Allergan Receives Positive Opinions for COMBIGAN(TM) From 21 Countries in European Union
Allergan, Inc. (NYSE:AGN) today announced that it received positive opinions for COMBIGAN(TM), Allergan’s ALPHAGAN(R)/timolol combination product for glaucoma (brimonidine tartrate/timolol ophthalmic solution), from all twenty-one Concerned Member States included in the COMBIGAN(TM) Mutual Recognition Procedure (MRP) for the European Union. Allergan received notification of the positive opinions for COMBIGAN(TM) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, which acted as the Reference Member State for the MRP. Marketing authorization and national licenses for COMBIGAN(TM) are expected to be issued in the coming months following each country’s assessment of the local product labeling making COMBIGAN(TM) available in all countries of the European Union.
COMBIGAN(TM) is indicated for reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers.
“We are extremely pleased by the successful conclusion of the mutual recognition procedure for COMBIGAN(TM), which allows us to make this valuable medicine available to glaucoma patients throughout the European Union,” said Dr. Scott Whitcup, Allergan’s Executive Vice President, Research & Development.
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, 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.