Amgen to Collaborate With GlaxoSmithKline to Commercialize Denosumab in Europe for Postmenopausal Osteoporosis (PMO)
Amgen to Retain Full Rights for Denosumab in the United States and Canada and
for Oncology Indications in Europe
GlaxoSmithKline Will Commercialize Denosumab for PMO and Oncology in Emerging
Markets
THOUSAND OAKS, Calif. and LONDON, July 27 /PRNewswire-FirstCall/ -- Amgen
(Nasdaq: AMGN) and GlaxoSmithKline (GSK) today announced a collaboration in
which the companies will share commercialization of Amgen's monoclonal
antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia,
New Zealand and Mexico once the product is approved in these countries. Amgen
will commercialize the drug for PMO and oncology in the United States (U.S.)
and Canada and for all oncology indications in Europe and specified markets.
GlaxoSmithKline will register and commercialize denosumab for all
indications in countries where Amgen does not currently have a commercial
presence, including China, Brazil, India and South Korea. The structure of
the collaboration allows Amgen the option of an expanded role in
commercialization in both Europe and certain emerging markets in the future.
Financial terms of the partnership include an initial payment and
near-term commercial milestones to Amgen totaling $120 million, and ongoing
royalties. In Europe, Amgen and GlaxoSmithKline will share profits after
accounting for expenses associated with the partnership. In emerging markets,
GlaxoSmithKline will be responsible for all commercialization expenses and
purchase denosumab from Amgen to meet demand.
The companies' combined commercialization activities will expand access to
denosumab, once approved, to patients worldwide who are afflicted by
osteoporosis and other bone loss conditions.
"Our collaboration with GlaxoSmithKline will help Amgen bring the promise
of denosumab to patients in Europe and other parts of the world more
effectively than if we commercialized the drug globally on our own," said
Amgen CEO Kevin Sharer. "Amgen and GlaxoSmithKline together are uniquely
positioned to help medical providers and patients understand the clinical
promise and economic value of denosumab."
"This pioneering treatment that Amgen has developed will be a strong
addition to our biopharmaceuticals portfolio," commented Andrew Witty, CEO of
GlaxoSmithKline. "The data for denosumab is very encouraging and we believe
it will provide significant benefit and value to patients with postmenopausal
osteoporosis and other bone disease conditions. Together with Amgen we are
committed to increasing worldwide access to this medicine."
In July 2007, Amgen granted Daiichi Sankyo exclusive rights to develop and
commercialize denosumab in Japan in PMO and oncology with the potential for
additional indications. This arrangement remains in place.
About Denosumab
Denosumab is a fully human monoclonal antibody that targets RANK Ligand
and is being investigated for its potential to prevent and treat a broad range
of bone disease conditions including osteoporosis, bone metastases and their
consequences, cancer treatment-induced bone loss due to hormone ablative
therapy, multiple myeloma and bone erosions in rheumatoid arthritis.
Denosumab is the first late-stage investigational therapy that specifically
inhibits RANK Ligand, an essential mediator of the cells that break down bone.
With more than 19,000 patients in trials across indications worldwide, the
denosumab development program is the largest ever initiated by Amgen. This
broad and deep development program demonstrates Amgen's commitment to
researching and delivering pioneering medicines to patients with unmet medical
needs.
Amgen has submitted marketing applications for denosumab in the United
States, European Union, Canada, Switzerland, and Australia.
About Osteoporosis
Often referred to as the "silent epidemic," osteoporosis is a global
problem that is increasing in significance as the population of the world both
increases and ages. The World Health Organization (WHO) has recently
identified osteoporosis as a priority health issue along with other major
non-communicable diseases.
Despite availability of osteoporosis treatments for more than 10 years,
patients with osteoporosis still experience a substantial number of
fractures.(1) Out of an estimated 9 million new osteoporotic fractures
globally in 2000, 1.7 million were at the forearm, 1.6 million were at the
hip, and 1.4 million were clinical (symptomatic) fractures of the vertebrae in
the backbone.(2)
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, 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.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality of human life
by enabling people to do more, feel better and live longer. For further
information please visit www.gsk.com
Forward-Looking Statements
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
others that can be found in Amgen's Form 10-K for the year ended December 31,
2008, and in its periodic reports on Form 10-Q and Form 8-K. Amgen is
providing this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements contained in
this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may
differ materially from those Amgen projects. Amgen's results may be affected
by Amgen's ability to successfully market both new and existing products
domestically and internationally, clinical and regulatory developments
(domestic or foreign) involving current and future products, sales growth of
recently launched products, competition from other products (domestic or
foreign), difficulties or delays in manufacturing its products. In addition,
sales of Amgen products are affected by reimbursement policies imposed by
third-party payors, including governments, private insurance plans and managed
care providers and may be affected by regulatory, clinical and guideline
developments and domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others' regulations
and reimbursement policies may affect the development, usage and pricing of
Amgen products. Furthermore, Amgen's research, testing, pricing, marketing
and other operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. Amgen or others could identify
safety, side effects or manufacturing problems with Amgen products after they
are on the market. Amgen's business may be impacted by government
investigations, litigation and products liability claims. Further, while
Amgen routinely obtains patents for its products and technology, the
protection offered by its patents and patent applications may be challenged,
invalidated or circumvented by its competitors. 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. In addition, Amgen competes with other companies with respect to
some of its marketed products as well as for the discovery and development of
new products. Discovery or identification of new product candidates cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate will be
successful and become a commercial product. Further, some raw materials,
medical devices and component parts for Amgen products are supplied by sole
third-party suppliers.
The scientific information discussed in this news release related to
Amgen's product candidates is preliminary and investigative. Such product
candidates are not approved by the U.S. Food and Drug Administration (FDA) or
other regulatory bodies, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates. Only the FDA can
determine whether the product candidates are safe and effective for the use(s)
being investigated. Healthcare professionals should refer to and rely upon
the labeling approved by the FDA or other regulatory bodies for the products,
and not the information discussed in this news release.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the company' s
Annual Report on Form 20-F for 2008.
CONTACT: Amgen, Thousand Oaks
David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)
Enquiries GSK:
UK Media enquiries: Philip Thomson (020) 8047 5502
David Outhwaite (020) 8047 5502
Stephen Rea (020) 8047 5502
Alexandra Harrison (020) 8047 5502
US Media enquiries: Nancy Pekarek (919) 483 2839
Mary Anne Rhyne (919) 483 2839
Kevin Colgan (919) 483 2839
Lisa Behrens (919) 483 2839
European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564
Sally Ferguson (020) 8047 5543
Gary Davies (020) 8047 5503
US Analyst/ Investor enquiries: Tom Curry (215) 751 5419
Jen Hill Baxter (215) 751 7002
(1) Secular data
(2) Johnell O, Kanis JA. An estimate of the worldwide prevalence and
disability associated with osteoporotic fractures. Osteoporosis Int. 2006;
17(12):1726-33
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SOURCE Amgen; GlaxoSmithKline
