October 2006 Issues

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

Summary: The European launch of Biogen Idec/Elan’s Tysabri has gotten off to a slow start. Neurologists plan to use it, but very selectively until they see if more cases of PML develop. ♦ A 16-year study of Schering AG’s Betaseron had a surprising finding: lower all-cause mortality with Betaseron than placebo. Researchers aren’t sure why, but the finding was intriguing. ♦ Serono’s new formulation of Rebif has fewer injection site reactions and neutralizing antibodies, but flu-like symptoms are increased. ♦ A trial of a double dose of Teva’s Copaxone missed its primary endpoint, failing to significantly reduce Gd+ lesions. ♦ The early benefits of Novartis’s oral fingolimod held up at 24 months in a Phase II extension study. The drug looks very promising, but there are still several safety issues that need to be watched in the ongoing Phase III trials. ♦ Schering AG continues to work on development of IV Campath and is optimistic that the efficacy will be excellent with a manageable risk management plan. ♦ Numerous other drugs, both oral and IV, are in development.

Continuous Glucose Monitoring Systems (CGMS)

Summary: Use of CGMS is progressing like a tortoise. ♦ Reimbursement is miserable, but even with good reimbursement, usage is expected to grow slowly. ♦ DexCom is holding its own against Medtronic based on price, but doctors are keeping an eye on Abbott’s device, which could be a game changer if it lives up to its hype.

Drug-Eluting Stent Update -- Quick Pulse

Summary: Twelve interventional cardiologists, cath lab directors, and cath lab managers/ supervisors in the U.S. were interviewed to see if drug-eluting stent (DES) use is changing due to concerns about late stent thrombosis. Sources were well aware of the stent thrombosis issue; doctors are concerned about it, and they have been discussing it among themselves. DES use remains relatively unaffected. Although some cath labs cut their use slightly over the summer, there is no continuing shift from DES to bare metal stents (BMS). However, doctors are prescribing longer use of dual antiplatelet therapy – Sanofi-Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel) and aspirin.

Inflammation Research Association -- Quick Pulse

Summary: More than 300 researchers from pharma and biotech industries and academia attended this biennial conference on inflammation. The focus this year was on cardiovascular disease, fibrosis, and novel anti-inflammatory agents. The poster considered to have the greatest therapeutic relevance was on Praecis’ PPI-2458, an oral MetAP2 inhibitor for rheumatoid arthritis (RA). The runner-up was a poster by an Array BioPharma researcher on ARRY-371797, an aerosol p38 inhibitor.