Advicor

Business Editors/Legal Writers/Health/Medical Writers

MIAMI--(BUSINESS WIRE)--June 10, 2004

Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) announced today that it has successfully settled its trademark infringement lawsuit against Andrx Corporation (Nasdaq:ADRX) and Andrx Laboratories, Inc. As part of this settlement, Andrx will pay Kos $6 million and has agreed to cease using the Altocor trademark for any of its products to avoid further confusion between Andrx's cholesterol product, Altocor, and Kos' highly differentiated cholesterol product, Advicor(R). In January 2002, Kos launched Advicor (extended release niacin/lovastatin), the first and only FDA approved dual-component prescription therapy for the treatment of multiple cholesterol disorders. Advicor, Kos' second internally-developed cholesterol product, participates in the approximately $13 billion cholesterol market in the United States. In 2003, sales for Advicor were $67 million, reflecting an increase of 150% from the prior year.

On May 24, 2004, the U.S. Court of Appeals for the Third Circuit directed the New Jersey District Court to enter a preliminary injunction against Andrx's use of the Altocor trademark. This decision was the result of a trademark infringement lawsuit and Motion for Preliminary Injunction filed by Kos against Andrx on August 6, 2003.

"Our first priority is the well being and safety of patients. Therefore, we are extremely pleased with the Court's ruling and this settlement agreement because we believe this will greatly benefit patients and physicians in avoiding confusion between the two products," commented Adrian Adams, Kos' President and Chief Executive Officer. "Moreover, the Court's decision and the ultimate settlement reached further demonstrate the seriousness with which we regard our intellectual property."

About Advicor

Advicor is a fixed-dose combination product and is not indicated for initial therapy. Advicor is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone have been inadequate. Advicor is indicated for the treatment of primary hypercholesterolemia and mixed dyslipidemia in patients who are taking: lovastatin who require additional TG-lowering or HDL-raising who may benefit from having niacin added to their therapy or; niacin who require further LDL-lowering who may benefit from having lovastatin added to their therapy.

Advicor is contraindicated in patients with a known hypersensitivity to their components, active liver or peptic ulcer disease, unexplained persistent liver enzyme elevation, arterial bleeding. Advicor should not be taken by pregnant or nursing women. This product should be prescribed with caution in patients who drink substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be monitored periodically. Combination therapy with niacin and a statin may increase the risk of myopathy and a serious but rare condition referred to as rhabdomyolysis. The most common adverse event with Advicor is flushing of the skin. Other commonly reported adverse events include headache, gastrointestinal symptoms and rash. Diabetic patients may experience a dose-related rise in blood sugar with these products.

Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in developing, commercializing, manufacturing and marketing proprietary prescription products for the treatment of chronic diseases. The Company's principal product development strategy is to reformulate existing pharmaceutical products with large market potential to improve safety, efficacy, or patient compliance. The Company currently markets Niaspan and Advicor for the treatment of cholesterol disorders, and Azmacort(R) for the treatment of asthma. Kos is developing additional products, has proprietary drug delivery technologies in solid-dose and aerosol metered-dose inhalation administration and is pursuing certain strategic business development and licensing opportunities.

This press release contains forward-looking statements based on current expectations, and Kos assumes no obligation to update these statements or make any further statements on any of these issues. These forward-looking statements are intended to fall within the safe harbor provisions under the U.S. Private Securities Litigation Reform Act. These forward-looking statements are often identified by words such as "hope," "may," "believe," "anticipate," "plan," "expect," "require," "intend," "assume," and similar words and include statements relating to the protection afforded by the Company's new and existing patents, the continued safety, efficacy and acceptability of its products, and the development of additional products. Several factors could cause actual events to differ materially from the forward-looking statements, including its ability to meet its production requirements, the Company's ability to maintain regulatory approvals for its products, the validity, scope and enforceability of Kos' patents, the outcome of the pending litigation relating to certain of the Company's existing patents, the Company's success in pursuing several strategic business development and licensing opportunities, the effect of conditions in the pharmaceutical industry and the economy in general, as well as certain other risks. A more detailed discussion of risks attendant to the forward-looking statements included in this press release is set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of the Company's Annual Report on Form 10-K for the period ended December 31, 2003, filed with the Securities and Exchange Commission, and in other reports and documents filed with the SEC.

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