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Niaspan

AbbVie Inc.

Drug Names(s): Niacin extended-release optimized modified formulation, Niaspan CF, Niaspan MF

Description: Niaspan contains niacin, or vitamin B3. In gram doses, niacin reduces total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG), and increases high-density lipoprotein cholesterol (HDL-C). The magnitude of individual lipid and lipoprotein responses may be influenced by the severity and type of underlying lipid abnormality.

The mechanism by which Niaspan alters lipid profiles has not been well defined. It may involve agonism of the niacin receptor GPR109A (HM74A), which inhibits the release of free fatty acids from adipose tissue and may play a role in effects on macrophages and cholesterol efflux. However, recent evidence suggests it may not play a role in niacin's major lipoprotein effects in the liver. Other mechanisms may also be responsible (such as inhibition of diacylglycerol acyltransferase 2 [DGAT2] in hepatocytes and different effects on HDL metabolism).

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

Merck KGaA and Kos
In October of 2002, Merck KGaA and Kos Pharmaceuticals announced amanufacturing and licensing agreement for Niaspan and Advicor. Pursuant to the agreement, Merck will receive exclusiveinternational commercialization rights to Niaspan and Advicor outside NorthAmerica and Japan.

Under terms of the agreement, Merck will provide licensing and milestonepayments to Kos of up to $61 million, including $15 million of up-frontpayments. Milestone payments are dependent on the achievement of certainregulatory approvals and sales thresholds.

Kos will also receive 25% of net sales of the products in the territory,which includes the cost of manufacture. Merck will be responsible forconducting Phase IV clinical studies and promotional investments while Kos isresponsible for obtaining initial marketing authorization in all EU countries.Both products will be manufactured and supplied by Kos. Kos...See full deal structure in Biomedtracker

Partners: Teva Pharmaceutical Industries Ltd. Merck KGaA Abbott Laboratories


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