Yesterday, Biogen Idec [NASDAQ: BIIB] announced that they would move BIIB037 (human anti-amyloid beta mAb) to Phase III for Alzheimer’s disease, based on its promising Phase I results. The drug has shown to reduce amyloid plaque in the brain and statistically significant improvement in cognition at 54 weeks.
Earlier this week, Switzerland-based Novartis [NYSE:NVS]’s multiple sclerosis (MS) drug, Gilenya, failed in its Fingolimod Phase III clinical trial to meet its primary goal for treatment of patients with primary-progressive MS (PPMS). Last month, BIIB was under selling pressure as Credit Suisse sent out a note suggesting that a successful PPMS Gilenya clinical trial could have a potentially significant impact on all MS drug manufacturers.
The investigation of the death of a patient who had taken Tecfidera for more than four years and died after getting a rare brain infection, known as progressive multifocal leukoencephalopathy or PML, has been resolved. The FDA is updating the label for Tecfidera to describe the recent case.
Biogen Idec is still facing patent litigation from the Danish company, Forward Pharma [NASDAQ:FWP], over patent rights for the small molecule dimethyl fumarate (DMF), the same active compound in Biogen Idec’s Tecfidera. Last month, Forward Pharma filed a patent infringement lawsuit against Biogen Idec in Germany and asked for damages.
Biogen Idec and its partner Swedish Orphan Biovitrum (Sobi), already submitted their hemophilia A drug, ELOCTATE to European Medicines Agency (EMA) for review as the drug is set up for European approval in 2015. ELOCTATE will compete against Novo Nordisk’s NN7088, which is still in clinical trials, and BAY 81-8973. Today, Bayer announced that they would file for FDA approval for their BAY 81-8973.
DISCLOSURE: Long position BIIB |