San Diego, CA -- (SBWIRE) -- 01/31/2012 -- The Shareholders Foundation announces that an investigation on behalf of investors in shares of Columbia Laboratories Inc. (NASDAQ:CBRX) was initiated over potential securities laws violations by certain officers and directors at Columbia Laboratories in connection with certain statements over its progesterone gel to reduce the risk of preterm birth.
Investors who purchased shares of Columbia Laboratories Inc. (NASDAQ:CBRX), have certain options and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Columbia Laboratories Inc. (NASDAQ:CBRX) concerning whether the company, certain of its officers and directors, or others have possibly violated federal securities laws. Specifically, the investigation concerns whether certain statements Columbia Laboratories’ business, its prospects and its operations were potentially materially false and misleading at the time they were made.
On December 14, 2011, Columbia Laboratories Inc announced that a meta-analysis of data from five double-blind, placebo-controlled trials its progesterone gel product "significantly reduces the risk of preterm birth and neonatal morbidity."
However, then on January 17, 2012, a report by the Food and Drug Administration staff about Columbia Laboratories progesterone gel to reduce the risk of preterm birth was released. According to the report Columbia Laboratories’ progesterone gel wasn’t effective.
On January 20, 2012, Columbia Laboratories, Inc. (Nasdaq:CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) declined to recommend the approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval.
Columbia Laboratories, Inc said the final decision regarding the approval of the product rests solely with the FDA and the FDA's Division of Reproductive and Urologic Products is expected to take action on Columbia's New Drug Application (NDA) by February 26, 2012.
On the same day a media report cited advisors to U.S. regulators saying Columbia Laboratories Inc. (CBRX) and Watson Pharmaceuticals Inc. (WPI) didn’t provide sufficient data that their progesterone gel reduces the risk of preterm birth.
Shares of Columbia Laboratories Inc. (NASDAQ:CBRX) dropped from $2.90 per share on January 10, 2012 to as low as $0.65 per share on Jan. 23, 2012.
Those who purchased shares of Columbia Laboratories Inc. (Public, NASDAQ:CBRX) , have certain options and should contact the Shareholders Foundation.
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