Healthcare Industry News:  Biovail 


 News Release - February 23, 2006

Kos Reports Summary Results of Key Phase IV Research and Development Studies

Kos' optimized Niaspan(R) modified formulation ("MF") shows an improved overall flushing profile vs. commercialized Niaspan, with a 42 percent reduction in severity, and a 43 percent reduction in duration of flushing.

COMPELL Study shows significantly greater reductions in triglycerides and Lp(a), as well as superior 2.5-3.5 fold increases in HDL-C versus Crestor(R) and Zocor(R)/Zetia(R) and comparable lowering of LDL-C with Niaspan Combination Therapy.

CRANBURY, N.J.--(HSMN NewsFeed)--Feb. 23, 2006--Kos Pharmaceuticals, Inc. (Nasdaq:KOSP ) announced today results from two studies that represent significant milestones in its research and development activities: data from a study with an optimized Niaspan® MF dosage strength and data from the COMPELL (COMParative Effects on Lipid Levels of Niaspan and Statins Versus Other Lipid Therapies) Phase IV efficacy trial.

The Niaspan MF Study

This study was a single dose, double-blind, randomized, placebo-controlled three-way crossover, human study (N=156) evaluating a Niaspan (niacin extended-release tablets) modified formulation for reduction in severity and duration of flushing, a relatively common and transient nuisance side effect for patients who take Niaspan to increase HDL-C, or "good" cholesterol.

Niaspan MF is one of the first products to emerge from a dedicated research and development program designed to further enhance the tolerability profile of Niaspan products by taking advantage of Kos expertise in formulation development. In a study designed to provoke flushing, patients received a single dose of Niaspan MF 2000 mg, regular Niaspan 2000 mg, or placebo. Flushing symptoms and duration were recorded on an electronic diary. Niaspan MF showed a significantly improved (p<0.0001) overall flushing profile vs. commercialized Niaspan, with a 42 percent reduction in severity, and a 43 percent reduction in duration of flushing.

Notably, 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. Most patients will experience at least one flushing episode while on Niaspan, and tolerance generally develops during long-term use.


COMPELL was a 12-week, randomized, multicenter, open-label study in 292 patients comparing the efficacy of combination therapy with Niaspan and low to moderate doses of Lipitor® and Crestor® against moderate to high dose Crestor and Zocor®/Zetia® (sold as the fixed-dose combination tablet, Vytorin®). In a dose-escalation study design, Niaspan 1000 mg with Crestor 10 mg, 20 mg, and Lipitor 20 mg, and Niaspan 2000 mg with Lipitor 40 mg, were compared with Crestor 20 mg and 40 mg and Zocor/Zetia 20mg/10mg and 40mg/10 mg.

Study results showed that, for LDL-C, all treatments were equivalent in their ability to lower LDL-C, achieving ~50% or greater lowering in LDL-C at both time points evaluated (weeks 8 and 12). However, both Niaspan combinations achieved significantly greater (2.5 - 3.5 fold) increases in HDL-C, and significantly greater reductions in triglycerides and Lp(a) compared to the other two treatment arms. All treatments were well tolerated, with similar numbers of patients reporting adverse events and serious adverse events. No drug-related myopathy was observed.

"We do not believe that lowering LDL to ultra-low levels is enough to protect against heart disease," said Adrian Adams, President and CEO of Kos Pharmaceuticals, "There seems to be a diminishing rate of return in the benefit for reducing coronary events as LDL is lowered progressively below 100 mg/dL. Most LDL-lowering trials show that two-thirds to three-quarters of statin-treated patients who are at risk in fact progress to a cardiovascular event despite treatment."

"Aggressively treating multiple lipid parameters simultaneously is important in combating the worldwide epidemic of heart disease," Adams continued. "Attention is shifting to raising HDL cholesterol in light of recent landmark clinical trials demonstrating that lowering LDL cholesterol may have reached its peak in its ability to reduce heart attacks or strokes. HDL is emerging as a major focus as physicians begin to look beyond LDL, and Niaspan and its combinations remain well positioned for growth, particularly given their highly differentiated clinical profiles."

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® for the treatment of cholesterol disorders, Azmacort® for the treatment of asthma, Cardizem®LA for the treatment of hypertension and angina, and Teveten® 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, Niaspan MF, the results of the Niaspan MF study and COMPELL study, the growth prospects of the markets in which the Company's products compete, including Niaspan and its combinations, 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 grow revenue and control expenses, the protection afforded by the Company's patents and those related to the acquired and licensed products, the ability to build awareness for Niaspan, Advicor, Azmacort, Cardizem LA, Teveten and Teveten HCT within the medical community, the continued success of the alliances with Takeda, Merck KGaA, Oryx, Arisaph, Barr, Biovail and Jerini, the continuing growth of the cardiovascular and respiratory markets, the Company's ability to maintain its compliance with FDA regulations and standards without adversely affecting the Company's manufacturing capability or ability to meet its production requirements or profit margins, the Company's ability to increase the size of its sales force and to attract and retain sales professionals, and, ensure compliance with prescription drug sales and marketing laws and regulations, changes in the regulatory environment governing the Company's compliance with the FDA, PTO, tax and competition issues, the impact of a possible generic version of the Cardizem LA product or other products sold by the Company, the ability of third party suppliers to the Company continuing to be able to perform their supply obligations, the Company's ability to achieve regulatory approvals for its products under development in a timely manner, such as the modified formulation of Niaspan and others, the Company's ability to establish a footprint and generate sales in the hypertension and angina markets, the Company's ability to successfully negotiate additional important strategic business development opportunities, the progress of the Company's research and development pipeline, fluctuating buying patterns by the Company's wholesalers and distributors, the Company's ability to maintain coverage of its products by government agencies and the effects of the loss of such coverage with such agencies, such as the Centers for Medicare and Medicaid Services, 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, 2004, filed with the Securities and Exchange Commission, and in other reports filed with the SEC. All information in this press release is as of February 23, 2006 and the Company undertakes no duty to update this information.

Crestor is a registered trademark of AstraZeneca group of companies. Zocor is a registered trademark of Merck & Co, Inc. Zetia and Vytorin are registered trademarks of MPS Singapore Company, Inc.

Source: Kos Pharmaceuticals

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