1Q Wrap-Up: Relatively unnoticed

If one could produce a first quarter Nielsen Rating on the biotech group, it would be like one of those "quality" TV shows that nobody watches. With investors riveted on the Iraq conflict, Wall Street seemed to care more about safe havens than biotech fundamentals. That's too bad, because the industry put in a solid quarter on the fundamentals: approvals out-numbered significant late-stage setbacks close to 2-1 (see "Approvals/Setbacks," A20).The approvals included the first ever biologic to treat psoriasis - Amevive alefacept from Biogen (BGEN) - and the first HIV fusion inhibitor - Fuzeon enfuviritide from Trimeris (TRMS) and partner Roche (ROCZ).

Also, a few products neared final approval during the quarter. In January, BioMarin (BMRN; SWX:BMRN) and partner Genzyme (GENZ) received a complete response letter from the FDA for their BLA for Aldurazyme laronidase to treat mucopolysaccharidosis I (MPS I) after a positive FDA panel earlier that month. Also in January, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 that clearance of globotriasylceramide (GL-3) from endothelial kidney cells, the surrogate marker in GENZ's pivotal trial of its Fabrazyme agalsidase beta, is reasonably likely to predict clinical benefit in Fabry's disease patients (see BioCentury, Jan. 15). ...