Medarex to Receive Milestone Payment for the Approval of Ilaris for the Treatment of Cryopyrin-Associated Periodic Syndrome
2009年6月30日 - 9:00PM
ビジネスワイヤ(英語)
Medarex, Inc. (NASDAQ:MEDX) today announced it will receive a
milestone payment of an undisclosed amount from Novartis Pharma AG
(Novartis), in connection with the marketing approval from the U.S.
Food and Drug Administration (FDA), to market Ilaris� (canakinumab,
previously known as ACZ885) for the treatment of children as young
as four years old and adults with cryopyrin-associated periodic
syndrome, or CAPS, a serious life-long auto-inflammatory disease
caused by rare genetic mutations.
CAPS comprises three disorders of increasing severity: familial
cold auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS)
and neonatal-onset multisystem inflammatory disease (NOMID). A
clinical study is ongoing to evaluate the potential of Ilaris� to
treat patients with NOMID. In addition to ongoing studies in CAPS,
clinical trials are also under way with Ilaris� in systemic
juvenile idiopathic arthritis (SJIA), and more common disorders
such as some forms of gout, chronic obstructive pulmonary disorder
(COPD) and type 2 diabetes.
Ilaris� is a fully human monoclonal antibody generated using
Medarex's UltiMAb� technology that rapidly and selectively blocks
interleukin-1 beta (IL-1?). Regulatory applications have also been
filed in Europe, Switzerland, Australia and other countries. Under
the agreement with Novartis, Medarex will receive future
sales-based royalty payments from the commercial sales of
Ilaris�.
�Ilaris� represents the third antibody generated from our
UltiMAb� technology to receive regulatory approval and reinforces
the important role of our antibody technology platform in
developing new treatment options for unmet medical needs,� said
Howard H. Pien, Chairman and CEO of Medarex. �The royalty stream
generated from future product sales will provide valuable financial
support to advancing our own maturing product pipeline toward
commercialization.�
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human
antibody-based therapeutics to treat life-threatening and
debilitating diseases, including cancer, inflammation, autoimmune
disorders and infectious diseases. Medarex applies its UltiMAb�
technology, product development and clinical manufacturing
experience to generate, support and potentially commercialize a
broad range of fully human antibody product candidates for itself
and its partners. Over forty of these therapeutic product
candidates derived from Medarex technology are in human clinical
testing or have had INDs submitted for such trials, with the most
advanced product candidates currently approved for commercial sale,
the subject of regulatory applications for marketing authorization
or in Phase 3 clinical trials. Medarex is committed to building
value by developing a diverse pipeline of antibody products to
address the world�s unmet healthcare needs. For more information
about Medarex, visit its website at www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements, as
defined in the Private Securities Litigation Reform Act of 1995,
that are subject to certain risks and uncertainties that could
cause actual results to differ materially from any future results,
performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including
statements preceded by, followed by, or that include the words
�will�; �believe�; �future�; �potential� or similar statements are
forward-looking statements. Medarex disclaims, however, any intent
or obligation to update these forward-looking statements. Risks and
uncertainties include risks associated with the development and
commercialization of Ilaris�, as well as risks detailed from time
to time in Medarex�s public disclosure filings with the U.S.
Securities and Exchange Commission (SEC), including its Annual
Report on Form 10-K for the fiscal year ended December 31, 2008 and
its quarterly reports on Form 10-Q. There can be no assurance that
future milestone payments will be paid or that Ilaris� will be
commercially successful. Copies of Medarex�s public disclosure
filings are available from its investor relations department.
Medarex�, the Medarex logo and UltiMAb� are registered
trademarks of Medarex, Inc. All rights are reserved.
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