AMGN PRESS RELEASE: Amgen and AstraZeneca Announce Collaboration to
Jointly Develop and Commercialize Clinical-Stage Inflammation Portfolio
Collaboration Comprises Five Monoclonal Antibodies
Brodalumab (AMG 827) Phase 3 Trial Planned in 2012
THOUSAND OAKS, Calif. and LONDON, April 2, 2012 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and AstraZeneca Plc, today 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)).
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.
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 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 (U.S.) 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.
"We are delighted to join forces with Amgen in developing and commercializing
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
organization 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 commercialize the
following five assets 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 being investigated
for psoriasis (completed Phase 2 and planned Phase 3), psoriatic
arthritis (Phase 2) and asthma (Phase 2).
-- AMG 139 is a human monoclonal antibody. AMG 139 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). AMG 557 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. AMG 157 is being
investigated in Phase 1b for asthma.
About Amgen
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.
About AstraZeneca
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.
Amgen Forward Looking Statements
This news release contains forward-looking statements that are based on
Amgen's current expectations and beliefs and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to differ
materially from those described. All statements, other than statements of
historical fact, are statements that could be deemed forward-looking
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Amgen's most recent annual report on Form 10-K and most recent periodic reports
on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q
and 8-K for additional information on the uncertainties and risk factors
related to Amgen's business. Unless otherwise noted, Amgen is providing this
information as of April 2, 2012 and expressly disclaims any duty to update
information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ
materially from those Amgen projects. Discovery or identification of new
product candidates or development of new indications for existing products
cannot be guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful
and become a commercial product. Further, preclinical results do not guarantee
safe and effective performance of product candidates in humans. The complexity
of the human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for Amgen to complete clinical trials and obtain regulatory approval for
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in the future. Amgen develops product candidates internally and through
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could identify safety, side effects or manufacturing problems with Amgen's
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government investigations, litigation and products liability claims. Amgen
depends on third parties for a significant portion of its manufacturing
capacity for the supply of certain of its current and future products and
limits on supply may constrain sales of certain of its current products and
product candidate development.
(MORE TO FOLLOW) Dow Jones Newswires
April 02, 2012 16:02 ET (20:02 GMT)
040212 20:02 -- GMT
