Pro-Pharma up on FDA agreement. Dynavax completes study enrollment. Ardea earns Bayer milestone payment. PDL BioPharma loses patent suit, shares fall Print E-mail
By Staff and Wire Reports   
Monday, 10 January 2011 20:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 10, 2011.

Pro-Pharmaceuticals, Inc. (OTC:PRWP.ob), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that on December 17, 2010, Company representatives met with officials from the U.S. Food & Drug Administration (FDA) to present its Phase III clinical development program for DAVANAT. The company reports that an agreement was reached on the design of a pivotal, randomized, controlled, and blinded Phase III clinical trial of DAVANAT co-administered with standard chemotherapy for second line treatment of patients with metastatic colorectal cancer. The primary end point for the trial will be increased survival with a secondary end point of reduced serious side effects of chemotherapy.

"This successful meeting with the FDA clears the way for Pro-Pharmaceuticals to begin the Phase III development program following submission and approval of the final protocol," said Peter G. Traber, M.D., Chief Medical Officer, Pro-Pharmaceuticals. "Extending patient survival, while decreasing severe adverse effects of chemotherapy, is significant and unique. The successful meeting with the FDA is an essential step in the DAVANAT development program and we look forward to implementing it in 2011."

"The Phase III development program is an important milestone towards achieving our goal of commercializing DAVANAT, an innovative approach to treating cancer patients," said Theodore Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "We are highly encouraged by the findings of our previous clinical studies, which suggest that DAVANAT may be an effective anti-cancer agent that also reduces side effects. We are optimistic that our novel Galectin-targeting compound may improve treatment for metastatic colorectal cancer.

On heavy volume, shares of Pro-Pharma surged 19.5 cents or 20% closing at its high of the day, $1.16.

Dynavax Technologies Corporation (NASDAQ:DVAX) moved higher today after the company announced that it had completed the enrollment of its Phase III study of HEPLISAV, Dynavax's novel vaccine for the prevention of hepatitis B infection, in subjects with chronic kidney disease. Patients involved in the study will receive three immunizations over a six month period, with the primary endpoint being the comparison of the drug to GlaxoSmithKlines Energerix-B.

Tyler Martin, M.D., President and Chief Medical Officer of Dynavax, noted, "Completion of enrollment in this trial is another important milestone in the development of HEPLISAV and keeps us on track for BLA submission in Q4 2011. We expect the last immunizations to be administered in June 2011."

Shares of Dynavex juped 26 cents or 8% to $3.53.

Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced that it has earned a $15 million milestone payment from Bayer HealthCare AG (Bayer) under the terms of their April 2009 global license agreement to develop and commercialize Ardea's mitogen-activated ERK kinase (MEK) inhibitor compounds for cancer and other indications. The milestone was triggered by the initiation of a Phase 2 clinical study evaluating BAY 86-9766 in combination with sorafenib for the treatment of primary liver cancer.

Upon receipt of this milestone payment Ardea will have received license fee and milestone payments under the agreement totaling $50 million and is eligible to receive up to an additional $357 million for achievement of future development and commercialization milestones. Ardea will also be eligible to receive royalties on worldwide sales of products under the license agreement.

Shares of Ardea gained $1.51 or 5.27% to $30.17.

Shares of PDL BioPharma, Inc. (Nasdaq:PDLI) fell on heavy volume today after the company announced that the United States District Court for the Northern District of California ruled against it in a patent infringement claim. The court said that PDL's patent infringement claim against AstraZeneca's Medimmune unit was invalid and that Medimmune did not vilolate a royalty license agreement for the antibody Synagis. A jury trial is expected to start in January to decide other claims made by PDL.

On volume of more than 6.5 million shares, PDL tumbled 78 cents or 12.64 % to $5.39.

Shares of Elite Pharmaceuticals, Inc. (OTCBB:ELTP) jumped today after the company announced that they had entered into an agreement Hi-Tech Pharmacal Co., Inc. (Nasdaq:HITK) for Elite to develop for Hi-Tech an intermediate for a generic version of a prescription product for which the branded product had sales in 2010 of over $100 million.

Elite will undertake a developmental program for an intermediate product that Hi-Tech will then incorporate into a final product. Hi-Tech will be responsible for the filing of the Abbreviated New Drug Application for the finished product and the ANDA will be filed under the Hi-Tech name. Upon approval of the ANDA, Elite will manufacture the intermediate product and Hi-Tech will manufacture, market and sell the final product. Under the terms of the agreement, Hi-Tech will pay Elite milestone payments for the development work and upon commercialization, Elite will receive payment for the manufacturing of the intermediate product and a percentage of the profits generated from the eventual sales.

17 million shares traded hands as Elite jumped as high as $.08 cents before settling at $.0510, up 6.25%.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper highlighting positive preclinical results from Inovio’s novel DNA vaccine targeting HIV Clade C viruses in the journal Vaccine. Clade C is the predominant HIV-1 strain infecting people in sub-Saharan Africa, India, and China, and there is a critical need for a vaccine targeted to these areas.


AdCare Health Systems, Inc. (NYSE Amex: ADK) , a recognized innovator in senior living and health care facility management, has appointed company director, Boyd P. Gentry, as co-chief executive officer effective today.

Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) today outlined its strategic corporate priorities for 2011, highlighting its continued focus on strong fiscal discipline while maximizing the value of the Company's diabetes franchise, notably through advancing the investigational compound BYDUREON™ (exenatide extended-release for injectable suspension) and other value-driving development programs.

Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced that it has earned a $15 million milestone payment from Bayer HealthCare AG (Bayer) under the terms of their April 2009 global license agreement to develop and commercialize Ardea's mitogen-activated ERK kinase (MEK) inhibitor compounds for cancer and other indications.

BioLife Solutions, Inc. (OTC Bulletin Board:BLFS) is issuing a corporate update today by its Chairman and Chief Executive Officer Mike Rice, to summarize the continued progress the Company made in 2010 on a number of strategic growth initiatives.

D. Medical Industries Ltd. (NASDAQ:DMED) (TASE:DMDC) a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced the successful bid by its Swedish distributor for the marketing and sales of D. Medical's Universal Detach Detect Infusion Sets in Sweden.

Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced the appointment of Charles Liamos as the company's Chief Operating Officer.

InsWeb Corp. (NASDAQ: INSW), a leading online insurance comparison provider, today announced that Elisabeth DeMarse has been elected to the company's board of directors, becoming the fifth independent board member and bringing the total number of board members to six.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today preliminary unaudited financial results for the full year ended December 31, 2010.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced the appointment of Dr. Hank McKinnell to its Board of Directors. Dr. McKinnell is the former Chief Executive Officer and former Chairman of the Board of Directors of Pfizer Inc.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced the appointment of Linda Amper, Ph.D., as Senior Vice President of Human Resources, Hemal Shah as Senior Vice President of Health, Economics & Outcomes Research (HEOR), and John Womelsdorf, Ph.D., as Vice President of Business Development.

PAREXEL International Corporation (Nasdaq:PRXL) will release Second Quarter Fiscal Year 2011 financial results on Monday, January 31, 2011 after the close of the stock market.

PharmAthene, Inc. (NYSE Amex:PIP) announced today that it has strengthened its research and development and program management functions with the addition of several new leadership appointments.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced today that it has joined the Rimonim pharmaceutical consortium. The goal of the consortium, which is funded by the Office of the Israeli Chief Scientist ("OCS"), is to bring together leading Israeli biotechnology companies in order to advance RNAi-based therapeutics.

Sequenom (Nasdaq:SQNM) today announced the appointment of William (Bill) Welch to the position of senior vice president of diagnostics.

WaferGen Biosystems, Inc. (OTC Bulletin Board:WGBS), a leading developer of state-of-the-art genomic analysis systems, today announced general availability of its Quick-Turnaround SmartChip Custom Panels to enable validation studies of specific genes of interest through customization of high-throughput, real-time PCR SmartChip assay panels -- all on a Quick-Turnaround basis.

Waters Corporation (NYSE:WAT) today introduced its Waters® Biopharmaceutical System Solution at WCBP, the 15th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products in Washington, D.C.

WuXi PharmaTech (NYSE:WX), a leading pharmaceutical, biotechnology, and medical-device research and development outsourcing company, with operations in China and the United States, today announced that it will present at the 29th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2011 at 3:30 p.m. Pacific Standard Time and updated its 2010 financial guidance.



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