Columbia Laboratories Confirms FDA Denies Watson’s Appeal Related to Prochieve NDA for the Prevention of Preterm Birth
<0> Columbia Laboratories, Inc.Lawrence A. Gyenes, 973-486-8860Senior Vice President,CFO & TreasurerorThe Trout Group LLCSeth Lewis, 646-378-2952Vice President </0>
Columbia Laboratories Inc. (Nasdaq: CBRX) today confirmed that the U.S. Food and Drug Administration (FDA) has denied Watson Pharmaceuticals’ (NYSE:WPI) Formal Dispute Resolution Request (FDRR) related to its New Drug Application (NDA 22-139) for Prochieve for the prevention of preterm birth in women with a short cervical length. Watson said it intends to review possible options related to the continued pursuit of the NDA. Watson filed its FDRR in August of 2012.
Columbia Laboratories, Inc. is a publicly traded specialty pharmaceutical company with a successful history of developing proprietary, vaginally administered products for women’s health indications. The Company receives sales and royalty revenues from CRINONE 8% (progesterone gel), which is marketed by Watson Pharmaceuticals, Inc. in the United States and by Merck Serono S.A. in over 60 foreign countries.
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Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “intends,” “anticipates,” “potential,” “should,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: Watson's and Merck Serono's success in marketing CRINONE for use in infertility in their respective markets; successful development of a next-generation vaginal progesterone product; difficulties or delays in manufacturing; the availability and pricing of third-party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in the laws and regulations, including Medicaid; the ability to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the evaluation of potential strategic transactions; Columbia’s ability to timely regain compliance with the Nasdaq minimum closing bid price rule; the strength of the United States dollar relative to international currencies, particularly the euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
CRINONE is a registered trademark of Watson Pharmaceuticals, Inc.