Key Developments: Columbia Laboratories Inc (CBRX.W)
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14 May 2013
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Latest Key Developments (Source: Significant Developments)
Columbia Laboratories Inc Extends Agreement With Merck Serono For Crinone Ex US Into 2020
Columbia Laboratories Inc announced that it has amended its license and supply agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for CRINONE (progesterone gel) through May 2020, representing an extension of five years beyond the current term, which was due to expire in May 2015. Under the terms of the amended license and supply agreement, Columbia will remain the sole supplier of CRINONE to Merck Serono and will continue to sell CRINONE to Merck Serono on a country by country basis. From 2014 through 2020, the sourcing conditions for Merck Serono will include incremental volume discounts to incentivize Merck Serono to continue developing existing markets and investing in entry into new markets. Full Article
Columbia Laboratories Inc Appoints Jonathan B. Lloyd Jones As Chief Financial Officer
Columbia Laboratories Inc announced the appointment of Jonathan B. Lloyd Jones, as Vice President, Finance, Chief Financial Officer, Treasurer and Secretary, effective January 21. He will be based at Columbia's corporate headquarters, which will be relocated to the area of Boston, Massachusetts during the first half of 2013. Mr. Lloyd Jones replaces Lawrence A. Gyenes, formerly Columbia's Chief Financial Officer, who will remain with the Company through January 31, 2013, which will also be Michael McGrane's last day as Columbia's General Counsel. Full Article
Law Firm of Levi & Korsinsky Announces Class Action Lawsuit Of Columbia Laboratories Inc.
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the District of New Jersey on behalf of investors who purchased Columbia Laboratories, Inc. stock between December 6, 2010 and January 20, 2012. Full Article
Columbia Laboratories Inc Announces 42% Workforce Reduction; Sees Q1 2012 Charge Guidance
Columbia Laboratories Inc announced a 42% workforce reduction from 24 employees at December 31, 2011, to 14 employees. The Company will record a severance charge of approximately $0.5 million in the first quarter of 2012, and expects to realize annual savings of over $1.5 million. The reduction primarily impacts research and development and general administrative positions. Columbia's remaining staff will continue to focus on the future course of Columbia's business, executing its public reporting obligations, management of its supply chain, and its role on the Joint Development Committee with Watson Pharmaceuticals, Inc. for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with premature cervical shortening. Full Article
Brower Piven Announces Class Action Lawsuit Against Columbia Laboratories Inc
Brower Piven announced that a class action lawsuit has been commenced in the United States District Court for the District of New Jersey on behalf of purchasers of the securities of Columbia Laboratories, Inc. during the period between December 6, 2010 and January 20, 2012, inclusive (Class Period). The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the Company's failure to disclose during the Class Period that the Company's positive statements regarding the safety and efficacy of PROCHIEVE progesterone vaginal gel 8% (PROCHIEVE), a gel intended to prevent preterm births in women with short cervices, and regarding positive results from PROCHIEVE's clinical trials were unfounded. According to the complaint, after, on January 17, 2012, the FDA published information ahead of a meeting by the Advisory Committee for Reproductive Health Drugs of the FDA (Advisory Committee) scheduled for January 20, 2012, and revealed that PROCHIEVE did not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks of gestation among women with a short cervical strength and that the safety of the gel was similar to a placebo as [n]o maternal deaths occurred and the rates of fetal, neonatal and infant deaths were similar in both treatment arms, and after, on January 20, 2012. Full Article
Columbia Laboratories Inc Transfers NDA for Progesterone Vaginal Gel 8% to Watson Pharmaceuticals, Inc.
Columbia Laboratories Inc and Watson Pharmaceuticals, Inc. announced that Columbia has transferred the new drug application for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy (NDA 22-139) to Watson. Watson has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application as of February 10, 2012 . The companies indicated that Watson is continuing to work with FDA in support of the review of the NDA. Full Article
Faruqi & Faruqi, LLP Announces Investigation Of Columbia Laboratories Inc
Faruqi & Faruqi, LLP announced that it is investigating potential securities fraud at Columbia Laboratories Inc. (Columbia or the Company). The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose that: the Company's PROCHIEVE product was not delivering desired results; the Food & Drug Administration ("FDA") was unlikely to give approval to Columbia's PROCHIEVE product; and contrary to Company representations, Columbia's future was not "very good" due to the efficacy issues with PROCHIEVE. Columbia's much touted product "PROCHIEVE" is a gel intended to prevent preterm births. On December 14, 2011, the Company issued a press release highlighting the purported results of clinical trials that showed that PROCHIEVE "significantly reduces the risk of preterm birth and neonatal morbidity." Following this announcement, Columbia's stock increased in price significantly. Full Article
Robbins Geller Rudman & Dowd LLP Files Class Action Suit Against Columbia Laboratories Inc
Robbins Geller Rudman & Dowd LLP announced that a class action has been commenced in the United States District Court for the District of New Jersey on behalf of purchasers of Columbia Laboratories, Inc. (Columbia) publicly traded securities during the period between December 6, 2010 and January 20, 2012 (the Class Period). The complaint charges Columbia and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Columbia is engaged in the business of developing, manufacturing and selling pharmaceutical products that utilize its bioadhesive drug delivery technologies to treat various medical conditions. The complaint alleges that during the Class Period, defendants issued materially false and misleading statements regarding the Company’s progesterone vaginal gel product, PROCHIEVE, for reducing the risk of preterm birth in women. Instead of truthfully disclosing concerns about PROCHIEVE’s efficacy in reducing the risk of preterm birth, defendants continuously hyped PROCHIEVE’s combination of efficacy, safety and tolerability during the Class Period. As a result of defendants’ false statements, Columbia’s stock traded at artificially inflated prices during the Class Period, reaching a high of $4.03 per share on April 6, 2011. Full Article
Levi & Korsinsky Announces Investigation Of Columbia Laboratories Inc
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the District of New Jersey on behalf of investors who purchased Columbia Laboratories, Inc. stock between December 6, 2010 and January 20, 2012 (Class Period). The Complaint alleges that Columbia Labs and certain of its Officers and Directors issued materially false and/or misleading statements regarding the safety and efficacy of its product PROCHIEVE, a gel intended to prevent preterm births. On December 14, 2011, the Company issued a press release highlighting the purported results of clinical trials that showed that PROCHIEVE significantly reduces the risk of preterm birth and neonatal morbidity. Following this announcement Columbia’s stock increased in price significantly. Full Article
Robbins Umeda LLP Announces Investigation Of Columbia Laboratories, Inc.
Robbins Umeda LLP announced that an investigation into Columbia Laboratories, Inc. Robbins Umeda LLP is investigating whether officers or directors at Columbia Laboratories issued improper statements to investors that were designed to deceive the market and artificially inflate the Company's stock price. In particular, the firm is examining allegations that senior officials at Columbia Laboratories misled investors about the commercial viability, effectiveness, and market potential for Prochieve, an experimental progesterone vaginal gel designed to reduce the risk of preterm birth. On December 14, 2011, officials at Columbia Laboratories announced that clinical trials of Prochieve showed that the drug reduced "the risk of preterm birth in women with premature cervical shortening," and that administration of the drug "significantly reduces the risk of preterm birth and neonatal morbidity" for certain women. However, on January 20, 2012, Columbia Laboratories confirmed that the U.S. Food and Drug Administration would not recommend approval of Prochieve after data showed that the Company's gel was ineffective. Since these facts have emerged, shares of Columbia Laboratories have lost over 50% of their value. Robbins Umeda LLP highlights that one option available to Columbia Laboratories shareholders is filing a class action lawsuit on behalf of investors to recover damages incurred as a result of the wrongdoing. Full Article
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