LIVINGSTON, N.J. (AP) – Columbia Laboratories Inc. said results from a late-stage trial of a progesterone gel showed a statistically significant reduction in pre-term birth rates and evidence of improved infant outcomes.
The Livingston, N.J., company said Prochieve 8 percent vaginal progesterone gel aims to reduce the risk of pre-term birth in women with a short cervical length. The company plans to seek regulatory approval for that use in the second quarter of 2011.
Prochieve, also marketed under the name Crinone, already is approved for use as an infertility treatment and for secondary amenorrhea, or the lack of a menstrual period.
Shares of Columbia Laboratories soared 29 cents, or 19 percent, to $1.80 in Monday afternoon trading after rising of a 52-week high of $2 earlier in the session. Shares of Watson Pharmaceuticals Inc. also rose $1.40, or nearly 3 percent, to $50.95.
Watson said in July it completed the acquisition of U.S. rights to the gel in a deal that could be worth more than $92.5 million if the drug is approved for the prevention of premature birth. Columbia will get royalties on sales.
Date: December 6, 2010
Source: Associated Press