Allergan Receives Approvable Letter for LUMIGAN -- bimatoprost-timolol
IRVINE, Calif., Aug 2, 2004 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its LUMIGAN(R) timolol combination product for glaucoma (bimatoprost 0.03 percent/timolol 0.05 percent ophthalmic solution). An approvable letter sets out the conditions that a company must meet in order to obtain FDA final marketing approval.
"The FDA's response necessitates additional clinical investigation," explained Dr. Scott Whitcup, Allergan's Executive Vice President, Research and Development. "Allergan has already initiated an additional clinical study that we currently anticipate will be completed by the end of 2004."
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
Forward-Looking Statements
This press release contains "forward-looking statements," including the statements by Dr. Whitcup, statements regarding research and development outcomes, efficacy, and market and product potential. 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 general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or acceptance of new indications for such products; potential difficulties in manufacturing a new product formulation; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; 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 "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's 2003 Form 10-K and Form 10-Q for the quarter ended June 25, 2004. 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.
SOURCE: Allergan, Inc.
Allergan, Inc. Jim Hindman, 714-246-4636 (investors) Joann Bradley, 714-246-4766 (investors) Ashwin Agarwal, 714-246-4582 (investors) Stephanie Fagan, 714-246-5232 (media) Caroline Van Hove, 714-246-5134 (media)
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