Allergan Announces Intent to File New Drug Application for Bimatoprost as Novel Treatment to Stimulate Natural Eyelash Growth
IRVINE, Calif., Jun 04, 2008 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) announced today that it intends to file a New Drug Application by end of the third quarter of 2008 with the U.S. Food and Drug Administration (FDA) for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth.
"Our exploration of bimatoprost as an eyelash growth enhancer reflects our continuing commitment to offer innovative medical aesthetic treatments that are science-based, with the clinically proven safety and efficacy that consumers have come to trust Allergan to provide," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "We are pleased with the results of our clinical program and believe this innovative product, if approved, could meet a significant and currently unmet demand in the medical aesthetic marketplace."
The global mascara market is presently estimated to be $3.7 billion annually.(1) If approved by the FDA for eyelash growth, which Allergan currently anticipates in 2009, the company estimates global peak sales of bimatoprost for this indication could exceed $500 million per year. Allergan has exclusive U.S. and foreign patents on the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate natural eyelash growth. If approved by the FDA, Allergan's bimatoprost product for eyelash growth will be available by prescription only to consumers in the United States.
"The development of this innovative product stems from our 60-year expertise and leadership in prescription eye care products," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "As the largest medical aesthetics company worldwide, we are particularly pleased with the prospect of bringing to market yet another science-based medical treatment that fits into our overall facial aesthetics product portfolio and further reflects our commitment to the Science of Rejuvenation(TM)."
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The company employs approximately 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.
This press release contains "forward-looking statements", including the statements by Mr. Pyott and Dr. Whitcup, and other statements regarding research and development outcomes, efficacy, market and product potential regarding bimatoprost. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry, economic and pharmaceutical market conditions; technological advances and patents attained by competitors; the ongoing viability of our intellectual property; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2007 Form 10-K and Allergan's Form 10-Q for the period ended March 31, 2008. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
(1) Allergan estimate based on data from Colipa, Euromonitor, Kline, others
SOURCE: Allergan, Inc.
Allergan Contacts Caroline Van Hove, (714) 246-5134 (media) Heather Katt, (714) 246-6224 (media) Jim Hindman, (714) 246-4636 (investors) Joann Bradley, (714) 246-4766 (investors) Emil Schultz, (714) 246-4474 (investors)
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