Berlex Laboratories and Allergan Enter into an Agreement for the Co-Promotion of New Rosacea Treatment FINACEA; Sales Force Synergies Will Drive Product Success.Business Editors/Health/Medical Writers MONTVILLE, N.J. & IRVINE, Calif.--(BUSINESS WIRE)--March 20, 2003 Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE NYSE See: New York Stock Exchange :SHR SHR Shore SHR Spontaneously Hypertensive Rat SHR Staff Human Resources SHR Saskatoon Health Region (Saskatoon, SK, Canada) SHR Shift Logical Right SHR Sensible Heat Ratio SHR Supplementary Homicide Report SHR Steroid Hormone Receptor ), and Allergan, Inc. (NYSE:AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ) announced today that they have entered into an agreement for the co-promotion of Berlex's new topical rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and treatment FINACEA(TM) (azelaic acid) Gel 15%. The co-promotion agreement calls for joint sales and marketing activities for FINACEA, for which Berlex received marketing approval from the U.S. Food and Drug Administration (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. ) in December 2002. "We are excited about the opportunity that FINACEA brings to the market. Given the limited treatment options available for rosacea, and the recent availability of positive clinical trial data from a Comparative Study of FINACEA and metronidazole metronidazole /met·ro·ni·da·zole/ (-ni´dah-zol) an antiprotozoal and antibacterial effective against obligate anaerobes; used as the base or the hydrochloride salt. It is also used as a topical treatment for rosacea. gel, we anticipate strong physician and patient trial and acceptance of the product," said Elise Klein, Vice President and General Manager of Berlex Dermatology. "To optimize the impact of this product, we are teaming up with another seasoned, successful sales organization. We see this as an opportunity to reach our goals of establishing FINACEA as a first line agent in rosacea." "The introduction of FINACEA brings to this important market an exciting new therapy for the treatment of rosacea," said Bill Humphries, Allergan's Vice President U.S. Skin Care. "This synergistic collaboration plays to the business strengths in the dermatologic community of both organizations, which should ultimately benefit physicians treating rosacea and patients suffering from this condition." FINACEA, the first new therapeutic class option to be approved for the treatment of rosacea in more than a decade, will be launched in March 2003 at the Winter American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world. The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). (AAD AAD American Academy of Dermatology. AAD American Association of Dermatology ) meeting in San Francisco. Under the co-promotion agreement, the sales forces of both companies will call on dermatologists to provide information and product samples for FINACEA. About FINACEA FINACEA is indicated for topical treatment of the inflammatory papules Papules Firm bumps on the skin. Mentioned in: Smallpox and pustules of mild to moderate rosacea. Results of two identically designed, multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, Phase III studies involving 664 patients showed that FINACEA had a significantly greater efficacy than its vehicle in reducing the number of inflammatory papules and pustules associated with rosacea. Significant treatment effects were discernible as early as four weeks and improvement continued to be shown during the 12-week treatment period. FINACEA is contraindicated in individuals with a history of hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to propylene glycol or any other component of the formulation. The most frequently reported adverse events related to FINACEA included burning/tingling, and itching. These occurred in more than 10 percent of patients. The majority of adverse events were mild in severity. For full prescribing information, please call 1-888-BERLEX4, or log on to www.finacea.com. About Berlex Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc. develops and markets ethical pharmaceuticals in the areas of Female Healthcare, Diagnostic Imaging, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex has business operations in Montville and Wayne, New Jersey Wayne is a township in Passaic County, New Jersey, United States, located less than 20 miles from midtown Manhattan. As of the United States 2000 Census, the township had a total population of 54,069. ; Richmond and San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. ; as well as Bothell and Seattle, Washington. For more information on currently marketed products, please visit www.berlex.com. 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. Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's and Allergan's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in Schering AG's Form 20-F and Form 6-K reports and Allergan's Form 10-K for the year ended December 31, 2002 filed with the U.S. Securities and Exchange Commission. Schering AG and Allergan undertake no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise. |
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