Daiichi Sankyo and UCB Biopharma SPRL have announced that the companies entered into an agreement to jointly commercialise Lacosamide for epilepsy patients in Japan. Under this agreement, UCB will manufacture and supply the product for commercialisation. Daiichi Sankyo will manage the distribution and book sales, with both Daiichi Sankyo and UCB commercialising Lacosamide in Japan.
"We continue executing on our partnering strategy for Japan to enhance patient access to our core medicines in concert with strong and patient-focussed partners," said Jean-Christophe Tellier, chief executive officer-elect of UCB. "We share our partner's passion for people living with epilepsy and for Lacosamide, and believe that Daiichi Sankyo’s excellence and overall market presence, including specialist areas addressing epilepsy such as neurology, neurosurgery and psychiatry, will enhance and broaden patients' access to new treatment options for epilepsy in Japan."
"Daiichi Sankyo expects to contribute to the management of the treatment of epilepsy and provide a new therapeutic option by adding Lacosamide to our product portfolio in the field of CNS in Japan," said George Nakayama, representative director, president and chief executive officer.
Based on the agreement and subject to achievement of certain milestones in the future, UCB will receive from Daiichi Sankyo up to a total of approx. € 180 million of upfront and milestones payments during the coming years. This agreement does not change UCB's financial outlook for 2014. The impact from this agreement on Daiichi Sankyo’s business results of current fiscal year will be announced at a later date. Further details of the agreement are not disclosed.
Lacosamide is currently not approved in Japan for the treatment of epilepsy. On 28 October 2014, UCB announced that the phase 3 clinical study evaluating Lacosamide as adjunctive therapy in the treatment of Japanese and Chinese adult patients with partial-onset seizures2 met its primary efficacy endpoint. The top-line results demonstrated that Lacosamide (200 and 400 mg/day) significantly reduced partial-onset seizure frequency, when compared to placebo. The adverse event profile in this study was consistent with that known for Lacosamide.1 Based on the positive results of this study, UCB plans to submit regulatory applications in Japan and China in 2015 for Lacosamide as adjunctive therapy in the treatment of adult patients with partial-onset seizures.
Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60 per cent) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of novel antiepileptic drugs. Every day, thousands of people use AEDs from our portfolio to help control their seizures. As a company with a long-term commitment to epilepsy research our goal is to address unmet medical needs and to deliver solutions that improve patients’ lives. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organisations who share our goals. At UCB, we are inspired by patients and driven by science in our commitment to support patients with epilepsy.
Lacosamide was first launched in the European Union in September 2008 under the name of Vimpat, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. Lacosamide is available in 44 countries including the US and in Europe. UCB holds the world-wide rights for development, manufacturing and marketing of Lacosamide. Lacosamide is currently not approved in Japan for the treatment of epilepsy.