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Unilife Completes Unitract 1ml Syringe Ageing Studies
Published: 21-Dec-2009
http://drugdelivery.pharmaceutical-business-review.com/news/unilife_completes_unitract_1ml_syringe_ageing_studies_091221/
To commence commercial release and sale within Europe in Q1, 2010
Unilife Medical Solutions (Unilife) has commenced final preparations for the commercial release and sale of its Unitract 1ml syringes, following the completion of device ageing studies for product manufactured at its manufacturing facility in Pennsylvania.
The company expects to be in a position to shortly announce the appointment of a number of agreements for the sale and distribution of its Unitract 1ml syringes by pharmaceutical companies and other healthcare distributors, which are active across a number of international markets including North America and Asia.
Following the successful completion this week of a Medical Device Directive (MDD) audit for CE Mark registration of US-manufactured product, Unilife also expects to be in a position to commence Unitract 1ml syringe sales within Europe during the first quarter of 2010. Final negotiations regarding the placement of initial orders for the Unitract 1ml syringes with interested distributors in Europe are also now taking place.
Bernhard Opitz, senior vice president of operations at Unilife, said: “The operational resources of Unilife remain very much focused upon the on-time completion of the industrialisation program for the Unifill syringe. Also, I am pleased that we are now moving into a position where we can commence the commercial release of our Unitract 1ml Syringes. The company is building its product inventory at its Lewisberry facility in Pennsylvania to fulfil initial orders from a number of interested parties.”
Mark Iampietro, vice-president of quality and regulatory affairs at Unilife, said: “The completion of device ageing studies for the Unitract™ range of 1mL syringes manufactured at our Lewisberry facility in Pennsylvania is a positive sign. It reflects the significant work which has been undertaken this year to build a Quality Management System that is fully compliant to international medical device and pharmaceutical regulations. We are now in a strong position to commence the commercial release of our Unitract 1ml syringes within the US, Europe and other international markets.”
Mark Hassett, director of sales and marketing at Unilife, said: “The Unitract range of 1ml syringes is to our knowledge the world’s first product with an automatic retraction mechanism enabling operators to control the speed of needle withdrawal directly from the body into the barrel of the syringe. Our products are well positioned to protect those at risk of infection from HIV and hepatitis C via potential transmission routes such as needlestick injuries and splatter. We are excited by the level of interest we have received from healthcare workers, patients who selfadminister prescription medication, distributors and pharmaceutical companies. We look forward to strengthening our relationships with these, and other industry leaders, as we roll out our Unitract 1ml Syringes across key international markets throughout 2010.”
Well something must be up...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44712219
Posted by: TheInvisibleHand ™
Date: Sunday, December 20, 2009 7:44:07 PM
In reply to: Vulcanized Crawler
Well something must be up, I received a very threatening message from Johnny winter aka basher227 on the yahoo boards (and who knows how many other countless screen-names) He stated that if I didn't stop posting the articles on Wamuq, there would be physical harm done to me. So must be getting closer and closer to a settlement, who knows if a full investigation goes maybe they will research all the cyber bashers who helped JPM with their crimes.....
BTW, so you all know the brain surgeon also threatened me via email, so I guess if anything does happen to me the rocket scientist that he is will be the first suspect. Not to smart to send threatening messages via email according to my lawyer its also a felony.
=]
Lets see how it plays out....
European Medicines Agency Grants Cell Therapeutics Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma
Date : 12/21/2009 @ 1:30AM
Source : PR Newswire
Stock : (CTIC)
http://ih.advfn.com/p.php?pid=nmona&article=40837972&symbol=CTIC
ProLogis Closes 10 Billion Yen ($113 Million) TMK Bond Financing
http://ir.prologis.com/releaseDetail.cfm?ReleaseID=430925
DENVER, Dec 16, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- ProLogis (NYSE: PLD), a leading global provider of distribution facilities, announced today that it has completed a 10 billion yen ($113 million) TMK bond secured financing. Sumitomo Mitsui Banking Corp. was lead on the financing, which has a three-year maturity and is secured by ProLogis Parc Osaka II. Proceeds from this financing were used to pay down ProLogis' global line of credit. Tokutei Mokuteki Kaisha (TMK) is a tax favored, special purpose securitization vehicle that issues corporate bonds secured by real estate assets.
"The TMK bond market in Japan continues to be a very attractive capital source. We are fortunate to have strong relationships with some of the premier lenders in the region and to have a product type that continues to be attractive as a source of security," said Phillip D. Joseph, Jr., senior vice president and treasurer. ProLogis Parc Osaka II is a 1.4 million-square-foot, multi-tenant facility located in Osaka, Japan, that is over 95 percent leased to well-known companies like Nipro Corporation, Kintetsu World Express and Sankyu Inc.
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to www.prologis.com.
SOURCE ProLogis
http://www.prologis.com
Copyright (C) 2009 PR Newswire. All rights reserved
Oilpatch veteran Clay Riddell is making a big investment in Canadian Superior Energy Inc.
Posted by: Jean01234
Date: Saturday, December 19, 2009 7:58:16 AM
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44694308
Reknown oilpatch veteran Clay Riddell is making a big investment in Canadian Superior Energy Inc. (TSX:SNG), a Calgary-based natural gas producer that has seen a great deal of upheaval in the past year.
"I´m excited about their project in Trinidad," said Riddell in an interview, referring to an offshore block believed to contain between three and five trillion cubic feet of natural gas.
When asked what about the offshore Trinidad natural gas field piqued his interest, Riddell said bluntly: "It´s big."
A long-time investor in Canadian Superior, Riddell had been following the evolution of exploration Block 5 (c), in which Canadian Superior used to have a controlling stake.
After a series of developments over the past year _ including a dispute with one joint venture partner and the takeover of another _Canadian Superior now has a 25 per cent interest in the field, which is believed to contain between three and five trillion cubic feet of natural gas.
Canadian Superior said Friday it plans to raise up to $50 million through a non-brokered private placement issue of up to 96.2 million common shares. The company said it will issue the stock at 52 cents each.
Shares in the company soared 15.7 per cent to 59 cents on the Toronto Stock Exchange on Friday.
The financing is slated to close Jan. 14, and the money raised will be used for exploration and development and for general corporate purposes.
Treherne Resources Ltd., a private company controlled by Riddell, has subscribed for $20 million of that private placement.
Riddell, or someone else from Treherne, was offered a spot on Canadian Superior´s board, which was overhauled at the behest of a major shareholder in September.
"I´ll have such a large interest in the company and I´d like to participate in how it goes forward," Riddell said.
The Riddell name is well known in Alberta´s oil and gas industry.
A geologist by trade, Riddell founded Paramount Resources Ltd. in 1974, which has since been spun off into different firms.
His daughter Sue Riddell Rose runs Paramount Energy Trust (TSX:PET.UN) and his son Jim Riddell is chief utive of Trilogy Energy Trust (TSX:TET.UN).
He is also the chairman and chief utive of another company he founded, Arctic natural gas explorer MGM Energy Corp. (TSX:MGX).
In February, a partner in the Trinidad block, U.K.-based BG Group, persuaded an Alberta judge to put Canadian Superior´s stake under the control of a receiver.
BG had feared final testing and completion of a well would not be completed, given the financial problems of Canadian Superior and a third partner in the project, Challenger Energy Corp.
A month later, Canadian Superior and Challenger both filed for protection from creditors under the Companies´ Creditors Arrangement Act.
In May, Canadian Superior sold its 45 per cent stake in the Trinidad field for US$142.5 million to BG Group.
And then in June, Canadian Superior agreed to merge with Challenger in a friendly deal worth $77.8 million.
Canadian Superior explores for and produces oil and natural gas and is developing a liquefied natural gas project.
In addition to its venture in Trinidad and Tobago, Canadian Superior is also active in Western Canada, North Africa, off Eastern Canada and the United States.
Read more: http://www.oilweek.com/news.asp?ID=25666#ixzz0a8gKZuQU
******************************************************************
NexMed Granted Continued Listing on NASDAQ
Date : 12/18/2009 @ 9:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1261169030&article=40824321&symbol=N^NEXM
NexMed, Inc. Leases Its Facility in New Jersey
Date : 12/17/2009 @ 9:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1261069261&article=40804024&symbol=N%5ENEXM
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that it has signed an agreement to lease its facility in East Windsor, NJ, commencing February 1, 2010. The lease agreement also contains an option to purchase the facility during the term of the lease
Commenting on today’s news, NexMed’s Chief Financial Officer, Mark Westgate, said, “In light of our announcement earlier this week regarding the closing of the Bio-Quant acquisition, the timing is ideal, as we move our headquarters from New Jersey to San Diego. Additionally, the monthly rental payment will more than cover the existing debt service on our mortgage, thus making this a cash positive transaction. Further, the initial purchase option price which we have negotiated, of $4.4 million, is approximately $1.4 million above the existing debt on our building.”
About NexMed NexMed, due to its recent acquisition of Bio-Quant, 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. NexMed is also developing a proprietary product pipeline based on its NexACT® drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information, go to www.nexmed.com and www.bio-quant.com
Yingli Green Energy Announces Major Business Milestones
Date : 12/15/2009 @ 6:00AM
Source : PR Newswire
Stock : Yingli Grn Engy Adr (YGE)
http://ih.advfn.com/p.php?pid=nmona&cb=1260986674&article=40765088&symbol=NY^YGE
Cardium Reports on Recent Norwegian Study Revealing That History of Foot Ulcers Is a Significant Predictor of Mortality in Diabetic Patients
Date : 12/16/2009 @ 12:10PM
Source : PR Newswire
Stock : (CXM)
http://ih.advfn.com/p.php?pid=nmona&article=40790584&symbol=CXM
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Adva
Date : 12/16/2009 @ 8:30AM
Source : PR Newswire
Stock : (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=40785755&symbol=KERX
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Adva
Date : 12/16/2009 @ 8:30AM
Source : PR Newswire
Stock : (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=40785755&symbol=KERX
Trial conducted pursuant to Special Protocol Assessment with the Food and Drug Administration
NEW YORK, Dec. 16 /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 PI3K/Akt pathway inhibitor, in relapsed / refractory multiple myeloma patients
The trial, entitled, "A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade®) and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib" is a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade®) and dexamethasone. The trial will enroll approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication
The Phase 3 trial is being led by the Principal Investigator, Dr. Paul Richardson, Clinical Director of the Jerome Lipper Multiple Myeloma Center, at Dana-Farber Cancer Institute (DFCI) in Boston, MA and Dr. Kenneth C, Anderson, Chief, Division of Hematologic Neoplasia at DFCI. An estimated 40 to 50 centers throughout the United States and select centers outside of the United States will be participating in this Phase 3 trial
Dr. Richardson's clinical research focuses on studying novel therapies for multiple myeloma. He was the lead investigator of the SUMMIT and APEX clinical trials that led to the FDA approval of bortezomib (Velcade®) for the treatment of multiple myeloma. More recently, he served as clinical trials core chair of the Multiple Myeloma Research Consortium, completing 5 years of service in the role this year. Dr. Anderson serves as Chair of the NCCN Multiple Myeloma Clinical Practice Guidelines Committee and chairs the scientific advisory board for the Multiple Myeloma Research Foundation. In addition to playing an integral role in the development and approval of bortezomib, Drs. Richardson and Anderson led both preclinical and early phase clinical trials for the immunomodulatory drug lenalidomide (Revlimid®), leading to its FDA approval in 2007
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very excited to be initiating the first pivotal program, under an SPA, for perifosine, a novel, oral inhibitor of a critical target in cancer development and progression. This study initiation represents a major milestone for the Company and demonstrates the capabilities of our internal clinical team." Mr. Bentsur added, "We would like to thank Dr. Richardson, Dr. Anderson and the other clinical investigators involved for their dedication to the perifosine multiple myeloma development program."
Dr. Richardson stated, "Despite recent advances, multiple myeloma remains a devastating and challenging disease for which we believe combination treatment will be beneficial to the majority of patients. We are very encouraged by the perifosine + bortezomib combination in regards to overall response rate, progression-free survival and overall survival data observed to date. If the results from this Phase 3 study prove positive, we believe that this orally administered novel agent could make an important difference for patients with advanced multiple myeloma."
Dr. Ken Anderson commented, "We are very excited to be leading this pivotal program alongside our multiple myeloma colleagues nationwide. Based on the synergies observed in preclinical models, and most importantly, the clinical data generated in the Phase 1/2 study, we believe the combination of perifosine with bortezomib can significantly improve patient outcomes in this disease."
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico. In addition to multiple myeloma, other clinical development efforts with perifosine are focused in the areas of colorectal cancer, renal cell carcinoma and other tumor types
About the Phase 3 Trial Design
The Phase 3 trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of KRX-0401 (perifosine) to placebo when combined with bortezomib and dexamethasone in approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. Patients will be randomized to bortezomib at 1.3 mg/m2 days 1, 4, 8 and 11 every 21 days in combination with dexamethasone 20 mg on the day of and day after bortezomib treatment, and either perifosine 50 mg daily or placebo. The Phase 3 trial design is based on positive data reported from the Phase 1/2 trial which was recently reported at the 51st American Society of Hematology meeting. Patients eligible for the Phase 3 trial must have been previously treated with both bortezomib (VELCADE® ) and an immunomodulatory agent (REVLIMID® and/or THALIDOMID® ), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Patients can be relapsed from and refractory to all non-bortezomib based therapies, however, patients can only be relapsed (progressed > 60 days after discontinuing therapy) from prior bortezomib-based therapies. The study is powered at 90% to demonstrate the required difference in progression-free survival between the two arms. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data
The Company expects a patient recruitment period of approximately 16-18 months, with study completion within approximately 20-22 months from today
The trial is being conducted under a Special Protocol Assessment with the FDA
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival
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/Gui dances/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 the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. 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 also modulates a number of other key signal transduction pathways, including the JNK pathway, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma, 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. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and Keryx is in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation 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 trial will not coincide with the data analyses from the Phase 1 / 2 clinical trial 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: 212.531.5962 E-mail:
DATASOURCE: Keryx Biopharmaceuticals, Inc
CONTACT: Lauren Fischer, Director, Investor Relations of Keryx
Biopharmaceuticals, Inc., +1-212-531-5962,
Web Site: http://www.keryx.com/
Cardium Reports on Recent Norwegian Study Revealing That History of Foot Ulcers Is a Significant Predictor of Mortality in Diabetic Patients
Date : 12/16/2009 @ 12:10PM
Source : PR Newswire
Stock : (CXM)
http://ih.advfn.com/p.php?pid=nmona&article=40790584&symbol=CXM
SAN DIEGO, Dec. 16 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported on recent clinical findings published in the December issue of Diabetes Care showing an increase in mortality in diabetic patients with a history of foot ulcer (HFU) compared with diabetic patients without HFU and with non-diabetic patients
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO )
The study titled, "A history of foot ulcer increases mortality among persons with diabetes. 10-year follow-up of the Nord-Trondelag Health Study, Norway", (Diabetes Care. 2009 Dec;32(12): 2193-9. Epub 2009 Sep 3) followed 63,632 non-diabetic individuals, 1,339 diabetic patients without a history of foot ulcers, and 155 diabetic patients with a history of foot ulcers for 10 years with mortality as the endpoint. During the 10-year period, 49.0% of adults with diabetes and a history of foot ulcers died compared to 35.2% with diabetes and no HFU and 10.5% without diabetes. With adjustments for lifestyle and demographic factors, diabetic patients with HFU were more than two times more likely to die during the follow up period than the subjects that were non-diabetic. Comparing diabetic individuals, a HFU was associated with 47% increased mortality. The increased risk persisted after adjustment for co-morbidity and depression scores
The prevalence of diabetes is rapidly increasing and it is predicted that by the year 2025, an estimated 300 million people in the world will have the disease. One of the most common complications of diabetes is the development of lower extremity ulcers and in the U.S. about 15% of the almost 24 million diabetics, or 3.6 million people, will develop these wounds
"This new study shows that a history of diabetic foot ulcers is a predictor of mortality in diabetic patients. In addition to finding new ways to educate diabetic patients on how to avoid developing ulcers, it is also important to provide health care providers with a wide array of advanced care technologies to treat these wounds when they do occur. We recently announced the submission of our FDA 510(k) premarket notification of our Excellagen collagen protein-based wound management product candidate, which represents an important step forward in the commercialization of our Excellagen technology platform. Our advanced wound healing technology platform also involves Cardium's Gene Activated Matrix technology which covers DNA-based wound healing, as well as DNA-based orthobiologics," reported Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer
Gene Activated Matrix Technology Platform
Cardium recently reported on data from the Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on its Gene Activated Matrix technology platform. The study evaluated patients treated with the Excellarate product candidate (combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone compared to patients who received only the protocol specified standard of care. Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. The Company plans to schedule a meeting with the FDA in early 2010 to review the complete integrated data set and outline plans for a Phase 3 clinical study program designed to confirm the safety and effectiveness of Excellarate as compared to standard of care, since PDGF-B is known to contribute to the biologic process of wound healing and is itself an approved protein product for use in advanced wound care. Cardium believes that the combination of collagen and PDGF-B as provided by the Excellarate product candidate holds the potential to further promote wound healing in non-healing diabetic foot ulcers and other difficult-to-treat wounds
On December 3, 2009, the Company filed a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based in part on the positive data from the Company's Phase 2b clinical trial that demonstrated substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen. Excellagen(TM) is an advanced wound care device composed of highly-refined, soluble bovine dermal collagen (Type I), which is modified to reduce immunogenicity and promote its usefulness in wound settings. Excellagen is designed for use by health care professionals in patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds. The Company plans to develop additional new product opportunities by incorporating other agents into Excellagen formulations, including antimicrobials, DNA and/or other biologics, which are designed to address particular wound healing and other tissue repair applications
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the U.S. Food and Drug Administration will grant marketing clearance of the ExcellagenXL(TM) and ExcellagenFX(TM) product candidates or that we can successfully introduce these or additional products into advanced wound care markets; that Excellagen, Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellagen or Excellarate product candidate offers the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that the Matrix clinical study program or other human clinical trials can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved
For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics, Inc
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM)
are trademarks of Tissue Repair Company.
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/
DATASOURCE: Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations, Cardium
Therapeutics, Inc., +1-858-436-1018,
Web Site: http://www.cardiumthx.com/
Unilife Medical Solutions - Unilife Commences Development of Facility
Wed, 16 Dec 2009 09:40:00
http://wotnews.com.au/announcement/Unilife_Medical_Solutions_-_Unilife_Commences_Development_of_Facility/1023038/
EMCORE Corporation F4Q09 (Qtr End 09/30/09) Earnings Call Transcript
December 15, 2009
http://seekingalpha.com/article/178344-emcore-corporation-f4q09-qtr-end-09-30-09-earnings-call-transcript?source=feed
EMCORE Corporation Announces Unaudited Results for Its Fourth Quarter and Fiscal Year Ended September 30, 2009
Dec 15, 2009 16:00 ET
http://www.marketwire.com/press-release/Emcore-NASDAQ-emkr-1091378.html
Company Generates Positive Cash Flow From Operations for Second Consecutive Quarter; Consolidated Order Backlog Increases Over 26% to Approximately $63 million
ALBUQUERQUE, NM--(Marketwire - December 15, 2009) - EMCORE Corporation (NASDAQ: EMKR), a leading provider of compound semiconductor-based components, subsystems, and systems for the fiber optics and solar power markets, today announced unaudited financial results for its fourth quarter and fiscal year ended September 30, 2009.
Quarterly Results:
Revenue:
Revenue for the fourth quarter of fiscal 2009 was $40.5 million, an increase of $2.0 million, or 5%, from $38.5 million reported in the immediately preceding quarter.
On a segment basis, fourth quarter revenue for the Photovoltaics segment was $16.4 million, an increase of $0.3 million, or 2%, from $16.1 million reported in the immediately preceding quarter with the increase due primarily to greater demand for terrestrial concentrated photovoltaic (CPV) products. The Photovoltaics segment accounted for 40% of the Company's consolidated fourth quarter revenue compared to 42% in the preceding third fiscal quarter.
Fourth quarter revenue for the Fiber Optics segment was $24.1 million, an increase of $1.7 million, or 8%, from $22.4 million reported in the immediately preceding quarter with the increase concentrated primarily in the CATV product lines. The Fiber Optics segment accounted for 60% of the Company's consolidated fourth quarter revenue compared to 58% in the preceding third fiscal quarter.
Gross Profit:
On a GAAP basis, the consolidated gross profit for the fourth quarter was $4.1 million, an improvement of $6.5 million from a $2.4 million gross loss reported in the immediately preceding quarter and a $0.5 million gross loss reported in the prior year period. The $4.1 million fourth quarter gross profit represents the Company's best gross profit performance since the third quarter of fiscal 2008.
On a segment basis, fourth quarter Photovoltaics GAAP gross margin was 28.5%, a decrease from a record 33.9% gross margin reported in the preceding quarter with the decrease due primarily to product mix and one-time yield excursion for certain products. On a non-GAAP basis, the fourth quarter Photovoltaics gross margin was 10.6%, a decrease from a record 33.9% gross margin reported in the preceding quarter with the decrease due primarily to the sale during the fourth quarter of $2.9 million in previously fully-reserved legacy CPV products.
Fourth quarter Fiber Optics non-GAAP gross margin was 13.0%, a significant increase from a 1.9% non-GAAP gross margin reported in the preceding quarter with the improvement due primarily to higher margins in the Company's broadband product lines. On a GAAP basis, the fourth quarter Fiber Optics gross margin was negative 2.5%, a significant improvement from a negative 35.2% gross margin reported in the preceding quarter with the increase due primarily to a lower loss being recorded on firm inventory purchase commitments and lower inventory excess and obsolescence charges when compared to the preceding quarter. During the quarter, the Fiber Optics segment recorded approximately $2.0 million in non-cash losses on firm inventory purchase commitments and $2.0 million in non-cash inventory reserve adjustments, both of which adversely impacted gross profit and margins.
Net Loss:
On a GAAP basis, the consolidated net loss for the fourth quarter was $13.5 million, a $31.8 million improvement from a net loss of $45.3 million reported in the preceding quarter. After excluding certain non-cash and other adjustments as set forth in the attached non-GAAP tables, the fourth quarter consolidated non-GAAP net loss was $9.1 million, a $1.8 million increase from a $7.3 million net loss reported in the preceding quarter.
On a GAAP basis, the fourth quarter net loss per share was $0.17, an improvement of $0.40 per share from a $0.57 net loss per share reported in the preceding quarter. On a non-GAAP basis, the fourth quarter net loss per share was $0.11, an increase of $0.02 per share from a $0.09 loss per share reported in the preceding quarter.
Fiscal Year Results:
For the fiscal year ended September 30, 2009, consolidated revenue totaled $176.4 million compared to $239.3 million in the prior year. On a segment basis, annual revenue for the Photovoltaics segment totaled $62.2 million compared to $68.0 million in the prior year while annual revenue for the Fiber Optics segment totaled $114.1 million compared to $171.3 million in the prior year.
On a GAAP basis, the fiscal 2009 consolidated gross loss totaled $3.8 million compared to a gross profit of $29.9 million in the prior year. On a segment basis, annual Photovoltaics GAAP gross margins improved from a negative 8.3% to a positive 13.6%, while the Fiber Optics GAAP gross margins decreased from 20.7% in fiscal 2008 to a negative 10.7% in fiscal 2009.
On a GAAP basis, the Company's fiscal 2009 net loss totaled $136.1 million, including $60.8 million in non-cash impairment charges, compared to a net loss of $80.9 million in fiscal 2008. This represents a net loss per share of $1.72 in fiscal 2009 compared to a net loss per share in fiscal 2008 of $1.20 per share.
Order Backlog:
As of September 30, 2009, the Company had a consolidated order backlog of approximately $62.6 million, a $13.0 million, or 26%, increase from a $49.6 million order backlog reported as of the end of the preceding quarter. On a segment basis, the quarter-end Photovoltaics order backlog totaled $47.7 million, an $11.5 million, or 32%, increase from $36.2 million reported as of the end of the preceding quarter. The quarter-end Fiber Optics order backlog totaled $14.9 million, a $1.5 million, or 11% increase from $13.4 million reported as of the end of the preceding quarter. The fourth quarter is the second consecutive quarter wherein the Company's order backlog for both its Photovoltaics and Fiber Optics segments has increased. Order backlog is defined as purchase orders or supply agreements accepted by the Company with expected product delivery and / or services to be performed within the next twelve months.
Cash Flow:
During the fourth quarter, the Company generated $0.9 million in cash from operations due to the combination of a lower cash operating loss and the continuation of improved working capital management. The fourth quarter represents the second consecutive quarter that the Company has been cash flow positive from operations and the third consecutive quarter that the Company has generated cash from reductions in both inventories and accounts receivable. For the fiscal year ended September 30, 2009, the Company generated $32.4 million in cash from lowering both inventory and accounts receivable levels while paying down $27.4 million in accounts payable.
Balance Sheet Highlights:
As of September 30, 2009, cash, cash equivalents, and restricted cash totaled approximately $15.5 million which represents a $5.7 million, or 58%, increase from $9.8 million as of the end of the preceding quarter, and net working capital totaled $37.5 million.
Liquidity Update:
In addition to generating positive cash flow from operations over the last two quarters, the Company maintains a $14 million credit facility with Bank of America and, immediately subsequent to the end of the fourth quarter; the Company closed a two-year $25 million committed equity line of credit facility with the Commerce Court Small Cap Value Fund, Ltd. In addition, the Company continues to pursue and evaluate other capital raising alternatives, product joint-venture opportunities and the potential separation of certain portions of the Company's business.
Business Outlook:
For the first quarter of fiscal 2010 ending December 31, 2009, the Company expects consolidated revenue to be in the range of $41million to $43 million with increases in both the Photovoltaics and Fiber Optics segments.
Annual Report:
As a result of the additional time necessary to complete the compilation and audit of the Company's financial statements, the Company filed a Form 12b-25 requesting an extension to file its Annual Report on Form 10-K for the fiscal year ended September 30, 2009 with the Securities and Exchange Commission. The Company believes that it will be able to file its Form 10-K for the fiscal year ended September 30, 2009 within the fifteen calendar day period provided under Rule 12b-25(b).
Conference Call:
EMCORE will discuss its unaudited results for its fourth quarter and fiscal year ended September 30, 2009 on a conference call to be held on Tuesday, December 15, 2009 at 5:00 pm ET. To participate in the conference call, U.S. callers should dial (toll free) 877-857-6176 and international callers should dial 719-325-4880. The access code for the call is 4486919. A replay of the call will be available beginning December 15, 2009 at 8:30pm ET until December 22, 2009 at 11:59 pm ET. The replay call-in number for U.S. callers is 888-203-1112 and is 719-457-0820 for international callers. The access code for the replay call-in number is 4486919. The conference call also will be webcast via the Company's website at http://www.emcore.com. Please go to the site beforehand to download any necessary software.
NEXM - Conference Call
http://ih.advfn.com/p.php?pid=nmona&article=40758606&symbol=NEXM
The Company will hold a conference call to discuss the closing of the Bio-Quant acquisition tomorrow, Tuesday, December 15, 2009 at 3:30 pm EST. The call can be accessed in the U.S. by dialing 877-407-0778 and outside of the U.S. by dialing 201-689-8565 and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week in the U.S. by dialing 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 339648 are both required for playback. The conference call will also be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=153616.
NEXM - Conference Call
http://ih.advfn.com/p.php?pid=nmona&article=40758606&symbol=NEXM
The Company will hold a conference call to discuss the closing of the Bio-Quant acquisition tomorrow, Tuesday, December 15, 2009 at 3:30 pm EST. The call can be accessed in the U.S. by dialing 877-407-0778 and outside of the U.S. by dialing 201-689-8565 and asking the conference operator for the NexMed Conference Call. The teleconference replay is available for one week in the U.S. by dialing 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay pass codes 286 and 339648 are both required for playback. The conference call will also be Webcast live at URL http://www.investorcalendar.com/IC/CEPage.asp?ID=153616.
NexMed Closes Acquisition of Bio-Quant
Date : 12/14/2009 @ 3:54PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=40758606&symbol=NEXM
...AH: $.47 !
IBOX updated!
CXM - Annual Wound Healing Conference Presentation (12/11/09)
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MjM4MzJ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
Annual Wound Healing Conference Presentation (12/11/09)
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MjM4MzJ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
Unilife Medical (ASX: UNI.AX) (UNIFF.PK): Recent Sell-Off Unwarranted, Quick Rebound Likely
Written by Mike Havrilla
Sunday, 13 December 2009 13:14
http://biomedreports.com/articles/most-popular/21859-unilife-medical-asx-uniax-uniffpk-recent-sell-off-unwarranted-quick-rebound-likely.html
Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing services.
Last Thursday afternoon, a large block of stock (over 1 million shares) hit the tape, sending Unilife's primary ASX stock listing from around $1 to 87 cents before recovering about half of this loss and settling back to the mid 90 cent range. While there is no fundamental reason for the initial 13% plunge given all of the positive developments at the Company, a large holder of Unilife's stock apparently had another, unrelated reason to unload the stock before year-end ahead of the holidays and expected slowdown in trading volume from the current average of about 1.5 million shares per day on the ASX.
The following are some key milestones that Unilife expects to achieve over the next year:
1.) the commercial release of Unitract 1mL plastic safety syringes in early 2010;
2.) complete negotiations with Sanofi-Aventis (NYSE: SNY) by end of February for Unifill therapeutic class exclusivity;
3.) redomiciliation to the U.S. (Central Pennsylvania) and NASDAQ stock listing (ticker will be UNIS) expected by end of February;
4.) complete the Unifill industrialization program by the end of 2010 (one year ahead of original plan) with initial production goal of 60 million units per year and projected increases to approximately 150 million units annually by 2012, and over 400 million units annually by 2014 and beyond; and
5.) agreement(s) are possible as early as mid-2010 with additional pharmaceutical companies for Unifill pre-filled syringes outside of the exclusive therapeutic categories agreed upon with SNY.
More than 2 billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000) in the U.S. (enforced by OSHA) with Europe expected to follow with similar regulations by 2012 based on the model that is currently enforced in Germany. The Unitract product line-up includes plastic safety syringes as 1mL fixed-needle + 3mL and 5mL attachable needles while the Unifill product line-up includes a glass ready-to-fill solution with both fixed needle and attachable options for medications delivered by pre-filled syringes.
A strong resistance to change and high barrier to entry exists for competitors in the medical device / safety syringe market because once supply contracts are agreed upon and products receive marketing clearance; there is little incentive to change components (e.g. a pre-filled syringe) since this would require a new approval process to certify the new components being utilized. The unique features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes are outlined below and the Company has a major advantage and pending customer in the form of SNY along with a strategic plan that targets companies with new products in development that are designed for delivery through pre-filled syringes.
1.) a passive needle retraction system that is activated inside the body
2.) healthcare providers / shot administrators control the speed of needle retraction
3.) auto-disabling prevents the re-use or tampering of used syringes
The market opportunity for prefilled syringes includes over 50 medications (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including a projected 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features, adding to the manufacturing and shipping costs while significantly increasing the overall packaging size (i.e. Unifill reduces packaging volume for drug products by 60% without the need for ancillary safety instruments that must be attached / assembled as with standard prefilled syringes), resulting in both waste disposal and marketing issues.
In mid-August, Unilife announced that it has commenced U.S. production of the Unitract 1mL Insulin Syringe at its FDA-registered manufacturing facility in Pennsylvania. The Company's automated assembly system is now rated at up to 90% of efficiency and Unilife will continue to work towards achieving the optimum productivity rate for this assembly system of about 40 million units per year. Unilife is building inventory to fulfill current and anticipated orders for the Unitract 1mL Syringes, which has already received key regulatory certifications for use in major markets such as the U.S., Canada, Europe, and Australia.
The Company's strategic partner for exclusive manufacturing and distribution of sharps safety products is Shanghai Kindly Enterprise Development Group (KDL). This facility currently produces Unitract 1mL syringes and blood collection safety devices using semi-automated assembly systems developed and qualified by Unilife. KDL is the second largest medical device manufacturer in China and has two-thirds market share of the Chinese needle market, manufacturing over 5 billion needles and 600 million syringes per year while serving as a key partner for the Asia-Pacific region.
The key strategic business partner for Unilife is Sanofi-Aventis, which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company (Griffin Securities estimates that SNY purchases 40% of all pre-filled syringes on a global basis). This key partnership provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of initial commercial demand for Unifill in 2011 with an initial production target of 60 million units per year.
In July, Unilife and SNY agreed to a five-year exclusive licensing agreement for Unifill. SNY is paying A$46M for the right to negotiate purchase of the Unifill RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class. While the therapeutic exclusivity agreement (expected by February) will not be disclosed to the public to protect Sanofi's R&D pipeline; blood thinners and vaccines are two major product segments for SNY that are obvious inclusions and agreements that are announced with other companies will provide this information over time.
The industrialization program was originally intended to be completed by the end of 2011, but it is proceeding ahead of schedule so that both parties have agreed to bring its scheduled completion date forward to the end of 2010 (an entire year ahead of schedule). Unilife is scheduled to commence supply of Unifill RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system, and the design of this first line will also be used to develop a higher-volume automated assembly system scheduled to be completed by the end of 2011.
In November, Unilife announced the appointment of Mikron Group as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill ready-to-fill syringe. This high-volume automated assembly system is anticipated to have an annual production capacity greater than 100 million units and Unilife has a target production plan for the RTFS of about 400 million units per year beyond 2014.
Mikron was chosen after an extensive due diligence process by Unilife that began with the evaluation of 30 automated assembly partner candidates. The initial list was narrowed down to five suppliers that were each visited and asked to submit proof of principle samples for their high-volume, automated manufacturing systems before Mikron was ultimately chosen by Unilife. The high-volume manufacturing system is scheduled for delivery by October 2010 as part of finalizing the industrialization agreement between Unilife and SNY that is targeted for the end of next year.
In addition, the centralization of RTFS production activities within Central PA will reduce the Company's operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply the RTFS to all of its anticipated customers while leveraging the Company's strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs. In late October, Unilife announced the acceptance of a US$5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County as part of the Company's relocation of its global headquarters and manufacturing facilities to Central PA.
In late October Unilife also announced that CEO Alan Shortall purchased 479,800 shares of the Company's stock on the open market at an average price of A$1.026 per share and the CEO has authorized his broker to purchase additional shares that will bring the total number of shares purchased to over 500,000. Mr. Shortall commented that he elected to purchase the shares in the open market rather than participate in the Company's private placement from earlier in the month (conducted at a 7.7% discount to the market price at the time) as a sign of confidence to shareholders by purchasing at regular market prices.
Unilife announced a A$42.1M capital raise to accelerate the expansion of its operational capabilities, production facilities, and equipment requirements in the U.S., in addition to completing the industrialization program for Unifill. Unilife also plans to expedite the commercialization of additional pipeline products with other interested major pharmaceutical companies with whom the Company is currently in discussions. Finally, the proceeds of the capital raise will ensure adequate cash reserves leading to the U.S. relocation and planned NASDAQ listing for the stock.
The expected NASDAQ primary stock listing by February as ticker ‘UNIS' is not a capital raising event as Unilife already enjoys a strong balance sheet with A$55.7 million in cash and additional sources of revenue such as pending milestone payments from SNY, commercial release of Unitract syringes, and the pending sale of Unifill to SNY starting in 2011. Unilife has been listed on the Australian Stock Exchange (ASX) since 2002 with approximately 310 million shares outstanding and 8,000 shareholders at this time.
A shareholder meeting and vote will be conducted on 1/8/10 to approve a proposed transaction whereby Unilife USA will replace Unilife Australia as the entity which is listed on the ASX. Unilife Australia shareholders will receive common stock or CHESS Depositary Interests (CDIs) in Unilife USA. The CDIs will trade on ASX and are analogous to American Depository Receipts (ADRs), which represent ownership stakes in foreign companies that trade on U.S. financial exchanges. Unilife USA will seek a NASDAQ listing under ticker ‘UNIS' and six CDIs will be equivalent to one ordinary share in Unilife USA. Given the current foreign exchange ratio of approximately A$1 to US$0.91, a share price of $1 for the ASX stock listing would translate into $5.46 per share for Unilife USA when it begins trading on the NASDAQ (= $1 share price for CDIs on ASX * 6 * 0.91 for-ex ratio).
NEXM BREAKOUT !
Cardium Presents at Tenth Annual Wound Healing: Science and Industry Conference on Matrix Wound Healing Clinical Development
Date : 12/14/2009 @ 9:15AM
Source : PR Newswire
Stock : (CXM)
http://ih.advfn.com/p.php?pid=nmona&article=40752919&symbol=CXM
Cardium Presents at Tenth Annual Wound Healing: Science and Industry Conference on Matrix Wound Healing Clinical Development
Date : 12/14/2009 @ 9:15AM
Source : PR Newswire
Stock : (CXM)
http://ih.advfn.com/p.php?pid=nmona&article=40752919&symbol=CXM
SAN DIEGO, Dec. 14 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) announced a presentation titled, "Phase 2b Study of GAM501 (Ad5PDGF-B/Collagen) in the Treatment of Diabetic Ulcers," at the Tenth Annual Wound Healing: Science and Industry Conference held December 10-13, 2009 in St. Thomas, U.S. Virgin Islands. The conference is attended by top industry leaders and renowned researchers in the field of advanced wound healing. Dr. Barbara K. Sosnowski, Cardium's Vice President of Biologics Development and the Chief Operating Officer of Cardium's wholly-owned subsidiary, the Tissue Repair Company, presented data from the recently completed Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of non-healing diabetic ulcers, as well as data from the Phase 1/2 Excellarate clinical study which was published in the November-December 2009 Wound Repair and Regeneration, a peer-reviewed journal of the Wound Healing Society. In addition, Dr. Sosnowski discussed the Company's plans for the reformulation of Excellarate and its new Excellagen(TM) product candidate. The presentation slides can be accessed at the Investors section of Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
On December 3, 2009, the Company filed a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company's recently completed Phase 2b Matrix clinical study that demonstrated substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen, an enhanced, customized collagen-based gel matrix. The application filed with the FDA covers ExcellagenXL(TM) and ExcellagenFX(TM), advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds. The Company also plans to develop and introduce additional new product opportunities by incorporating other agents into the Excellagen formulation, including antimicrobials, DNA and/or other biologics, which will be designed to address particular wound healing and other tissue repair applications
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the U.S. Food and Drug Administration will grant marketing clearance of the ExcellagenXL(TM) and ExcellagenFX(TM) product candidates or that we can successfully introduce these or additional products into advanced wound care markets; that Excellagen, Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellagen or Excellarate product candidate offers the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that the Matrix clinical study program or other human clinical trials can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved
For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics, Inc
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM) are trademarks of Tissue Repair Company.
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/
DATASOURCE: Cardium Therapeutics
CONTACT: Press and Investors, Bonnie Ortega, Director, Investor/Public
Relations for Cardium Therapeutics, Inc., +1-858-436-1018,
Web Site: http://www.cardiumthx.com/
Christmas time - part2
Looney Tunes "Jingle Bells"
...because it's christmas time!
Mariah Carey "All I want for Christmas is you"
added as an Assistant : CEOA1US
...updated
EMCORE Corporation to Report Fiscal 2009 Fourth Quarter and Year-End Results on Tuesday, December 15, 2009
Date : 12/08/2009 @ 7:42PM
Source : MarketWire
Stock : EMCORE (EMKR)
http://ih.advfn.com/p.php?pid=nmona&cb=1260618541&article=40690427&symbol=N^EMKR
ALBUQUERQUE, NM -- (Marketwire) -- 12/08/09 --
EMCORE Corporation (NASDAQ: EMKR), a leading provider of compound semiconductor-based components and subsystems for the fiber optics and solar power markets, will announce its fiscal 2009 fourth quarter and year-end results for the period ended September 30, 2009 on Tuesday, December 15, 2009 after market close. A conference call discussing the results is scheduled for Tuesday, December 15, 2009 at 5:00pm ET
Conference Call Information:
To participate in the conference call, U.S. callers should dial (toll free) 877-857-6176 and international callers should dial 719-325-4880. The access code for the call is 4486919. A replay of the call will be available beginning December 15, 2009 at 8:00pm ET until December 22, 2009 at 11:59 pm ET. The replay call-in number for U.S. callers is 888-203-1112 and is 719-457-0820 for international callers. The access code for the replay call-in number is 4486919. The conference call also will be webcast via the Company's website at http://www.emcore.com. Please go to the site beforehand to download any necessary software
About EMCORE:
EMCORE Corporation offers a broad portfolio of compound semiconductor-based products for the broadband, fiber optics, satellite and solar power markets. EMCORE's Fiber Optics segment offers optical components, subsystems and systems for high speed data and telecommunications networks, cable television (CATV) and fiber-to-the-premises (FTTP). EMCORE's Photovoltaics segment provides products for both satellite and terrestrial applications. For satellite applications, EMCORE offers high efficiency gallium arsenide (GaAs) solar cells, covered interconnect cells (CICs) and panels. For terrestrial applications, EMCORE is adapting its high-efficiency GaAs solar cells for use in solar concentrator systems. For further information about EMCORE, visit http://www.emcore.com
Promising Companies for 2010 provided byFortuneonCNNMoney.com
by Katie Benner, Scott Cendrowski, Mina Kimes, and Marilyn Adam
Friday, December 11, 2009
http://finance.yahoo.com/retirement/article/108354/promising-companies-for-2010;_ylt=Aky1.utbyyjjvDct5981I61O7sMF;_ylu=X3oDMTE1ODlyZjJsBHBvcwMzBHNlYwN3ZWVrZW5kRWRpdGlvbgRzbGsDcmVhZG1vcmU-?mod=retire-planning