SAN DIEGO, Aug. 30, 2016 - Orexigen Therapeutics, Inc. (OREX) today announced that Valeant Canada, a subsidiary of Valeant Pharmaceuticals International, Inc., or its affiliates, will commercialize Contrave® (naltrexone HCl / bupropion HCl extended release) in Canada. Under the terms of the agreement between Valeant and Orexigen's wholly owned subsidiary Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining Canadian regulatory approval and for all commercialization activity and expenses. Orexigen will supply Contrave tablets to Valeant Canada or its affiliates for an agreed transfer price and certain potential regulatory and sales milestone payments. Orexigen expects Valeant to file with Health Canada for regulatory approval by January 2017.

 

"Valeant Canada has a growing portfolio of innovative medicines addressing cardiometabolic disease, as well as strong regulatory and commercial capabilities, and we believe they are an ideal partner for Contrave in Canada," said Mike Narachi, CEO of Orexigen. "Partnering with strong pharmaceutical companies outside the United States supports our global mission to improve the health and lives of patients struggling to lose weight and allows Orexigen to realize the global value of Contrave / Mysimba®."

CAMBRIDGE, Mass. -- Syros Pharmaceuticals (SYRS) announced today that research from its scientific founders validates CDK12 and CDK13, members of the transcriptional cyclin-dependent kinase family that play a critical role in regulating gene expression, as promising new drug targets for a range of aggressive and difficult-to-treat cancers. These findings were possible as a result of the discovery of a highly selective CDK12 and CDK13 inhibitor by Syros’ scientific founders and underscore the potential of Syros’ pioneering approach for understanding and drugging transcriptional targets to advance a new wave of medicines that control the expression of disease-driving genes.

SOUTH SAN FRANCISCO, Calif., Aug. 30, 2016  -- Rigel Pharmaceuticals, Inc. (RIGL) today announced that fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, met the primary endpoint in the first of two double-blind studies in the FIT Phase 3 clinical program for the treatment of adult chronic/persistent immune thrombocytopenia (ITP).  The study (n=76) showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control (p=0.0261).  A stable platelet response was defined as achieving greater than 50,000 platelets per uL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment. The results from the second FIT Phase 3 study are expected in October/November 2016.

 

The most frequent adverse events were gastrointestinal-related, and the safety profile of the product was consistent with prior clinical experience, and no new or unusual safety issues were discovered. 

Company provides timing updates

 

TORONTO, Aug. 29, 2016 -- Cynapsus Therapeutics Inc. (CYNA) (CTH.TO), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson`s disease (PD).

 

"The FDA`s recognition of the significant need to address OFF episodes in Parkinson`s disease with the Fast Track Designation is further validation of the value in our fast-acting, thin strip approach," said Anthony Giovinazzo, President and CEO of Cynapsus. "We look forward to continuing to work with the FDA to advance APL-130277 through the regulatory process to bring relief to patients suffering with OFF episodes as expeditiously as possible.  Our Phase 3 clinical program is nearing completion and we plan to submit a new drug application (NDA) to the FDA in the first half of 2017."