Negative opinions for Lyrica, Impulsor, Erbitux

EMEA's CHMP issued several negative opinions on Friday, including recommending against approval of two fibromyalgia treatments marketed in the U.S. On reexamination, the agency reaffirmed its April negative opinion for Lyrica pregabalin from Pfizer Inc. (NYSE:PFE). The committee said the benefits of the drug in the indication had not been shown in either the short or long term, including no consistent or relevant reductions in pain or other symptoms in the short-term studies or maintenance of the drug's effects in a long-term study. Lyrica is already approved in the EU for neuropathic pain, epilepsy and generalized anxiety disorder.

The agency issued a negative opinion for Impulsor milnacipran from Laboratoires Pierre Fabre S.A. (Castres, France). The committee said the effect of milnacipran was marginal and that there was a lack of data on the compound's long-term effects in a European population. Cypress Bioscience Inc. (NASDAQ:CYPB) and Forest Laboratories Inc. (NYSE:FRX) market milnacipran as Savella in the U.S. Cypress was up $0.11 to $9.73 on Friday, while Forest added $0.45 to $26.03. ...