Date: 2013-09-09
Type of information: Commercialisation agreement
Compound: Kineret® and additional clinical data for Kepivance®
Company: Swedish Orphan Biovitrum - Sobi (Sweden) Amgen (USA)
Therapeutic area: Rare diseases - Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Type agreement: commercialisation
Action mechanism:
Disease: rheumatoid arthritis and all therapeutic indications
Details: * On September 9, 2013, Swedish Orphan Biovitrum (Sobi) has announced that the company has acquired the full rights to develop and commercialize Kineret® (anakinra) from Amgen for all therapeutic indications. The revised agreement builds on the previous agreement that gave Sobi rights for Kineret® within the field of rheumatoid arthritis (RA) and four orphan drug indications, including Cryopyrin Associated Periodic Syndrome (CAPS). Sobi also acquired the right to additional data for Kepivance® allowing the company to explore a potential new therapeutic indication based on two completed phase III trials performed by Amgen. The two randomized double blind placebo controlled trials, involving over 400 patients, demonstrate the potential for Kepivance® to reduce the incidence of severe oral mucositis in patients undergoing treatment for advanced head and neck cancer.
The initial agreement was closed on December 16, 2008. Under this agreement, Biovitrum has obtained a worldwide exclusive license to Kineret® (anakinra) for its current approved indication, and has acquired from Amgen global rights to the marketed biologic therapeutic products Kepivance® (palifermin) and Stemgen® (ancestim). In early 2013, the FDA had approved Kineret® for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe form of CAPS.
Financial terms: Under the terms of the amended agreement, Sobi and Amgen have restructured the financial terms of their original deal to accommodate the acquisition of additional rights and data.
Latest news:
