BioWa and Medarex Announce Allowance of Investigational New Drug Application for Second-Generation Anti-CD30 Antibody (MDX-1401) Enhanced Using Potelligent(TM) Technology

BioWa and Medarex Announce Allowance of Investigational New Drug Application for Second-Generation Anti-CD30 Antibody (MDX-1401) Enhanced Using Potelligent(TM) Technology

January 09, 2007

    PRINCETON, N.J., Jan. 9 /Xinhua-PRNewswire/ -- BioWa,
Inc. and Medarex, Inc. (Nasdaq: MEDX) announced today the
allowance of an investigational new drug application (IND)
filed with the U.S. Food & Drug Administration (FDA)
for MDX-1401, a fully human antibody that targets
CD30-positive lymphomas. MDX-1401 is enhanced for greater
Fc receptor mediated antibody activity, one critical
mechanism in tumor lysis by antibodies, using BioWa's
Potelligent Technology.

    The dose-escalation, multi-dose Phase I clinical trial
is expected to enroll up to 36 patients with relapsed or
refractory Hodgkin's disease. The trial is designed to
establish and evaluate the safety profile and initial
efficacy of MDX-1401. Preclinical in vitro studies showed
that this second-generation nonfucosylated anti-CD30
antibody demonstrated enhanced antibody-dependent cellular
cytotoxicity (ADCC), an important mechanism of action of
therapeutic antibodies, and was active in inhibiting tumor
growth in in vivo xenograft models.

    "Today's announcement demonstrates our commitment
to innovative approaches that have the potential to enhance
our fully-human monoclonal antibody technology for
developing important new therapies," said Irwin
Lerner, Chairman of the Board of Directors and Interim
President and CEO of Medarex. "We are pleased with our
partnership with BioWa and with its technology as a method
for increasing the potency of MDX-1401, a novel product
that broadens our anti-CD30 clinical program for Hodgkin's
disease."

    "Medarex, one of our key strategic partners,
continues to make exciting progress with Potelligent
Technology," said Nobuo Hanai, President and CEO of
BioWa. "We believe that this clinical development
milestone is another demonstration of the significance of
our antibody technology for generating and developing
potentially important new therapeutics."

    About Potelligent Technology 

    Antibody-dependent cellular cytotoxicity (ADCC)
activity is an important function of the human immune
system, whereby immune cells can kill target cells, e.g.
cancer cells.  ADCC activity is one important mechanism
underlying the efficacy of some currently approved
anti-cancer antibodies. Enhancement of this activity is in
the spotlight as one promising possibility for the next
generation of antibody technology. 

    Potelligent(TM) Technology involves the reduction of
the amount of fucose in the carbohydrate structure of an
antibody. Research shows that Potelligent(TM) Technology
significantly enhances binding affinity of antibodies for
Fc receptors and increases ADCC activity in vitro.  One
potential benefit of Potelligent(TM) derived therapeutic
antibodies is greater tumor cell killing activity than with
conventional antibodies.

    About BioWa

    BioWa is a wholly owned subsidiary of Kyowa Hakko Kogyo
Co, Ltd, Japan's leading pharmaceutical and largest biotech
company. BioWa is the exclusive worldwide licensor of
Potelligent(TM) Technology. Potelligent(TM) Technology
creates high antibody-dependent cellular cytotoxicity
(ADCC) monoclonal antibodies. ADCC is a critical function
of the immune system that enhances the ability of
antibodies to kill tumor cells. The enhancement of ADCC is
seen up to 100 fold in vitro. Both BioWa and Kyowa Hakko
are currently developing ADCC enhanced monoclonal
antibody-based therapeutics to fight cancer and other life
threatening and debilitating diseases in various clinical
stages. BioWa creates and develops enhanced ADCC antibodies
for itself and others, offering a full range of antibody
discovery and development capabilities. For more
information about BioWa visit its web site at
http://www.biowa.com .

    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(R) technology and
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. With this announcement, thirty-six of
these therapeutic product candidates derived from Medarex
technology are in human clinical testing or have had INDs
submitted for such trials, with six of the most advanced
product candidates currently in Phase III 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 .

    Cautionary Statement

    For Medarex: Except for the historical information
presented herein, matters discussed herein may constitute
forward-looking statements 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 "potential"; "believe";
"anticipate"; "intend";
"plan"; "expect"; "estimate";
"could"; "may"; 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 product discovery and development,
uncertainties related to the outcome of clinical trials,
slower than expected rates of patient recruitment,
unforeseen safety issues resulting from the administration
of MDX-1401 in patients, uncertainties related to product
manufacturing 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, 2005 and subsequent Quarterly Reports on Form
10-Q. There can be no assurance that such development
efforts will succeed or that other developed products will
receive required regulatory clearance or that, even if such
regulatory clearance were received, such products would
ultimately achieve commercial success. Copies of Medarex's
public disclosure filings are available from its investor
relations department. 

    Medarex(R), the Medarex logo and UltiMAb(R) are
registered trademarks of Medarex, Inc. All rights are
reserved. 

    Potelligent(TM) is the registered trademark of Kyowa
Hakko Kogyo Co., Ltd. All rights are reserved. 

    For more information, please contact:

    Medarex Inc.
     Laura S. Choi
     Investor Relations
     Tel: [phone], x2216 

     Jean Mantuano
     Corporate Communications (media)
     Tel: [phone], x2221

    BioWa
     Nobuo Hanai, Ph.D.
     President and CEO
     Tel: [phone], x7501

     Martina Molsbergen
     Director, Business Development
     Tel: [phone], x7506 


SOURCE  BioWa, Inc.