KOSP Kos Pharmaceuticals

Kos Pharmaceuticals, Inc. (Nasdaq:KOSP): -- Includes new optimized 1000mg Niaspan(R) CF formulation that has demonstrated an improved overall flushing profile vs. currently commercialized Niaspan, with a 42 percent reduction in severity, and a 43 percent reduction in duration of flushing -- Niaspan CF launch planned for first quarter 2007 -- Plans in place to incorporate optimized Niaspan CF in future products over time Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) announced today that it has submitted a supplemental New Drug Application for a complete dosage range of Niaspan Caplet Formulation (CF) products for review to the U.S. Food and Drug Administration (FDA). The Company has begun planning for a first quarter 2007 launch of this new product. The new range of Niaspan CF products include an optimized 1000mg formulation of the Kos HDL-boosting therapy Niaspan (niacin once-daily, extended-release tablets). As previously announced, a recent clinical study demonstrated a significantly improved (p greater than 0.0001) overall flushing profile of optimized Niaspan CF versus commercialized Niaspan, with a 42 percent reduction in flushing severity and 43 percent reduction in the duration of flush. Notably, the significant reductions in flushing severity and duration were achieved in the absence of aspirin or other NSAID co-administration, which is often recommended to mitigate flushing during the first weeks of therapy when the side effect is most likely to occur. Flushing is a relatively common and transient side effect reported by patients when taking Niaspan to increase their HDL-C, or "good" cholesterol, and reduce LDL and triglycerides. "This complete dosage range of Niaspan CF products draws upon the proven efficacy and safety of Niaspan, and could further enhance patient acceptance and compliance in addition to improving tablet aesthetics and mechanical strength," said Adrian Adams, President and CEO of Kos Pharmaceuticals. "Our planned and evolving lifecycle management initiatives further leverage our expertise in formulation development and continue to help address a significant clinical need. The potential for improved tolerability of Niaspan CF could therefore increase the number of patients who can benefit from this highly differentiated and potentially life-saving therapy." Niaspan is the only FDA-approved once-daily prescription niacin formulation for the treatment of lipid disorders with the ability to elevate HDL by up to 26 percent. It is also indicated for the secondary prevention of heart attacks, and in combination with a bile-acid binding resin, to promote regression of coronary atherosclerosis in patients with high cholesterol. Based on the demonstrated patient benefits of the optimized Niaspan CF product, Kos is planning to develop other optimized products as part of a fully integrated development program designed to further enhance Kos' pioneering and leading position in the HDL raising area. 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, Inc. 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 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 anticipated launch date for Niaspan CF, the development of future optimized Niaspan products, the potential increase in the number of patients and enhancement of patient acceptance and compliance as a result of improved tolerability of Niaspan CF, the further enhancement of the Company's pioneering and leading position in the HDL raising area, 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 market acceptance of Niaspan CF and optimized Niaspan CF, the protection afforded by the Company's patents and those related to its acquired and licensed products, the ability to build awareness for the Company's products, including Niaspan CF and optimized Niaspan CF, within the medical community, the continuing growth of the cardiovascular, respiratory and allergy markets, the Company's ability to increase the size of its sales force and to attract and retain sales professionals, the Company's and its licensors' ability to achieve regulatory approvals for products under development and to successfully launch such products in a timely manner, the ability of third party suppliers to the Company continuing to be able to perform their supply obligations, the Company's ability to entered into additional new business development opportunities, the progress of the Company's research and development pipeline, 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 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 July 12, 2006 and the Company undertakes no duty to update this information.