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news.In a move that ends their pending patent litigation, Kos Pharmaceuticals and Barr Pharmaceuticals have signed co-promotion, licensing and manufacturing, and settlement and license agreements relating to Kos' Niaspan cholesterol products.
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The co-promotion agreement provides that Kos and Duramed Pharmaceuticals, a subsidiary of Barr, will co-promote the current Niaspan and Advicor products, as well as future dosage formulations, strengths or modified versions, in the US with a focus on women’s healthcare.
Under the terms of the seven-year agreement, Kos will train a 40-person Duramed specialty sales force, which will begin promoting the cholesterol products in mid-2005. Kos will pay Duramed royalties based on quarterly and yearly net sales of the products, subject to certain maximum sales levels.
Kos’ cholesterol products will be marketed with an aim to serving the growing need to treat the risks of cardiovascular disease in the 28 million women identified by the American Heart Association (AHA) who require HDL-C (“good” cholesterol) raising therapy.
The settlement and license agreement permits Barr Laboratories to launch generic versions of Niaspan and Advicor, as well as future dosage formulations, strengths or modified versions, under terms of an exclusive license commencing on September 20, 2013, approximately four years earlier than the last-to-expire Kos patent.
Upon launch, Barr would pay Kos a royalty equal to a portion of profits generated from the sales of generic versions of the products. As part of the settlement, Barr admits that Kos’ patents are valid and enforceable and that Barr infringes the Kos patents.
In a separate license and manufacturing agreement, Barr has agreed to stand ready to supply Kos Life Sciences quantities of Niaspan 500mg, 750mg and 1000mg extended-release niacin tablets and Advicor 500mg/20mg, 750mg/20mg and 1000mg/20mg extended release niacin/lovastatin tablets, under or pursuant to the approval of Barr’s abbreviated new drug applications (ANDAs).
Under the terms of this agreement, Barr will receive an initial license fee and quarterly payments to stand ready to meet Kos’ manufacturing requirements. In addition, if Kos engages Barr to manufacture these products, Kos will purchase such products at an agreed upon supply price.