KOSP Kos Pharmaceuticals

Kos Pharmaceuticals, Inc. (Nasdaq:KOSP): -- The study shows that 2000 mg of optimized Niaspan(R) CF, when given with aspirin, results in approximately 44% reduction in the incidence, duration and severity of flushing relative to optimized Niaspan CF alone -- The study results are in addition to previously reported decreases in flushing severity and duration when comparing optimized Niaspan CF to currently available Niaspan in the absence of aspirin -- A supplemental New Drug Application for a complete dosage range of new Niaspan CF products was recently submitted to the Food and Drug Administration -- Additional longer term and confirmatory studies are planned Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) today announced results from a study that demonstrates the benefits of combining aspirin with its new optimized Niaspan(R) (niacin extended-release tablets) Caplet Formulation (CF). This study was a single-dose, placebo-controlled three-way crossover, flush provocation study (N=156) evaluating the benefits of aspirin in combination with a maximum dose of optimized Niaspan CF for reducing the incidence, duration and severity of flushing, a relatively common, but transient effect for patients who take Niaspan to increase HDL-C, or "good" cholesterol. In this flush provocation study, subjects were administered 650 mg of aspirin either 30 minutes before or at the same time as a single dose of 2000 mg of optimized Niaspan CF. Results show statistically significant reductions in the incidence (number of subjects reporting a flush) and intensity of flushing, compared to placebo administration. Flushing symptoms and duration data were recorded in an electronic diary. Even though the study was specifically designed to provoke flushing by administering 2000 mg of optimized Niaspan CF to treatment-naive subjects, only about one-half of the subjects reported a flush with optimized Niaspan CF plus aspirin. In addition, the flushing that did occur was generally reported to be mild. Flushing duration was also reduced. There were no significant differences in the incidence, duration or severity of flushing when aspirin was administered either 30 minutes prior to, or simultaneous with, the dosing of optimized Niaspan CF. Other characteristics of flushing including redness, warmth, tingling and itching, were all also reduced with optimized Niaspan CF and aspirin compared to placebo. "Data from this study represents the latest output from a long term, multifaceted development program initiated several years ago which was designed to enhance the tolerability of Niaspan by capitalizing on Kos' expertise, knowledge and strengths in reformulation and product development," said Adrian Adams, President and CEO of Kos Pharmaceuticals. "The benefits of aspirin in reducing niacin-induced flushing have been known for many years, and so the next stage in the natural evolution and life-cycle management of our HDL boosting franchise was to test the combination of aspirin with the new optimized Niaspan CF, a reformulation of Niaspan that was recently shown in a previously announced clinical study to decrease the severity and duration of flushing by around 42%." He continued, "Furthermore, aspirin use is well established and is not known to be associated with adverse cardiovascular side effects that have recently come to light with some other, non-aspirin nonsteroidal anti-inflammatory agents." Kos recently announced the submission of a supplemental New Drug Application for a complete dosage range of Niaspan CF products for review to the U.S. Food and Drug Administration. The Company is planning for a first quarter 2007 launch of the new range of Niaspan CF products. 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 the active ingredient in Niaspan, 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), Azmacort(R), Cardizem(R)LA, and Teveten(R) and Teveten(R)HCT. 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 CF (including optimized Niaspan CF), the timing of the launch of the new range of Niaspan CF products (including optimized Niaspan CF), 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 (including 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 25, 2006 and the Company undertakes no duty to update this information.