Allergan Comments on Diquafosol Results.IRVINE, Calif. -- 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 commented on the announcement by Inspire Pharmaceuticals, Inc. that Inspire's diquafosol product failed to demonstrate statistically significant improvement as compared to placebo for its primary endpoint. "We remain hopeful that Inspire will find a pathway to 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. approval for diquafosol since it could be synergistic with our 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%) product for the treatment of chronic dry eye disease," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research & Development. "However, as we know from our own experience, the development of a pharmaceutical to treat chronic dry eye disease can be extremely challenging."David E.I. Pyott, Allergan's Chairman of the Board, President and Chief Executive Officer, explained: "Given the challenges associated with the research, development and regulatory approval of dry eye pharmaceuticals, we have always taken a conservative approach and have not included diquafosol in our strategic plans. Instead, our strategic plans have focused on vigorously building Restasis(R), the only pharmaceutical approved by the FDA for the treatment of chronic dry eye disease." Restasis(R) was 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. in December 2002. It was the first and remains the only prescription therapy for patients with keratoconjunctivitis sicca keratoconjunctivitis sic·ca n. See dry eye. keratoconjunctivitis sicca (ker´ (chronic dry eye disease-CDED) whose tear production is presumed to be suppressed due to ocular inflammation. Forward-Looking Statements This press release contains "forward-looking statements," including the statements by Dr. Whitcup and Mr. Pyott. 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. Those 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 obtained by competitors; challenges inherent in new 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; potential difficulties in manufacturing a new product formulation; 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 cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. ; the results of any pending or future litigations or claims; 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 2003 Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and Allergan's Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 24, 2004. 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 Investor relations The process by which the corporation communicates with its investors. Department by calling 1-714-246-4636. About Allergan, Inc. Allergan, Inc., with headquarters in Irvine, California Irvine is an incorporated city in Orange County, California, United States. It is a planned city, mainly developed by the Irvine Company since the 1960s. Formally incorporated on December 28 1971, the 69.7 square mile (180.5 km²) city has a population of 202,079 (as of 2007). , 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. |
|
||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion