Sepracor Inc. and Bial have announced an exclusive licensing agreement for the development and commercialization of Bial's anti-epileptic compound BIA 2-093 in the United States and Canada.
Under the terms of the agreement, Sepracor will be responsible for filing the US NDA and seeking marketing approval from the US Food and Drug Administration (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. "We are very pleased with the addition of this late-stage asset to our growing product pipeline," said Adrian Adams, president and chief executive officer of Sepracor. "Strategically, BIA 2-093 further strengthens our existing central nervous system portfolio, which includes Lunesta brand eszopiclone for the treatment of insomnia, as well as earlier-stage candidates for various central nervous system disorders. This milestone in-licensing event is reflective of our overall global corporate 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 Sepracor we have found a partner who truly shares our vision and commitment to this compound and a company with a proven commercial track record in the US market. This is a landmark event for BIAL and represents the first result of our R&D work within the CNS area. I am very proud of the people within Bial who have helped to make this happen through their hard work and dedication" said Luis Portela, president and chief executive officer of Bial.
BIA 2-093 (eslicarbazepine acetate) is a new chemical entity which has been designed to offer patients suffering with partial epilepsy additional control of their seizures and improved quality of life. Bial is currently completing clinical evaluation of BIA 2-093 for the adjunctive use in partial seizures in adults with epilepsy.
Eslicarbazepine acetate has been shown in clinical studies to be safe and effective in the control of seizures as adjunctive therapy in adults. Bial has tested the compound in three phase III trials in 22 countries with over one thousand patients randomized to an 18-week acute double-blind therapy and subsequently followed in a one year, open label extension study. The potential for once-daily administration could be an important clinical advantage for patients with epilepsy in the US and Canada. In addition, there may be benefits to patients such as reduced drug-drug interactions, which may distinguish this drug from commonly used compounds such as carbamazepine.