Allergan and Inspire Enter into Collaboration to Co-Promote Elestat in the U.S.Business Editors/Health/Medical Writers IRVINE, Calif. & DURHAM, N.C.--(BUSINESS WIRE)--Dec. 8, 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) ) and Inspire Pharmaceuticals, Inc. (Nasdaq:ISPH ISPH Inspire Pharmaceuticals, Inc. ) today announced that they have entered into a co-promotion agreement in the United States for Elestat(TM) (epinastine HCL HCl hydrochloric acid. ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. 0.05%) within the ophthalmic specialty area. Elestat(TM) was approved by the U.S. Food & Drug Administration in October 2003 for the prevention of itching associated with allergic conjunctivitis allergic conjunctivitis n. Conjunctivitis caused by an allergic reaction to a substance. Also called atopic conjunctivitis. allergic conjunctivitis . Under the terms of the agreement, Inspire will provide Allergan with an up-front payment and Allergan will pay a royalty to Inspire on Elestat(TM) net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight . In addition, this agreement calls for Allergan to significantly reduce its existing royalty payment to Inspire for Restasis(R) (cyclosporine ophthalmic emulsion cyclosporine ophthalmic emulsion Sandimmun (UK), Restasis Pharmacologic class: Polypeptide antibiotic Therapeutic class: Immunosuppressant Pregnancy risk category C FDA Boxed Warning0.05%), that is covered by a previous agreement between Allergan and Inspire.Inspire will have the primary responsibility for selling, promotional and marketing activities related to Elestat(TM), and will incur associated costs. Allergan and Inspire will work collaboratively on overall product strategy and management. Allergan will record Elestat(TM) sales and retain all other product costs and licensing rights. Allergan will also maintain responsibility for all international marketing and selling activities and expects to launch Elestat(TM) in Europe under the brand name Relestat(TM) in early 2004. David Pyott, Allergan's Chairman, President and Chief Executive Officer said: "With four new Allergan Eye Care products approved in the last 12 months, this partnership with Inspire for Elestat(TM) will allow Allergan to focus its sales and marketing organization on its key business drivers: Lumigan(R), (bimatoprost ophthalmic solution 0.03%) Restasis(R), Zymar(TM) (gatifloxacin ophthalmic solution 0.3%), and Acular LS(R) (ketorolac tromethamine ketorolac tromethamine Acular, Acular LS Pharmacologic class: Nonsteroidal anti-inflammatory drug (NSAID) Therapeutic class: Analgesic, antipyretic, anti-inflammatory Pregnancy risk category C ophthalmic solution 0.5%) while maximizing the value of this recently approved technology with a high quality company such as Inspire." Christy L. Shaffer, Ph.D., Chief Executive Officer of Inspire, said, "Inspire has made significant progress in building its ophthalmology sales and marketing organization and will have a first-rate force in place to launch Elestat(TM) in the first quarter of 2004. This will be the first product launch for Inspire -- a major milestone for our growing company as we prepare for the potential approval of diquafosol." Elestat(TM), a topical antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. with mast cell mast cell n. A cell found in connective tissue that contains numerous basophilic granules and releases substances such as heparin and histamine in response to injury or inflammation of bodily tissues. Also called labrocyte, mastocyte. stabilizing and anti-inflammatory activity, is licensed from Boehringer-Ingelheim and was developed by Allergan for the relief of ocular itching associated with ocular allergies. Its multi-action effects inhibit binding to both H1 and H2 receptors, while preventing recruitment and activation of pro-inflammatory mediators that can trigger and exacerbate the allergic response. Elestat(TM) has a rapid onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. , and in pivotal clinical trials was well tolerated by patients and demonstrated a favorable safety profile. The most frequently reported ocular side effects occurring in approximately 1-10% of patients included burning sensation in the eye, folliculosis, 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. and 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. . The annual U.S. market for ocular allergy approximates $325 million, with a strong growth rate of 23%. (Source: IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. -- the market and growth rate information is a moving annual total as of the end of June 2003.) Forward-looking Statements This press release contains "forward-looking statements," such as the statements by Mr. Pyott and Dr. Shaffer and other statements regarding ELESTAT(TM), potential growth rates, the ELESTAT(TM) product launch, adverse effects and product availability, among other statements. 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 and Inspire'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 and Inspire as well as Allergan's and Inspire's public periodic filings with the Securities and Exchange Commission, including Allergan's and Inspire's respective Forms 10-K for the year ended December 31, 2002, Allergan's Form 10-Q for the quarter ended September 26, 2003 and Inspire's Form 10-Q for the quarter ended September 30, 2003. Copies of Allergan's press releases, public filings 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. For copies of Elestat(TM) prescribing information, please contact Allergan's scientific information and medical compliance department at 800-433-8871. Copies of Inspire's press releases, public filings and additional information about Inspire are available on the World Wide Web at www.inspirepharm.com, or you can contact the Inspire Investor Relations Department at 919-941-9777. About Allergan 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. About Inspire Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration hydration /hy·dra·tion/ (hi-dra´shun) the absorption of or combination with water. hy·dra·tion n. 1. The addition of water to a chemical molecule without hydrolysis. 2. and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments. In addition to this partnership with Allergan, Inspire has development and commercialization alliances with Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd., and a collaboration with Cystic Fibrosis Foundation The Cystic Fibrosis Foundation (CFF) is a non-profit organization in the United States established to provide the means to cure and control cystic fibrosis. The Foundation provides information about cystic fibrosis (CF) and finances CF research that aims to improve the Therapeutics, Inc. Inspire's products are based on proprietary technology relating to P2Y2 receptors and to non-P2Y2 receptors that show therapeutic promise, including P2Y12. |
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