|Pro-Pharma up on FDA agreement. Dynavax completes study enrollment. Ardea earns Bayer milestone payment. PDL BioPharma loses patent suit, shares fall|
|By Staff and Wire Reports|
|Monday, 10 January 2011 20:05|
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.
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.