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New Formulation of Allergan's ALPHAGAN P Receives U.S. FDA Approval
Business Wire, August 19, 2005
IRVINE, Calif. -- Allergan, Inc. (NYSE:AGN) today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market ALPHAGAN(R) P (brimonidine tartrate ophthalmic solution) 0.1%, indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The new product is an optimized formulation of ALPHAGAN(R) (brimonidine tartrate ophthalmic solution) 0.2%, and was developed to further minimize drug exposure while maintaining the drug's favorable efficacy profile. This FDA approval is the latest advance in the ALPHAGAN(R) Franchise, which includes ALPHAGAN(R) P 0.15%, and currently reflects the third-largest selling glaucoma franchise in the world(1).
"Our goal in developing ALPHAGAN(R) P 0.1% has been to ensure maximal efficacy of brimonidine with the least drug exposure possible," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research & Development. "By improving bioavailability compared to the original ALPHAGAN(R) 0.2%, we have managed to decrease drug concentration by half without sacrificing efficacy. This milestone underscores Allergan's commitment to providing eye care specialists and patients with safe and efficacious medicines."
In a clinical trial, ALPHAGAN(R) P ophthalmic solution 0.1% was proven to have IOP-lowering efficacy equivalent to ALPHAGAN(R) 0.2%, effectively lowering IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2-6 mmHg. ALPHAGAN(R) P 0.1% is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. The most frequently reported adverse events included allergic conjunctivitis, conjunctival hyperemia and eye pruritus. Full prescribing information for ALPHAGAN(R) P 0.1% can be found at www.Allergan.com.
Forward-Looking Statements
This press release contains "forward-looking statements," including, among other statements, 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 obtained by competitors; challenges inherent in 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; 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. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. 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 2004 Form 10-K and Allergan's Form 10-Q for the quarter ended June 24, 2005. 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.
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.
(1) IMS Health, Inc., 2004 Revenue
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