Columbia Laboratories' Names Michael McGrane New Vice President, General Counsel and Secretary.Business Editors/Health & Medical Writers LIVINGSTON, N.J.--(BUSINESS WIRE)--Jan. 9, 2002 Columbia Laboratories (AMEX AMEX See: American Stock Exchange :COB) today announced that Michael McGrane has joined the Company as Vice President, General Counsel and Secretary. He is responsible for legal affairs, regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Prior to joining Columbia Laboratories, Mr. McGrane served as Vice President, General Counsel and Secretary for The Liposome liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. Company, Inc., a subsidiary of Elan Corporation plc from 1999 to 2001, and for Novartis Consumer Health, Inc. from 1997 to 1999. Mr. McGrane also spent twelve years in regulatory and legal positions with Sandoz Pharmaceuticals Corporation and nine years as Regulatory Counsel to the U.S. Food and Drug Administration. He holds a law degree from Georgetown University and is a member of the New Jersey Bar Association. Commenting on the appointment, Fred Wilkinson, president and chief executive officer of Columbia Laboratories, stated, "I am delighted to have Mike join our management team. He brings outstanding skills and experience in handling legal activities related to patents and trademarks, human resources, business development, and general litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. as well as management of regulatory filings and compliance." Mr. Wilkinson added, "Mike will have an immediate impact on two key projects; the Serono litigation and the filing of the testosterone buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal tablet NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any . Importantly, the addition of Mike as an integral member of the Columbia management team will improve the probability for success as we re-focus the company in 2002." Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. care and endocrinology products, including those intended to treat infertility, dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. , endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. and hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal delivery system for peptides. Columbia's products primarily utilize the company's patented bioadhesive delivery technology. This press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, the successful revalidation of the Crinone manufacturing process, timely and successful completion of clinical studies, competitive economic and regulatory factors in the pharmaceutical and health care industry, the outcome of the Serono litigation, general economic conditions and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. |
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