Penwest Pharma jumps on suit settlement. Rexahn engages renowned investment banker. FDA grants CryoLife heart valve technology 510k clearence Print E-mail
By BioMedReports.com Staff   
Tuesday, 08 June 2010 18:42
Below is a list of the companies that made news in the healthcare sector on Tuesday, June 8, 2010.

Penwest Pharmaceuticals (Nasdaq:PPCO) along with Endo Pharmaceuticals (Nasdaq:ENDP) announced today that the companies have settled litigation with Impax Laboratories, Inc. (Nasdaq:IPXL) regarding the production and sale of generic formulations of OPANA® ER (oxymorphone hydrochloride) Extended Release tablets.

Under the terms of the settlement, Endo and Penwest have agreed to grant IMPAX a license to sell a generic of OPANA ER on Jan. 1, 2013. Impax Laboratories will have 180-days of exclusivity for 5, 10, 20, 30 and 40 mg tablets. Further terms of the settlement were not disclosed.

Endo and Penwest also announced that they have executed an amendment to their existing strategic collaboration agreement under which the royalty rate on net sales of Opana ER would now be capped at 22 percent during the period from April 1, 2010 through Dec. 31, 2012, subject to adjustment in the fourth quarter of 2012, and 20 percent during calendar 2013, subject to adjustment in the fourth quarter of 2013.

Penwest shot up 25% on the news, closing the day at $3.50, up 72 cents.

Rexahn Pharmaceuticals, Inc. (NYSE Amex:RNN) today announced that it has engaged renowned investment banker Frederick Frank, Vice Chairman of Peter J. Solomon Company (PJSC), as an independent consultant, to advise on a range of corporate activities.

"We are extremely pleased to have Fred on our team to advise the company on building our assets and driving shareholder value. His expertise in global healthcare and 50 years of banking experience focused in biotechnology will be a great asset to the company," said Dr. Chang Ahn, Chairman and CEO of Rexahn.

Over his distinguished career, Mr. Frederick Frank has provided investment banking services to an extensive number of companies in the pharmaceutical, biotechnology, healthcare services, medical device and nutraceutical industries, and he has been involved in hundreds of financings, strategic alliances and merger and acquisition transactions in the global healthcare industry. Prior to joining PJSC, he held leadership positions at leading global banks, such as Lehman Brothers, Smith, Barney & Co. and Barclays Bank.

"Rexahn is in a great position with a strong pipeline, best-in-class products, and the positive Phase II clinical results of Serdaxin and Zoraxel. I am looking forward to helping the company build value for these assets," said Mr. Frank.

Shares of Rexahn moved higher by 6% Tuesday.

CryoLife, Inc., (NYSE:CRY) a biomaterials, medical device and tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration for a five-year shelf-life on its CryoValve® SG pulmonary human heart valve processed with the Company's proprietary SynerGraft® technology. CryoLife's SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. This biotechnology is used by cardiovascular surgeons for complex reconstructive surgeries, including those performed on children.

"This shelf-life extension to five years simplifies the purchasing decisions and tissue inventory management issues presented to hospitals by the previous one-year shelf life," said Steven G. Anderson, CryoLife's president and chief executive officer. "Additionally, the extended shelf life will allow us more flexibility to increase the percentage of heart valves processed utilizing the SynerGraft technology. This will serve to make this technology available to more patients."

The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient's defective aortic valve is removed and replaced with his own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.

CryoLife was up more than 5% on the news, rising 28 cents to $5.40.

Abraxis BioScience, Inc. (NASDAQ:ABII) presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE®) for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Seperately, the company presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) today reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, in combination with capecitabine (Xeloda(R)) as a treatment for advanced, metastatic colorectal cancer. Abstract #3531, entitled, "Final results of a randomized Phase 2 study of perifosine in combination with capecitabine (P-CAP) versus capecitabine plus placebo (CAP) in patients with second- or third-line metastatic colorectal cancer (mCRC)" was presented today in a poster discussion held during the 2010 Annual Meeting of the American Society of Clinical Oncology.

Discovery Laboratories, Inc. (Nasdaq:DSCO) edged higher after the company announced today that it has received written guidance from the U.S. Food and Drug Administration that is consistent with its ongoing, comprehensive preclinical program to resolve the sole remaining chemistry, manufacturing & control (CMC) issue necessary to potentially gain FDA marketing approval for Surfaxin(R) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a Phase 3 clinical program. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine. Discovery Labs believes it remains on track to complete the preclinical program and submit its Complete Response to the FDA in the first quarter of 2011.

GTx, Inc. (Nasdaq: GTXI) announced today that in the Phase III clinical trial evaluating toremifene 80 mg for the reduction of fractures and treatment of other estrogen deficiency side effects in men with prostate cancer on androgen deprivation therapy (ADT), toremifene treatment demonstrated an improved benefit/risk ratio in men less than 80 years of age. The data were presented yesterday at the 2010 Annual Meeting of the American Society of Clinical Oncology in Chicago.

"Data from the TREAT 1 clinical trial clearly show that toremifene treatment had a more pronounced fracture reduction and better safety profile in men less than age 80," said Mitchell S. Steiner, MD, CEO of GTx. "Based on these results, we designed the TREAT 2 Phase III clinical trial which will enroll men with prostate cancer on ADT with measured bone loss who are younger than 80 years. We expect this next study to confirm the robust fracture reduction which toremifene 80 mg demonstrated in the first Phase III clinical trial, the TREAT 1 study."

VIVUS, Inc. (Nasdaq:VVUS) today announced that data from a previously reported phase 2 study evaluating the safety and efficacy of the investigational drug Qnexa® for the treatment of obstructive sleep apnea (OSA) were presented at SLEEP 2010, the 24th Annual Meeting of the Associated Professional Sleep Societies (APSS). Data from the study entitled, "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Phentermine/Topiramate CR (VI-0521) for the Treatment of Obstructive Sleep Apnea/Hypopnea Syndrome in Obese Adults," were presented by David Winslow, MD, president, Kentucky Research Group, Chest Medicine Associates, P.S.C., Louisville and the study's principal investigator. The presentation marks the first time these results have been presented at a major medical meeting.

The study demonstrated statistically significant improvement in the apnea/hypopnea index (AHI), a measure of the severity of sleep apnea, in patients with OSA treated with Qnexa for 28 weeks. Qnexa-treated patients also experienced significant weight loss, reductions in both systolic and diastolic blood pressure, and reductions in respiratory disturbances and improvements in overnight blood oxygen levels.

Also Tuesday:

Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer, will present at the Jefferies 2010 Global Life Sciences Conference on Thursday, June 10, 2010 at 10 a.m. ET.

ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Jefferies 2010 Global Life Sciences Conference on June 9, 2010, beginning at 9:30 p.m. eastern time, and at the 9th Annual Needham Healthcare Conference on June 10, 2010, beginning at 10:40 a.m. eastern time. Both conferences will be held in New York.

Baxter International Inc. (NYSE: BAX) announced today that it will present at the Goldman Sachs 31st Annual Global Healthcare Conference on Wednesday, June 16, 2010 at 8:00 a.m. (PT) or 10:00 a.m. (CT).

BioTime, Inc. (AMEX: BTIM) Chief Executive Officer Michael West, Ph.D., will give a presentation this week at the Inaugural Jefferies Global Life Sciences Conference being held June 8-11, 2010 in New York City.

Bristol-Myers Squibb Company (NYSE: BMY) will present at the Goldman Sachs Global Health Care Conference on Tuesday, June 15, 2010, at the Hyatt Regency Century Plaza in Los Angeles. Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb, will make a formal presentation about the company at 11:30 a.m. PDT.

Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at the Jefferies 2010 Global Life Sciences Conference in New York on Thursday, June 10th, at 10:00 a.m. ET.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the U.S. District Court for the District of Delaware issued a claim construction order in the litigation between Cubist and Teva.

Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Goldman Sachs 31st Annual Healthcare Conference on Tuesday, June 15, 2010, at 2:30 p.m. Eastern Time, 7:30 p.m. GMT.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that John G. McHutchison, MD, will join the company as Senior Vice President, Liver Disease Therapeutics.

IBM (NYSE: IBM) and ProtonMedia have entered into a teaming agreement that will result in the delivery of innovative, 3-D virtual collaboration and communication solutions engineered specifically for global life sciences organizations.

MMR Information Systems, Inc. (OTCBB:MMRF) announced today that it has entered into an agreement with The MichaelBass Group, Inc. to identify strategic partnerships and acquisition opportunities in healthcare information technology as part of the Company's plans to expand its line of products and services.

Pall Corporation (NYSE:PLL) today reported financial results for the third quarter ended April 30, 2010.

PolyMedix, Inc. (OTCBB: PYMX), an emerging bio-technology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has scheduled a webcast for Wednesday, June 9 at 4:00 PM Eastern Time.

VIVALIS (NYSE Euronext: VLS) announced today the signature with Sanofi Pasteur, the vaccines division of sanofi-aventis Group (Euronext: SAN and NYSE: SNY), of a commercial license and collaboration agreement for the discovery and development of fully human monoclonal antibodies against several infectious diseases targets.

XenoPort, Inc. (Nasdaq: XNPT) announced today that it will provide access via the World Wide Web to its presentation at the Goldman Sachs Healthcare Conference 2010.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

 

 




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