San Diego, CA -- (SBWIRE) -- 04/18/2012 -- Certain directors and officers of Columbia Laboratories Inc. are under the investigation on behalf of current long term investors in NASDAQ:CBRX shares over possible breaches of fiduciary duties.
Investors who are current long term investors in Columbia Laboratories Inc. (NASDAQ:CBRX) shares, 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 for current long term investors in Columbia Laboratories Inc. (NASDAQ:CBRX) stocks follows a lawsuit filed earlier by certain NASDAQ:CBRX investors. The investigation on behalf of current long term investors in Columbia Laboratories Inc. (NASDAQ:CBRX) stocks concerns whether certain Columbia Laboratories Inc. (NASDAQ:CBRX) officers and directors are liable in connection with the allegations made in that lawsuit.
According to that complaint filed in the the U.S. District Court, District of New Jersey the plaintiff alleges that Columbia Laboratories, Inc violated the Securities Exchange Act of 1934 by issuing allegedly materially false and misleading statements.
Specifically, the plaintiff claims that Columbia Laboratories, Inc conditioned investors to believe that Columbia Laboratories’ PROCHIEVE progesterone vaginal gel 8% , a gel intended to prevent preterm births in women with short cervices, would receive Food and Drug Administration (“FDA”) approval through a host of statements regarding the safety and efficacy of the product, as well as reportedly positive results from PROCHIEVE's clinical trials.
In Decmeber 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 in January 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.
Shares of Columbia Laboratories Inc. (NASDAQ:CBRX) fell from slightly below $3 on January 10, 2012 to as low as $1.05 per share on January 17, 2012.
Then 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.
Columbia Laboratories Inc. (NASDAQ: CBRX) shares declined from $2.90 on January 2012 to as low as 0.62 in March 2012 and closed on April 17, 2012 at $0.70 per share.
Those who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
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