Its so nice to see Kos and Barr deciding to kiss and make-up and come to an agreement over the generic versions of Niaspan and Advicor. I am not taking sides in this dispute. Rather, I feel that this settlement agreement is in the best interest of the patients that need these drugs, and that should be the bottom line here, with issues of patent validity and infringement aside. So, regardless of how these two companies were brought to the negotiating table to come up with this three-part agreement, it would appear to be an equitable solution without court intervention and both parties should be applauded for their efforts at constructing this settlement agreement.
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 of the Products, under terms of an exclusive license commencing on September 20, 2013, approximately four years earlier than the last-to-expire Kos patent. In other words, what this settlement agreement provides for is the certainty of generic entry by Barr four years before the Kos patents expire, or potentially earlier in certain circumstances.
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 February 2004, the AHA raised its guidelines for HDL-C in women from 40 mg/dl to 50 mg/dl. The new guidelines also recommended that women maintain triglycerides levels below 150 mg/dl, a 25% change from past guidelines. These new guidelines essentially tripled the number of women who are candidates for Niaspan and Advicor therapy to about 28 million.
At the same time, a second study published in Circulation found that nearly two-thirds of women at highest risk for a heart attack receive no treatment at all, despite having levels of “good” and “bad” cholesterol that endanger them. Only 7 percent of women had lipid levels considered optimal by the AHA women’s guidelines issued last year (LDL-C of less than 100mg/dL and HDL-C above 50 mg/dL).
The Co-Promotion, Licensing and Manufacturing, and Settlement and License Agreements signed by Barr and Kos relate to the resolution of the patent litigation involving Kos’ Niaspan® products. The United States District Court for the Southern District of New York entered into a Consent Dismissal ending the pending litigation between the two companies. These arrangements have been established to provide benefits to millions of female patients who have multiple lipid disorders and are candidates for Kos’ niacin-based pharmaceutical cholesterol products.
Kos will allow Barr to launch generic versions of Niaspan and Advicor, under an exclusive license as of Sept. 20, 2013. The companies have also signed co-promotion and manufacturing agreements. As part of the settlement, Barr will pay royalties to Kos from the sales of generic versions of Niaspan and Advicor.
Niaspan is the only prescription extended-release form of niacin, also known as vitamin B3, which reduces cholesterol levels and triglycerides. Advicor is a combination of the extended-release niacin product and a cholesterol-reducing statin drug.
Co-Promotion Agreement
The Co-Promotion Agreement provides that Kos and Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, will co-promote the current Niaspan and Advicor® products, as well as future dosage formulations, strengths or modified versions of those products (“the Products”), to obstetricians, gynecologists and other practitioners with a focus on women’s healthcare in the United States using a Duramed specialty sales force.
Under the terms of the seven-year agreement (with renewal rights), Kos will train a 40-person Duramed specialty sales force, which will begin promoting the Products in mid- 2005. In consideration of the Co-Promotion, Kos will pay Duramed royalties based on quarterly and yearly net sales of the Products, subject to certain maximum sales levels. The Co-Promotion would address a new discrete population of obstetricians, gynecologists and other practitioners with a focus on women’s healthcare who have not previously been detailed on Kos’ cholesterol products. Kos’ cholesterol products could directly serve 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 (the “good” cholesterol) raising therapy.
Settlement and License Agreement
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 of the Products, 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.
License and Manufacturing Agreement
In a separate License and Manufacturing Agreement, Barr Laboratories has agreed to stand ready to supply Kos Life Sciences, Inc. quantities of Niaspan 500 mg, 750 mg and 1000 mg Extended-Release Niacin Tablets and Advicor 500 mg/20 mg, 750 mg/20 mg and 1000 mg/20 mg Extended Release Niacin/Lovastatin Tablets, under or pursuant to the approval of Barr’s Abbreviated New Drug Applications (ANDAs). Under the terms of the License and Manufacturing 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.
