antiquity
10-08-2002, 05:43 PM
Kos Pharmaceuticals Files sNDA for Niaspan(R) for Reducing Risk of Stroke
*Submission to Expand Label for Niaspan
MIAMI, Oct. 7 /PRNewswire-FirstCall/ -- Kos Pharmaceuticals (Nasdaq:KOSP) announced today that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Niaspan(R) to expand the current label to include reducing the risk of stroke or transient ischemic attack (TIA: sometimes referred to as "ministrokes") in patients with a previous heart attack and elevated cholesterol levels.
Niaspan is the only FDA-approved once-daily formulation of niacin for the treatment of lipid disorders. 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.
The sNDA for Niaspan is based on results from the landmark Coronary Drug Project, a double-blind, placebo-controlled, long term secondary prevention study. This morbidity/mortality study, sponsored by the National Institutes of Health, showed that people taking niacin had significantly fewer strokes and TIAs compared with patients taking the placebo. The study involved 1,119 patients randomized to niacin and 2,789 to a placebo, who were then followed for a period of 5 to 8.5 years. The data show that the risk of stroke or TIA was reduced by 21% to 26% in the niacin group compared with placebo, during the follow-up time period. For example, among all patients followed through the end of the study, 11.2% in the placebo group had suffered a stroke or TIA compared with 8.5% receiving niacin (p<0.05).
The reduction in the risk of stroke or TIA in the Coronary Drug Project is comparable to that observed in two other secondary prevention studies: the CARE trial, which resulted in a 26% reduction (6.0% in the placebo group versus 4.5% with pravastatin) and the 4S trial, which found a 28% reduction (4.6% in the placebo group versus 3.4% with simvastatin).
According to the American Heart Association, 600,000 Americans suffer a stroke each year and $50 billion will be spent in 2002 alone for stroke- related medical costs and disability. But despite the devastating effects and economic expense related to stroke, American Stroke Association surveys have shown that nearly 43% of Americans cannot name a single warning sign of stroke. With the number of deaths from stroke rising 8.6% from 1989 to 1999, it is now the third leading cause of death after heart disease and cancer.
"Hypercholesterolemia and low HDL are recognized risk factors for stroke," said Adrian Adams, President and Chief Executive Officer. "Stroke can be an extremely debilitating event and is the leading cause of long-term disability in the United States. The impressive data from the Coronary Drug Project should provide excellent support for our sNDA submission, which if approved, could expand the already broad label for Niaspan. Moreover, such a label enhancement could have a significant impact on Niaspan's robust prescription and market share growth as physicians have begun to accept the link between abnormal lipid levels and increased risk for stroke."
Niaspan is contraindicated in patients with a known hypersensitivity to niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease or arterial bleeding. The most common adverse event with Niaspan is flushing. Other adverse events include headache, abdominal pain, diarrhea, dyspepsia, nausea, vomiting and rash. As liver function can be affected by Niaspan, periodic testing may be required. Patients who drink large amounts of alcohol should use Niaspan with caution. Equivalent doses of immediate-release niacin should not be substituted directly for Niaspan. Niacin together with a statin may increase the risk of myopathy and a serious but rare condition referred to as rhabdomyolysis.
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. 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(TM) 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.
Certain statements in this press release, including statements relating to the expected continued growth of the Niaspan product, are forward-looking and are subject to risks and uncertainties. These risks and uncertainties include regulatory risk associated with an application for approval by the FDA, the ability of the Company to maintain the size of its sales force, the Company's ability to market its Niaspan product, the Company's ability to meet the conditions necessary to obtain funding under its funding arrangements, the validity, scope and enforceability of its patents, 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 is set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of the Company's Annual Report on Form 10-K for the period ended December 31, 2001, filed with the Securities and Exchange Commission (SEC), and in other reports and documents filed with the SEC.
*Submission to Expand Label for Niaspan
MIAMI, Oct. 7 /PRNewswire-FirstCall/ -- Kos Pharmaceuticals (Nasdaq:KOSP) announced today that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Niaspan(R) to expand the current label to include reducing the risk of stroke or transient ischemic attack (TIA: sometimes referred to as "ministrokes") in patients with a previous heart attack and elevated cholesterol levels.
Niaspan is the only FDA-approved once-daily formulation of niacin for the treatment of lipid disorders. 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.
The sNDA for Niaspan is based on results from the landmark Coronary Drug Project, a double-blind, placebo-controlled, long term secondary prevention study. This morbidity/mortality study, sponsored by the National Institutes of Health, showed that people taking niacin had significantly fewer strokes and TIAs compared with patients taking the placebo. The study involved 1,119 patients randomized to niacin and 2,789 to a placebo, who were then followed for a period of 5 to 8.5 years. The data show that the risk of stroke or TIA was reduced by 21% to 26% in the niacin group compared with placebo, during the follow-up time period. For example, among all patients followed through the end of the study, 11.2% in the placebo group had suffered a stroke or TIA compared with 8.5% receiving niacin (p<0.05).
The reduction in the risk of stroke or TIA in the Coronary Drug Project is comparable to that observed in two other secondary prevention studies: the CARE trial, which resulted in a 26% reduction (6.0% in the placebo group versus 4.5% with pravastatin) and the 4S trial, which found a 28% reduction (4.6% in the placebo group versus 3.4% with simvastatin).
According to the American Heart Association, 600,000 Americans suffer a stroke each year and $50 billion will be spent in 2002 alone for stroke- related medical costs and disability. But despite the devastating effects and economic expense related to stroke, American Stroke Association surveys have shown that nearly 43% of Americans cannot name a single warning sign of stroke. With the number of deaths from stroke rising 8.6% from 1989 to 1999, it is now the third leading cause of death after heart disease and cancer.
"Hypercholesterolemia and low HDL are recognized risk factors for stroke," said Adrian Adams, President and Chief Executive Officer. "Stroke can be an extremely debilitating event and is the leading cause of long-term disability in the United States. The impressive data from the Coronary Drug Project should provide excellent support for our sNDA submission, which if approved, could expand the already broad label for Niaspan. Moreover, such a label enhancement could have a significant impact on Niaspan's robust prescription and market share growth as physicians have begun to accept the link between abnormal lipid levels and increased risk for stroke."
Niaspan is contraindicated in patients with a known hypersensitivity to niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease or arterial bleeding. The most common adverse event with Niaspan is flushing. Other adverse events include headache, abdominal pain, diarrhea, dyspepsia, nausea, vomiting and rash. As liver function can be affected by Niaspan, periodic testing may be required. Patients who drink large amounts of alcohol should use Niaspan with caution. Equivalent doses of immediate-release niacin should not be substituted directly for Niaspan. Niacin together with a statin may increase the risk of myopathy and a serious but rare condition referred to as rhabdomyolysis.
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. 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(TM) 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.
Certain statements in this press release, including statements relating to the expected continued growth of the Niaspan product, are forward-looking and are subject to risks and uncertainties. These risks and uncertainties include regulatory risk associated with an application for approval by the FDA, the ability of the Company to maintain the size of its sales force, the Company's ability to market its Niaspan product, the Company's ability to meet the conditions necessary to obtain funding under its funding arrangements, the validity, scope and enforceability of its patents, 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 is set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of the Company's Annual Report on Form 10-K for the period ended December 31, 2001, filed with the Securities and Exchange Commission (SEC), and in other reports and documents filed with the SEC.