Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) announced today that the Centers for Medicare and Medicaid Services (CMS) advised that the dyslipidemic therapy Niaspan(R) will continue to be eligible for coverage under the Medicare prescription drug program. The announcement was made to all Prescription Drug Plans and Part D Managed Care Plans (Plans). CMS issued a policy memorandum to Plans Tuesday, April 11, 2006. The new policy allows Plans to cover, or continue coverage of, Niaspan immediately, and enables patients needing Niaspan therapy to contact their healthcare professionals to discuss continued access. Previously, seniors participating in Part D Plans with Niaspan on formulary were assured reimbursement until May 31, 2006. "This prompt CMS review of prescription Niaspan therapy demonstrates how Part D is an important tool to help seniors enhance healthcare options," said Adrian Adams, President and CEO, Kos Pharmaceuticals, Inc. "CMS staff clearly realizes the importance of Niaspan as a unique therapy for raising good cholesterol. Thankfully, their prompt decision assures healthcare professionals and patients access to the one therapy that can significantly raise HDL, and we appreciate CMS's efforts on behalf of America's seniors," he added. About Niaspan Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels. 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-C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction or coronary artery disease and hypercholesterolemia. Niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, running nose, vomiting and rash. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. About Kos Pharmaceuticals 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 with a particular focus on the cardiovascular, metabolic and respiratory disease areas. The Company's principal product development strategy is to reformulate existing pharmaceutical products with large market potential to improve safety, efficacy, and patient compliance. Kos' strategy also includes making measured investments in new chemical entity research through in-house and sponsored research, scientific in-licensing and general corporate development activities. The Company currently markets Niaspan and Advicor(R) for the treatment of cholesterol disorders, Azmacort(R) for the treatment of asthma, Cardizem(R)LA for the treatment of hypertension and angina, and Teveten(R) and Teveten(R)HCT for the treatment of hypertension. Kos has a strong and growing research and development pipeline including proprietary drug delivery technologies in solid-dose, inhalation and aerosol metered-dose device administration to help fuel sustained, organic sales growth into the future. Certain statements in this press release, including statements relating to Niaspan, the Company's strong and growing research and development pipeline and future sales growth are forward-looking and are subject to risks and uncertainties which may cause actual results to differ materially from those projected in a forward-looking statement. These risks and uncertainties include, the Company's ability to attract and retain sales professionals and increase the size of its sales force, the Company's ability to successfully develop (both internally and through sponsored research arrangements with third parties) and commercialize new products under development and within expected timeframes, the Company's ability to successfully negotiate additional important strategic business development and corporate opportunities, the progress of the Company's research and development pipeline, the protection afforded by the Company's patents and those related to the acquired and licensed products, the effect of conditions in the pharmaceutical industry and the economy in general, the Company's ability to maintain compliance with FDA standards without adversely affecting its manufacturing capability or ability to meet its production requirements, the Company's ability to ensure compliance with prescription drug sales and marketing laws and regulations, and changes in the regulatory environment governing the Company's compliance with FDA. 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 the Company's Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission, and in other reports filed with the SEC. All information in this press release is as of April 12, 2006 and the Company undertakes no duty to update this information.
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