Sepracor Inc. and Bial Announce Exclusive Licensing Agreement for Development and Commercialization of Anti-Epileptic Compound in United States and Canada
Wednesday January 2, 7:00 am ET
BIA 2-093, Eslicarbazepine Acetate, has Completed Large-Scale Phase III Clinical Studies
Submission of U.S. New Drug Application (NDA) Anticipated Late 2008 or Early 2009
U.S. Anti-Epileptic Market Estimated at Approximately $4 Billion in 2006
MARLBOROUGH, Mass. & S. MAMEDE DO CORONADO, Portugal--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) and Bial today 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 U.S. NDA and seeking marketing approval from the U.S. Food and Drug Administration (FDA), and contingent on obtaining regulatory approval, commercialization of the product in the U.S. 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.
“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 U.S. 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 U.S. 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.
According to the National Institute of Neurological Disorders and Stroke, epilepsy is a brain disorder in which clusters of nerve cells, or neurons, in the brain sometimes signal abnormally. In epilepsy, the normal pattern of neuronal activity becomes disturbed, causing strange sensations, emotions, and behavior or sometimes convulsions, muscle spasms, and loss of consciousness. Epilepsy is a disorder with many possible causes. Anything that disturbs the normal pattern of neuron activity - from illness to brain damage to abnormal brain development - can lead to seizures. Epilepsy may develop because of an abnormality in brain wiring, an imbalance of nerve signaling chemicals called neurotransmitters, or some combination of these factors. |
