Columbia Labs shares slide on shift in Prochieve regulatory strategy

Shares of Columbia Laboratories ($CBRX) slid this morning after the company said that it has opted to drop its request for a priority review of Prochieve, a vaginal gel designed to lower the risk of premature births, and go for a standard review. Columbia and Watson Pharmaceuticals are pushing for an approval, also noting that the FDA has accepted their NDA for review.

"Following discussions with FDA, the companies determined that a standard review would afford the agency the appropriate timeframe necessary to complete its review of the application, including empaneling an agency advisory committee, if necessary," said Columbia in a release.

Today's milestone was worth a $5 million milestone payment for Columbia. But investors were more focused on the new approval timeline, with the FDA scheduled to make a final decision by February 26 of next year. The release spurred a 10 percent drop in Columbia's shares by mid-morning.

"Premature birth is a critical problem in this country and currently no therapeutic option exists for preventing preterm birth in women with premature cervical shortening, an emerging risk factor," said Fred Wilkinson, Watson's EVP of global brands. "The Prochieve New Drug Application represents an important step in the evaluation of a potential new treatment, and if approved, could have a meaningful impact on mothers and the health of their babies, as well as a significant economic impact on the healthcare system."

- see the Columbia Labs release
- here's the story from Reuters

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