Agreement Marks Significant Commitment by Amgen to Development
of Metabolic Disease Treatments
THOUSAND OAKS, CA and STOCKHOLM, SWEDEN – September 8, 2003 –
Amgen Inc. (NASDAQ: AMGN) and Biovitrum AB today announced that they have signed
a multifaceted agreement under which Amgen receives exclusive rights to develop
and commercialize Biovitrum's small molecule 11âHSD1 enzyme inhibitors
for the treatment of metabolic diseases and certain other medical disorders.
The most advanced compound included in the agreement is BVT.3498, currently
in Phase IIa clinical trials for type 2 diabetes. Type 2 diabetes, a disease
in which insulin resistance leads to elevated blood sugar levels, currently
afflicts over 160 million people worldwide. Approximately 20 million Americans
currently suffer from type 2 diabetes. Early intervention using innovative therapies
has the potential to delay the onset of life-threatening metabolic disorders.
Amgen will make an upfront payment of $86.5 million and will fund and conduct
all further development and commercialization activities in the licensed territory,
which includes North and South America, the European Union, Australia and New
Zealand. Amgen will also make significant periodic milestone payments related
to development progress, regulatory submissions and approvals for metabolic
diseases and certain other indications. Once a product has been approved, Biovitrum
will also receive tiered royalties on future sales of all products arising from
the agreement. In addition, Amgen will fund a three-year research program conducted
by Biovitrum to develop additional 11âHSD1 enzyme inhibitor compounds.
Amgen has also granted co-promotion rights in the European Union for Amgen's
Kineret® (anakinra), a rheumatoid arthritis treatment. Biovitrum will also
have co-promotion rights in the Nordic region for all products developed under
the agreement as well as for Amgen's cinacalcet hydrochloride (HCI), a
treatment for some hyperparathyroid conditions, and palifermin, a therapy for
treating chemotherapy-related inflammations of the mouth. Cinacalcet and palifermin
are investigational products in clinical development. In addition, Biovitrum
will perform biopharmaceutical process development work funded and directed
by Amgen over the next three years.
The agreement is subject to review by applicable governmental antitrust and
competition authorities.
“This agreement represents a significant commitment by Amgen to pursue
innovative treatments for metabolic diseases including insulin resistance”
said Roger M. Perlmutter, Executive Vice President – Research and Development
for Amgen. “Through this agreement we are gaining access to important research
that we hope will develop into an effective treatment for type 2 diabetes and
related metabolic diseases. At the same time, we are establishing a strong working
relationship with an organization whose work complements our own.”
“Amgen has a history of pioneering work, excellent research and development
capabilities, and extensive marketing and distribution expertise,” said
Mats Pettersson, CEO of Biovitrum. “We are confident that in Amgen we have
a strong and committed partner for completing development of this innovative
approach for helping those suffering from type 2 diabetes and related disorders.”
Paul de Potocki, Head of Commercial Operations at Biovitrum said, “We are
also pleased to have reached an agreement that will assist Biovitrum in developing
a marketing and sales presence in Europe.”
About Amgen
Amgen is a global biotechnology company that discovers, develops, manufactures
and markets important human therapeutics based on advances in cellular and molecular
biology.
About Biovitrum
Biovitrum is a privately-held biotech company active in the discovery and development
of drugs to treat metabolic diseases, such as type 2 diabetes and obesity, and
in the process development and contract manufacturing of protein therapeutics.
The company has a strong intellectual property and technology platform, with
a number of compounds in pre-clinical and clinical development. Biovitrum is
one of the largest biotech companies in Europe with more than 575 employees.
Annual revenues, including royalties and contract service fees, finance the
major part of the annual research budget. For more information, please visit
Biovitrum's website at www.biovitrum.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 our Form 10-K for the year ended December 31, 2002, and in our 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 we project. The Company's results may be affected
by our ability to successfully market both new and existing products domestically
and internationally, sales growth of recently launched products, difficulties
or delays in manufacturing our products, and regulatory developments (domestic
or foreign) involving current and future products and manufacturing facilities.
In addition, sales of our 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 domestic and international trends toward
managed care and healthcare cost containment as well as possible US legislation
affecting pharmaceutical pricing and reimbursement. Government regulations and
reimbursement policies may affect the development, usage and pricing of our
product. Furthermore, our research, testing, pricing, marketing and other operations
are subject to extensive regulation by domestic and foreign government regulatory
authorities. We, or others could identify side effects or manufacturing problems
with our products after they are on the market. In addition, we compete with
other companies with respect to some of our 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. In addition, while
we routinely obtain patents for our products and technology, the protection
offered by our patents and patent applications may be challenged, invalidated
or circumvented by our competitors. Further, some raw materials, medical devices,
and component parts for our products are supplied by sole third party suppliers.
Amgen is a global biotechnology company that discovers, develops, manufactures
and markets important human therapeutics based on advances in cellular and molecular
biology.
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