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>IDRA< Idera Pharmaceuticals Achieves Clinical Milestone Under Its Collaboration with Merck KGaA for Cancer Treatment
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7854244
Idera Pharmaceuticals Incorporated
IDRA | 8/27/2010 9:20:00 AM
- Clinical Trial Initiated in First-Line Treatment of Patients with Head and Neck Cancer --
CAMBRIDGE, Mass., Aug 27, 2010 (BUSINESS WIRE) --
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon Merck KGaA's initiation of a Phase 1b clinical trial of IMO-2055 (EMD 1201081), an agonist of Toll-like Receptor 9 (TLR9), in combination with cisplatin, fluorouracil and cetuximab (Erbitux(R)) in first-line treatment of patients with squamous cell carcinoma of the head and neck (SCCHN). Under the terms of the agreement, Idera is entitled to receive a payment of EUR3.0 million (approximately $3.8 million) from Merck KGaA.
"We are very pleased that Merck KGaA has initiated a clinical trial to evaluate IMO-2055 in the first-line treatment of patients with head and neck cancer," said Tim Sullivan, Ph.D., Idera's Vice President of Development Programs and Alliance Management. "The first-line trial is in addition to the Phase 2 clinical trial announced earlier this year to evaluate IMO-2055in second-line treatment of patients with recurrent or metastatic SCCHN."
About the Collaboration
Idera Pharmaceuticals entered into a worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany in December 2007 for the research, development and commercialization of Idera's Toll-like Receptor 9 (TLR9) agonists, including IMO-2055, for the potential treatment of cancers. In addition to the clinical study announced today, under the company's collaboration with Merck KGaA, IMO-2055 is being evaluated in a Phase 2 clinical trial in combination with Erbitux(R) in second-line patients with recurrent or metastatic SCCHN, in a Phase 1b clinical trial in combination with erlotinib (Tarceva(R)) and bevacizumab (Avastin(R)) in patients with advanced non-small cell lung cancer and in a Phase 1b clinical trial in combination with Erbitux(R) and an irinotecan-containing treatment regimen in patients with colorectal cancer.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. Our proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors that direct immune system responses. Our pioneering DNA and RNA chemistry expertise enables us to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit www.iderapharma.com.
Ambac Withdraws Plans for $1B Offering
08/26/10 - 05:17 PM EDT
by Michael Baron
http://www.thestreet.com/story/10845871/1/ambac-withdraws-plans-for-1b-offering.html?puc=_tscrss
NEW YORK (TheStreet) -- Ambac Financial Group(ABK) has withdrawn plans filed more than a year ago for the sale of up to $1 billion worth of securities.
The New York City-based company, whose mortgage bond insurance business remains hamstrung from the financial crisis, said in a filing with the Securities and Exchange Commission after Thursday's closing bell that it was withdrawing the S-3 registration statement it filed on April 1, 2009 because it has been unable to meet a deadline to file its 10-K for fiscal 2009, rendering it ineligible to issue securities.
Ambac shares finished Thursday's session down 5 cents, or 8.5%, at 49 cents on volume of 7.6 million, less than half the issue's trailing three-month daily average of 17.8 million. The volatile stock is down more than 50% since the start of 2010, but it was trading above $1 as recently as July 27.
The company has been the subject of speculation about a possible filing for bankruptcy protection for months, and it first raised the possibility of pursuing a prepackaged bankruptcy plan when it filed ts 10-Q for the third quarter of fiscal 2009 back in November of last year.
An Ambac spokesperson wasn't immediately available for comment.
--Written by Michael Baron in New York.
ThermoGenesis Announces Reverse Stock Split Effective on NASDAQ Capital Market August 27, 2010
Date : 08/26/2010 @ 12:30PM
Source : PR Newswire
Stock : Thermogenesis (MM) (KOOL)
http://ih.advfn.com/p.php?pid=nmona&article=44151217&symbol=KOOL
ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said it has filed a Certificate of Amendment to its Amended and Restated Certification of Incorporation to effect its previously announced one-for-four reverse stock split of its common stock.
The split-adjusted shares of the Company's common stock will begin trading on the NASDAQ tomorrow. The Company's shares will continue to trade under the symbol "KOOL," with a "D" added for 20 trading days to signify the reverse stock split has occurred. A new CUSIP number has been assigned to the Company's common stock as a result of the reverse stock split.
The one-for-four reverse stock split will convert all shares of the Company's common stock issued and outstanding, plus all outstanding stock options, restricted stock and the number of shares of common stock available for issuance under the Company's approved stock plans.
The reverse split was approved by the Company's stockholders at a special meeting and authorized by its Board of Directors on August 9, 2010. It will reduce the Company's outstanding common stock from approximately 56.1 million shares, as of its most recent quarterly report on Form 10-Q, to approximately 14.0 million shares.
...
ThermoGenesis Announces Reverse Stock Split Effective on NASDAQ Capital Market August 27, 2010
Date : 08/26/2010 @ 12:30PM
Source : PR Newswire
Stock : Thermogenesis (MM) (KOOL)
http://ih.advfn.com/p.php?pid=nmona&article=44151217&symbol=KOOL
ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said it has filed a Certificate of Amendment to its Amended and Restated Certification of Incorporation to effect its previously announced one-for-four reverse stock split of its common stock.
The split-adjusted shares of the Company's common stock will begin trading on the NASDAQ tomorrow. The Company's shares will continue to trade under the symbol "KOOL," with a "D" added for 20 trading days to signify the reverse stock split has occurred. A new CUSIP number has been assigned to the Company's common stock as a result of the reverse stock split.
The one-for-four reverse stock split will convert all shares of the Company's common stock issued and outstanding, plus all outstanding stock options, restricted stock and the number of shares of common stock available for issuance under the Company's approved stock plans.
The reverse split was approved by the Company's stockholders at a special meeting and authorized by its Board of Directors on August 9, 2010. It will reduce the Company's outstanding common stock from approximately 56.1 million shares, as of its most recent quarterly report on Form 10-Q, to approximately 14.0 million shares.
"We appreciate the support of our stockholders in approving this authorization," said J. Melville Engle, Chief Executive officer of ThermoGenesis. "We ended fiscal 2010 in strong fashion and believe the programs we have in place will result in a successful fiscal 2011 and lead to enhanced long term stockholder value as we continue our focus on the development of enabling technologies for the stem cell regenerative medicine market," he added.
The Company said a reverse split may enable it to meet the continued listing rules of the NASDAQ Capital Market, and could serve to improve the marketability and liquidity of its common stock over the long term. In order to maintain its listing on NASDAQ, the Company's common stock must have a closing bid price of $1.00 or more for a minimum of ten consecutive trading days, on or before September 13, 2010.
Computershare Trust Company, together with its affiliate Computershare, Inc., the transfer agent for the Company, will act as Exchange Agent for the exchange. Stockholders will receive the forms and notices to exchange their existing shares for new shares from the Exchange Agent or their broker. No fractional shares will be issued if, as a result of the reverse stock split, a registered stockholder will otherwise become entitled to a fractional share. Instead, stockholders who otherwise would be entitled to receive fractional shares because they hold a number of shares not evenly divisible by four, will automatically be entitled to receive an additional share of common stock as a fractional share will be rounded up to the nearest whole number. Additional details related to the reverse stock split may be obtained from the Company's Proxy Statement dated June 29, 2010. A copy of the Proxy Statements is available on the Company's web site under SEC filings at www.thermogenesis.com.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include:
* The BioArchive® System, an automated cryogenic device, is used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
* AXP® AutoXpress™ Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP™ MarrowXpress™ and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting.
* The Res-Q™ 60 BMC (Res-Q), a point-of-care system that is designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates.
* The CryoSeal® FS System, an automated device and companion sterile blood processing disposable, is used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the U.S. for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which allows sales of the product throughout the European community.
This press release contains forward-looking statements, and such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors, including timing of FDA approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal years 2010 and 2011, and introduction of competitive products and other factors beyond our control, could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2010 and 2011. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
ThermoGenesis Corp.
Web site: http://www.thermogenesis.com
Contact: Investor Relations
+1-916-858-5107, or
ir@thermogenesis.com
SOURCE ThermoGenesis Corp.
NexMed To Present at the Rodman & Renshaw 12th Annual Healthcare Conference
Date : 08/25/2010 @ 11:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=44133418&symbol=NEXM
NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT® drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, today announced that Dr. Bassam Damaj, President and Chief Executive Officer, will present at the Rodman & Renshaw 12th Annual Healthcare Conference at 10:25am ET on Tuesday, September 14, 2010, in the Winslow Salon on the 5th floor of the New York Palace Hotel in New York City.
The Company’s presentation will be available via webcast and can be accessed at: http://www.wsw.com/webcast/rrshq18/nexm.
About NexMed, Inc.
Backed by a solid, revenue generating CRO business, NexMed has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth will be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, 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.
EMC Helped Quantum, May Buy Company Outright Now
Posted on 08/24/10 at 12:00pm
http://www.benzinga.com/markets/company-news/10/08/439173/emc-helped-quantum-may-buy-company-outright-now-emc-qtm
EMC (NYSE: EMC) helped out Quantum (NYSE: QTM) with a $100 million lifeline.
Now there is chatter that EMC may eventually buy the company outright. This comes as the war between Dell (NASDAQ: DELL) and Hewlett-Packard (NYSE: HPQ) intensifies over 3Par (NYSE: PAR).
Quantum has three times the revenue that 3Par does, and has a much smaller market cap, at nearly 300 million. This compares to the $1.2 billion for 3Par.
In addition to the rumors that EMC may buy Quantum, last year the data storage company provided Quantum with a $100 million lifeline to essentially keep the company afloat.
It looks like now that the company may eventually be swallowed up into EMC.
Catalent, Sunesis sign Phase 3 Valor clinical trial supply services agreement
Published: 25-Aug-2010
Catalent Pharma Solutions and Sunesis Pharmaceuticals have signed clinical supply services agreement to support Sunesis’ pivotal Phase 3 Valor trial of Vosaroxin in first relapse or primary refractory acute myeloid leukemia (AML).
Catalent is expected to provide expertise in labeling and kitting of the clinical trial materials to be used in Sunesis’ multinational trial, and will provide supply chain support to clinical sites.
Catalent said that as part of its development and clinical services segment, the clinical packaging and logistics will be handled in Catalent’s Philadelphia, PA and Schorndorf, Germany facilities.
Sunesis Pharma CEO Daniel Swisher said that as they continue to make important strides towards ensuring that the pivotal Phase 3 Valor trial is a well-executed study and work diligently on its timely launch, a key to their progress is their clinical supply partnership with Catalent Pharma Solutions.
Catalent clinical supply services vice president and general manager Frank Lis said that they were pleased to work with Sunesis in providing clinical supply services support for Vosaroxin and the Valor trial, and that they were confident that Catalent’s integrated solution will help Sunesis advance this important compound.
http://contractservices.pharmaceutical-business-review.com/news/catalent_sunesis_sign_phase_3_valor_clinical_trial_supply_services_agreement_100825/
Judge’s decision has broad implications for generic versions of biologic drugs and companies who make them
Written by Patrick Crutcher
Wednesday, 25 August 2010 02:23
http://biomedreports.com/articles/most-popular/51615-judges-decision-has-broad-implications-for-biosimilars-companies-.html
A judge’s decision will have vast implications for some of the biosimilar companies in the healthcare sector.
Shareholders of Sanofi-Aventis (NASDAQ:SNY) and Momenta Pharmaceuticals (NASDAQ:MNTA) are anxiously awaiting a judge’s decision on whether to block the sale of a generic version of SNY’s blockbuster Lovenox. This comes after MNTA gained FDA approval for their generic version of Lovenox, a biologic-like blood thinner, and SNY later sought a temporary restraining order and preliminary injunction directing the FDA to suspend and withdraw its approval of MNTA’s generic version. Many were caught off guard, since this was the first approval of a generic version of a complex-drug like Lovenox in over 10 years.
To be specific, biosimilars or follow-on biologics are essentially generic versions of biologic drugs. Essentially, biologics are genetically engineered proteins derived from genes(human, animal, micro-organism) and involve some type of biological process to produce the medicinal product. As you can tell, these are incredibly complex-drug process, which are vastly different from creating copycat versions of typical drugs that usually only involve chemical processes. This is why the significance of MNTA’s approval is shaking the market and causing SNY to seek legal action.
The implications for MNTA and other biosimilar companies are far reaching and complex. If the judge throws out the case, MNTA and their partner Sandoz of Novartis (NASDA:NVS) will be cleared to compete with Lovenox, which had worldwide sales of $4 billion and 60% of that was in the US. They are planning on selling their generic version at roughly 30-35% less than Lovenox’s price. MNTA also has a great pipeline full of other potential blockbuster biosimilars, so they want all the cash they can get to pay their development. MNTA has another biosimilar awaiting FDA approval – M356(partnered with Sandoz), which is a biosimilar of TEVA’s $2.8 billion blockbuster Copaxone. Additionally, they have M118, a novel anti-coagulant for patients with acute coronary syndrome and M402, a novel preclinical anti-cancer compound with anti-metastatic properties and low anticoagulant activity.
This will also set precedence for other biosimilar type companies seeking to compete with other blockbuster drugs that are close to coming off patent protection, in particular, Teva’s (NASDAQ:TEVA) $2.8 billion blockbuster Copaxone and Amgen’s Procrit/Epogen and Enbrel which had US sales of over $6.5 billion. These will certainly be main targets in the follow-on biologics war that is coming and other big pharmas have taken notice. In late 2009, Insmed Inc.(NASDAQ:INSM) sold off their follow-on biologics unit to Merck (NASDAQ:MRK) for $123M. A positive result from the case could also lead to more mergers and acquisitions in this biotech area, since some of the larger pharmas have expressed great interest in this area. Pfizer has expressed great interest in this area and Teva Pharmaceutical (Nasdaq: TEVA), Novartis (NYSE: NVS), and Hospira (NYSE: HSP) already have approvals in the European Union for biogenerics. Companies like Protalix BioTherapeutics Inc. (AMEX: PLX), Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), PROLOR Biotech Inc. (AMEX: PBTH), Intellipharmaceutics (NasdaqCM: IPCI), and even iBio, Inc. (OTC: IBPM.OB) would certainly benefit from a positive opinion on the case. These companies pipelines and prospects would certainly warrant further attention from large pharmas.
A positive ruling for SNY would certainly send MNTA back down to the $10 range, since their future would be tied up in the courts. It would also cast into doubt a clear approval pathway for biosimilars, since the Pathway for Biosimilars Act of 2009 and Patient Protection and Affordable Care Act of 2010 would certainly come into question under U.S. Judge Emmet Sullivan’s ruling, if SNY were favored in the case.
The judge claims that he plans on delivering a decision soon. I imagine most investors in MNTA or SNY are wound tight, since it is not clear which way he is leaning on the issue. MNTA and SNY also have to worry about TEVA being close on their generic version of Lovenox, which I am sure will be stalled until a decision is made. One thing is for sure, either big pharma wins or biosimilars are on the way.
Pipeline Covering An Existing $25 billion Market
http://www.prolor-biotech.com/?CategoryID=0&ArticleID=76
Human growth hormone ($3 billion market, entering Phase II) that could potentially be injected twice per month instead of daily injections. Interferon beta for multiple sclerosis ($4.5 billion market) that may have dramatically lower side effects. Our CTP-enhanced therapeutic proteins pipeline has the potential to dominate a $25 billion market. Our products are expected have significant competitive advantage over current therapies via reduced injection frequency and lower side effects. Our products will:
* Dramatically reduce the number of interventions required to achieve the same therapeutic effect from the same dosage; e.g. reduce the number of injections needed from a daily schedule to weekly.
* Gain extended patent protection as proprietary new formulations of existing therapies;
* Achieve faster commercialization with lower risks and costs than those typically associated with a new therapeutic protein; and
* Be manufactured using industry standard biotechnology based protein production processes.
Corporate Fact Sheet
Please open the PROLOR Biotech Corporate Fact Sheet by clicking
http://www.prolor-biotech.com/_Uploads/dbsAttachedFiles/PROLORCorporateFactSheet.pdf
Equity Research on YRC Worldwide and Con-Way -- Mixed Financial Results for Transportation & Logistics Providers
Date : 08/24/2010 @ 9:14AM
Source : MarketWire
Stock : StockCall (YRCW)
http://ih.advfn.com/p.php?pid=nmona&article=44116306
www.stockcall.com/ offers investors comprehensive research on the transportation & logistics industry and has completed analytical research on YRC Worldwide Inc. (NASDAQ: YRCW) and Con-Way Inc. (NYSE: CNW). Register with us today at www.stockcall.com/ to have free access to these researches.
During the recession significantly reduced shipping of goods caused the transportation and logistics industry to downsize. Trucking was hit especially hard, as about 2000 companies went out of business and others contracted the size of their fleets. However, with the rebound in the world economy there are now, ironically, concerns of shortages. Register now at https://stockcall.com/development/stockcall/page.php?name=register.html to have free access to our reports on the transportation & logistics industry.
www.stockcall.com/ is an online platform where investors doing their due-diligence on the transportation & logistics industry can have easy and free access to our analyst research and opinions on YRC Worldwide Inc. and Con-Way Inc.; investors and shareholders of these companies can simply register for a complimentary membership at https://stockcall.com/development/stockcall/page.php?name=register.html
PBTH - daily chart:
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
PROLOR Biotech Inc
PBTH | 8/24/2010 7:30:00 AM
NES-ZIONA, Israel, Aug 24, 2010 /PRNewswire via COMTEX News Network/ --
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850136
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850136
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
PROLOR Biotech Inc
PBTH | 8/24/2010 7:30:00 AM
NES-ZIONA, Israel, Aug 24, 2010 /PRNewswire via COMTEX News Network/ --
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850136
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides. For more information on PROLOR, visit www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
PROLOR CONTACT: MEDIA CONTACT: Shai Novik, President Barbara Lindheim PROLOR Biotech, Inc. GendeLLindheim BioCom Partners Tel: +1-866- 644-7811 +1-212-918-4650 Email: shai@prolor-biotech.com
SOURCE PROLOR Biotech, Inc.
Copyright (C) 2010 PR Newswire. All rights reserved
Study Published in the Journal Endocrinology Further Confirms Therapeutic Potential of PROLOR's Long-Acting Human Growth Hormone
PROLOR Biotech, Inc.
Monday August 2, 2010, 7:30 am EDT
http://finance.yahoo.com/news/Study-Published-in-the-prnews-3583197343.html?x=0&.v=1
NES-ZIONA, Israel, Aug. 2 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. PROLOR recently initiated a Phase II clinical trial of hGH-CTP, following a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
"The publication of this study in Endocrinology, considered to be one of the most authoritative biomedical research journals in the world, further validates the growing body of clinical and preclinical data supporting the ability of CTP technology to significantly extend the half-life and duration of action of therapeutic proteins," said Dr. Fuad Fares, lead author of the study and Chief Scientific Officer of PROLOR. "Therapeutic proteins are increasingly important treatments for a variety of diseases, and we believe the demonstrated ability of CTP technology to reduce the frequency of required injections could provide important benefits to the many patients who depend on these drugs. We look forward to completing the ongoing Phase II trial of hGH-CTP and anticipate initiating Phase III studies during 2011."
The publication is currently available on-line at: http://endo.endojournals.org/cgi/content/abstract/en.2009-1431v1. It will be published in the September print edition of Endocrinology as "Designing a Long-Acting Human Growth Hormone (hGH) by Fusing the Carboxyl-Terminal Peptide of Human Chorionic Gonadotropin Subunit to the Coding Sequence of hGH," Fuad Fares, Rachel Guy, Ahuva Bar-Ilan, Yana Felikman, and Eyal Fima, Endocrinology, September 2010.151(9).
ABOUT PROLOR'S hGH-CTP PHASE II CLINICAL TRIAL
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
ABOUT THE JOURNAL ENDOCRINOLOGY
Endocrinology has defined the science of endocrinology for most of the twentieth century. One of the most authoritative biomedical research journals in the world, it publishes 6,000 pages annually of the highest quality original work ranging from subcellular mechanisms to whole animal physiology. Topics include bone and mineral; growth factors; reproductive/steroids; neuroendocrinology/signal transduction; thyroid; and physiology. The low manuscript acceptance rate of 30% reflects the degree to which it is committed to the highest scientific standard.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides. For more information on PROLOR, visit www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
PROLOR CONTACT:
MEDIA CONTACT:
Shai Novik, President
Barbara Lindheim
PROLOR Biotech, Inc.
GendeLLindheim BioCom Partners
Tel: +1 866 644-7811
+1 212 918-4650
Email: shai@prolor-biotech.com
Celsion Receives Fast Track Designation for ThermoDox(R) Development Program to Treat Primary Liver Cancer
Celsion Corp
CLSN | 8/24/2010 8:00:00 AM
Supplements Special Protocol Assessment for Global Phase III HEAT Study
COLUMBIA, Md., Aug 24, 2010 /PRNewswire via COMTEX News Network/ --
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850192
Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, today announced that the U.S. Food and Drug Administration (FDA) has designated the HEAT Study of its investigational drug, ThermoDox(R), in combination with radiofrequency ablation (RFA), as a Fast Track Development Program. ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in a 600 patient global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. With nearly 70% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment by year end 2010.
"We are very pleased to receive the Agency's Fast Track Designation for ThermoDox," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder. It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease. Together with the FDA's SPA agreement, granting accelerated review for the HEAT Study, the Fast Track status provides Celsion with the shortest time to approval. Supported further by the National Cancer Institute's recent designation of the HEAT Study as a Priority Clinical Trial, it is clear that the major U.S. healthcare agencies and the liver cancer medical community recognize the potential of ThermoDox. We look forward to working with the FDA and other regulatory agencies around the world to make ThermoDox available to patients as soon as possible."
The FDA's Fast Track Development Program provides for expedited regulatory review for new drugs that treat serious or life threatening diseases which are not satisfactorily treated by existing therapies, or for drugs that provide a significant advantage over existing therapies for serious diseases. Under the Fast Track Designation, Celsion is now eligible to submit a U.S. New Drug Application (NDA) on a rolling basis. This permits the FDA to review sections of the NDA in advance of receiving the complete submission.
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately 1,000,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasing become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About ThermoDox(R)
ThermoDox(R) in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox(R) is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox(R) is being evaluated in a 600 patient global Phase III study at 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival and enrollment is expected to be completed by year end 2010. For recurrent chest wall breast cancer, ThermoDox(R) is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients across the United States and to complete the study by the first half of 2011. Additional information on the Company's ThermoDox(R) clinical studies may be found at http://www.clinicaltrials.gov
About Celsion
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Investor Contact Marcy Nanus The Trout Group 646-378-2927, mnanus@troutgroup.com
SOURCE Celsion Corporation
Copyright (C) 2010 PR Newswire. All rights reserved
AVI BioPharma Announces Positive Results Against Human Pandemic H1N1 Influenza Virus in Preclinical Studies of AVI-7100
AVI BioPharma Inc
AVII | 8/24/2010 8:03:16 AM
AVI-7100 Demonstrates Statistically Significant Activity Versus Saline and Tamiflu(R) Controls, Up to 3.9 Log Greater Reduction in Average Viral Titer AVI BioPharma and US Department of Defense Conduct Successful Rapid Response Exercise Against Real-World Threat, Pandemic H1N1 Virus
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850181
BOTHELL, WA, Aug 24, 2010 (MARKETWIRE via COMTEX News Network) --
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced positive results from two preclinical studies evaluating the therapeutic potential of AVI-7100 against a fully virulent pandemic H1N1 virus, also known as swine flu or swine origin influenza virus. An analysis of the data from the studies demonstrated statistically significant reductions in average viral titer versus a saline control and a control with Tamiflu(R), a standard of care drug. The studies of AVI-7100, which used AVI's proprietary PMOplus(TM) chemistry, were supported by the Transformational Medical Technologies program (TMT) of the U.S. Department of Defense to identify RNA-based drug candidates against pandemic H1N1 virus. The studies were undertaken as part of a rapid response exercise demonstrating TMT's ability, in partnership with AVI, to rapidly respond to a real-world emerging viral threat.
"These H1N1 results build on the significant success we've had applying our RNA-based technologies and advanced proprietary chemistries, such as PMOplus(TM), to anti-infective therapeutic candidates," said J. David Boyle II, interim President and CEO of AVI BioPharma. "Based on these results, TMT continues to support AVI-7100, funding an accelerated IND enabling program and Phase 1 study, as well as expanded preclinical evaluation that explores AVI-7100's potential as a broad spectrum influenza therapeutic. We look forward to continuing to work closely with TMT to support our national preparedness against biological threats."
Study Results An analysis of the results from the two preclinical studies evaluating AVI-7100 against a fully virulent strain of pandemic H1N1 virus in a ferret model demonstrated potent, statistically significant reductions in the average viral titer in the upper respiratory region versus saline and Tamiflu controls. In the analysis of these two studies, AVI-7100 administered intraperitoneally at 10 mg/kg resulted in statistically significant reductions in the combined daily average viral titer through peak viral load (days 1-3) versus saline control (p=0.0012) and Tamiflu control (p=0.0103) by up to 3.9 log. Maximum reductions in the cumulative average viral titer of 5.1 log versus saline control and 4.52 log versus Tamiflu control were observed through day 5, but statistical analysis at this time point was not possible due to limited animal numbers.
Microscopic examination of the lungs of the infected ferrets seven days after infection evaluated the extent of regional tissue damage. Pathology scores in each study revealed only mild damage in the AVI-7100 treated ferrets versus severe damage in both saline controls and Tamiflu controls. The gross examination of the lung and spleens of the AVI-7100 treated ferrets appear normal, but obvious damage was observed in these tissues in the saline and Tamiflu controls. Finally, the number of infiltrating macrophages in the bronchiolar space was reduced in the AVI-7100 treated ferrets compared to the saline or the Tamiflu controls.
Presentation of the final data from these studies is planned for a medical conference in 2010.
About The TMT/AVI H1N1 Rapid Response Exercise As part of its ongoing evaluation of programs being conducted in cooperation with AVI, the U.S. Department of Defense Transformational Medical Technologies program established a contract with AVI to conduct a rapid response exercise against a real-world emerging threat, the pandemic H1N1 virus. The intent of the exercise was to demonstrate the capability of AVI to efficiently respond to a real-world emerging viral threat by rapidly designing and producing multiple therapeutic candidates and evaluating preclinical efficacy.
Initially the exercise involved identifying target sequences against H1N1, designing several drug candidates utilizing proprietary derivatives of AVI's antisense phosphorodiamidate morpholino oligomers (PMO) chemistry, and then manufacturing the candidates in sufficient quantity for preclinical testing. This was successfully accomplished in approximately one week, demonstrating AVI's ability to rapidly respond to a real-world viral threat utilizing the AVI's RNA based therapeutics platform.
Subsequently, AVI evaluated its RNA-based drug candidates in preclinical studies using a mouse model of seasonal flu and identified two lead candidates, including AVI-7100. The two lead candidates were tested in the more advanced ferret model utilizing a fully virulent human pandemic H1N1 virus. The ferret studies included various treatment groups employing the lead candidates administered via intraperitoneal and intranasal dosing routes, a saline control group, a scrambled RNA sequence control group and a control group dosed with Tamiflu, a standard of care drug. While both lead candidates and routes of administration were indicative of activity versus all controls, AVI-7100 administered intraperitoneally demonstrated overall superiority.
About AVI-7100 AVI-7100 employs AVI's patented PMOplus(TM) technology that selectively introduces positive charges to its phosphordiamidate morpholino oligomer (PMO) backbone to improve selective interaction between the drug and its target. The PMOplus(TM) chemistry platform previously generated two Investigational New Drugs (INDs) for AVI-6002 and AVI-6003, AVI's lead hemorrhagic fever virus therapeutic candidates for Ebola and Marburg viruses, respectively. These hemorrhagic fever virus therapeutic candidates are being developed under a July 2010 contract awarded through the U.S. Department of Defense Transformational Medical Technologies program (TMT). This contract provides funding to AVI of up to approximately $291 million.
Activities to develop AVI-7100 as a medical countermeasure against the pandemic H1N1 influenza virus are being funded under a June 2010 contract awarded to AVI through the TMT program. The contract provides for funding of up to $18 million to advance the development of AVI-7100, and includes studies enabling an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, the study of an intranasal delivery formulation, and the funding of a Phase 1 clinical trial to obtain human safety data to support potential use under an Emergency Use Authorization.
Additional funding under an earlier contract awarded to AVI via the TMT program is supporting continued preclinical evaluation of AVI-7100 against H1N1 as well as expanded preclinical evaluation against H5N1 (avian flu) and drug resistant H1N1 and H3N2 flu strains. Funding from this earlier contract also supported the rapid response exercise and is valued at up to $8.1 million.
About Pandemic H1N1 Influenza On June 11, 2009 the World Health Organization declared a pandemic of H1N1 influenza. The virus was first detected in people in the U.S. in April 2009 and was referred to as "swine flu" because many of the genes in the virus were very similar to those found in flu viruses that circulate in pigs (swine). Illness with the 2009 H1N1 virus has ranged from mild to severe. Symptoms include fever, cough, runny nose, headache, chills and fatigue. Many people infected with H1N1 also have respiratory symptoms without a fever. Severe illness and deaths have occurred as a result of illness associated with the virus. The Centers for Disease Control and Prevention (CDC) estimated that between April 2009 and April 2010 there were up to 89 million cases of H1N1 infection in the U.S. The CDC also estimated that there were up to 403,000 H1N1-related hospitalizations in the U.S. during the same time period.
About the Defense Threat Reduction Agency The Defense Threat Reduction Agency (DTRA) was founded in 1998 to integrate and focus the capabilities of the Department of Defense (DoD) that address the threat by weapons of mass destruction (WMD). DTRA's mission is to safeguard the United States and its allies from chemical, biological, radiological, nuclear and high-yield explosive WMDs by providing capabilities to reduce, eliminate and count the threat and mitigate its effects. DTRA combines DoD resources, expertise, and capabilities to ensure the United States remains ready and able to address the present and future WMD threats. For more information on DTRA, visit www.dtra.mil.
About the Transformational Medical Technologies Program (TMT) The TMT program was created by the U.S. Department of Defense to protect the Warfighter from emerging and genetically altered biological threats by discovering and developing a wide range of medical countermeasures through enhanced medical research, development, test and evaluation programs. The TMT Program Office is matrixed from the Joint Science and Technology Office -- DTRA and Joint Program Executive Office -- Chemical and Biological Defense, with oversight from the Office of the Secretary of Defense. For more information on TMT, visit http://www.tmti-cbdefense.org.
About AVI BioPharma AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. Applying pioneering technologies developed and optimized by AVI, we are able to target a broad range of diseases and disorders through distinct RNA-based mechanisms of action. Unlike other RNA-based approaches, our technologies can be used to directly target both messenger RNA (mRNA) and precursor messenger RNA (pre-mRNA) to either down-regulate (inhibit) or up-regulate (promote) the expression of targeted genes or proteins. By leveraging our highly differentiated RNA antisense-based technology platform, we have built a pipeline of potentially transformative therapeutic agents, including a clinical stage Duchenne muscular dystrophy candidate and anti-infective candidates for influenza and hemorrhagic fever viruses. For more information, visit www.avibio.com.
Forward-Looking Statements and Information
This press release contains statements that are forward-looking, including statements about the amount and timing of potential funding; the development of AVI 7100, AVI 6002 and AVI 6003, including preclinical development, filing of an IND application, completion of a Phase 1 human safety clinical trial, clinical development and FDA approval; AVI's PMOplus(TM) chemistry and other antisense-based technology and its ability to protect against the H1N1 virus, as well as its efficacy, potency and utility in the treatment of infectious diseases, and its potential to treat a broad number of human diseases. These forward-looking statements involve risks and uncertainties, many of which are beyond AVI's control. Known risk factors include, among others: development of any of AVI 7100 , AVI 6002 and/or AVI 6003 may not result in funding from the TMT in the anticipated amounts or on a timely basis, if at all; clinical trials may not demonstrate safety and efficacy of any of our drug candidates and/or our antisense-based technology platform; any of our drug candidates may fail in development, may not receive required regulatory approvals, or be delayed to a point where they do not become commercially viable. The results and analysis of the AVI 7100 studies described in this press release are subject to interpretation, and may not be repeated in later preclinical and clinical trials. The AVI 7100 study described in this press release is subject to interpretation and included small numbers of animal subjects which may limit the utility of the statistical analysis conducted in predicting future results. Further, the AVI 7100 study results described in this press release is not predictive of future outcomes and may not be repeated in later preclinical and clinical trials.
SOURCE: AVI BioPharma, Inc.
Copyright 2010 Marketwire, Inc., All rights reserved.
Aoxing Pharmaceutical Company Receives Clinical Trial Approval for Buprenorphine/Naloxone Sublingual Tablets for Opioid Addiction Treatment
Aoxing Pharmaceutical Company Inc
AXN | 8/24/2010 8:03:31 AM
National Institute on Drug Dependence to Administer Study for Novel Opioid Dependence Therapy in China
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850183
NEW YORK, NY, Aug 24, 2010 (MARKETWIRE via COMTEX News Network) --
Aoxing Pharmaceutical Company, Inc. (NYSE Amex: AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced that the China SFDA has granted approval of the company's New Drug Application to initiate the registration clinical trial of Buprenorphine/Naloxone sublingual tablets for opioid addiction treatment. The approval enables Aoxing Pharma to move forward to the final development stage with this therapy, which is novel in China as it is not yet available to patients.
The registration trial will be administered by the National Institute on Drug Dependence of China at Beijing University, the co-development partner of Aoxing Pharma. The patient enrollment will take place in at least three Compulsory Drug Dependence Treatment Centers. The trial is designed to establish the safety and efficacy of the Buprenorphine/Naloxone sublingual tablet therapy among patients who are suffering from opioid dependence.
"The SFDA's clearance of our Buprenorphine/Naloxone sublingual tablet program is the most significant accomplishments to date for our drug addiction franchise and marks the beginning of a new chapter in medical therapies for Chinese opioid dependence patients," said Zhenjiang Yue, the Chairman and CEO of Aoxing Pharma. "We look forward to starting patient enrollment in late 2010 and to finishing the clinical study by mid 2011. Under the current development schedule, the product launch is expected to take place in mid 2012. We believe that this drug could become an exciting therapeutic option for millions of patients and families in China who suffer painful drug dependence and its associated problems."
The registration trial is a multi-center, randomized, double-blind and active-control study, which is planned to enroll approximately 280 patients registered at Compulsory Drug Dependence Treatment Centers. Subjects are randomized during a brief induction phase, a multi-week maintenance phase and a detoxification phase.
About the Drug Addiction Problem in China
Based on Chinese government data, drug abuse and addiction has become a serious social problem and the situation has been getting worse and worse over the last two decades. As of December 2009 there were 1.3 million registered drug addicts in China, an increase of 15% from the prior year. However, the real population of drug addicts is estimated about 13 million in China. The Chinese government has taken comprehensive measures to address the problem, including centralized compulsory treatment camp, community clinics, psychological consulting and pharmacological therapies. In 2009 approximately 200,000 individuals received compulsory drug addiction treatment at over 80 centralized treatment centers and other centers managed by the Chinese government. The direct cost of illegal heroin purchase in China was estimated at $4 billion USD, and the overall monetary cost in connection with illegal drug purchase in China was estimated at $30 billion USD in 2009.
About Buprenorphine/Naloxone Sublingual Tablets
Buprenorphine/Naloxone sublingual tablets are a combo formulation of buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine: naloxone. Total sales of the branded Buprenorphine/Naloxone sublingual tablets reached $900 million USD in 2009, sold by a global group of pharmaceutical companies in the US, France and many other countries.
The tablets are usually taken once a day and are prescribed to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists, and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone prevent withdrawal symptoms when someone stops taking opioid drugs by producing effects similar to those produced by the opioids.
About Aoxing Pharmaceutical Company, Inc.
Aoxing Pharmaceutical Company, Inc. is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (SFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. It also has strategic alliance partnership with QRxPharma, Phoenix PharmaLabs, Inc and American Oriental Bioengineering, Inc. For more information, please visit: www.aoxingpharma.com.
Safe Harbor Statement from Aoxing Pharmaceutical Company, Inc.
Statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. The economic, competitive, governmental, technological and other risk factors identified in the Company's filings with the Securities and Exchange Commission, including the Form 10-K for the year ended June 30, 2009, may cause actual results or events to differ materially from those described in the forward looking statements in this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.
Investor Relations Contact: Brian Korb Vice President The Troup Group LLC Tel: +1 646 378 2923 Email: bkorb@troutgroup.com
SOURCE: Aoxing Pharmaceutical Co., Inc.
mailto:bkorb@troutgroup.com
Copyright 2010 Marketwire, Inc., All rights reserved.
Discovery Labs Realigns Executive Management
Discovery Laboratories Inc
DSCO | 8/24/2010 7:45:13 AM
WARRINGTON, Pa., Aug 24, 2010 (GlobeNewswire via COMTEX News Network) --
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850147
Discovery Laboratories, Inc. (Nasdaq:DSCO) today announces a realignment of the Company's executive management by appointing Dr. Thomas F. Miller as Chief Operating Officer, Mr. Charles F. Katzer as Chief Technical Officer, and Mr. John G. Cooper as President and Chief Financial Officer. These positions will report directly to Mr. W. Thomas Amick, Chairman of the Board and Interim Chief Executive Officer of Discovery Labs.
Mr. Amick commented, "We are realigning the leadership and technical talents of our executive team to strengthen our Company and better position us to execute our business plans successfully. Additionally, we intend to recruit for the Chief Executive Officer role with the goal of filling this key leadership position in 2011."
Thomas F. Miller, PhD., MBA, has been appointed Chief Operating Officer and will have responsibility for product development (including preclinical and clinical operations), regulatory affairs, and corporate and commercial development for the Company. Dr. Miller's relevant biopharmaceutical experience includes product development and commercial operations with Pfizer, Novartis, BASF Pharmaceuticals, Pharmacia, and Johnson & Johnson. Dr. Miller has significant related experience in the development of new therapies for neonatal critical care and with commercial strategy development for new synthetic alternatives to animal-derived medications. Additionally, he has developed a long-standing and well established relationship base with key neonatology and pulmonology academic thought leaders, including many currently collaborating with the Company. Dr. Miller initially joined Discovery Labs in 2004 and has most recently served as Senior Vice President, Commercial and Corporate Development.
Charles F. Katzer has been appointed Chief Technical Officer and will have responsibility for manufacturing operations, aerosol device development, formulations development, quality control and assurance, and analytical services. Mr. Katzer has over 35 years of related experience in drug manufacturing and supply, device development, and quality operations within the biopharmaceutical industry including Biological Specialties, MedImmune, U.S. Bioscience, Rhone-Poulenc Rorer and Baxter, and has successfully developed and manufactured small molecule and complex biotechnology drug products. Mr. Katzer has been with Discovery Labs since 2006, most recently serving as Senior Vice President, Manufacturing Operations.
John G. Cooper has been appointed President and Chief Financial Officer and will be responsible for the strategic and organizational development of the Company while retaining overall responsibility for the Company's financial operations. Mr. Cooper has over 25 years of experience in the life sciences industry including C.R. Bard, ENI Diagnostics, DNX Corporation, and Chrysalis Corporation, and has significant experience in managing emerging growth companies, public and private equity financings, investor relations, strategic alliances, and mergers and acquisitions. Mr. Cooper most recently served as the Company's Executive Vice President and has been Chief Financial Officer since joining Discovery Labs in 2001.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing KL4 surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Discovery Laboratories, Inc.
CONTACT: Discovery Laboratories, Inc. John G. Cooper, President and Chief Financial Officer 215-488-9490
(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
PROLOR Biotech Inc
PBTH | 8/24/2010 7:30:00 AM
NES-ZIONA, Israel, Aug 24, 2010 /PRNewswire via COMTEX News Network/ --
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850136
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides. For more information on PROLOR, visit www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
PROLOR CONTACT: MEDIA CONTACT: Shai Novik, President Barbara Lindheim PROLOR Biotech, Inc. GendeLLindheim BioCom Partners Tel: +1-866- 644-7811 +1-212-918-4650 Email: shai@prolor-biotech.com
SOURCE PROLOR Biotech, Inc.
Copyright (C) 2010 PR Newswire. All rights reserved
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
PROLOR Biotech Inc
PBTH | 8/24/2010 7:30:00 AM
NES-ZIONA, Israel, Aug 24, 2010 /PRNewswire via COMTEX News Network/ --
http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850136
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."
PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.
The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.
ABOUT PROLOR BIOTECH
PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides. For more information on PROLOR, visit www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
PROLOR CONTACT: MEDIA CONTACT: Shai Novik, President Barbara Lindheim PROLOR Biotech, Inc. GendeLLindheim BioCom Partners Tel: +1-866- 644-7811 +1-212-918-4650 Email: shai@prolor-biotech.com
SOURCE PROLOR Biotech, Inc.
Copyright (C) 2010 PR Newswire. All rights reserved
Securities Registration Statement (simplified form) (S-3/A)
The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities, and it is not soliciting offers to buy these securities in any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED AUGUST 23, 2010
$50,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
We may offer under this prospectus from time to time, at prices and on terms to be determined at or prior to the time of the offering, up to $50,000,000 of any combination of the securities described in this prospectus, either individually or in units. We may also offer common stock or preferred stock upon conversion of the debt securities, common stock upon conversion of the preferred stock, or common stock, preferred stock or debt securities upon the exercise of warrants. We will provide you with specific terms of any offering in one or more supplements to this prospectus. You should read this prospectus and any prospectus supplement, as well as any documents incorporated by reference into this prospectus or any prospectus supplement, carefully before you invest.
The aggregate market value of our outstanding common stock held by non-affiliates is $31,606,647, based on 77,852,154 shares of outstanding common stock, of which 70,236,994 shares are held by non-affiliates, at a per share price of $0.45 based on the average of the closing sale price of our common stock on August 20, 2010. As of the date of this prospectus, we have not offered any securities during the past twelve months pursuant to General Instruction I.B.6 of Form S-3.
Our common stock is traded on the NYSE Amex under the symbol “CXM”. On August 20, 2010, the closing sale price of our common stock was $0.45 per share. You are urged to obtain current market quotations for the common stock. Prospective purchasers of our securities are urged to obtain current information as to the market prices of our securities, where applicable.
Investing in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks that we have described in this prospectus under the caption “ Risk Factors ” starting on page 8. We may include specific risk factors in supplements to this prospectus under the caption “Risk Factors”. This prospectus may not be used to offer or sell our securities unless accompanied by a prospectus supplement.
Our securities may be sold directly by us to investors, through agents designated from time to time or to or through underwriters or dealers. For additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution” in this prospectus. If any underwriters are involved in the sale of our securities with respect to which this prospectus is being delivered, the names of such underwriters and any applicable commissions or discounts and over-allotment options will be set forth in a prospectus supplement. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is August , 2010
Unilife Corporation Schedules Fiscal 2010 Fourth Quarter and Year End Conference Call for Monday, August 30, 2010
Date : 08/23/2010 @ 10:44AM
Source : PR Newswire
Stock : Unilife (MM) (UNIS)
http://ih.advfn.com/p.php?pid=nmona&article=44103103&symbol=UNIS
Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS; ASX: UNS) announced today that it intends to release its financial results for the fiscal 2010 fourth quarter and year ended June 30, 2010 after market trading ends on Monday, August 30, 2010.
Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Time on August 30, 2010 (Tuesday, August 31 at 6.30 a.m. AEST), to review the Company's financial results, market trends, and future outlook. The conference call will be broadcast over the Internet as a "live" listen only Webcast.
To listen, please go to: http://ir.unilife.com/events.cfm.
Listeners are urged to login approximately 20 minutes before the conference call is scheduled to begin in order to register, as well as download and install any necessary audio software.
An archive of the webcast will be available for 30 days after the call.
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 in other reports which we file with the Securities and Exchange Commission.
NexMed Receives Additional Patent Coverage for Israel
Date : 08/23/2010 @ 9:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=44101210&symbol=NEXM
NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT® drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, today announced that the Israel Patent Office has issued an allowance notice for NexMed’s patent application entitled, “Topical Compositions for Prostaglandin E1 Delivery.” The patent, when issued, will provide coverage to May 13, 2019, and expand the protection of NexMed’s Prostaglandin E1 (alprostadil)-based products in Israel to seven granted patents. NexMed has several alprostadil-based treatments under development, including Vitaros®, for the treatment of erectile dysfunction; Femprox®, for female sexual arousal disorder, and RayVa™, for Raynaud’s syndrome.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “This addition to our patent portfolio strengthens our intellectual property position and bolsters our ongoing partnering discussions for the licensing of our products in Israel and the Middle East.”
About NexMed, Inc.
Backed by a solid, revenue generating CRO business, NexMed has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth will be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, 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, including but not limited to, its ability to obtain and/or enforce patent coverage or partner in international markets.
EpiCept Corporation Receives Refusal to File Letter from US FDA on Ceplene New Drug Application
Date : 08/23/2010 @ 12:01AM
Source : Business Wire
Stock : EpiCept Corporation (EPCT)
http://ih.advfn.com/p.php?pid=nmona&article=44094771&symbol=EPCT
Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene® (histamine dihydrochloride). Ceplene® is EpiCept’s novel therapeutic candidate for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission, which was approved in the European Union in 2008 and is co-administered with low-dose interleukin-2 (IL-2).
In its preliminary review of the Ceplene® NDA, the FDA concluded that the application did not establish Ceplene’s therapeutic contribution in its combination with IL-2, and recommended that an additional confirmatory pivotal trial assessing Ceplene’s contribution and using overall survival as a primary endpoint be conducted.
EpiCept intends to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission. The Company retains the right to file the NDA over FDA objections.
“We are surprised and obviously very disappointed by the FDA’s decision on our application,” commented Jack Talley, President and Chief Executive Officer of EpiCept. “The Ceplene/IL-2 regimen, which is being rolled out to patients in the European Union, is the only approved treatment that has been shown to prevent relapse of AML patients, of whom the majority will die within a year should a relapse occur. We believe that the results of the Ceplene® Phase III AML study, which demonstrated a statistically significant improvement in leukemia free survival without impacting patients’ quality of life and no treatment related mortality, together with the supporting data we generated for the application deserved a detailed review. In addition, six randomized large scale studies have shown that IL-2 alone is not an effective therapy for AML patients. We will meet with the FDA as soon as possible to explore whether a basis exists to resubmit the application without conducting a new clinical trial.”
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene®, which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has two oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept™ NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene® will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene® will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that Azixa™ will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, the risk that the development of our other apoptosis product candidates will not be successful, the risk that clinical trials for EpiCeptTM NP-1 or crolibulinTM will not be successful, the risk that EpiCept™ NP-1 or crolibulinTM will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCept™ NP-1 on attractive terms, a timely basis or at all, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote® Supplemental New Drug Application
Date : 08/20/2010 @ 4:05PM
Source : PR Newswire
Stock : Cumberland Pharmaceuticals Inc. (MM) (CPIX)
http://ih.advfn.com/p.php?pid=nmona&article=44089263&symbol=N^CPIX
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. The review has been extended by three months resulting in a new Prescription Drug User Fee Act (PDUFA) goal date in December 2010.
"We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.
Acute liver failure is a rare syndrome associated with a high mortality rate and frequent need for liver transplantation. Approximately 50 percent of acute liver failure cases are caused by acetaminophen poisoning. Other causes of acute liver failure not induced by acetaminophen overdose include hepatitis B disease, autoimmune hepatitis, Wilson disease, fatty liver of pregnancy, and HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome. Currently, transplantation of the liver is the only treatment for patients with liver failure not caused by acetaminophen overdose. In March 2010, Cumberland submitted the sNDA to the FDA for the use of Acetadote in patients with non-acetaminophen acute liver failure. The FDA formally accepted the application for review and designated the review classification as Priority in May 2010.
Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose. In 2006, the FDA approved Acetadote for use in pediatric patients. The Company also received FDA approval for updated labeling regarding the safety of Acetadote in 2008 based on new information from a post-marketing safety study reporting a lower-incidence of side effects compared to previously reported data.
About Acetadote
Acetadote® (acetylcysteine) Injection is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. It is the only approved injectable product in the United States for the treatment of acetaminophen overdose. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning and Kristalose® (lactulose) for Oral Solution, a prescription laxative. The Company also recently launched Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. The Company completed the initial public offering of its common stock in August 2009. For more information on Cumberland Pharmaceuticals, please visit www.cumberlandpharma.com.
Important Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that reflect Cumberland's current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company's control. Risk factors that could materially affect results of operations include, among others, those factors discussed in Cumberland's Registration Statement declared effective by the SEC on August 10, 2009. There can be no assurance that results or developments anticipated by Cumberland will be realized or, even if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Investor Contact:
Angela Novak
Cumberland Pharmaceuticals
615-255-0068
investors@cumberlandpharma.com
Media Contact:
Rebecca Kirkham
Lovell Communications
615-297-7766
rebecca@lovell.com
SOURCE Cumberland Pharmaceuticals Inc.
Keryx CFO sells 10K shares
Statement of Changes in Beneficial Ownership (4)
Date : 08/20/2010 @ 6:01PM
Source : Edgar (US Regulatory)
Stock : (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=44090251&symbol=N%5EKERX
Common Stock 8/20/2010 S 10000 D $3.84 (1) 358041 (2) D
Quarterly Report (10-Q)
Date : 08/19/2010 @ 4:07PM
Source : Edgar (US Regulatory)
Stock : (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=44075930&symbol=N^ZOOM
The number of shares of common stock, par value $0.01, outstanding as of August 16, 2010 is 12,979,776.
Zoom Technologies Reports Second Quarter 2010 Results
Date : 08/19/2010 @ 4:05PM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=44075901&symbol=ZOOM
Financial Highlights:
* Second quarter net income reached $2.03 million, up 20% year-over-year and up 7% sequentially
* Second quarter net margin increased to 4.7%
* Revenue for first six months increased 14.5% as compared to last year, despite impact of decreased second quarter pass-through revenue
* Net income for the first six months grew 50.0% over last year to $3.93 million
* LEIMONE brand phone sales reached 128,000 units
Guidance:
* Third Quarter 2010 net income between $2.7 and $3.3 million
* Third Quarter 2010 revenues between $55 and $61 million
* Reaffirms full year 2010 net income guidance of between $11.5 and $12.5 million
* Revises full year 2010 revenues guidance to between $210 and $230 million reflecting impact of pass-through revenue
* Expects to sell 600,000 LEIMONE units in 2010
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China-based manufacturer of mobile phones and other mobile electronic products, reported financial results for the second quarter ended June 30, 2010.
Mr. Lei Gu, Chairman and Chief Executive Officer of Zoom Technologies, commented, "We continue to gain market share and increase presence with our 3G LEIMONE brand phones in China. We are thrilled to report six month year-over-year revenue growth and sequentially higher net income, and we are encouraged by the strong acceptance of our LEIMONE brand phone in China. The decrease in our second quarter revenue is solely a reflection of the strength in our consignment business which impacted the total revenue figure while leaving net income unaffected. During the second quarter, one of our major customers provided us components that are normally sourced by Zoom and would have been included in our revenue. This is not a sign of reduced business activity, since we actually increased our manufacturing volume and posted higher net income than the previous quarter. We believe that the increased production capacity, along with the strength of our EMS business, will contribute to improving our margins and further our revenue growth through the second half of 2010."
For the second quarter of 2010, Zoom reported net revenue of $42.9 million, as compared to $53.1 million for the second quarter 2009. The reduced revenue figure in the quarter was due to proportionally more "consignment manufacturing" where the customer provided the components and Zoom was not required to procure components, resulting in less pass-through revenues. As a result, gross and net margins this quarter increased to 10.7% and 4.7% respectively, as compared to 5.9% and 3.2% respectively for the year ago quarter. The increase in margins was also attributed to the sales of Zoom's proprietary LEIMONE brand phones which carry higher margins.
Manufacturing volumes increased sequentially in the second quarter of 2010. Zoom manufactured 1.7 million mobile phone printed circuit board assembly (PCBA) units and 1.0 million whole phones in the quarter, up 17% and 14% respectively over the first quarter 2010. Revenue from the sale of our higher margin LEIMONE brand phones in the second quarter was $4.5 million, or 10.4% of total revenue. During the quarter, Zoom sold 56,714 units of LEIMONE brand mobile phones of which 18% were 3G units. Zoom did not sell its own branded phones in the year ago period.
Gross profit for the second quarter of 2010 was $4.58 million, up 45% from $3.16 million for the same quarter in 2009, and up 10% sequentially from $4.18 million for the first quarter 2010.
Net income for the second quarter was $2.03 million, up 20% from $1.70 million for the same quarter last year, and up 7.3% from $1.90 million of the first quarter 2010. Earnings per share for the second quarter 2010 was $0.17 as compared to $0.86 per share in the same quarter last year when the operating entity was a private company in China.
For the first six months of 2010, Zoom reported net revenue of $93.86 million, up 14.5% over $81.95 million for the first six months of 2009. The year over year revenue growth was primarily due to an increase in orders from domestic EMS customers and an increase in sales of Zoom's proprietary LEIMONE phones.
Mr. Gu continued, "We continue to build traction as a leading consumer recognized brand. This leadership is reflected by the launch of our third 3G LEIMONE phone reflects Zoom's outstanding technology and continues to solidify our already strong relationship with China Telecom. Zoom believes it is well positioned to benefit from the outstanding growth expected in the design and production of advanced mobile phones for China's 3G network. With the successful launches of several LEIMONE models so far in 2010, the Company anticipates selling more than 600,000 LEIMONE units by the end of this year. We are confident that our mobile phones will appeal to China's burgeoning young customer base."
Looking ahead, Mr. Gu remarked, "We will continue to focus on our mobile manufacturing business in the second half of 2010, as the market opportunity in China is enormous. We are ready to take advantage of the foreseeable growth in China's mobile market. For the third quarter 2010, we expect net revenue to be between $55 million and $61 million and net income is expected to be in the range of $2.7 and $3.3 million. For the full year 2010, we maintain our net income guidance of $11.5 million to $12.5 million, and revise our net revenue to be between $210 and $230 million reflecting the impact of pass-through revenue."
Conference Call Details
The company will host an investor call at 4:30pm EDT (1:30pm Pacific). To access the conference call, dial 877-941-2069 and enter access code 4351698. Callers outside the U.S. and Canada should dial 480-629-9713 and enter access code 4351698.
A replay of the conference call will be available through Thursday, August 26, 2010. To access the replay, please dial 800-406-7325 and enter access code 4351698. Callers outside the U.S. and Canada should dial 303-590-3030 and enter access code 4351698.
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 the latest 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 as well as its own brand under the brand name of Leimone. The company's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
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. 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.
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Investor Contacts:
Cynthia Hiponia
The Blueshirt Group
+1 415-217-4966
Quarterly Report (10-Q)
Edgar (US Regulatory) • Fri Aug 13,2010 5:01 PM
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The registrant had 221,821,563 shares of common stock, $0.0001 par value per share, outstanding as of July 31, 2010.
Quarterly Report (10-Q)
Edgar (US Regulatory) • Mon Aug 9,2010 5:26 PM
http://ih.advfn.com/p.php?pid=nmona&article=43941949&symbol=N%5EKERX
There were 58,921,322 shares of the registrant’s common stock, $0.001 par value, outstanding as of August 3, 2010.
Quarterly Report (10-Q)
Edgar (US Regulatory) • Mon Aug 9,2010 4:59 PM
http://ih.advfn.com/p.php?pid=nmona&article=43941434&symbol=N%5EDSCO
As of August 5, 2010, 194,075,646 shares of the registrant’s common stock, par value $0.001 per share, were outstanding.