PITTSBURGH, Feb. 27 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) announced today that it and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) have amended their January 2006 agreement to commercialize, develop and distribute the novel beta blocker Bystolic(TM) (nebivolol), which is currently approved in the United States for the treatment of hypertension. The companies have agreed that Forest will assume Mylan's commercial rights for Bystolic in the U.S. and Canada including, but not limited to, the elimination of Mylan's option to co-promote the product. Forest will be responsible for all future Bystolic development expenses as well as all sales and marketing expenses for the product.
Under the terms of this amendment, Forest Laboratories Holdings, Ltd. (Ireland) will make a one-time cash payment of $370 million to Mylan. Forest will continue to pay Mylan its contractual royalties for three years, through calendar 2010.
Robert J. Coury, Vice Chairman and CEO of Mylan, commented: "We are very proud of the role Mylan has played to date in Bystolic's development and commercialization in the U.S. and believe that today's agreement with Forest is evidence of the value we have created through this product. Today's announcement is just one of the many initiatives we have announced to enhance our strategic focus and ensure we are ideally positioned to maximize the significant opportunities of our world leading generics assets."
Bystolic (nebivolol) is a novel beta blocker that was approved by the FDA in December 2007 and is approved and marketed in more than 65 countries outside of North America. Mylan licensed the U.S. and Canadian rights to Bystolic from Janssen Pharmaceutical N.V. in 2001, and obtained Janssen's consent to sub-license Bystolic to Forest Laboratories in those territories in an initial agreement completed in January 2006. Bystolic is a cardio-selective beta-1 blocker, with vasodilation properties and a favorable tolerability profile. Upon FDA approval, Bystolic has received five years of marketing exclusivity under the Hatch Waxman legislation. In addition there is an issued U.S. pharmaceutical composition of matter patent that expires in 2021, which may offer additional exclusivity.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas. For more information about Mylan, please visit http://www.mylan.com
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995, including with regard to the future value of the product and the anticipated economic impact of the transaction. These statements involve a number of risks and uncertainties, including regulatory matters outside of the companies' control, the acceptance and demand for Bystolic, the impact of competitive products and pricing, and the risk factors listed from time to time in Mylan Inc.'s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
SOURCE Mylan Inc.