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Niaspan: Kos Advicor
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In September 2000 Kos filed a New Drug Application for a new product, then named Nicostatin, which integrated the benefits of Niaspan with lovastatin, a drug known to reduce cholesterol. In preparation for product launch Kos signed a marketing agreement with DuPont Pharmaceuticals to market Nicostatin. DuPont agreed to invest up to $80 million in Kos, beginning with an initial equity investment of $30 million plus $20 million for product development. Kos and DuPont agreed to share equally in promotional costs as well as profits, less initial royalties paid to Kos.
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Niaspan and Advicor are contraindicated in patients with a known hypersensitivity to their components, active liver or peptic ulcer disease, or unexplained persistent liver enzyme elevation or arterial bleeding. Advicor should not be taken by pregnant or nursing women. These products should be prescribed with caution in patients who drink substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be monitored periodically. Niaspan or Advicor should not be substituted directly for equal doses of immediate-release niacin. Combination therapy with niacin and a statin may increase the risk of myopathy and a serious but rare condition referred to as rhabdomyolysis.
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''With the acceptance by the two states' stringent Medicaid programs, Niaspan is now reimbursable by Medicaid programs in all 50,'' says Peggy Farley, president of Ascent/Meredith Asset Management. So prescriptions for Niaspan should jump, says Farley. She expects Kos to be in the black in 2001, on revenues that she thinks will at least double, to $26 million. Despite its recent surge, the stock is still undervalued, she says. Farley's two-month target: 20.
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Advicor, the first and only FDA-approved combination therapy for the treatment of patients with multiple lipid disorders, combines Niaspan with lovastatin, the first in the class of cholesterol drugs known as statins, in a single tablet formulation. Statins are known to be the most effective class of lipid-modifying drugs for reducing LDL levels, with lovastatin being the most time-tested, while niacin is the most powerful agent available for increasing HDL. Advicor gives physicians a convenient and safe option for the treatment of mixed dyslipidemia. Advicor is a single tablet medication that treats the major lipid parameters: LDL, HDL, and TGs and the emerging risk factor lipoprotein (a). Advicor is a fixed-dose combination product and is not indicated for initial therapy. Advicor 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, for the treatment of primary hypercholesterolemia and mixed dyslipidemia in patients who are taking lovastatin and need further TG lowering or HDL raising who may benefit from having niacin added to their regimen, who need further LDL lowering, or who may benefit from having lovastatin added to their regimen.
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In late July Kos received final FDA approval to market Niaspan for lowering LDL cholesterol, triglycerides (TG), and ApoB in patients with hypercholesterolemia (high cholesterol) and mixed dyslipidemia (mixed lipid disorder). A few days later Kos hired a staff of 85 sales representatives experienced in cardiovascular medical products to promote Niaspan. The initial market involved 70,000 specialists in coronary heart disease, including cardiologists, endocrinologists, and internists, as well as general practice physicians. On August 15, the company shipped its first orders to wholesalers, meeting its promise to shareholders to bring a new product to market in a timely manner.
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In October 2005, Kos contacted FDA about changing the description of Niaspan in its official labeling. The company said FDA "authorized the proposed labeling change for immediate use," with written confirmation to come later.
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