San Diego, CA -- (SBWIRE) -- 02/14/2012 -- The Shareholders Foundation announces that an investor in shares of Columbia Laboratories Inc. (NASDAQ:CBRX) filed a lawsuit in the U.S. District Court, District of New Jersey against Columbia Laboratories Inc. over alleged Violations of Federal Securities Laws in connection with certain statements concerning Columbia Laboratories’ progesterone vaginal gel.
Investors who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and for certain NASDAQ:BRX stockholders are strict and short deadlines running. Deadline: April 2, 2012. NASDAQ:CBRX investors should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
According to the complaint the plaintiff alleges on behalf of all persons or entities who purchased Columbia Laboratories Inc. (NASDAQ: CBRX) securities between December 6, 2010 and January 20, 2012, that Columbia Laboratories, Inc and certain of its officers violated the Securities Exchange Act of 1934 by issuing allegedly materially false and misleading statements. Specficially the plaintiff alleges 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.
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 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.
Columbia Laboratories Inc. (NASDAQ: CBRX) shares declined an additional $0.874 per share or more than 55%, to close at $0.706 per share on January 23, 2012.
Those who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX), including but not limited to those who purchased NASDAQ:CBRX shares between December 6, 2010 and January 20, 2012, have certain options and there are strict and short deadlines running. Deadline: April 2, 2012. NASDAQ:CBRX stockholders should contact the Shareholders Foundation.
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