Collaboration Comprises Five Monoclonal Antibodies
Brodalumab (AMG 827) Phase 3 Trial Planned in 2012
AstraZeneca and Amgen today announced an agreement to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio: AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG 827).
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 capitalise 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.
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.
AstraZeneca will lead the development and commercialisation strategy of AMG 139, 157 and 181, while Amgen will lead the development and commercialisation strategy of brodalumab and AMG 557. Each development and commercialisation 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 US and Canada, and in rheumatology indications in US, Canada and Europe. AstraZeneca will promote in respiratory and, initially, in dermatology indications of brodalumab across all territories outside of the US, Canada and those markets where Amgen has existing partnerships. Allocation of promotion rights for other territories, indications and molecules will be agreed later between the companies.
“We are delighted to join forces with Amgen in developing and commercialising these novel clinical-stage assets that add value to our pipeline and build on our expertise in biologics. This creative collaboration will make the most of both companies’ respective capabilities, including AstraZeneca’s extensive global reach, to help bring these potentially innovative treatment options for a variety of respiratory and inflammatory diseases to patients around the world,” said David Brennan, Chief Executive Officer, AstraZeneca.
“We are very excited at the prospect of collaborating with a well-respected organisation like AstraZeneca to advance our inflammation pipeline,” said Kevin Sharer, Chairman and CEO at Amgen. “We believe this collaboration has the potential to bring more therapies to patients sooner, across more geographic areas. We are impressed with AstraZeneca’s extensive experience in developing and launching products in the respiratory and gastroenterology areas, and believe this collaboration is an opportunity to work with a partner that has leading regulatory and commercial expertise in inflammation indications.”
NOTES TO EDITORS
About the inflammation portfolio included in the agreement
Under the agreement, the companies will jointly develop and commercialise the following five monoclonal antibodies (immunoglobin proteins that have been synthesized using recombinant DNA technology) from Amgen’s clinical-stage portfolio:
- Brodalumab (AMG 827) is a human monoclonal antibody that binds to and blocks signaling via the IL-17 receptor. Brodalumab is currently being investigated for the treatment of psoriasis (completed Phase 2 and planned Phase 3), psoriatic arthritis (Phase 2) and asthma (Phase 2).
- AMG 139 is a human monoclonal antibody that neutralises IL-23 interaction with its receptor while sparing IL-12. It is being investigated as a treatment for a variety of inflammatory disorders. AMG 139 is being investigated in Phase 1 for Crohn’s disease, with lifecycle possibilities in psoriasis and other inflammatory conditions.
- AMG 181 is a human monoclonal antibody to alpha4/beta7 that blocks binding to MAdCAM-1. It is being investigated in Phase 1b trials for the treatment of ulcerative colitis and Crohn’s disease.
- AMG 557 is a human monoclonal antibody that binds to B7 related protein (B7RP-1). It is being investigated in Phase 1b for its utility in autoimmune diseases such as systemic lupus erythematosus.
- AMG 157 is a human monoclonal antibody that blocks the interaction of thymic stromal lymphopoietin (TSLP) with the TSLP receptor. AMG 157 is being investigated in Phase 1b trials for its potential as a treatment for asthma.
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.