Mylan licenses nebivolol to Forest, to receive $75 million and milestones

By Lisa Kerner

Erie, Pa., Jan. 11 - Mylan Laboratories Inc. and Forest Laboratories Holdings, Ltd. have entered into an agreement for the commercialization, development and distribution of Mylan's novel beta blocker nebivolol in the United States and Canada.

Under the terms of the agreement, Forest will make a $75 million upfront payment to Mylan as well as potential future milestone payments. Mylan will also receive royalty payments based on nebivolol sales, according to a company news release.

Forest will assume all nebivolol development expenses for current and future development programs. The company also will be responsible for all sales and marketing expenses.

Mylan has retained an option to co-promote the product in the future.

Nebivolol is approved and marketed in more than 65 countries outside of North America.

In May, Mylan received an approvable letter from the U.S. Food and Drug Administration on its New Drug Application for nebivolol for the treatment of hypertension. Final approval is contingent upon successfully satisfying additional FDA requirements included in the approvable letter.

Mylan has completed a pre-clinical study designed to address certain questions posed by the FDA and is working towards submitting the results and other information to the FDA for review. Upon FDA approval nebivolol will receive five years of marketing exclusivity under the Hatch Waxman legislation.

The company Mylan intends to submit a separate nebivolol New Drug Application to the FDA for the treatment of congestive heart failure, according to officials.

Mylan licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica NV and has Janssen's consent to sub-license nebivolol to Forest Laboratories in those territories.

Mylan is a Pittsburgh-based pharmaceutical company develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

New York-based Forest identifies, develops and delivers a variety of pharmaceutical products for the treatment illnesses such as depression, hypertension, and Alzheimer's disease.

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