Barr Labs to settle Mirapex and Aggrenox patent challenges

Aug 12 2008

Barr Pharmaceuticals, Inc announced today that its Barr Laboratories subsidiary has signed a Settlement Agreement and a License Agreement with Boehringer Ingelheim to resolve the patent litigation involving Boehringer Ingelheim's Mirapex product.

Separately, Barr Laboratories entered into a Settlement Agreement and a Supply Agreement to resolve the patent litigation regarding Boehringer Ingelheim's Aggrenox product and Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, entered into a Co-Promotion Agreement with Boehringer Ingelheim relating to Aggrenox.

"The agreements announced today equitably resolve our patent litigation regarding these two products in a way that benefits consumers and Barr's shareholders," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "In addition, the co-promotion agreement creates significant opportunities for both Barr and Boehringer Ingelheim, adding a new product to Duramed's promotional portfolio and providing Boehringer Ingelheim with unique access to physicians in the women's health care area, through the Duramed sales force."

Mirapex Settlement Agreement and License Agreement

Under these agreements, Barr Laboratories is permitted to launch its generic version of Mirapex commencing no later than January 1, 2010, approximately 10 months earlier than the expiration of the Boehringer Ingelheim patent at issue in the patent challenge litigation. Upon launch, Barr would pay Boehringer Ingelheim an undisclosed royalty amount.

Aggrenox Settlement Agreement and Supply Agreement

Under these agreements, Barr Laboratories is permitted to launch an authorized generic version of Aggrenox commencing no later than July 1, 2015, approximately 18 months earlier than the last-to-expire Boehringer Ingelheim patent listed in the U.S. Food and Drug Administration's (FDA's) Orange Book. Upon launch, Barr would pay Boehringer Ingelheim an undisclosed royalty amount.

Aggrenox Co-Promotion Agreement

Under this agreement, Duramed Pharmaceuticals is required to co-promote Aggrenox to obstetricians, gynecologists and other practitioners with a focus on women's healthcare in the United States using its Specialty Sales Force. Under the terms of the agreement, Boehringer Ingelheim will train the 93- person Duramed Specialty Sales Force, which will begin promoting Aggrenox in March 2009. Under terms of the agreement, Boehringer Ingelheim will pay Duramed undisclosed royalties based on net sales of Aggrenox.

The settlements and the related agreements are conditional upon entry of a proposed order dismissing the underlying litigation in the respective patent challenge cases.

Mirapex (pramipexole dihydrochloride) had annualized sales of approximately $389 million for the twelve months ended May 2008, based on IMS sales data.

Aggrenox (aspirin/extended-release dipyridamole) had annualized sales of approximately $331 million for the twelve months ended May 2008, based on IMS sales data.