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-1ß). 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.
