Date: 2015-05-22
Type of information: Termination of an agreement
Compound: five monoclonal antibodies (AMG 139, AMG 157, AMG 181, AMG 557, brodalumab - AMG 827)
Company: Amgen (USA) AstraZeneca (UK)
Therapeutic area: Allergic diseases - Autoimmune diseases - Dermatological diseases - Digestive diseases - Inflammatory diseases - Rheumatic diseases
Type agreement: R&D
development
commercialisation
Action mechanism:
Disease: asthma, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, ystemic lupus erythematosus
Details: Amgen and AstraZeneca have announced an agreement to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab - AMG 827). Brodalumab (AMG 827) is a human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor. It is being investigated for psoriasis (completed Phase 2 and planned Phase 3), psoriatic arthritis (Phase 2) and asthma (Phase 2).
The companies believe all the molecules have novel profiles and offer the potential to deliver important treatments across multiple indications in inflammatory diseases. The collaboration will provide Amgen with additional resources to optimally progress its portfolio, and Amgen will benefit from the strong respiratory, inflammation and asthma development expertise of MedImmune, AstraZeneca's biologics arm. The collaboration will also capitalize on AstraZeneca's global commercial reach in respiratory and gastrointestinal diseases. The agreement does not include certain territories previously partnered by Amgen for brodalumab with Kyowa Hakko Kirin and AMG 557 with Takeda.
AstraZeneca will lead the development and commercial strategy of AMG 139, AMG 157 and AMG 181, while Amgen will lead the development and commercial strategy of brodalumab and AMG 557. Each development and commercialization lead will be under the oversight of joint governing bodies. For brodalumab, commercial promotion will be split. Amgen will promote in dermatology indications in the United States and Canada, and in rheumatology indications in the U.S., Canada and Europe. AstraZeneca will promote in respiratory and, initially, in dermatology indications of brodalumab across all territories outside the U.S., Canada and those markets where Amgen has existing partnerships. Allocation of promotional rights for other territories, indications and molecules will be agreed later between the companies.
AMG 139 is a human monoclonal antibody. It is being investigated in Phase 1b for Crohn's disease.
AMG 181 is a human monoclonal antibody. AMG 181 is being investigated in Phase 1a and Phase 1b for ulcerative colitis and Crohn's disease.
AMG 557 is a human monoclonal antibody that binds to B7-related protein 1 (B7RP-1). It is being investigated in Phase 1b for autoimmune diseases such as systemic lupus erythematosus.
AMG 157 is a human monoclonal antibody that blocks interaction of thymic stromal lymphopoietin (TSLP) with the TSLP receptor. It is being investigated in Phase 1b for asthma.
Financial terms: Under the terms of the agreement, AstraZeneca will make a one-time $50 million upfront payment and the companies will share both costs and profits. Based on current plans, approximately 65 percent of costs for the 2012-2014 period will be funded by AstraZeneca. Thereafter, the companies will split costs equally. Amgen will book sales globally and will retain a low single-digit royalty for brodalumab and a mid single-digit royalty for the rest of the portfolio, after which the companies will share profits equally.
Latest news: * On May 22, 2015, Amgen announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab, an investigational IL-17 receptor inhibitor in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The announcement follows Amgen’s decision to concentrate on other portfolio priorities after observing suicidal ideation and behaviour events in the brodalumab programme which may result in restrictive labelling. After Amgen transitions the program to AstraZeneca , future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan , where Kyowa Hakko Kirin has rights to brodalumab.
