Portuguese drugmaker Bial is celebrating the signing of a licensing deal with Sepracor which will see the US firm receive certain rights to a late-stage anti-epileptic compound.
The drug candidate in question, BIA 2-093 (eslicarbazepine), has completed three Phase III trials in 22 countries with over 1,000 patients randomised to an 18-week acute double-blind therapy and subsequently followed in a one-year, open-label extension study. Now Sepracor will submit a New Drug Application in the USA for the therapy by the end of the year and will also be responsible for a regulatory filing in Canada.
In addition, the firms said that eslicarbazepine may offer benefits to patients such as reduced drug-drug interactions, which may distinguish this drug from commonly used compounds such as carbamazepine
Cashwise, Bial will receive an upfront fee of $75 million and subsequent payments upon accomplishment of various development and regulatory milestones, which could bring in up to an additional $100 million. The Sao Mamede Do Coronado-based group will also receive compensation for providing finished product and milestone payments upon US Food and Drug Administration approval of additional indications, if any.
Sepracor’s chief executive Adrian Adams said that in strategic terms, “BIA 2-093 further strengthens our existing central nervous system portfolio”, which includes Lunesta (eszopiclone) for the treatment of insomnia, as well as earlier-stage candidates for various CNS disorders. His counterpart at Bial, Luis Portela, said the deal “is a landmark event for Bial and represents the first result of our R&D work within the CNS area”, and he said he was pleased to have teamed up with a company that has “a proven commercial track record in the US market”.
Bial, which was founded in 1924 is the largest Portuguese pharmaceutical company with an international presence in over 30 countries. It claims to be “the partner of choice for many global companies wishing to commercialise products within the Iberian Peninsula, Latin America and Africa” and says it has “several other innovative programmes under development”.
