Regulatory milestones

Highlights of weekly biotech stock moves; Regulatory, clinical and other milestones

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) added $2.38 to $102.38 last week after submitting regulatory applications to FDA and EMA for Soliris eculizumab to treat atypical hemolytic uremic syndrome (aHUS). Soliris is already approved to treat paroxysmal nocturnal hemoglobinuria (PNH).

Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) shed $0.18 to $12.95 last week after FDA's Anti-Infective Drugs Advisory Committee voted 13-0 that Dificid fidaxomicin was safe and effective at treating Clostridium difficile-associated diarrhea. However, the panel also voted 7-6 that the finding of lower recurrence of CDAD at day 31 vs. Vancocin vancomycin was not clinically significant (see "Dificid's Recurring Theme," A7).

ViroPharma Inc. (NASDAQ:VPHM), which markets Vancocin in the U.S., was off $0.32 to $19.37.

The day after the panel meeting, Optimer granted U.S. co-promotion rights to Dificid to Cubist Pharmaceuticals Inc. (NASDAQ:CBST), which gained $4.85 (19%) to $29.99 (see B5).

Separately, Cubist settled a 2009 suit related to a generic version of its antibiotic Cubicin daptomycin from Teva Pharmaceutical Industries

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