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Sepracor and Bial to commercialise anti-epileptic in US and Canada

Sepracor and Portuguese-headquartered Bial enter into a licensing agreement for the development and commercialisation of Bial's anti-epilepsy drug BIA 2-093 in the US and Canada

US-based pharmaceutical company Sepracor and Portuguese-headquartered Bial have entered into an exclusive licensing agreement for the development and commercialisation of the latter's anti-epileptic compound BIA 2-093 (eslicarbazepine) in the US and Canada.

BIA 2-093 is designed to give patients with partial epilepsy more control of their seizures, according to Sepracor. The compound is in three phase III studies in 22 countries around the world. The company added that the drug grows the firm's pipeline of products for central nervous system disorders, which includes Lunesta (eszopiclone) for insomnia.

Bial is currently completing clinical evaluation of BIA 2-093 for the adjunctive use in partial seizures in adults with epilepsy.

Eslicarbazepine 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 randomised to an 18-week acute double-blind therapy and subsequently followed in a one year, open label extension study.

Per the agreement, Sepracor will be responsible for filing the US NDA and seeking marketing approval from the FDA. The company estimates 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.

Bial, for its part, will receive an upfront payment of USD 75m and subsequent payments upon accomplishment of various development and regulatory milestones, which could include up to an additional USD 100m if all milestones are met. The company will also receive compensation for providing finished product and milestone payments upon FDA approval of additional indications.

FY06 net income at Sepracor was USD 184.6m on revenue of almost USD 1.2bn.

3rd January 2008

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