LIVINGSTON, N.J.--(BUSINESS WIRE)--Columbia Laboratories, Inc. (Nasdaq: CBRX) announced today that Roberto Romero, M.D., chief of the Perinatology Research Branch of the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), of the National Institutes of Health (NIH), was awarded the 2011 John Dingell Hero for Babies Award by the March of Dimes Michigan Chapter.
Dr. Romero was honored for his work in preterm birth at the Perinatology Research Branch (PRB) including the PREGNANT study, which was conducted collaboratively under a Clinical Trials Agreement between Columbia and the PRB/NICHD/NIH and of which Dr. Romero was the NIH Principal Investigator. This study demonstrated that administration of progesterone vaginal gel 8% from the midtrimester of pregnancy until term in women with a premature cervical shortening was associated with a 45% reduction in the incidence of preterm birth before 33 weeks gestation.
Frank Condella, Columbia’s president and chief executive officer, said, “We congratulate Dr. Romero on this recognition of his substantial contributions in the field of obstetrics and maternal-fetal medicine. We share in his conviction that the findings of the PREGNANT study will help change the practice of medicine.”
Dr. David Cotton, M.D., the chief executive officer of Health Plan of Michigan, also received the award. Dr. Cotton was recognized for his dedication to maternal infant health, including his contributions to the Perinatology Research Branch, which is located at Wayne State University and the Detroit Medical Center.
The John Dingell Hero for Babies Award is presented annually by the Michigan Chapter of the March of Dimes to a local community leader(s) who is a "true hero" in improving the well being of children in their community. The Hero for Babies Award is named after Representative John Dingell (D-MI 15), to whom it was awarded several years ago.
About Columbia Laboratories
Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel), for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono. The Company’s New Drug Application (NDA) for progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy was accepted for filing by the Food and Drug Administration (FDA) with a PDUFA date of February 26, 2012.
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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,” “anticipates,” “potential,” 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: the outcome of further analyses by the FDA of the clinical data in the Preterm Birth NDA; success in obtaining timely approval of the Preterm Birth NDA by the FDA; the timing and level of success of a future product launch, if any; the ability of Columbia's third-party manufacturers to supply CRINONE®; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; the ability to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies; 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.