Sepracor Inc. (Nasdaq: SEPR) 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.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol and BROVANA® brand arformoterol tartrate Inhalation Solution. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
About Bial
Bial is a Portuguese research-based pharmaceutical company headquartered in S. Mamede do Coronado, Portugal, whose goal is to improve health and wellbeing. Bial was founded in 1924 and is the largest Portuguese pharmaceutical company with an international presence in over 30 countries. It is the partner of choice for many global companies wishing to commercialize products within the Iberian Peninsula, Latin America and Africa. Research and development is focused on the central nervous and cardiovascular systems and Bial currently has several other innovative programs under development, which the company expects to bring to the market within the next years.
Sepracor Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of BIA 2-093; the timing and success of regulatory events relating to BIA 2-093, including the possible submission of an NDA late 2008 or early 2009 and potential commercialization in late 2009 or early 2010; and future payments by Sepracor to Bial. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: clinical benefits, efficacy and safety of BIA 2-093; the timing and success of submission, acceptance, and approval of regulatory filings for BIA 2-093; unexpected delays in commercial introduction of, and the commercial success of, BIA 2-093; the success of Sepracor's alliance with Bial; Sepracor’s ability to obtain favorable reimbursement approval levels, or obtain reimbursement approval at all, for BIA 2-093, if approved for commercialization; the scope of Bial’s and/or Sepracor’s patents and the patents of others; the ability of Sepracor and Bial to attract and retain qualified personnel; and certain other factors that may affect future operating results that are detailed in Sepracor’s quarterly report on Form 10-Q for the quarter ended September 30, 2007 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc