Date: 2014-12-10
Type of information: Commercialisation agreement
Compound: Vimpat® (lacosamide)
Company: UCB (Belgium) Daiichi Sankyo (Japan)
Therapeutic area: CNS diseases - Neurological diseases
Type agreement: production manufacturing distribution commercialisation
Action mechanism:
Disease: epilepsy
Details: * On November 28, 2014, Daiichi Sankyo and UCB Biopharma announced that the companies entered into an agreement to jointly commercialize Lacosamide for epilepsy patients in Japan. Under this agreement, UCB will manufacture and supply the product for commercialization. Daiichi Sankyo will manage the distribution and book sales, with both Daiichi Sankyo and UCB commercializing Lacosamide in Japan. 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.
Financial terms: 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.
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