Printer Friendly

FDA Advisory Committee Unanimously Recommends Approval of LATISSE[TM] (Bimatoprost Solution 0.03%) as a Treatment for Hypotrichosis of Eyelashes.

IRVINE, Calif. -- Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (9-0) to recommend that the FDA approve LATISSE[TM] (bimatoprost solution 0.03%) as a treatment for hypotrichosis (or reduced amount of hair) of the eyelashes. If approved, LATISSE[TM] would be the first and only FDA-approved pharmaceutical to enhance eyelash prominence.

"Today's Advisory Committee recommendation is an important step in the FDA review process to provide consumers with a safe and effective treatment to improve the length, thickness and darkness of natural eyelashes," said Scott Whitcup M.D., Allergan's Executive Vice President of Research and Development. "Recently, unapproved eyelash products containing active drug ingredients have appeared on the market. If approved, LATISSE[TM] will offer consumers an FDA-approved product which has been extensively studied in well-controlled clinical trials, is manufactured to pharmaceutical standards, is appropriately labeled for use, and is regulated as a prescription product."

In addition to its unanimous recommendation for approval of LATISSE[TM], the Committee also voted 5-3 (1 abstained vote) in favor of Phase 4 (post-market studies) to assess use in certain patient populations, including patients of younger age and post-chemotherapy patients with loss of eyelashes.

The Committee's recommendation, although not binding, will be considered by the FDA as it contemplates approval for LATISSE[TM] as a treatment for eyelash growth. If approved by the FDA, Allergan anticipates launching LATISSE[TM] in 2009.

Forward-Looking Statements

This press release contains "forward-looking statements," including the statements by Dr. Whitcup and other statements regarding the safety, effectiveness, approval and market potential associated with LATISSE[TM]. 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, biologic and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; 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 quarter ended September 30, 2008. Copies of Allergan's press releases and additional information about Allergan are 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.

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 more than 8,500 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.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Dec 5, 2008
Words:533
Previous Article:General American Investors Announces: Issue Price for the 2008 Year-End Dividend and Distribution Payable on December 26, 2008.
Next Article:Allegiance Capital to Chair Wind and Solar Power Investment Summit - Dec. 10-11.
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters