Repros Therapeutics : Randomization Of Subjects In Androxal® Type II Diabetes Phase II Trial

October 25, 2010 - New FDA Ruling On Potential For Development Of Diabetes Due To Castrating Effects Of GnRH Administration Reinforces Company Strategy For Androxal - Repros Therapeutics Inc.® (NasdaqCM:RPRXD) announced it has commenced randomization of subjects into its Phase II Androxal® study in the treatment of type 2 diabetes (T2DM) in men with low testosterone. Low testosterone and T2DM are co-morbid conditions in a significant number of men. The study is being conducted at nine sites across the US including both academic and private practices and will enroll up to 150 patients. The five private practices are located in the metropolitan New York area, San Antonio and Houston and were selected based on their current data base of patients that meet the inclusion criteria. These private practices have already begun to enroll and randomize subjects. Four academic sites were selected based on the same criteria, but were further assessed based on the expertise they bring to the study. The academic sites will require individual institutional review board approval, which can take a few months, before enrolling subjects... Repros Therapeutics' Press Release -

Biocon and Pfizer : Global Commercialization Agreement

Oct. 18, 2010 - Creates Global Alliance Well Positioned to Deliver Essential Insulin Treatments to Diabetes Patients Worldwide - Biocon, Asia's premier biotechnology company, and Pfizer Inc. (NYSE: PFE), the world's leading biopharmaceutical company, announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro. Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India and Malaysia. Pfizer will also have co-exclusive rights with existing Biocon licensees with respect to some of the products, primarily in a number of developing markets.



Biocon will remain responsible for the clinical development, manufacture and supply of these biosimilar Insulin products, as well as for regulatory activities to secure approval for these products in various geographies. Biocon's Recombinant Human Insulin formulations are approved in 27 countries in developing markets, and commercialized in 23, while Glargine has been launched in its first market, India... Pfizer's Press Release - [PDF] Biocon's Press Release -

Dynavax Technologies : New HEPLISAV(TM) Data in Diabetics

Oct 11, 2010 - Dynavax Technologies Corporation (NASDAQ: DVAX) said that Dr. William L. Heyward, Vice President, Clinical Development, will make an oral presentation of new data from a subset of diabetes subjects evaluated as part of the company's previously reported multicenter, observer-blinded phase 3 study. The PHAST (Phase 3 HeplisAv Short-regimen Trial) study compared two doses of HEPLISAV (20ug HBsAg combined with 3000ug 1018 immunostimulatory sequence, Dynavax's Toll-like receptor agonist) given at 0 and 4 weeks (placebo at 24 weeks) to three doses of Engerix-B given at 0, 4 and 24 weeks. The presentation will be made in a late-breaker session on October 23, 2010 at the Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, British Columbia.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the hepatitis B infection rates among diabetics and in long-term care facilities for quite some time. Later this month, ACIP will consider a recommendation for hepatitis B vaccination of adults with diabetes. Diabetics are at risk for hepatitis B infection and once infected, their disease frequently results in more severe chronic illness. Multiple outbreaks of hepatitis B among diabetics have occurred over the last several years in long-term care facilities, but prevention by vaccine has been complicated by the fact that diabetics are not routinely immunized and commonly do not respond well to currently licensed hepatitis B vaccines... Dynavax Technologies' Press Release -

TransPharma Medical : Successful Completion of Phase 1a Clinical Trial of ViaDerm-GLP1 Agonist Indicated for the Treatment of Type II Diabetes Study

September 14, 2010 - endpoints of pharmacokinetic profile, safety and tolerability successfully met - Phase 1b clinical study in patients has been initiated – TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced the successful completion of a Phase 1a trial of ViaDerm-GLP1 agonist which is being developed for the treatment of diabetes mellitus type II. The Phase 1 study was a three-way cross over study designed to evaluate the pharmacokinetic (PK) profile and assess safety and tolerability of two doses of ViaDerm-GLP1 agonist in healthy volunteers, as compared to a subcutaneous injection of Exenatide (Byetta). Each volunteer received all three treatments with a washout period of one week between treatments.

The results of the study demonstrate ViaDerm-GLP1 agonist to be safe and well-tolerated with a preferable extended PK profile compared to an injection of Exenatide (Byetta). Transdermal application of ViaDerm-GLP1 agonist resulted in therapeutic GLP1 blood levels for approximately 13 hours compared to 6 hours of the injected form. In addition, ViaDerm-GLP1 agonist was demonstrated to be biologically active based on changes in glucose levels during the treatment. TransPharma has initiated enrollment of Type II diabetic patients to a phase 1b clinical trial using its dry form, extended release state-of-the-art patch formulation of GLP1 agonist... TransPharma Medical's Press release -