therapy with either cetuximab or panitumumab. Once patients progress on these agents, there are no further standard treatment options.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.
Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both multiple myeloma and refractory advanced colorectal cancer, and in Phase 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 trials will not coincide with the data analyses from the Phase 1 and Phase 2 clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director – Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Clinilabs Signs MSA with NewCardio, Inc. for QTinno
Date : 04/08/2010 @ 8:00AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&cb=1270728608&article=42299034&symbol=NB%5ENWCI
Master Services Agreement Enables Clinilabs to Add ECG Core Lab Services, Extending its Scope of Services and Capturing Additional Revenue
PR Newswire
NEW YORK, April 8
NEW YORK, April 8 /PRNewswire-FirstCall/ --
Clinilabs, a New York-based contract research organization that provides early phase and specialty clinical drug development services to the pharmaceutical industry, announced today that it has signed a Master Services Agreement (MSA) with NewCardio, Inc. (OTC Bulletin Board: NWCI), a cardiac diagnostic technology provider. Clinilabs has licensed NewCardio's QTinno™ software solution in order to perform fully-automated cardiac safety analyses in cardiac intensive and thorough QT studies. In addition, Clinilabs has signed a services work order, including standard operating procedures (SOP) and validation kits, as well as professional services, so NewCardio can assist Clinilabs in developing an ECG core laboratory.
The Master Services Agreement enables Clinilabs to utilize QTinno to provide customers with advanced, accurate, and efficient fully-automated cardiac safety studies at its clinical research unit (CRU) in Manhattan. The relationship with NewCardio also will enable Clinilabs to compete in the market for ECG core laboratory services by providing the professional services needed to integrate ECG core lab functions into Clinilabs' existing core data center, which currently serves clinical trials in 33 countries. NewCardio is expected to recognize revenue from this relationship beginning in March 2010 with the installation and validation of its systems. Clinilabs is expected to recognize revenue as early as Q3 2010 from clinical trials conducted with the QTinno software solution.
"This announcement is further evidence of the growing adoption of QTinno™ by innovative clinical trial service providers looking to deliver quality cardiac safety analysis with higher accuracy and lower intrinsic variability in a timely and cost-effective manner," said Vincent Renz, NewCardio's President and Chief Operating Officer. "Our target customers are clinical trial service providers looking to deploy our proven technology to expand services and grow market opportunities. For Clinilabs, adding to its available scope of services by utilizing QTinno accomplished these two important goals."
Gary K. Zammit, PhD, President and CEO of Clinilabs, added, "NewCardio's QTinno, coupled with its team's history and expertise in delivering cardiac safety services to leading pharmaceutical companies, has given us an incredible opportunity to expand our service portfolio and deliver value to our clients. We can now provide a differentiated and low cost solution for ECG data analysis to an industry that has been seeking a meaningful alternative to existing methods for some time."
Both NewCardio and Clinilabs will be present at the upcoming 19th Annual Partnerships in Clinical Trials conference to be held in Orlando, FL April 12-14th. NewCardio will be at booth # 624 and Clinilabs at booth # 650. To schedule a private meeting with the Clinilabs and NewCardio teams, please contact Jeanine M. Estrada, Clinilabs' Director of Business Development, at 646.438.4431.
About Clinilabs, Inc.
Clinilabs is a contract research organization (CRO) that provides clinical drug development services to industry. The Company offers teams, facilities, processes, and technology solutions for the conduct of early phase and specialty studies, and also operates a core data center that processes biomedical device data from global, multicenter projects. Since 2001, the company has worked with nine of the top 20 pharma companies in the world on trials conducted in 33 countries to support nine successful new drug applications. For more information, visit www.clinilabs.com.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding NewCardio. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward- looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contacts:
Clinilabs, Inc.
Ron Falcone, Controller
(646) 215-6407
rfalcone@clinilabs.com
NewCardio
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
SOURCE NewCardio, Inc.
Keryx Biotechs (KERX) Cancer Drug Perifosine To Undergo Phase III Trials; Given Buy Rating For Top Drug And Market Successes
http://finance.yahoo.com/news/Keryx-Biotechs-KERX-Cancer-twst-4228504958.html?x=0&.v=1
On Wednesday April 7, 2010, 11:39 am EDT
67 WALL STREET, New York - April 7, 2010 - The Wall Street Transcript has just published its Biotechnology & Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This Special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Clinical, Financial & Regulatory Risks To Drug Development - Easing Capital Markets - Managing Inherent Volatility - FDA Approval Process - Small- & Mid-Cap M&A Rally - Basket Investment Approach - Impact Of Health Care Reform - Therapeutic Cardiovascular Plays - Investable Trend In Antibody Technology
Companies include: Genentech/Roche (RHHBY); Medivation (MDVN); Seattle Genetics (SGEN); AEterna Zentaris (AEZS); Abbott (ABT); Alexion (ALXN); Amgen (AMGN); Antares Pharmaceuticals (AIS); Ardea (RDEA); Astellas (4503); AstraZeneca (AZN); Auxilium (AUXL); Biogen (BIIB); CardioGenics (CHNG); Celera (CRA); Celgene (CELG); Celldex (CLDX); Corcept (CORT); and many more.
In the following brief excerpt from this Biotech And Pharmaceuticals Report, expert analysts discuss the outlook for the sector and for investors.
Dr. Jonathan Aschoff, Ph.D., is a Senior Equity Analyst at Brean Murray, Carret & Co., LLC. Prior to joining the firm in 2003, he held positions as a Senior Biotechnology Analyst at Friedman, Billings, Ramsey & Co., Inc., and at what is now RBC. He also served as an Analyst at Sturza Institutional Research. Prior to Wall Street, Dr. Aschoff was a Research Technician at New England Medical Center. He earned a Ph.D. in molecular biology and microbiology, as well as a B.S. in biology from Tufts University.
TWST: How important to you is company management?
Dr. Aschoff: The earlier the assets, the less I care. But it matters more when it comes to commercializing something, and then I care more. Early on it is only about what the drug does, and that's in the hands of the patients and the people at the clinical trial sites. Management then gets more involved as you get into writing up the application efficiently and considering if management is likely to give a good retort to anything that might be argued against them at an FDA panel. Are they now likely to get a partner on good terms? Can they actually sell this treatment alone or with a partner? That's really what brings more to bear on management. The pivotal data, relatively speaking, is more out of their hands.
TWST: Any other stocks?
Dr. Aschoff: There is a company called Pozen (POZN) that I like quite a lot. I think that partner Glaxo (GSK) will sell Treximet much more aggressively than before, given the new material financial incentive in place for Glaxo's sales force, and therefore it will no longer be a flat-selling drug. I think that there will be an unexpectedly increasing sales ramp and therefore my peers will have to raise their estimates. On April 30 the FDA should easily approve arthritis pain drug Vimovo, a drug that is partnered with AstraZeneca (AZN), and this event will trigger a $20 million milestone payment. A month or two later, Europe should also approve Vimovo, and those three events, should they all go the way I think they'll go, will create a material change in the company's value.
TWST: Are there other companies you want to mention that you have positive ratings on?
Dr. Aschoff: There is Celldex (CLDX) and Keryx (KERX). Celldex is a company with several cancer vaccines as well as antibodies for cancer. It's fully an oncology company; they are going to have a lot to show at this year's ASCO, and the stock has done remarkably well into the last two ASCO conferences due to positive Phase II data from CDX-110 in glioblastoma. This is about a $5 stock that hit $20 into the 2008 ASCO, $14 at last ASCO, and I'm looking for at least a double from here into ASCO 2010, when they show their best cancer results generated between last year's ASCO and the current. Buying CuraGen was a useful acquisition, mostly for the cash it had but also for one Phase II antibody for breast cancer, and there's also a whole bunch of pre-clinical antibodies. And maybe they will develop some, but more likely and hopefully they'll try to partner some because their clinical plate is rather full at present with CDX-1307, CDX-011 and CDX-1401.
TWST: Tell us about Keryx.
Dr. Aschoff: I've covered Keryx for six years and it's really nice to see perifosine, their Akt-inhibiting cancer drug and main value driver, find two niches where it had positive data in multiple myeloma and in third-line colorectal cancer. In multiple myeloma patients who are failing Velcade, the most widely used drug in multiple myeloma, perifosine resensitizes them to Velcade. Perifosine is also in third-line metastatic colorectal cancer, where it beat Xeloda in a head-to-head trial.
So after looking for a niche for this drug ever since I knew the company in early 2004, they have found two really definable areas where perifosine is likely to have a measurable benefit that's worthy of approval, and both trials have received an SPA from the FDA - multiple myeloma Phase III is ongoing; Phase III in third-line colorectal cancer will start soon. Perifosine is the more valuable of their two drugs, and clearly the market cap of Keryx does not capture the success of just perifosine. So that's the upside because $153 million in market capitalization does not capture the upside. Keryx also has an SPA for Zerenex, its hyperphosphatemia drug, which will start Phase III soon. Importantly, Keryx has enough money to fund these three Phase III trials.
TWST: What factors do you look at when selecting companies you want to follow?
Dr. Aschoff: I generally seek companies having a relatively near-term catalyst and a stock that is not efficiently priced given the outcome I expect. It's got to be undervalued for a positive event I think is coming or overvalued for a negative event. It doesn't matter if it's going to be a good event or a bad event, as long as it's inefficiently priced and there is a meaningful catalyst coming within a time frame that appeals to investors.
The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This Special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online .
The Wall Street Transcript does not endorse the views of any interviewees nor does it make stock recommendations.
For Information on subscribing to The Wall Street Transcript, please call 800/246-7673
Keryx Biotechs (KERX) Cancer Drug Perifosine To Undergo Phase III Trials; Given Buy Rating For Top Drug And Market Successes
http://finance.yahoo.com/news/Keryx-Biotechs-KERX-Cancer-twst-4228504958.html?x=0&.v=1
On Wednesday April 7, 2010, 11:39 am EDT
67 WALL STREET, New York - April 7, 2010 - The Wall Street Transcript has just published its Biotechnology & Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This Special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Clinical, Financial & Regulatory Risks To Drug Development - Easing Capital Markets - Managing Inherent Volatility - FDA Approval Process - Small- & Mid-Cap M&A Rally - Basket Investment Approach - Impact Of Health Care Reform - Therapeutic Cardiovascular Plays - Investable Trend In Antibody Technology
Companies include: Genentech/Roche (RHHBY); Medivation (MDVN); Seattle Genetics (SGEN); AEterna Zentaris (AEZS); Abbott (ABT); Alexion (ALXN); Amgen (AMGN); Antares Pharmaceuticals (AIS); Ardea (RDEA); Astellas (4503); AstraZeneca (AZN); Auxilium (AUXL); Biogen (BIIB); CardioGenics (CHNG); Celera (CRA); Celgene (CELG); Celldex (CLDX); Corcept (CORT); and many more.
In the following brief excerpt from this Biotech And Pharmaceuticals Report, expert analysts discuss the outlook for the sector and for investors.
Dr. Jonathan Aschoff, Ph.D., is a Senior Equity Analyst at Brean Murray, Carret & Co., LLC. Prior to joining the firm in 2003, he held positions as a Senior Biotechnology Analyst at Friedman, Billings, Ramsey & Co., Inc., and at what is now RBC. He also served as an Analyst at Sturza Institutional Research. Prior to Wall Street, Dr. Aschoff was a Research Technician at New England Medical Center. He earned a Ph.D. in molecular biology and microbiology, as well as a B.S. in biology from Tufts University.
TWST: How important to you is company management?
Dr. Aschoff: The earlier the assets, the less I care. But it matters more when it comes to commercializing something, and then I care more. Early on it is only about what the drug does, and that's in the hands of the patients and the people at the clinical trial sites. Management then gets more involved as you get into writing up the application efficiently and considering if management is likely to give a good retort to anything that might be argued against them at an FDA panel. Are they now likely to get a partner on good terms? Can they actually sell this treatment alone or with a partner? That's really what brings more to bear on management. The pivotal data, relatively speaking, is more out of their hands.
TWST: Any other stocks?
Dr. Aschoff: There is a company called Pozen (POZN) that I like quite a lot. I think that partner Glaxo (GSK) will sell Treximet much more aggressively than before, given the new material financial incentive in place for Glaxo's sales force, and therefore it will no longer be a flat-selling drug. I think that there will be an unexpectedly increasing sales ramp and therefore my peers will have to raise their estimates. On April 30 the FDA should easily approve arthritis pain drug Vimovo, a drug that is partnered with AstraZeneca (AZN), and this event will trigger a $20 million milestone payment. A month or two later, Europe should also approve Vimovo, and those three events, should they all go the way I think they'll go, will create a material change in the company's value.
TWST: Are there other companies you want to mention that you have positive ratings on?
Dr. Aschoff: There is Celldex (CLDX) and Keryx (KERX). Celldex is a company with several cancer vaccines as well as antibodies for cancer. It's fully an oncology company; they are going to have a lot to show at this year's ASCO, and the stock has done remarkably well into the last two ASCO conferences due to positive Phase II data from CDX-110 in glioblastoma. This is about a $5 stock that hit $20 into the 2008 ASCO, $14 at last ASCO, and I'm looking for at least a double from here into ASCO 2010, when they show their best cancer results generated between last year's ASCO and the current. Buying CuraGen was a useful acquisition, mostly for the cash it had but also for one Phase II antibody for breast cancer, and there's also a whole bunch of pre-clinical antibodies. And maybe they will develop some, but more likely and hopefully they'll try to partner some because their clinical plate is rather full at present with CDX-1307, CDX-011 and CDX-1401.
TWST: Tell us about Keryx.
Dr. Aschoff: I've covered Keryx for six years and it's really nice to see perifosine, their Akt-inhibiting cancer drug and main value driver, find two niches where it had positive data in multiple myeloma and in third-line colorectal cancer. In multiple myeloma patients who are failing Velcade, the most widely used drug in multiple myeloma, perifosine resensitizes them to Velcade. Perifosine is also in third-line metastatic colorectal cancer, where it beat Xeloda in a head-to-head trial.
So after looking for a niche for this drug ever since I knew the company in early 2004, they have found two really definable areas where perifosine is likely to have a measurable benefit that's worthy of approval, and both trials have received an SPA from the FDA - multiple myeloma Phase III is ongoing; Phase III in third-line colorectal cancer will start soon. Perifosine is the more valuable of their two drugs, and clearly the market cap of Keryx does not capture the success of just perifosine. So that's the upside because $153 million in market capitalization does not capture the upside. Keryx also has an SPA for Zerenex, its hyperphosphatemia drug, which will start Phase III soon. Importantly, Keryx has enough money to fund these three Phase III trials.
TWST: What factors do you look at when selecting companies you want to follow?
Dr. Aschoff: I generally seek companies having a relatively near-term catalyst and a stock that is not efficiently priced given the outcome I expect. It's got to be undervalued for a positive event I think is coming or overvalued for a negative event. It doesn't matter if it's going to be a good event or a bad event, as long as it's inefficiently priced and there is a meaningful catalyst coming within a time frame that appeals to investors.
The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This Special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online .
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Generex Launches $250,000,000 Lawsuit Against TheStreet.com and Feuerstein
Company Seeks Damages for Business Defamation, Product Disparagement and Injurious Falsehood
http://www.globenewswire.com/newsroom/news.html?ref=rss&d=188084
WORCESTER, Mass., April 6, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has commenced legal proceedings against TheStreet.com, Inc. and Adam Feuerstein in the Supreme Court of the State of New York seeking $250,000,000 in damages for business defamation, product disparagement, and injurious falsehood. The claims arise out of articles authored by Feuerstein and published on TheStreet.com website on March 19 and March 26, 2010.
Generex contends that the articles disseminate numerous defamatory statements about the Company, its management, and its flagship product, Generex Oral-lyn™, and that the articles put forward several ostensible statements of fact that are, in truth, misleading or outright misstatements made with malicious intent or with a reckless disregard for the truth.
"These articles go well beyond the expression of disparaging opinion or fair comment," said Mark Fletcher, Generex's Executive Vice-President & General Counsel. "Feuerstein and TheStreet.com have abused their public forum by spreading categorical falsehoods about Generex and Generex Oral-lyn™ when a modicum of due diligence would have revealed the truth, an injury then compounded by unfounded and libelous allegation and innuendo. We are now seeking to hold Feuerstein and TheStreet.com accountable for the damage they have unjustifiably inflicted on Generex and its stockholders."
About Generex Biotechnology Corporation
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which has been launched in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831
Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
CONTACT: American Capital Ventures, Inc.
Investor Relations Contact:
Howard Gostfrand
1-877-918-0774
Beckerman
Media Contact:
Christina Brozek
201-465-8002
Unilife Receives U.S. FDA Clearance for Unitract(TM) 1mL Insulin Syringes
Date : 04/05/2010 @ 12:55PM
Source : PR Newswire
Stock : Unilife (MM) (UNIS)
http://ih.advfn.com/p.php?pid=nmona&article=42253297&symbol=UNIS
Lewisberry Operations go to a 24/7 Manufacturing Cycle
PR Newswire
LEWISBERRY, Pa., April 5
LEWISBERRY, Pa., April 5 /PRNewswire-FirstCall/ --
Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS; ASX: UNS) today announced it has received from the U.S. Food and Drug Administration (FDA) 510(k) market clearance for the Unitract™ 1mL Insulin Syringes assembled at its Lewisberry, PA manufacturing facility.
The Unitract™ range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication.
In August 2008, Unilife first secured U.S. FDA clearance for the Unitract™ 1mL Insulin Syringe assembled at the Shanghai facilities of a Chinese manufacturing partner. With Unilife's FDA-registered Lewisberry facility being considered as a new manufacturing site by the FDA, the Company was required to submit an additional 510(k) for U.S.-assembled stock.
Production of the Unitract™ 1mL Insulin Syringe at Unilife's Lewisberry facility is occurring on a fully automated assembly system that the Company designed, developed and built using in-house expertise. A video of this automated production system, which has an annual production capacity of approximately 40 million units per year, can be viewed at www.unilife.com.
Following FDA-clearance for US-assembled units of the Unitract™ 1mL Insulin Syringe, Unilife has immediately shifted manufacturing activities at Lewisberry to a four shift, 24 hour, 7 day per week (24/7) manufacturing cycle. This 24/7 manufacturing cycle is expected to maximize annual production capacities for the Unitract™ 1mL syringes and further improve manufacturing cost-efficiencies.
Unilife will now immediately file an additional 510(k) with the FDA seeking clearance for the Unitract™ 1mL Tuberculin (TB) Syringe. FDA clearance of the Unitract™ 1mL TB Syringe, which is a variant of the Insulin syringe product, will further expand the ability of the Company to market its range of safety syringes to U.S. healthcare facilities.
The Company recently announced the appointment of Stason Pharmaceuticals as a distribution partner for Asian countries including Japan, Taiwan and China. As part of this agreement, Stason is coordinating local regulatory submissions, establishing business relationships with Asian pharmaceutical and healthcare companies, and has placed an initial order for one million units of the Unitract™ 1mL syringes assembled at Unilife's U.S. production facility.
Unilife is currently negotiating with a number of other interested healthcare and pharmaceutical companies in the U.S., Europe and Asia regarding its Unitract™ 1mL syringes, and will also continue to send shipments to Haiti to support ongoing humanitarian relief efforts.
"With the FDA placing an increasingly stringent focus on approved medical devices, the receipt of clearance for our U.S. assembled syringes further underlines the strength of Unilife's quality management and production systems," stated Alan Shortall, CEO of Unilife Corporation.
"We have experienced significant progress with the international rollout of our Unitract™ 1mL safety syringe over the past year. We believe this most recent FDA clearance now allows Unilife to more aggressively target U.S. customers and further drive market awareness of our leading safety syringe technology. In addition, with the majority of those pharmaceutical and healthcare companies seeking to utilize product assembled at our U.S. facility, we can now further accelerate the rollout of this product."
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time inotherreports which wefile with the Securities and Exchange Commission.
General: UNIS-G
Investor Contacts (US):
Todd Fromer / Garth Russell
KCSA Strategic Communications
Phone + 1 212-682-6300
Stuart Fine
Carpe DM Inc
Phone + 1 908 469 1788
Investor Contacts (Australia)
Jeff Carter
Unilife Corporation
Phone + 61 2 8346 6500
SOURCE Unilife Corporation
Keryx Biopharma's Colorectal Cancer Drug Granted Fast Track Designation By FDA; Shares Up - Update
4/5/2010 12:40 PM ET
http://www.rttnews.com/ArticleView.aspx?Id=1260318
(RTTNews) - Keryx Biopharmaceuticals, Inc. (KERX) said Monday that the U.S. Food and Drug Administration or FDA granted Fast Track designation for perifosine for the treatment of refractory advanced colorectal cancer. Keryx shares reached as high as 41% in the pre market session, and is currently up over 28%.
New York-based Keryx is a partner of Aeterna Zentaris (AEZS, AES.TO) and holds the license for perifosine in US, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while Aeterna retains rights for the rest of the world.
The Fast Track designation from FDA facilitates development and expedition of the review of new drugs that are intended to treat serious or life-threatening conditions. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States, with nearly 146,000 people diagnosed with some form of colorectal cancer and over 49,000 patients dying from colorectal cancer in 2009. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease.
KRX-0401 or perifosine is a potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase or PI3K pathway, for the treatment of refractory advanced colorectal cancer. KRX-0401 demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies.
Keryx informed that a randomized, double-blind Phase III trial investigating perifosine in combination with capecitabine, or Xeloda versus placebo plus capecitabine in patients with refractory advanced colorectal cancer, to be initiated in the second quarter, with study completion expected in the second half of 2011. The company expects commercialization of perifosine in current indication to potentially commence by mid-2012.
The phase III study is under a Special Protocol Assessment, or SPA, with the FDA. Xeloda is owned by Swiss drugmaker Roche Holding AG (RHHBY.PK: News ). Last week, the EMEA approved cancer drug Xeloda for treating patients with early colon cancer.
Juergen Engel, president and chief executive officer of Aeterna said, "We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012. These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."
In addition to colorectal cancer, perifosine is currently in a Phase III trial, under SPA, for the treatment of relapsed or refractory multiple myeloma, with Orphan Drug Status and Fast Track designation granted by the FDA.
Earlier, Aeterna Zentaris informed that it received a positive opinion for Orphan Medicinal Product Designation for perifosine from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency for the treatment of multiple myeloma.
Currently, there are seven approved drugs for patients with metastatic/advanced colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda), irinotecan (Camptosar), oxaliplatin (Eloxatin), bevacizumab (Avastin), cetuximab (Erbitux), and panitumumab (Vectibix).
Keryx also develops Zerenex to treat elevated phosphate levels or hyperphosphatemia, in patients with end-stage renal disease. The Phase III clinical program of Zerenex is pending commencement under an SPA agreement with the FDA.
by RTT Staff Writer
NexMed Announces the Expansion of Its Senior Management Team
Date : 04/05/2010 @ 9:15AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=42251506&symbol=NEXM
NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, announced today announced the expansion of its senior management team within its operating subsidiaries, with the appointment of Terry Ladd as Vice-President of Business Development at Bio-Quant, Inc. and Richard Martin, Ph.D., as Vice President of Chemistry for NexMed (U.S.A.), Inc. Both executives will report to Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, Inc.
In his new position, effective April 12, 2010, Mr. Ladd will be responsible for the worldwide business development operations of Bio-Quant, NexMed’s discovery pre-clinical service subsidiary. Mr. Ladd brings more than 20 years of sales experience in the preclinical field, including senior management positions in sales and marketing with Calvert Laboratories, Inc., MDS Pharma Services, Inc., SkeleTech, Inc., Phoenix International Life Sciences, Inc., Chrysalis International, Inc., Pharmakon Research International, Inc., and ITR Laboratories, Inc. Mr. Ladd holds an M.B.A. in Marketing and Finance from McGill University, an M.A. from the University of Sherbrooke, and a B.A. Honors degree from Bishop’s University.
As Vice President of Chemistry, effective immediately, Dr. Martin is leading the development work for the next generation of NexACT technology and NexACT-based products at NexMed (U.S.A.). Dr. Martin has over 20 years of medicinal chemistry research and development experience in the fields of antibacterial, inflammation, oncology, antiviral, cardiovascular and metabolic diseases. Prior to joining NexMed (U.S.A.), Dr. Martin was Senior Director of Chemistry at RetroVirox, Inc. a privately-held biotechnology company engaged in the discovery of new treatments for patients with infectious diseases. Dr. Martin also served as Director of Chemistry at Exelixis, Inc./X-Ceptor Therapeutics, Inc. and Group Leader at Tanabe Research Laboratories U.S.A., Inc. in San Diego -- a wholly owned subsidiary of Mitsubishi-Tanabe in Japan. Dr. Martin received his Ph.D. in Organic Chemistry from the University of Toronto and completed his postdoctoral research at The Scripps Research Institute in San Diego. Dr. Martin holds over 20 patents and patent applications and has authored/co-authored over 20 papers.
Commenting on today’s news, Dr, Damaj stated, “We are delighted to welcome both Terry and Richard to the NexMed team. These highly regarded experts in their respective fields join the Company at an exciting time in its corporate development. Their individual experience within both pre-clinical business development and medicinal chemistry is expected to be invaluable as we execute on our growth plan, including the expansion of our CRO business as well as the out-licensing of our proprietary NexACT technology and advancement beyond transdermal delivery to include oral and subcutaneous deliveries of new classes of drugs.”
NASDAQ Disclosure
In connection with his employment with NexMed, each new executive received a grant of an aggregate of 225,000 shares of restricted common stock, vesting in equal installments over three years, subject to his remaining in continuous and uninterrupted employment with NexMed or its subsidiaries. These grants, which were approved by a majority of the non-employee directors sitting on the NexMed board, were made outside of the NexMed stockholder-approved equity compensation plans, as permitted under NASDAQ Marketplace Rule 5635(c)(4).
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company. For example, and without limitation, there can be no assurance that the Company will be able to grow its CRO business or will succeed in advancing the development and use of the NexACT technology.
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
Date : 04/05/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42251074&symbol=KERX
PR Newswire
NEW YORK, April 5
NEW YORK, April 5 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda®) versus placebo in combination with capecitabine in patients with refractory advanced colorectal cancer is expected to commence in the second quarter of 2010 under a Special Protocol Assessment (SPA) with the FDA.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We believe that this Fast Track designation adds substantial value to perifosine's development in refractory advanced colorectal cancer. We intend to initiate the Phase 3 colorectal study in the second quarter, with study completion expected in the second half of 2011. With the SPA and Fast Track designation in place, we believe that commercialization of perifosine in this indication could potentially commence by mid-2012."
In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track designation granted.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
About KRX-0401 (perifosine)
KRX-0401 (perifosine) is a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of KRX-0401 on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with metastatic/advanced colorectal cancer. Currently, there are seven approved drugs for patients with metastatic/advanced colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda®), irinotecan (Camptosar®), oxaliplatin (Eloxatin®), bevacizumab (Avastin®), cetuximab (Erbitux®), and panitumumab (Vectibix®). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Bevacizumab, a VEGF monoclonal antibody, is commonly administered with chemotherapy. Typically, patients who fail 5-FU, oxaliplatin, irinotecan, and bevacizumab-containing therapies, and who have wild-type KRAS status receive EGFR monoclonal antibody therapy with either cetuximab or panitumumab. Once patients progress on these agents, there are no further standard treatment options.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma, with a Phase 3 trial in refractory advanced colorectal cancer, under SPA, pending commencement, and in Phase 2 clinical development for several other tumor types. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 trials will not coincide with the data analyses from the Phase 1 and Phase 2 clinical trials previously reported by the Company; the risk that fast track designation and priority review may not result in earlier approval; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Notification that Annual Report will be submitted late (NT 10-K)
Date : 04/01/2010 @ 2:00PM
Source : Edgar (US Regulatory)
Stock : (ENCO)
http://ih.advfn.com/p.php?pid=nmona&cb=1270147231&article=42235080&symbol=N^ENCO
PART IV - OTHER INFORMATION
(1) Name and telephone number of person to contact in regard to this notification
Philip L. Calamia 484-588-5400
(Name) (Telephone Number)
(2) Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If answer is no, identify report(s). x Yes ¨ No
(3) Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof? x Yes ¨ No
Hartford Financial Sees '10 EPS $2.60-$2.90 After TARP Repayment
4-1-10 12:13 PM EDT
http://news.morningstar.com/newsnet/ViewNews.aspx?article=/DJ/201004011213DOWJONESDJONLINE000560_univ.xml
Hartford Financial Services Group Inc. (HIG) said it estimates earnings per share for 2010 of $2.60 to $2.90 after taking into account the impact of repaying federal aid.
This estimate includes the impact of the dilution in the life and property insurer's shares as a result of its equity raising to repay the federal funds and other charges related to the repayment, said Christopher Swift, Hartford's chief financial officer, during a Webcast Thursday of the company's annual day.
The company said there was no change in guidance on core earnings, which it estimated in February at $3.70 to $4 a share for 2010.
Hartford also said it expects a total company return on equity of 11% by 2012.
The company said Wednesday it repaid $3.4 billion to the U.S. Treasury Department that Hartford received under the Troubled Asset Relief Program.
The insurer, which has a market capitalization of about $12.7 billion, funded the repayment, in part, with net proceeds of $2.58 billion from equity and debt offerings undertaken earlier this month.
The Treasury Department continues to hold warrants to purchase about 52 million shares of Hartford's stock at an initial exercise price of $9.79 a share. Hartford confirmed Wednesday it doesn't plan to repurchase the warrants.
That price is attractive for the government. Hartford's shares recently rose 2.6% to $29.17.
-By Aparajita Saha-Bubna, Dow Jones Newswires; 617-654-6729; aparajita.saha- bubna@dowjones.com
(END) Dow Jones Newswires
04-01-101213ET
Copyright (c) 2010 Dow Jones & Company, Inc.
The Hartford Outlines Customer-centric Strategy at Investor Meeting
Date : 04/01/2010 @ 9:05AM
Source : Business Wire
Stock : The Hartford Financial Services Group, Inc. (HIG)
http://ih.advfn.com/p.php?pid=nmona&cb=1270127826&article=42228269&symbol=NY^HIG
The Hartford Outlines Customer-centric Strategy at Investor Meeting
The Hartford Financial Services Group, Inc. (NYSE: HIG)
* Strategy focuses on the company’s unique product breadth, distribution channel advantages, large and growing customer base and strong brand to deliver sustained, profitable growth
* Company announces three businesses to execute on key customer growth opportunities:
o Commercial Markets
o Wealth Management
o Consumer Markets
* New digital commerce effort launched to expand services and offerings
The Hartford Financial Services Group, Inc. (NYSE: HIG) today discussed its go-forward business plan, including a customer-centric business strategy and organizational structure at its investor meeting in New York City.
“With the successful capital raise, repayment of the Treasury investment and customer-focused strategy, we are well positioned to move The Hartford forward with confidence to achieve what’s ahead,” said Liam E. McGee, The Hartford’s Chairman, President and Chief Executive Officer. “The go-forward plan will focus the company around our customers, partners and The Hartford’s strong brand. We will organize around our key customer growth opportunities: risk protection and benefits for businesses, wealth management, and consumer risk protection for affinity groups and select customer segments.”
“The new go-to-market organization will allow us to better capitalize on our competitive advantages. We have a large and growing customer base; a broad and diverse product portfolio; and an enviable distribution network of agents, brokers and advisors. The Hartford’s goal is to deliver sustained, profitable growth with strength, confidence, focus and discipline,” added McGee.
Commercial Markets
Commercial Markets will provide risk protection and benefits for businesses, offering small commercial, middle market and specialty property and casualty, and group benefits, with a growth focus on small and mid-sized businesses. Juan Andrade will serve as President of Commercial Markets.
Wealth Management
The Wealth Management business will provide solutions for the retirement savings, income and estate planning needs of consumers and small business owners. The aging of America presents significant opportunities for The Hartford’s wealth management businesses as the 65+ population is expected to increase by 36 percent by 2020. John Walters will serve as President of Wealth Management.
Consumer Markets
Through this business, The Hartford will continue to grow its AARP auto and homeowners insurance program through independent agents and direct distribution, and grow its non-AARP business, with an initial focus on customers age 40+, through independent agents. Going forward, the company intends to use its expertise to pursue additional affinity relationships and targeted customer segments. The company is conducting an internal and external search for a Consumer Markets leader.
The company also discussed its launch of a new effort to enhance its ability to reach customers through the web and to generate customer research and analytics. The group will be led by Jonathan Bennett, Executive Vice President of Digital Commerce and Customer Analytics. Bennett, who previously led personal and small business insurance in the company’s Property and Casualty Operations, will report directly to McGee.
About The Hartford
Celebrating nearly 200 years of helping its customers achieve what’s ahead, The Hartford (NYSE: HIG) is an insurance and wealth management company. Through its unique focus on customer needs, the company serves businesses and consumers by providing the products and solutions they need to protect their assets and income from risks and manage their wealth and retirement needs. A Fortune 500 company, The Hartford is recognized widely for its service expertise and as one of the world's most ethical companies. More information on the company and its financial performance is available at www.thehartford.com.
HIG-F
Some of the statements in this release may be considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. We caution investors that these forward-looking statements are not guarantees of future performance, and actual results may differ materially. Investors should consider the important risks and uncertainties that may cause actual results to differ. These important risks and uncertainties include those discussed in our Annual Report for fiscal year 2009 on Form 10-K and the other filings we make with the Securities and Exchange Commission. We assume no obligation to update this release, which speaks as of the date issued.
Evergreen Energy Provides 2010 Update and Announces Timing of the Fourth Quarter and Year-End 2009 Results Conference Call to be on April 5th
01.04.2010 09:15
http://www.finanznachrichten.de/nachrichten-2010-04/16527419-evergreen-energy-provides-2010-update-and-announces-timing-of-the-fourth-quarter-and-year-end-2009-results-conference-call-to-be-on-april-5th-004.htm
- Buckeye Sale Now Expected to Close on or Before April 2nd -
- Reviews GreenCert&K-Fuel Progress -
Yesterday Evergreen Energy Inc. (NYSE Arca: EEE) filed with the SEC its Form 10-K for the period ended December 31, 2009 and intends to conduct a conference call on April 5th at 11:00 a.m. Eastern Daylight Time (9:00 a.m. MDT, 8:00 a.m. PDT) to discuss its financial results and recent company events. Management is also providing strategic updates regarding Buckeye Industrial Mining Co., K-Fuel® and GreenCert™.
"Evergreen has taken several very important steps toward executing on the strategic imperatives necessary to solidify our transition to a green technology company," stated Thomas H. Stoner, Jr., CEO of Evergreen. "We entered into an agreement to sell our Buckeye Industrial Mining Co. subsidiary. We progressed with the construction of a K-Fuel plant, continued to advance GreenCert, strengthened our balance sheet, and realigned our board of directors."
Buckeye Industrial Mining Co.
As previously announced, Evergreen signed a definitive agreement on March 12th with respect to the sale of certain assets of Buckeye for $32.9 million, including the release of $5.0 million of cash reclamation bonds. Further, $2.8 million of the purchase price will be placed in escrow for twelve months to cover amounts payable to the buyer pursuant to the indemnification provision of the sales agreement. The transaction is now expected to close on or before April 2nd, ahead of the original schedule of mid-May.
K-Fuel Technology
To further the letter of intent (LOI) to build a commercial scale reference K-Fuel plant in Inner Mongolia, as announced in January, Evergreen China, a Sino-US joint venture between Evergreen Energy Inc. and Chinese industry investors, has signed a three-way agreement with an integrated utility/chemical manufacturer and a large Chinese design institute to assess project scope and schedule for incorporation into a commercial agreement.
"A project of this magnitude takes time, yet Evergreen Energy continues to make significant progress," Stoner continued. "Now we have incorporated the design team that will complete the detailed engineering into the process. In addition, the application of K-Fuel as a pre-treatment for gasifier feed provides another market for Evergreen's proprietary coal upgrading technology. The coal chemical industry accounts for 50% of the Chinese chemical industry output, and K-Fuel will allow owners to capture greater profits through the efficient use of low-grade feedstock not directly suitable for gasification. Successful completion of the project will expand the interest in K-Fuel technology from coal and conventional power producers to chemical manufacturers and owners of integrated gasification combined cycle, or IGCC, facilities."
The Inner Mongolia K-Fuel facility is expected to consist of a single processor train to upgrade sub-bituminous coal that will produce feedstock for a slurry-type gasifier producing methanol and urea as end products within an integrated chemical facility. Design and construction of the chemical/fertilizer facility has already commenced and the K-Fuel plant would address a key project need to improve gasifier efficiency and capacity.
Since signing the LOI in January 2010, preliminary testing and analysis has been conducted to characterize product quality and performance and to provide process design information. Based on positive results, the three parties are moving forward with more detailed engineering analyses. This technical work will support the commercial agreement negotiations, including evaluation of options for integrating the K-Fuel plant into downstream processing units, development of a detailed design basis, validation of the site-specific heat and material balance, and definition of utility requirements. In an effort to accelerate the design and construction schedule US and China based engineers have also begun to pre-qualify key equipment and service suppliers that will support the technology implementation.
GreenCert
"We are excited about 2010 as we are making significant progress and believe the time is right as the market adoption for GreenCert is heating up. As reported by Bloomberg New Energy Finance, the greenhouse gas market is projected to grow to nearly $1.4 trillion by 2020," stated Miles Mahoney, president and chief operating officer of Evergreen. "We continue to focus on selling GreenCert as an on-premise offering and as a hosted software as a service, or SaaS solution, enabling a faster sales cycle and generating better returns with license, renewal and services fees incorporated into the offering. This is expected to create revenue streams for consulting and implementation services as well as the needed infrastructure for support, which we expect will help incentivize our partners' sales programs and sales channels."
The company has expanded GreenCert partnerships to increase market penetration; strengthening its localized sales and marketing expertise; and furthering product development programs for worldwide deployment capabilities.
Please refer to the 10-K for discussion of the December 31, 2009 financial results.
Copies of the 10-K are available on the SEC's website or on the company's website at www.evgenergy.com.
In the Form 10-K filed with the SEC for the year ended December 31, 2009, the company's auditors expressed an unqualified opinion on the company's consolidated financial statements as of and for the year ended December 31, 2009 and included an explanatory paragraph regarding substantial doubt about the company's ability to continue as a going concern.
Conference Call Information
Evergreen management will host a conference call on Monday, April 5th at 11:00 a.m. Eastern Daylight Time (9:00 a.m. MDT, 8:00 a.m. PDT) to discuss its fourth quarter and year end financial results. Participating on the call will be Tom Stoner, CEO, Miles Mahoney, President and COO, and Diana Kubik, CFO.
The call is being webcast live and can be accessed from the "Investor Relations" section of the company's website at http://www.evgenergy.com/. Participants may dial 877-407-9210 and International callers may dial 201-689-8049 ten minutes prior to the scheduled conference call time. The Conference ID will be #348431. A telephone replay will be available for two business days by dialing 877-660-6853 or 201-612-7415 and the following: Account #: 286, Conference ID #: 348431. The audio webcast will also be archived on Evergreen's website for 90 days.
Evergreen Energy Inc.
Evergreen Energy Inc. (NYSE Arca: EEE) has developed two proven, proprietary, patented, and transformative green technologies: the GreenCert™ suite of software and services and K-Fuel®. GreenCert, which is owned exclusively by Evergreen, is a scientifically accurate, scalable environment intelligence solution that measures greenhouse gases and generates verifiable emissions credits. K-Fuel technology significantly improves the performance of low-rank coals yielding higher efficiency and lowering emissions. Visit www.evgenergy.com for more information.
Safe Harbor Statement
Statements in this release that relate to future plans or projected results of Evergreen Energy Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended by the Private Securities Litigation Reform Act of 1995 (the "PSLRA"), and Section 21E of the Securities Exchange Act of 1934, as amended by the PSLRA, and all such statements fall under the "safe harbor" provisions of the PSLRA. Our actual results may vary materially from those described in any "forward-looking statement" due to, among other possible reasons, the realization of any one or more of the risk factors described in our annual or quarterly reports, or in any of our other filings with the Securities and Exchange Commission, all of which filings any reader of this release is encouraged to study. In addition, our ability to execute our business plan and develop the GreenCert™ or K-Fuel® technologies may be adversely impacted by the inability to complete the sale of Buckeye, raise significant additional capital or effectively complete any restructure transaction on a timely basis to fund our business operations. Readers of this release are cautioned not to put undue reliance on forward-looking statements.
Contacts:
Evergreen Investor Contact:
Lippert / Heilshorn&Associates
Kirsten Chapman&Becky Herrick, 415-433-3777
bherrick@lhai.com
© 2010 Business Wire
Annual Report (10-K)
Date : 03/31/2010 @ 4:06PM
Source : Edgar (US Regulatory)
Stock : (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1270091713&article=42215627&symbol=N^NEXM
...
#As of March 26, 2010, 126,902,281 shares of the common stock, par value $.001, of the registrant were outstanding.
#On December 14, 2009, we acquired Bio-Quant, Inc. (“Bio-Quant”),...
Bio-Quant has over 300 clients world-wide and performs hundreds of studies a year both in in vitro and in vivo pharmacology, pharmacokinetics (PK) and toxicology to support pre-investigational new drug (“IND”) enabling packages.
As a result of our acquisition of Bio-Quant, we now have two operating segments...
#In March 2010, we acquired PrevOnco™, a marketed anti-ulcer compound, lansoprazole, for the treatment of solid tumors
#Our current cash reserves of approximately $3.25 million as of the date of this report, should provide us with sufficient cash to fund our operations into the second half of 2011
#The net loss was $32,042,562 or $0.36 per share and $5,171,198 or $0.06 per share in 2009 and 2008, respectively. The significant increase in net loss is the result of imputed interest expense recognized as a result of beneficial conversions of the convertible mortgage note as discussed in Note 8 of the Notes to the consolidated financial statements.
#The acquisition of Bio-Quant occurred on December 14, 2009 as discussed in Note 3 above. The revenue and expenses of Bio-Quant for the16 day period ended December 31, 2009 are not material to present as a separate segment in 2009. Total assets of the CRO segment at December 31, 2009 are approximately $15 million.
NM100060 Anti-Fungal Treatment
We had an exclusive global licensing agreement with Novartis International Pharmaceutical Ltd. (“Novartis”) for NM100060, our proprietary topical nail solution for the treatment of onychomycosis (nail fungal infection). Under the agreement, Novartis acquired the exclusive worldwide rights to NM100060 and had assumed all further development, regulatory, manufacturing and commercialization responsibilities as well as costs. Novartis agreed to pay us up to $51 million in upfront and milestone payments on the achievement of specific development and regulatory milestones, including an initial cash payment of $4 million at signing. In addition, we were eligible to receive royalties based upon the level of sales achieved.
The completion of patient enrollment in the Phase 3 clinical trials for NM100060 triggered a $3 million milestone payment from Novartis to be paid 7 months after the last patient enrolled in the Phase 3 studies. However, the agreement also provided that clinical milestones paid to us by Novartis would be reduced by 50% until we received an approved patent claim on the NM100060. As such, we initially received only $1.5 million from Novartis.
On October 17, 2008, the U.S. Patent and Trademark Office issued the Notice of Allowance on our patent application for NM100060. This triggered a $2 million milestone payment from Novartis. On October 30, 2008 we received a payment of $3.5 million from Novartis consisting of the balance of $1.5 million of the patient enrollment milestone and the $2 million patent milestone.
In July 2008, Novartis completed the Phase 3 clinical trials for NM100060. The Phase 3 program required for the filing of the New Drug Application (“NDA”) in the U.S. for NM100060 consisted of two pivotal, randomized, double-blind, placebo-controlled studies. The parallel studies were designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate toenail onychomycosis. Approximately 1,000 patients completed testing in the two studies, which took place in the U.S., Europe, Canada and Iceland. On August 26, 2008, we announced that based on First Interpretable Results of these two Phase 3 studies, Novartis had decided not to submit the NDA at that time.
In July 2009, Novartis completed final analysis of the comparator study which they had initiated in March 2007 in ten European countries. The study results were insufficient to support marketing approval in Europe. As such, on July 8, 2009, we announced the mutual decision reached with Novartis to terminate the licensing agreement. In accordance with the terms of the termination agreement, Novartis has provided us with all of the requested reports to date for the three Phase 3 studies that they conducted for NM100060 and is assisting and supporting us in connection with the assignment, transfer and delivery to us of all know-how and data relating to the product.
In consideration of such assistance and support, we will pay to Novartis 15% of any upfront and/or milestone payments that we receive from any future third party licensee of NM100060, as well as a royalty fee ranging from 2.8% to 6.5% of annual net sales of products developed from NM100060 (collectively, “Products”), with such royalty fee varying based on volume of such annual net sales. In the event that the Company, or a substantial part of our assets, is sold, we will pay to Novartis 15% of any upfront and/or milestone payments received by us or our successor relating to the Products, as well as a royalty fee ranging from 3% to 6.5% of annual net sales of any Products, with such royalty fee varying based on volume of such annual net sales. If the acquirer makes no upfront or milestone payments, the royalty fees payable to Novartis will range from 4% to 6.5% of annual net sales of any Products.
We have completed our analysis of the two pivotal Phase 3 studies completed by Novartis. Based on this analysis, we believe the product’s potential for treating patients with mild onychomycosis and warrants further studies for regulatory approval. We are sharing the clinical database and our conclusion with potential partners interested in licensing NM100060 for further development or for Over The Counter (OTC) direct approval due to its safety profile.
Vitaros ®
We also have under development a topical alprostadil-based cream treatment intended for patients with erectile dysfunction (“Vitaros ® ”), which was previously known as Alprox-TD ® . Our NDA was filed and accepted for review by the FDA in September and November 2007, respectively. During a teleconference with the FDA in early July 2008, our use of the name Vitaros ® for the ED Product was verbally approved by the FDA.
On November 1, 2007, we licensed the U.S. rights of Vitaros ® to Warner Chilcott Company, Inc. (“Warner”). Warner paid us $500,000 upon signing and agreed to pay us up to $12.5 million on the achievement of specific regulatory milestones and to undertake the manufacturing investment and any other investment for further product development that may be required for product approval. Additionally, Warner was responsible for the commercialization and manufacturing of Vitaros ® .
On July 21, 2008, we received a not approvable action letter (the “Action Letter”) from the FDA in response to our NDA. The major regulatory issues raised by the FDA were related to the results of the transgenic (“TgAC”) mouse carcinogenicity study which NexMed completed in 2002. The TgAC concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline, specifically NM100060.
On October 15, 2008, we met with the FDA to discuss the major deficiencies cited in the Action Letter and to reach consensus on the necessary actions for addressing these deficiencies for our Vitaros ® NDA. Several key regulatory concerns were addressed and agreements were reached at the meeting. The FDA agreed to: (a) a review by the Carcinogenicity Advisory Committee (“CAC”) of the 2 two-year carcinogenicity studies which were recently completed; (b) one Phase 1 study in healthy volunteers to assess any transfer to the partner of the NexACT ® technology and (c) one animal study to assess the transmission of sexually transmitted diseases with the design of the study to be determined. The FDA also confirmed the revision on the status of our manufacturing facility from “withhold” to “acceptable”, based on our having adequately addressed the deficiencies cited in their Pre-Approval Inspection (“PAI”) of our facility in January 2008. It is also our understanding that at this time the FDA does not require a one-year open-label safety study for regulatory approval. After the meeting we estimated that an additional $4 to $5 million would be needed to be spent to complete the above mentioned requirements prior to the resubmission of the NDA.
On February 3, 2009, we announced the sale of the U.S. rights for Vitaros ® and the specific U.S. patents covering Vitaros ® to Warner which terminated the previous licensing agreement. Under the terms of the agreement, we received gross proceeds of $2.5 million as an up-front payment and are eligible to receive an additional payment of $2.5 million upon Warner’s receipt of an NDA approval from the FDA. In addition, Warner has paid us a total of $350,000 for the manufacturing equipment for Vitaros ® . The purchase agreement with Warner gives us the right to reference their work on Vitaros ® in our future filings outside the U.S., which may benefit us in international partnering opportunities because the additional data may further validate the safety of the product and enhance its potential value. While Warner is not obligated by the purchase agreement to continue with the development of Vitaros ® and the filing of the NDA, as of the date of this report, Warner submitted the CAC assessment package to the FDA during the 4 th quarter of 2009. Based on previous discussion with the FDA, we had expected them to make their decision during the first quarter of 2010. However, as of the date of this report, we have nothing new to report.
In Canada, we filed the New Drug Submission (“NDS”) for Vitaros in February 2008 and received a Notice of Non-Compliance (“Notice”) on January 19, 2010. The Notice was an end-of-review communication from Health Canada when additional information was needed to reach final decision on product approval. The deficiencies cited in the Notice were related specifically to the product’s CMC (Chemistry, Manufacturing and Controls), and no pre-clinical or clinical deficiencies cited in the Notice. In February 2010, we met with Health Canada to discuss their concerns and were able to reach agreement with them on the necessary action steps which would be completed and included in our response to the Notice due on or before April 14, 2010. Assuming that we successfully submit our response before the 90 day deadline, our NDS would then undergo a 45 day screening process by Heath Canada’s Regulatory Project Management group to determine the adequacy of our response and if deemed adequate, our response to the Notice would then go through a 150 day review cycle by the NDS reviewers.
For Europe, we are currently pursuing a decentralized filing strategy and our first Marketing Authorization Application (“MAA”) is planned for the United Kingdom. The Medicines and Healthcare Products Regulatory Agency (the “MHRA”) has confirmed that due to the backlog of MAA filings, they would not be able to receive and start reviewing our MAA until October 2010. Our intention is to pursue filing of the MAA with a local European partner. With that goal in mind, we are actively pursuing licensing partners and have engaged a business development consultant to assist us in that endeavour. There is no assurance that we will be able to find a partner, file our MAA on a timely basis or obtain regulatory approval.
Femprox ® and Other Products
Our product pipeline also includes Femprox ® , which is an alprostadil-based cream product intended for the treatment of female sexual arousal disorder. We have completed nine clinical studies to date, including one 98-patient Phase 2 study in the U.S. for Femprox ® , and also a 400-patient study for Femprox ® in China, where the cost for conducting clinical studies was significantly lower than in the U.S. We do not intend to conduct additional studies for this product until we have secured a co-development partner, which we are actively seeking.
We have also continued early stage development work for our product pipeline with the goal of focusing our attention on product opportunities that would replicate the model of our previously licensed anti-fungal nail treatment. We have in our pipeline a viable topical treatment for psoriasis, a common dermatological condition . Since the acquisition on December 14, 2009, our Bio-Quant team has been reviewing and studying the pre-clinical stage topical products in our pipeline to determine if additional value can be created through further testing in-house. These products include the above-mentioned treatment for psoriasis, cancer inflammation and also treatments for pain and wound healing.
Bio-Quant CRO Business
Bio-Quant has over 300 clients world-wide and performs hundreds of studies a year both in in vitro and in vivo pharmacology, pharmacokinetics (PK) and toxicology to support pre-IND enabling packages. Bio-Quant performs studies for its clients in the early stages of drug development and discovery. To provide the needed flexibility, this discovery work is best performed by Bio-Quant’s highly experienced and trained scientists who know how to recognize and address the unusual and unexpected outcomes that are the norm during discovery. Because the path to success at the discovery stage is through the process of failing fast and failing often, the optimal discovery research methodology focuses on the fastest and most cost-effective methods for getting correct scientific answers to direct further research.
To date, approximately 80% of Bio-Quant’s revenue has been generated from pre-clinical contract services. The CRO industry in general continues to be dependent on the research and development efforts of pharmaceutical and biotechnology companies as major customers, and we believe this dependence will continue. The current uncertain economic conditions have caused customers to re-evaluate priorities resulting in increases in contracts for the more promising projects, scaling back and/or canceling other GLP projects towards clinical trials. The biopharmaceutical industry is reducing costs and, often, their workforce. Bio-Quant may benefit from increased outsourcing on the part of its customers, or it may be harmed by a reduction in spending if the biopharmaceutical industry scales back on pre-clinical projects. Bio-Quant views the current conditions as an opportunity to attract well qualified candidates to strengthen and improve its operations. Another trend in the industry is the decline in prescription drug sales caused by cost conscious patients opting for less expensive generic drugs or none at all. This presents both an opportunity and a challenge to Bio-Quant, as its customers will need to find less costly, or more efficient research options often through the establishment of strategic alliances or partnerships. Bio-Quant believes it is well positioned for this development.
With access to our NexACT technology, we intend to differentiate the Bio-Quant business from its competitors because it now can offer a proprietary drug delivery technology as a service to current and potential clients who need innovative alternatives and solutions to their development problems.
Bio-Quant has two labs and housing facilities along with an experienced scientific staff of 19 employees.
There are many different types of clients that need these types of studies performed during these early stages of drug discovery and development. Bio-Quant’s clients range from larger global pharmaceutical companies to midsize and small biotechnology companies.
Patents
We hold ten U.S. patents out of a series of patent applications that we have filed in connection with our NexACT ® technology and our NexACT ® -based products under development. To further strengthen our global patent position on our proprietary products under development, and to expand the patent protection to other markets, we have filed under the Patent Cooperation Treaty corresponding international applications for our issued U.S. patents and pending U.S. patent applications.
...
Amended Annual Report (10-K/A)
Date : 03/31/2010 @ 2:53PM
Source : Edgar (US Regulatory)
Stock : (SRZ)
http://ih.advfn.com/p.php?pid=nmona&cb=1270065456&article=42214381&symbol=NY^SRZ
... ARCA (BID) 50k @ .46
The Hartford Returns U.S. Treasury Investment
Date : 03/31/2010 @ 12:53PM
Source : Business Wire
Stock : The Hartford Financial Services Group, Inc. (HIG)
http://ih.advfn.com/p.php?pid=nmona&cb=1270054476&article=42212514&symbol=NY^HIG
The Hartford Financial Services Group, Inc. (NYSE: HIG) today announced that it has repurchased all of The Hartford’s preferred shares issued to the U.S. Department of Treasury under the Capital Purchase Program (CPP).
“We are pleased to complete our plan to return the U.S. Treasury’s investment in The Hartford and appreciated the opportunity to participate in CPP and the support of the government and American taxpayers,” said Liam E. McGee, The Hartford’s Chairman, President and Chief Executive Officer. “With the capital raise completed and the investment repaid, we are well positioned from both a capital and balance sheet perspective.”
The Hartford paid $3.4 billion to the U.S. Treasury to repurchase the preferred stock, plus a final dividend payment of about $21.7 million. The Hartford funded the repurchase with proceeds from its recent equity and debt offerings, as well as from available resources. The U.S. Treasury continues to hold warrants to purchase approximately 52 million shares of The Hartford’s common stock at an initial exercise price of $9.79 per share. The company does not intend to repurchase the warrants from the U.S. Treasury.
About The Hartford
Celebrating nearly 200 years, The Hartford (NYSE: HIG) is an insurance-based financial services company that serves households, businesses and employees by helping to protect their assets and income from risks, and by managing wealth and retirement needs. A Fortune 500 company, The Hartford is recognized widely for its service expertise and as one of the world's most ethical companies.
HIG-F
This news release shall not constitute an offer to sell or a solicitation to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Some of the statements in this release may be considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. We caution investors that these forward-looking statements are not guarantees of future performance, and actual results may differ materially. Investors should consider the important risks and uncertainties that may cause actual results to differ. These important risks and uncertainties include those discussed in our Annual Report for fiscal year 2009 on Form 10-K and the other filings we make with the Securities and Exchange Commission. We assume no obligation to update this release, which speaks as of the date issued.
Liberty Analytics Co. Initiates Independent Research Coverage on Encorium Group, Inc.
Date : 03/31/2010 @ 9:15AM
Source : GlobeNewswire Inc.
Stock : (ENCO)
http://ih.advfn.com/p.php?pid=nmona&article=42206740&symbol=ENCO
Liberty Analytics Co., a leading provider of large, small- and micro-cap independent investment research, today initiated coverage on Encorium Group, Inc. (Nasdaq:ENCO). Liberty Analytics is currently offering a complimentary trial subscription. To view our research, go to: www.libertyanalyticsco.com .
About LAC:
Liberty Analytics Co. is a leading provider of independent investment research in North America. Our services include research analysis on the large, small- and micro-cap markets, real-time news and financial data, market commentary and the LAC newsletter. Liberty Analytics' staff of large and small-cap investment professionals is dedicated to providing the market's investment community with the tools and avenues necessary to make the important investment decisions. To view our research reports on a complimentary trial basis and take advantage of our other services, go to www.libertyanalyticsco.com and click on the complimentary trial subscription button on our home page, or go directly to our registration page at www.libertyanalyticsco.com/signup.php.
About Encorium Group, Inc. (Nasdaq:ENCO)
Encorium Group, Inc. (Nasdaq:ENCO) is a clinical research organization (CRO), which is engaged in the design and management of clinical trials for the pharmaceutical, biotechnology and medical device industries.
LAC Disclosure:
Libertyanalyticsco.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. Liberty Analytics has not been compensated by any of the above-mentioned companies. Please read our report and visit our Web site, www.libertyanalyticsco.com, for complete risks and disclosures.
CONTACT: Liberty Analytics
Kevin Mix
480-626-1850
info@libertyanalyticsco.com
Corporate Presentation (03/2010)
http://www.nexmed.com/pdf/CorporatePresentationMar_18_ROTH.pdf
Income per commom share: $1.22
http://www.sec.gov/Archives/edgar/data/822708/000113626110000074/form10k.htm
x PE (5) : $ 6.10
x PE (10): $12.20
x PE (15): $18.30
BARCHART -
http://quote.barchart.com/texpert.asp?sym=zoom&code=BSTK
Composite Indicator
Trend Spotter TM Buy
Short Term Indicators
7 Day Average Directional Indicator Buy
10 - 8 Day Moving Average Hilo Channel Buy
20 Day Moving Average vs Price Buy
20 - 50 Day MACD Oscillator Buy
20 Day Bollinger Bands Hold
Short Term Indicators Average: 80% - Buy
20-Day Average Volume - 342960
Medium Term Indicators
40 Day Commodity Channel Index Buy
50 Day Moving Average vs Price Buy
20 - 100 Day MACD Oscillator Buy
50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 100% - Buy
50-Day Average Volume - 160088
Long Term Indicators
60 Day Commodity Channel Index Buy
100 Day Moving Average vs Price Buy
50 - 100 Day MACD Oscillator Buy
Long Term Indicators Average: 100% - Buy
100-Day Average Volume - 152559
Overall Average: 96% - Buy
Price Support Pivot Point Resistance
8.16 7.75 8.11 8.47
BARCHART -
http://quote.barchart.com/texpert.asp?sym=enco&code=BSTK
Composite Indicator
Trend Spotter TM Buy
Short Term Indicators
7 Day Average Directional Indicator Buy
10 - 8 Day Moving Average Hilo Channel Buy
20 Day Moving Average vs Price Buy
20 - 50 Day MACD Oscillator Sell
20 Day Bollinger Bands Buy
Short Term Indicators Average: 60% - Buy
20-Day Average Volume - 506155
Medium Term Indicators
40 Day Commodity Channel Index Buy
50 Day Moving Average vs Price Buy
20 - 100 Day MACD Oscillator Sell
50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 50% - Buy
50-Day Average Volume - 217461
Long Term Indicators
60 Day Commodity Channel Index Buy
100 Day Moving Average vs Price Buy
50 - 100 Day MACD Oscillator Sell
Long Term Indicators Average: 33% - Buy
100-Day Average Volume - 134737
Overall Average: 56% - Buy
Price Support Pivot Point Resistance
3.28 0.66 3.56 6.46
IMO ...AH-short-attack!
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_Z/threadview?m=tm&bn=99502&tid=1515&mid=1518&tof=8&rt=1&frt=2&off=1
btw
FORM 10-K
For the fiscal year ended December 31, 2009
http://www.sec.gov/Archives/edgar/data/822708/000113626110000074/form10k.htm
The number of shares outstanding of the registrant's common stock, $0.01 par value, as of March 29, 2010 was 8,982,314 shares.
SOURCE: Zoom Technologies
http://www.marketwire.com/press-release/Zoom-Technologies-Reports-Full-Year-2009-Net-Income-up-121-Beats-Guidance-NASDAQ-ZOOM-1140217.htm
Mar 30, 2010 16:00 ET
Zoom Technologies Reports Full Year 2009 Net Income up 121%, Beats Guidance
Annual Revenue up 135%
BEIJING--(Marketwire - March 30, 2010) - Zoom Technologies, Inc. (NASDAQ: ZOOM)
Full Year 2009 Highlights:
-- Net income grew 121% year over year to $6.24 million, exceeded upper
end of guidance
-- Revenue increased 135% over last year to $189.06 million
-- EMS volume reached 8.5 million units as compared to 5.4 million for
2008
-- Sold 100,000 proprietary "Leimone" brand phones
Full Year 2010 Guidance:
-- Net income guidance in range of $10.5 million to $11.5 million
-- Revenue estimates between $240 and $260 million
-- EMS volume growth to 10 million units
-- "Leimone" brand phone sales at 700,000 units
-- Increase export activities to Asia, South America and the Middle East
First Quarter 2010 Guidance:
-- Net income in range of $1.5 to $1.7 million versus $0.92 million for
same quarter 2009
-- Revenue between $38 to $42 million as compared to $28.82 million for
year ago quarter
Zoom Technologies, Inc. (NASDAQ: ZOOM) a leading China based manufacturer of mobile phones and other mobile electronic products, reported financial results for the fourth quarter and full year ended December 31, 2009.
Mr. Lei Gu, Chairman and Chief Executive Officer of Zoom Technologies, commented, "Our 2009 financial results directly reflect the strength of the Chinese macroeconomic environment, the robust mobile phone industry and Zoom's strategy to gain market share. Catapulting Zoom's market opportunity is China's low user penetration rate of only 47%, as compared to over 90% or even over 100% in many developed and developing countries. We are extremely excited to report another quarter of tremendous year over year revenue growth and dramatic full-year revenue growth as a NASDAQ-listed company, offering an attractive investment opportunity for investors. Our ability to accomplish such growth reflects our strong expansion prospects for 2010 and beyond."
For the fourth quarter of 2009, Zoom reported net revenue of $51.82 million, up 31% over $39.47 million for the fourth quarter 2008; and down 6% sequentially from $55.29 million of a robust third quarter 2009. The year over year revenue growth was primarily due to an increase in orders by our EMS customers and sales of our own brand phones.
Mr. Gu continued, "We believe that China's pro-growth government backing of the 3G network commercialization will drive subscriber demand for feature-rich, customized mobile phones with new media applications and large volume data transmission. Earlier this month, we announced that our acquisition target, Leimone Culture, signed an agreement with CCTV. We are excited with the prospect of entering the mobile new media business through the acquisition of Leimone Culture. We will continue to focus our manufacturing activities on our core business and explore potential ancillary revenue streams made available by the increasing usage on China 3G networks."
For the full year of 2009, Zoom reported revenue of $189.06 million, up 135% over $80.61 million for the full year 2008. Net income for the full year ended December 31, 2009 was $6.24 million compared to net income of $2.82 million for the full year 2008. The increase was mainly due to large uptake in orders from domestic EMS customers.
Gross profit for the year 2009 was $11.4 million, up 39% from $8.2 million for 2008. Gross margin was 6% for 2009 down from 10.2% for 2008. Net margin was stable at 3.3% in 2009 as compared to 3.5% in 2008. The compression in gross margins reflects our strategy to win large orders in the competitive Chinese mobile manufacturing market, while our effective managerial control ensured profitability.
Mr. Gu continued, "In 2009, we made significant capacity expansion and we are ready to take advantage of the foreseeable growth in China's mobile market. With 14 production lines, we have the capacity to manufacture up to 10 million units for our EMS customers and at the same time, produce 12 models of our own feature-rich handsets equipped with the latest technologies, including 4 models for the 3G networks."
Looking ahead, Mr. Gu remarked, "We will continue to focus on our mobile manufacturing business in 2010, as the market opportunity in China is in high demand. For the first quarter ending March 31, 2010, we expect net revenue to be between $38 and $42 million and net income expectation to be in the range of $1.5 and $1.7 million. For the full year 2010, we expect net revenue to be between $240 and $260 million and maintain our previously given 2010 net income expectation range of $10.5 million to $11.5 million."
Conference Call Details
Zoom will review the fourth quarter and full year 2009 results and discuss management's expectations for 2010 today, Tuesday, March 30, 2010 at 5 p.m. EDT (2 p.m. PDT). The dial-in numbers are +1-877-407-9039 for US domestic callers and +1-201-689-8470 for international callers. A telephonic replay of the call will be available through April 14, 2010. The replay dial-in numbers are +1-877-660-6853 for US domestic callers and +1-201-612-7415 for international callers. The account number to access the replay is 3055 and the conference ID number is 348255.
About Zoom Technologies, Inc.
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for 3rd generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers and also designs and manufactures its own brand of mobile phones under the Leimone brand.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events, including the acquisition of Leimone Culture, which may require shareholder approval which cannot be assured. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
ZOOM TECHNOLOGIES, INC. AFFILIATES & SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME AND OTHER COMPREHENSIVE INCOME
Years Ended December 31
----------------------------
2009 2008
------------- -------------
Net revenues $ 189,055,742 $ 80,611,981
Cost of sales (177,653,678) (72,410,992)
------------- -------------
Gross profit 11,402,064 8,200,989
Operating expenses:
Sales and marketing expenses (1,338,999) (267,076)
General and administrative expenses (1,722,194) (1,685,885)
Research and development expenses - (871,238)
Non-cash equity-based compensation
charges - options (44,480) -
------------- -------------
Impairment loss of assets 0 0
------------- -------------
(3,105,673) (2,824,199)
------------- -------------
Income from operations 8,296,391 5,376,790
Other income (expenses)
Equity in earnings in investee - 3,191
Interest income 287,206 176,102
Gain/(Loss) on disposal of fixed assets - 0
Government grant income - 176,747
Other income 579,658 4,121
Interest expense (1,327,744) (1,599,139)
Exchange loss (30,536) (91,071)
Other expenses (150,265) (37,506)
------------- -------------
(641,681) (1,367,555)
------------- -------------
Income before income taxes and
noncontrolling interests 7,654,710 4,009,235
Income tax expense (1,231,180) (611,586)
------------- -------------
Income before noncontrolling interests and
discontinued operations 6,423,530 3,397,649
Loss from discontinued operation - (246,654)
------------- -------------
Income before noncontrolling interests 6,423,530 3,150,995
Less: Income attributable to
noncontrolling interests (180,383) (330,721)
------------- -------------
Net income attributable to Zoom Technologies
Inc 6,243,147 2,820,274
Other comprehensive income/(loss) (32,852) 8,708
------------- -------------
Comprehensive income $ 6,210,295 $ 2,828,982
============= =============
Basic and diluted income/(loss) per common
share:
Basic $ 1.22 $ 0.67
Diluted 1.22 0.67
Basic 5,110,340 4,225,219
============= =============
Diluted 5,131,563 4,225,219
============= =============
The accompanying notes are an integral part of these consolidated
financial statements.
ZOOM TECHNOLOGIES, INC. AFFILIATES & SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2009 2008
------------ ------------
ASSETS
Current assets
Cash and cash equivalents $ 1,472,300 $ 812,769
Restricted cash 11,993,214 8,753,757
Accounts receivable, net 16,835,074 12,366,814
Other receivables and prepaid expenses 311,808 1,119,881
Advance to suppliers 27,471,601 24,275,313
Inventories, net 1,534,989 3,742,046
Due from related parties 12,221,778 6,069,842
Deferred tax assets 504,222 -
------------ ------------
Total current assets 72,344,986 57,140,422
Property, plant and equipment, net 5,673,923 7,054,892
Construction in progress 32,849 -
Long-term investments - 65,653
Due from related parties-long term - 247,294
Deferred tax assets - 600,956
Goodwill 103,057 103,057
------------ ------------
TOTAL ASSETS $ 78,154,815 $ 65,212,274
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Short-term loans $ 16,000,702 $ 18,893,525
Notes payable 23,986,427 17,507,514
Accounts payable 2,439,925 3,580,720
Advance from customers 51,243 3,785,462
Dividends payable 579,579 578,142
Taxes payable 1,603,557 775,315
Accrued expenses and other payables 127,484 2,832,599
Due to related parties 5,245,415 5,161,169
------------ ------------
Total current liabilities 50,034,332 53,114,446
------------ ------------
Long-term loans - 1,167,168
TOTAL LIABILITIES 50,034,332 54,281,614
------------ ------------
STOCKHOLDERS' EQUITY
Common stock: authorized 25,000,000 shares,
par value $0.01 Issued 8,780,988 shares and
outstanding 8,779,308 shares at December 31,
2009; Issued 4,226,899 and 4,225,219
outstanding at December 31, 2008 87,793 42,252
Shares to be issued 592 -
Subscription receivable (378) -
Additional paid-in capital 14,309,538 3,518,363
Treasury shares: 1,680 shares at cost (7,322) (7,322)
Statutory surplus reserve 633,378 569,193
Accumulated other comprehensive income 210,773 243,625
Retained earnings 6,254,479 75,517
------------ ------------
TOTAL STOCKHOLDERS' EQUITY 21,488,853 4,441,628
------------ ------------
Noncontrolling interests 6,631,630 6,489,032
------------ ------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 78,154,815 $ 65,212,274
============ ============
The accompanying notes are an integral part of these consolidated
financial statements.
ZOOM TECHNOLOGIES, INC. AFFILIATES & SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2009 AND 2008
2009 2008
----------- -----------
Cash flows from operating activities:
Income including noncontrolling interests $ 6,423,530 $ 3,150,995
Adjustments to reconcile net income to cash used
in operating activities:
Depreciation and amortization 1,569,686 1,231,707
Non-cash equity-based compensation charges 44,480 -
Provision for inventory obsolescence (235,771) (173,528)
Provision for doubtful receivables 1,955 (86,390)
Loss on disposal of fixed assets 485 497
Investment income - (3,191)
Provision for long-term investment 65,781 -
Deferred tax assets 98,175 (130,508)
Changes in operating assets and liabilities:
Accounts receivable (4,442,927) 266,411
Inventories 2,422,307 3,292,582
Advances to suppliers (3,191,156) (16,037,819)
Prepaid expenses and other assets 906,196 1,541,259
Accounts payable (1,152,195) (1,543,164)
Advance from customers (3,741,596) 867,776
Related parties-net (8,126,760) (721,332)
Accrued expenses and other current liabilities (1,883,221) (110,174)
----------- -----------
Net cash used in operating activities (11,241,031) (8,454,879)
----------- -----------
Cash flows from investing activities:
Restricted cash (3,215,942) (2,890,163)
Purchase of property and equipment and other
long-term assets (244,426) (2,895,299)
Proceeds from disposal of fixed assets - 9,623
Proceeds from disposal of discontinued
operations - 1,749,258
Proceeds from notes receivable - 475,622
----------- -----------
Net cash used in investing activities (3,460,368) (3,550,959)
----------- -----------
Cash flows from financing activities:
Issuance of shares for cash 9,532,364 -
Proceeds from short-term loans 21,254,451 18,600,309
Proceeds from long-term loans - 1,149,054
Advance to related parties (10,580,810) (5,649,111)
Repayment on borrowing from related parties (13,977,180) (37,884,458)
Proceeds from notes payable 6,431,883 7,199,115
Collection on advance to related parties 12,780,855 18,484,740
Receipt from related parties 15,361,000 26,885,911
Repayments on short-term loans (24,192,652) (20,213,293)
Repayments on long-term loan (1,169,433) -
----------- -----------
Net cash provided by financing activities 15,440,478 8,572,267
----------- -----------
Effect of exchange rate changes on cash & cash
equivalents (79,548) 265,756
----------- -----------
Net increase (decrease) in cash and cash
equivalents 659,531 (3,167,815)
Cash and cash equivalents, beginning balance 812,769 3,980,584
----------- -----------
Cash and cash equivalents, ending balance $ 1,472,300 $ 812,769
=========== ===========
SUPPLEMENTARY DISCLOSURE:
Interest paid $ 1,221,979 $ 1,489,630
=========== ===========
Income tax paid $ 68,324 $ 931,854
=========== ===========
The accompanying notes are an integral part of these consolidated
financial statements.
Zoom Technologies Reports Full Year 2009 Net Income up 121%, Beats Guidance
Date : 03/30/2010 @ 4:00PM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&cb=1269979360&article=42192906&symbol=N^ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM)
Full Year 2009 Highlights:
-- Net income grew 121% year over year to $6.24 million, exceeded upper
end of guidance
-- Revenue increased 135% over last year to $189.06 million
-- EMS volume reached 8.5 million units as compared to 5.4 million for
2008
-- Sold 100,000 proprietary "Leimone" brand phones
Full Year 2010 Guidance:
-- Net income guidance in range of $10.5 million to $11.5 million
-- Revenue estimates between $240 and $260 million
-- EMS volume growth to 10 million units
-- "Leimone" brand phone sales at 700,000 units
-- Increase export activities to Asia, South America and the Middle East
First Quarter 2010 Guidance:
-- Net income in range of $1.5 to $1.7 million versus $0.92 million for
same quarter 2009
-- Revenue between $38 to $42 million as compared to $28.82 million for
year ago quarter
Zoom Technologies, Inc. (NASDAQ: ZOOM) a leading China based manufacturer
of mobile phones and other mobile electronic products, reported financial
results for the fourth quarter and full year ended December 31, 2009.
Mr. Lei Gu, Chairman and Chief Executive Officer of Zoom Technologies,
commented, "Our 2009 financial results directly reflect the strength of the
Chinese macroeconomic environment, the robust mobile phone industry and
Zoom's strategy to gain market share. Catapulting Zoom's market opportunity
is China's low user penetration rate of only 47%, as compared to over 90%
or even over 100% in many developed and developing countries. We are
extremely excited to report another quarter of tremendous year over year
revenue growth and dramatic full-year revenue growth as a NASDAQ-listed
company, offering an attractive investment opportunity for investors. Our
ability to accomplish such growth reflects our strong expansion prospects
for 2010 and beyond."
For the fourth quarter of 2009, Zoom reported net revenue of $51.82
million, up 31% over $39.47 million for the fourth quarter 2008; and down
6% sequentially from $55.29 million of a robust third quarter 2009. The
year over year revenue growth was primarily due to an increase in orders by
our EMS customers and sales of our own brand phones.
Mr. Gu continued, "We believe that China's pro-growth government backing of
the 3G network commercialization will drive subscriber demand for
feature-rich, customized mobile phones with new media applications and
large volume data transmission. Earlier this month, we announced that our
acquisition target, Leimone Culture, signed an agreement with CCTV. We are
excited with the prospect of entering the mobile new media business through
the acquisition of Leimone Culture. We will continue to focus our
manufacturing activities on our core business and explore potential
ancillary revenue streams made available by the increasing usage on China
3G networks."
For the full year of 2009, Zoom reported revenue of $189.06 million, up
135% over $80.61 million for the full year 2008. Net income for the full
year ended December 31, 2009 was $6.24 million compared to net income of
$2.82 million for the full year 2008. The increase was mainly due to large
uptake in orders from domestic EMS customers.
Gross profit for the year 2009 was $11.4 million, up 39% from $8.2 million
for 2008. Gross margin was 6% for 2009 down from 10.2% for 2008. Net margin
was stable at 3.3% in 2009 as compared to 3.5% in 2008. The compression in
gross margins reflects our strategy to win large orders in the competitive
Chinese mobile manufacturing market, while our effective managerial control
ensured profitability.
Mr. Gu continued, "In 2009, we made significant capacity expansion and we
are ready to take advantage of the foreseeable growth in China's mobile
market. With 14 production lines, we have the capacity to manufacture up to
10 million units for our EMS customers and at the same time, produce 12
models of our own feature-rich handsets equipped with the latest
technologies, including 4 models for the 3G networks."
Looking ahead, Mr. Gu remarked, "We will continue to focus on our mobile
manufacturing business in 2010, as the market opportunity in China is in
high demand. For the first quarter ending March 31, 2010, we expect net
revenue to be between $38 and $42 million and net income expectation to be
in the range of $1.5 and $1.7 million. For the full year 2010, we expect
net revenue to be between $240 and $260 million and maintain our previously
given 2010 net income expectation range of $10.5 million to $11.5 million."
Conference Call Details
Zoom will review the fourth quarter and full year 2009 results and discuss
management's expectations for 2010 today, Tuesday, March 30, 2010 at 5 p.m.
EDT (2 p.m. PDT). The dial-in numbers are +1-877-407-9039 for US domestic
callers and +1-201-689-8470 for international callers. A telephonic replay
of the call will be available through April 14, 2010. The replay dial-in
numbers are +1-877-660-6853 for US domestic callers and +1-201-612-7415 for
international callers. The account number to access the replay is 3055 and
the conference ID number is 348255.
About Zoom Technologies, Inc.
Zoom Technologies is a holding company with subsidiaries that engage in the
manufacturing, research and development, and sale of electronic and
telecommunication products for 3rd generation mobile phones, wireless
communication circuitry, and related software products. Zoom Technologies'
subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which
offers highly customized and high quality Electronic Manufacturing Service
(EMS) for Original Equipment Manufacturer (OEM) customers and also designs
and manufactures its own brand of mobile phones under the Leimone brand.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking
statements" that involve risks and uncertainties. These include statements
about our expectations, plans, objectives, assumptions or future events,
including the acquisition of Leimone Culture, which may require shareholder
approval which cannot be assured. You should not place undue reliance on
these forward-looking statements. Information concerning factors that could
cause our actual results to differ materially from these forward-looking
statements can be found in our periodic reports filed with the Securities
and Exchange Commission. We undertake no obligation to publicly release
revisions to these forward-looking statements to reflect future events or
circumstances or reflect the occurrence of unanticipated events.
ZOOM TECHNOLOGIES, INC. AFFILIATES & SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME AND OTHER COMPREHENSIVE INCOME
Years Ended December 31
----------------------------
2009 2008
------------- -------------
Net revenues $ 189,055,742 $ 80,611,981
Cost of sales (177,653,678) (72,410,992)
------------- -------------
Gross profit 11,402,064 8,200,989
Operating expenses:
Sales and marketing expenses (1,338,999) (267,076)
General and administrative expenses (1,722,194) (1,685,885)
Research and development expenses - (871,238)
Non-cash equity-based compensation
charges - options (44,480) -
------------- -------------
Impairment loss of assets 0 0
------------- -------------
(3,105,673) (2,824,199)
------------- -------------
Income from operations 8,296,391 5,376,790
Other income (expenses)
Equity in earnings in investee - 3,191
Interest income 287,206 176,102
Gain/(Loss) on disposal of fixed assets - 0
Government grant income - 176,747
Other income 579,658 4,121
Interest expense (1,327,744) (1,599,139)
Exchange loss (30,536) (91,071)
Other expenses (150,265) (37,506)
------------- -------------
(641,681) (1,367,555)
------------- -------------
Income before income taxes and
noncontrolling interests 7,654,710 4,009,235
Income tax expense (1,231,180) (611,586)
------------- -------------
Income before noncontrolling interests and
discontinued operations 6,423,530 3,397,649
Loss from discontinued operation - (246,654)
------------- -------------
Income before noncontrolling interests 6,423,530 3,150,995
Less: Income attributable to
noncontrolling interests (180,383) (330,721)
------------- -------------
Net income attributable to Zoom Technologies
Inc 6,243,147 2,820,274
Other comprehensive income/(loss) (32,852) 8,708
------------- -------------
Comprehensive income $ 6,210,295 $ 2,828,982
============= =============
Basic and diluted income/(loss) per common
share:
Basic $ 1.22 $ 0.67
Diluted 1.22 0.67
Basic 5,110,340 4,225,219
============= =============
Diluted 5,131,563 4,225,219
============= =============
The accompanying notes are an integral part of these consolidated
financial statements.
ZOOM TECHNOLOGIES, INC. AFFILIATES & SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2009 2008
------------ ------------
ASSETS
Current assets
Cash and cash equivalents $ 1,472,300 $ 812,769
Restricted cash 11,993,214 8,753,757
Accounts receivable, net 16,835,074 12,366,814
Other receivables and prepaid expenses 311,808 1,119,881
Advance to suppliers 27,471,601 24,275,313
Inventories, net 1,534,989 3,742,046
Due from related parties 12,221,778 6,069,842
Deferred tax assets 504,222 -
------------ ------------
Total current assets 72,344,986 57,140,422
Property, plant and equipment, net 5,673,923 7,054,892
Construction in progress 32,849 -
Long-term investments - 65,653
Due from related parties-long term - 247,294
Deferred tax assets - 600,956
Goodwill 103,057 103,057
------------ ------------
TOTAL ASSETS $ 78,154,815 $ 65,212,274
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Short-term loans $ 16,000,702 $ 18,893,525
Notes payable 23,986,427 17,507,514
Accounts payable 2,439,925 3,580,720
Advance from customers 51,243 3,785,462
Dividends payable 579,579 578,142
Taxes payable 1,603,557 775,315
Accrued expenses and other payables 127,484 2,832,599
Due to related parties 5,245,415 5,161,169
------------ ------------
Total current liabilities 50,034,332 53,114,446
------------ ------------
Long-term loans - 1,167,168
TOTAL LIABILITIES 50,034,332 54,281,614
------------ ------------
STOCKHOLDERS' EQUITY
Common stock: authorized 25,000,000 shares,
par value $0.01 Issued 8,780,988 shares and
outstanding 8,779,308 shares at December 31,
2009; Issued 4,226,899 and 4,225,219
outstanding at December 31, 2008 87,793 42,252
Shares to be issued 592 -
Subscription receivable (378) -
Additional paid-in capital 14,309,538 3,518,363
Treasury shares: 1,680 shares at cost (7,322) (7,322)
Statutory surplus reserve 633,378 569,193
Accumulated other comprehensive income 210,773 243,625
Retained earnings 6,254,479 75,517
------------ ------------
TOTAL STOCKHOLDERS' EQUITY 21,488,853 4,441,628
------------ ------------
Noncontrolling interests 6,631,630 6,489,032
------------ ------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 78,154,815 $ 65,212,274
============ ============
The accompanying notes are an integral part of these consolidated
financial statements.
ZOOM TECHNOLOGIES, INC. AFFILIATES & SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2009 AND 2008
2009 2008
----------- -----------
Cash flows from operating activities:
Income including noncontrolling interests $ 6,423,530 $ 3,150,995
Adjustments to reconcile net income to cash used
in operating activities:
Depreciation and amortization 1,569,686 1,231,707
Non-cash equity-based compensation charges 44,480 -
Provision for inventory obsolescence (235,771) (173,528)
Provision for doubtful receivables 1,955 (86,390)
Loss on disposal of fixed assets 485 497
Investment income - (3,191)
Provision for long-term investment 65,781 -
Deferred tax assets 98,175 (130,508)
Changes in operating assets and liabilities:
Accounts receivable (4,442,927) 266,411
Inventories 2,422,307 3,292,582
Advances to suppliers (3,191,156) (16,037,819)
Prepaid expenses and other assets 906,196 1,541,259
Accounts payable (1,152,195) (1,543,164)
Advance from customers (3,741,596) 867,776
Related parties-net (8,126,760) (721,332)
Accrued expenses and other current liabilities (1,883,221) (110,174)
----------- -----------
Net cash used in operating activities (11,241,031) (8,454,879)
----------- -----------
Cash flows from investing activities:
Restricted cash (3,215,942) (2,890,163)
Purchase of property and equipment and other
long-term assets (244,426) (2,895,299)
Proceeds from disposal of fixed assets - 9,623
Proceeds from disposal of discontinued
operations - 1,749,258
Proceeds from notes receivable - 475,622
----------- -----------
Net cash used in investing activities (3,460,368) (3,550,959)
----------- -----------
Cash flows from financing activities:
Issuance of shares for cash 9,532,364 -
Proceeds from short-term loans 21,254,451 18,600,309
Proceeds from long-term loans - 1,149,054
Advance to related parties (10,580,810) (5,649,111)
Repayment on borrowing from related parties (13,977,180) (37,884,458)
Proceeds from notes payable 6,431,883 7,199,115
Collection on advance to related parties 12,780,855 18,484,740
Receipt from related parties 15,361,000 26,885,911
Repayments on short-term loans (24,192,652) (20,213,293)
Repayments on long-term loan (1,169,433) -
----------- -----------
Net cash provided by financing activities 15,440,478 8,572,267
----------- -----------
Effect of exchange rate changes on cash & cash
equivalents (79,548) 265,756
----------- -----------
Net increase (decrease) in cash and cash
equivalents 659,531 (3,167,815)
Cash and cash equivalents, beginning balance 812,769 3,980,584
----------- -----------
Cash and cash equivalents, ending balance $ 1,472,300 $ 812,769
=========== ===========
SUPPLEMENTARY DISCLOSURE:
Interest paid $ 1,221,979 $ 1,489,630
=========== ===========
Income tax paid $ 68,324 $ 931,854
=========== ===========
The accompanying notes are an integral part of these consolidated
financial statements.
Investor Contacts:
Anthony Chan
Chief Financial Officer
Zoom Technologies, Inc.
+1 510-396-5831
Email Contact
Joseph Villalta/Ashleigh Barreto
The Ruth Group
+1 646-536-7003/7028
Email Contact
Email Contact
Media Contact:
Jason Rando
The Ruth Group
+1-646-536-7025
Email Contact
Low natural gas prices, restructuring costs widen Q4 losses at Canadian Superior
By The Canadian Press
http://ca.news.yahoo.com/s/capress/100330/business/canadian_superior
CALGARY - Weak natural gas prices and costs associated with an extensive restructuring at Canadian Superior Energy Inc. (TSX:SNG) led to widened losses for both the fourth quarter and full year of fiscal 2009, the company said Tuesday.
The Calgary-based natural gas producer reported a net loss of $63.9 million for the quarter ended Dec. 31, more than doubling losses of $18.2 million cents per share booked in the corresponding quarter of 2008.
The loss per share amounted to 32 cents for the quarter, compared with a loss of 11 cents per share a year earlier.
Apart from a 25 per cent decline in quarterly sales, which sagged to $9.9 million from year-earlier levels of $13.2 million, Canadian Superior said the increase in red ink could be attributed to low natural gas prices as well as costs associated with a sweeping restructuring effort.
Canadian Superior spent six months under creditor protection under the Companies' Creditors Arrangement Act, emerging in September.
The company reported $18.8 million in restructuring costs for the year as well as a $57.5 million writedown of petroleum and natural gas properties.
These costs took a toll on full-year financial results. Canadian Superior reported a full-year net loss of $53.3 million or 30 cents per share, widening year-earlier losses of $23.8 million or 16 cents per share.
Natural gas pricing dragged full-year sales down by 55 per cent to $33.8 million from $74.5 million posted in 2008.
"While the company has been through a very difficult period during 2009, we believe it has emerged and continues to evolve as a much stronger company than it has ever been," Canadian Superior chairman Marvin Chronister said in a statement.
"We are aggressively pursuing our growth strategy and development of our assets. Therefore, we believe the best is still to come for our shareholders."
Canadian Superior explores for and produces oil and natural gas and is developing a liquefied natural gas project.
The company is active in Western Canada, Trinidad and Tobago, North Africa, off Eastern Canada and the United States.