FDA Reviews Prochieve Application - Drug Discovery and Development

LIVINGTON, N.J. (AP) – Watson Pharmaceuticals Inc. said on June 27 that the Food and Drug Administration (FDA) has accepted its marketing application for a progesterone gel that is designed to reduce the risk of premature birth.

Watson said it expects the FDA to make a decision on Prochieve, by Feb. 26, 2012. Prochieve is designed to be applied directly to the cervix during the second trimester of pregnancy, and it is intended for women who have an unusually short cervix, which puts them at higher risk for premature birth. The drug is already approved as a treatment for secondary amenorrhea, or the lack of a menstrual period.

Prochieve was developed and marketed by Columbia Laboratories Inc., based in Livingston, N.J. Watson acquired the drug in July. It paid Watson $47.5 million upfront, and the acceptance of its marketing application triggers another $5 million payment to Columbia Labs. The deal could be worth as much as $92.5 million, and Columbia Labs would also get royalties on sales if the application is approved.

Columbia Labs had asked the FDA to conduct a six-month priority review of Prochieve, but Watson said it withdrew that application.

The Associated Press