MONTVALE, N.J., Aug. 12 Barr Pharmaceuticals,Inc. (NYSE: BRL) announced today that its Barr Laboratories subsidiary hassigned a Settlement Agreement and a License Agreement with BoehringerIngelheim to resolve the patent litigation involving Boehringer Ingelheim'sMirapex(R) product. Separately, Barr Laboratories entered into a SettlementAgreement and a Supply Agreement to resolve the patent litigation regardingBoehringer Ingelheim's Aggrenox(R) product and Duramed Pharmaceuticals, asubsidiary of Barr Pharmaceuticals, entered into a Co-Promotion Agreement withBoehringer Ingelheim relating to Aggrenox(R).
"The agreements announced today equitably resolve our patent litigationregarding these two products in a way that benefits consumers and Barr'sshareholders," said Bruce L. Downey, Barr's Chairman and Chief ExecutiveOfficer. "In addition, the co-promotion agreement creates significantopportunities for both Barr and Boehringer Ingelheim, adding a new product toDuramed's promotional portfolio and providing Boehringer Ingelheim with uniqueaccess to physicians in the women's health care area, through the Duramedsales force."
Mirapex(R) Settlement Agreement and License Agreement
Under these agreements, Barr Laboratories is permitted to launch itsgeneric version of Mirapex commencing no later than January 1, 2010,approximately 10 months earlier than the expiration of the BoehringerIngelheim patent at issue in the patent challenge litigation. Upon launch,Barr would pay Boehringer Ingelheim an undisclosed royalty amount.
Aggrenox(R) Settlement Agreement and Supply Agreement
Under these agreements, Barr Laboratories is permitted to launch anauthorized generic version of Aggrenox(R) commencing no later than July 1,2015, approximately 18 months earlier than the last-to-expire BoehringerIngelheim patent listed in the U.S. Food and Drug Administration's (FDA's)Orange Book. Upon launch, Barr would pay Boehringer Ingelheim an undisclosedroyalty amount.
Aggrenox(R) Co-Promotion Agreement
Under this agreement, Duramed Pharmaceuticals is required to co-promoteAggrenox to obstetricians, gynecologists and other practitioners with a focuson 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 inMarch 2009. Under terms of the agreement, Boehringer Ingelheim will payDuramed undisclosed royalties based on net sales of Aggrenox.
The settlements and the related agreements are conditional upon entry of aproposed order dismissing the underlying litigation in the respective patentchallenge cases.
Mirapex (pramipexole dihydrochloride) had annualized sales ofapproximately $389 million for the twelve months ended May 2008, based on IMSsales data.
Aggrenox (aspirin/extended-release dipyridamole) had annualized sales ofapproximately $331 million for the twelve months ended May 2008, based on IMSsales data.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical companythat operates in more than 30 countries worldwide and is engaged in thedevelopment, manufacture and marketing of generic and proprietarypharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. Aholding company, Barr operates through its principal subsidiaries: BarrLaboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and itssubsidiaries. The Barr Group of companies markets more than 120 generic and 27proprietary products in the U.S. and approximately 1,025 products globallyoutside of the U.S. For more information, visit www.barrlabs.com.
This communication contains "forward-looking statements" which representthe current expectations and beliefs of management