November 2007 Issues

European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

Summary: European neurologists viewed Biogen Idec’s decision to put itself up for sale as a sign that the company’s pipeline is not as robust as claimed. ♦ European use of Tysabri has just really gotten going, so the outlook is for use there to double over the next year, from ~7% of RRMS patients on therapy to about 16%, with a peak of about 25% market share by 2010. ♦ The monoclonal antibody neurologists are most excited about is Genzyme/Bayer Schering Pharma’s Campath (alemtuzumab), which they expect to use ahead of Tysabri. Doctors predicted that enrollment in the Phase III alemtuzumab trials will go quickly. ♦ There wasn’t the same enthusiasm for Biogen Idec’s Rituxan, and a new case of PML in a Waldenstrom’s disease patient on Rituxan increases the likelihood it will require a PML risk management program like Tysabri. ♦ Preliminary results of the Phase II CHOICE trial showed Biogen Idec/ PDL BioPharma’s daclizumab to be effective at both doses tested, with serious infections the serious adverse event to watch. ♦ Merck Serono’s cladribine is the lead oral agent, but neurologists are more excited about Novartis’s fingolimod (FTY-720) because it has more data, and the efficacy data look very good. The question with fingolimod is safety. ♦ With the results of the REGARD trial showing no difference between Rebif and Copaxone in a head-to-head comparison, neurologists predicted that Copaxone market share would increase, mostly at the expense of Rebif but probably affecting all interferon-βs.

FDA Orders New Black Box Warning for Diabetes Drug Avandia – but Leaves it on the Market -- Quick Pulse

Summary: The FDA announced on November 14, 2007 , that the black box warning on GlaxoSmithKline’s Avandia (rosiglitazone), a thiazolidinedione (TZD) for Type 2 diabetes, is being strengthened to include new information about an increased risk for heart attacks, but the Agency did not find the risk sufficient to withdraw Avandia from the market.

FDA Tightens the Labels on Epos -- Quick Pulse

Summary: On November 8, 2007 , the FDA strengthened the boxed warnings for erythropoiesis-stimulating agents (ESAs) – Amgen’s Epogen, Johnson & Johnson’s Procrit/Eprex, and Amgen’s Aranesp – and made other safety labeling changes to the drugs. ♦ ESAs are approved to treat anemia in patients with chronic kidney failure and in certain cancer patients with anemia caused by chemotherapy. Epogen and Procrit are also approved to reduce blood transfusions in certain patients with anemia who are scheduled to undergo major surgery, and they are approved to treat anemia caused by zidovudine (AZT) therapy in HIV patients.