Sepracor has entered a licensing deal with Bial for the development and commercialization of Bial's anti-epileptic compound BIA 2-093 in the US and Canada.
Under the terms of the deal, Sepracor will be responsible for filing the US NDA and seeking marketing approval from the FDA, and contingent on obtaining regulatory approval, commercialization of the product in the US.
Sepracor anticipates that the NDA will be submitted to the FDA in late 2008 or early 2009 with a potential product launch in late 2009 or early 2010, subject to FDA approval. In exchange, Bial is entitled to receive an upfront payment of $75 million and subsequent payments upon accomplishment of various development and regulatory milestones, which could include up to an additional $100 million if all milestones are met. Bial will also receive compensation for providing finished product and milestone payments upon FDA approval of additional indications, if any.
Friedman, Billings, Ramsey analyst David Amsellem said, that with the deal, Sepracor has begun to address its late-stage pipeline gap in a largely non-dilutive transaction and by adding a central nervous system product, it can leverage using its existing sales organization in a market that is largely specialist based.
“The epilepsy market is relatively crowded with a heavy generic presence. We believe that peak BIA 2-093 sales of $125 million-$150 million are realistic. With the addition of BIA 2-093 sales estimates to our model, we are slightly raising our price target to $28 from $26 and maintaining our market perform rating.”