Under the terms of the agreement, Forest will make an upfront payment to Mylan of $75 million as well as potential future milestone payments. In addition, Mylan will also receive royalty payments based on nebivolol sales.
Forest will assume all nebivolol development expenses for current and future development programs as well as taking responsibility for all sales and marketing expenses. Mylan has retained an option to co-promote the product in the future.
Howard Solomon, chairman and CEO of Forest, said: “We are excited about the opportunity to market nebivolol, a highly beta-1 selective beta blocker which, based on the phase III studies included in the NDA filed by Mylan, appears to have favorable differentiating characteristics.”
In May 2005 Mylan received an approvable letter from the FDA on its new drug application (NDA) 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 preclinical study designed to address certain questions posed by the FDA and is working towards submitting the results and other information to the FDA for their review.
In addition, Mylan intends to submit a separate nebivolol NDA to the FDA for the treatment of congestive heart failure. The submission, anticipated to occur sometime during the second half of calendar year 2006, will be based on data from a clinical study conducted in Europe by the Menarini Group.