Sepracor Inc. has partnered with Portuguese firm Bial SA in a deal potentially worth $175 million to develop and commercialize BIA 2-093 (eslicarbazepine acetate) as a therapy to control epileptic seizures.
Under the agreement, Marlborough, Mass.-based Sepracor will pay Bial an up-front payment of $75 million in exchange for the rights to develop and commercialize the antiepileptic compound in the U.S. and Canada.
Bial, based in S. Mamede do Coronado, Portugal, could bank an additional $100 million if certain milestones are met. In addition, the firm could receive additional payments in an undisclosed amount from Sepracor if BIA 2-093 is approved in the U.S. for other indications.
Sepracor, which markets the insomnia drug Lunesta (eszopiclone), said it expects to submit a new drug application to the FDA for BIA 2-093 in late 2008 or early 2009, with a potential product launch by early 2010.
BIA 2-093 was shown to be safe and effective in three Phase III clinical trials as an adjunctive therapy in controlling epileptic seizures in adults, Sepracor said.
The Bial deal, said Sepracor CEO Adrian Adams, strengthens the company's existing central nervous system portfolio and is part of the firm's overall global strategy to "fully leverage our product franchises and commercial infrastructure while driving enhanced research and development productivity and successfully pursuing aligned and value-enhancing corporate development and licensing initiatives."
In addition to Lunesta, which had $160.9 million in revenues for the third quarter of 2007, Sepracor's marketed products include Xopenex (levalbuterol HCl) inhalation solution, a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and Brovana (arformoterol tartrate) inhalation solution, a long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease.
Sepracor's investigational product pipeline includes two therapies for depression, SEP-225289, a serotonin-norepinephrine-dopamine-reuptake inhibitor, and SEP-227162, a serotonin-norepinephrine-reuptake inhibitor.
The firm also is investigating SEP-225441, a gamma-aminobutyric acid alpha agonist, as a treatment for generalized anxiety disorder.