Allergan Comments on Brimonidine Franchise.Business Editors/Health/Medical Writers IRVINE, Calif.--(BUSINESS WIRE)--May 28, 2003 Allergan, Inc. (NYSE NYSE See: New York Stock Exchange : AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) today reported that a generic form of its previously discontinued product ALPHAGAN(R) (brimonidine tartrate tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid. tar·trate n. A salt or ester of tartaric acid. tartrate a salt of tartaric acid. ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. ) 0.2% has been approved by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Allergan withdrew distribution of the original formulation of ALPHAGAN(R) in the United States in August 2002 in order to focus its efforts on its more advanced formulation, ALPHAGAN(R) P (brimonidine tartrate ophthalmic solution) 0.15%. ALPHAGAN(R) P is indicated for the lowering of intraocular pressure intraocular pressure n. The pressure of the intraocular fluid within the eye. intraocular pressure (in´tr (IOP IOP intraocular pressure. IOP Intraocular pressure, see there ) in patients with open-angle glaucoma and ocular hypertension and contains 25 percent less brimonidine than the original ALPHAGAN(R) formulation. In clinical studies, the discontinued 0.2% formulation showed higher rates of certain adverse events, including a 60% increase in the incidence of ocular allergy (16% vs. 10%). ALPHAGAN(R) P provides patients comparable efficacy with greater tolerability than the original 0.2% formulation. Under FDA regulations, the generic formulation of brimonidine 0.2% is not substitutable for ALPHAGAN(R) P due to the differences in the products. ALPHAGAN(R) P continues to have FDA marketing exclusivity and is protected by a number of formulation and other patents. The introduction of generic formulations of the first generation of ALPHAGAN(R) was anticipated and incorporated into estimates provided by Allergan at the beginning of 2003. The Company's generic division, Pacific Pharma, Inc., currently intends to make available a generic version of the 0.2% formulation. In the clinical trials, the most frequently reported adverse events with ALPHAGAN(R) P included allergic conjunctivitis, conjunctival con·junc·ti·val adj. Relating to the conjunctiva. conjunctival pertaining to or emanating from conjunctiva. congenital conjunctival membrane hyperemia hyperemia /hy·per·emia/ (-e´me-ah) engorgement; an excess of blood in a part.hypere´mic active hyperemia , arterial hyperemia that due to local or general relaxation of arterioles. , ocular pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic pruritus a´ni intense chronic itching in the anal region. pruritus hiema´lis xerotic eczema. , burning sensation, conjunctival foliculosis, hypertension, oral dryness and visual disturbance. Forward-Looking Statements This press release contains "forward-looking statements," such as statements regarding ALPHAGAN(R) P ophthalmic solution, potential growth rates, earnings and revenue guidance, adverse effects and availability of this product. 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 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 a new pharmaceutical product; potential difficulties in manufacturing a new product formulation; domestic and foreign healthcare reforms; trends toward managed care and healthcare 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 Form 10-K for the year ended December 31, 2002 and Allergan's Form 10-Q for the quarter ended March 28, 2003. Copies of Allergan's press releases, public filings, the full prescribing information for ALPHAGAN(R) P 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 at 714/246-4636. About Allergan, Inc. Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator and skin care markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives. |
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