Advicor

Business Editors/Health/Medical Writers

MIAMI--(BUSINESS WIRE)--Dec. 12, 2003

Submissions Filed Ahead of Schedule for These Innovative

Cholesterol Therapies

Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) announced today that its Canadian development partner and licensee, Oryx Pharmaceuticals, Inc., filed New Drug Submissions with Health Canada for regulatory clearance to market Niaspan(R) and Advicor(R) in Canada. Marketing clearance is expected in the second half of 2005. If approved, Niaspan (extended-release niacin) and Advicor (extended release niacin/lovastatin) will be a viable option in treating cardiovascular disease, the number one cause of death of Canadians, as well as Americans. In 2002, the Canadian cholesterol market was valued at about $1.2 billion and grew at an annual rate of 22 percent.

In August 2003, Kos and Oryx announced a development and commercialization agreement for Niaspan and Advicor, two products developed by Kos for the treatment of cholesterol disorders. Pursuant to the agreement, Oryx received exclusive commercialization rights to Niaspan and Advicor in Canada.

"The timing of these filings is actually ahead of our original expectations, and hopefully will translate into an accelerated launch of Niaspan and Advicor in Canada," said Adrian Adams, President and Chief Executive Officer of Kos. "Given the high prevalence of dyslipidemia in Canada and the uniqueness of our cholesterol franchise, we anticipate that Niaspan and Advicor will have strong appeal to healthcare practitioners there. We are also eagerly awaiting imminent approvals to market Niaspan in additional European countries, which will broaden our penetration in the $20 billion worldwide cholesterol market."

"We are very excited to have filed Niaspan and Advicor in Canada ahead of schedule," said Douglas Reynolds, President of Oryx. "The timely submissions highlight the importance we have placed in seeking approval for introducing these two innovative cholesterol therapies into the Canadian market. We also believe that the expertise and reach that our organization possesses in the cardiovascular arena, well positions us to successfully commercialize these differentiated therapies that address critical unmet needs, such as raising HDL cholesterol."

Oryx, a Canadian specialty pharmaceutical company focused on several therapeutic areas, including cardiovascular disease, will deploy a dedicated cardiovascular sales force to commercialize the products beginning late in 2005 following the approval of each drug. Oryx currently promotes several prescription pharmaceutical products in Canada including two cardiovascular therapies, Corvert(R), from Pfizer Canada, and Angiomax(R), from The Medicines Company.

About Niaspan:

Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels. Niacin is a B-vitamin that for decades had been known to be an effective cholesterol medication at high doses but was limited by significant side effects. Kos' solid-dose drug delivery technology transformed niacin, the most powerful agent available for increasing HDL (High-Density Lipoprotein; "good" cholesterol) into a highly effective, patient friendly therapy used by thousands of patients with coronary disease. Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL (Low-Density Lipoprotein; "bad" cholesterol), Apo B, and triglycerides (TG) levels, and to increase HDL in patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, Niaspan is also indicated to reduce the risk of recurrent heart attacks in patients who have a history of heart attack and hypercholesterolemia.

About Advicor:

Advicor, the first and only FDA-approved combination prescription therapy for the treatment of patients with multiple lipid disorders, combines Niaspan with lovastatin, the first in the class of cholesterol drugs known as statins, in a single tablet formulation. Statins are known to be the most effective class of lipid-modifying drugs for reducing LDL levels, with lovastatin being the most time-tested, while niacin is the most powerful agent available for increasing HDL. Advicor gives physicians a convenient and safe option for the treatment of mixed dyslipidemia. Advicor is a single tablet medication that treats the major lipid parameters: LDL, HDL, and TGs and the emerging risk factor lipoprotein (a). 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 has been inadequate, for the treatment of primary hypercholesterolemia and mixed dyslipidemia in patients who are taking lovastatin and need further TG lowering or HDL raising who may benefit from having niacin added to their regimen or niacin who need further LDL lowering who may benefit from having lovastatin added to their regimen.

Niaspan and Advicor are contraindicated in patients with a known hypersensitivity to their components, active liver or peptic ulcer disease, or unexplained persistent liver enzyme elevation, arterial bleeding or in pregnant or nursing women. Liver function tests should be monitored periodically. Niaspan or Advicor should not be substituted directly for equal doses of immediate-release niacin. 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 Niaspan and Advicor is flushing. Other commonly reported adverse events include gastrointestinal symptoms and rash.

About Kos Pharmaceuticals:

Kos Pharmaceuticals, Inc. (http://www.kospharm.com) 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. Kos is developing additional products and has proprietary drug delivery technologies in solid-dose and aerosol metered-dose inhalation administration.

About Oryx Pharmaceuticals:

Oryx Pharmaceuticals Inc. (http://www.oryxpharma.com) is a Canadian specialty pharmaceutical company with offices in Mississauga, Ontario. Its mission is to serve the needs of Canadian health care professionals and patients through the licensing and commercialization of unique pharmaceutical products. Oryx is focused in the therapeutic areas of cardiovascular disease, CNS and oncology.

This press release contains forward-looking statements based on current expectations, and the Company 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 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 Kos' statements of its expectations regarding the timing of marketing clearance and regulatory approval for Niaspan and Advicor in Canada and elsewhere, the accelerated launch of Niaspan and Advicor in Canada, the Company's ability to successfully commercialize the products, and the success of the Company's relationship with Oryx. All forward-looking statements are subject to risks and uncertainties. Several factors could cause actual events to differ materially from the forward-looking statements, including, but not limited to, the market acceptance of the Advicor and Niaspan products, the protection afforded by Kos' patents, the ability to obtain marketing clearance and regulatory approvals, 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 are set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of Kos' Annual Report on Form 10-K for the year ended December 31, 2002, filed with the Securities and Exchange Commission, and in other documents filed with the SEC.

COPYRIGHT 2003 Business Wire
COPYRIGHT 2003 Gale Group