PRINCETON, N.J., July 10 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) today provided a detailed overview of the company's
strategy, strength in research discovery and antibody development, and the
multiple opportunities Medarex is engaged in for creating long-term value.
In addition, comprehensive updates on current and future antibody programs
as well as updated 2008 financial guidance were presented by Medarex's
President and CEO, Howard H. Pien, and other members of senior management.
"Medarex's science and technology provides a solid foundation for
creating and renewing a broad portfolio of innovative and commercially
attractive product candidates," said Mr. Pien. "We remain excited and
confident of the path forward for the broad oncology program of ipilimumab,
our lead product candidate in development with Bristol-Myers Squibb
Company. We are also developing a strong pipeline that includes six other
exciting product candidates that represent multiple commercial
opportunities for Medarex. We believe that there is tremendous value in our
pipeline, and we are well- positioned in our research capabilities and
development strategy for sustaining a pipeline of commercially attractive
candidates to achieve significant growth in the years ahead."
Product Portfolio
Medarex has developed a portfolio of product candidates that address
important disease pathways in oncology and inflammatory diseases, including
immune modulation by co-stimulatory and checkpoint molecules, inhibition of
pro-inflammatory cytokines, and B-cell targeted approaches. In addition to
providing an update on the broad program for ipilimumab, an investigational
immunotherapy for multiple oncology indications, Medarex also highlighted
the company's scientific and commercial vision, clinical development plans
to proof-of-concept, and development milestones of select programs in
clinical development. Some of the programs discussed included the
following:
-- MDX-1106 (ONO-4538) is a fully human anti-PD-1 antibody in
development with Ono Pharmaceuticals, Inc. for solid tumors. Preliminary
data of anti- tumor activity in multiple tumor types from an ongoing Phase
1 trial were previously reported at a recent medical conference. A
multi-dose Phase 2 study in solid tumors is expected to begin in 2008. A
separate Phase 1 trial for hepatitis C viral infection is ongoing, with
data expected in 2009.
-- MDX-1100 is a fully human antibody that targets IP-10, a chemokine
that promotes the recruitment of pro-inflammatory cells that can cause
tissue damage in rheumatoid arthritis and inflammatory bowel diseases.
MDX-1100 represents a breakthrough mechanism of action for inflammatory
disease and is being investigated in separate Phase 2 proof-of-concept
trials for ulcerative colitis and rheumatoid arthritis. Interim data from
these trials are expected in 2009.
-- MDX-1401 is a fully human antibody that targets CD30, a member of
the TNF family expressed on CD30-positive lymphomas, including Hodgkin's
lymphoma. MDX-1401 is a second-generation antibody enhanced for improved
antibody effector function over the parental anti-CD30 antibody, MDX-060.
Preliminary data from an ongoing Phase 1 trial of MDX-1401 is expected in
2008 at a medical conference, with final data expected in 2009.
-- MDX-1342 is a fully human antibody with enhanced antibody effector
function that selectively binds to CD19, a molecule expressed on a broad
range of B-cell malignancies. MDX-1342 also induces the depletion and
elimination of B-cells for inflammatory disease indications. Phase 1 trials
in chronic lymphocytic leukemia and rheumatoid arthritis are ongoing with
data expected in 2009.
-- MDX-1411 is a fully human antibody with enhanced antibody effector
function that targets CD70, a member of the TNF family that is highly
expressed on multiple cancers, including renal cell carcinoma, lymphoma and
glioblastoma. CD70 expression on activated lymphocytes may also be
implicated in autoimmune diseases. Data from the ongoing Phase 1 trial in
clear cell renal carcinoma is expected in 2009. Additional opportunities
include the expected initiation of a Phase 1 trial of MDX-1411 in lymphomas
in 2008, as well as an anti-CD70 antibody-drug conjugate program.
-- MDX-1203 targets the CD70 molecule expressed on multiple cancers and
is expected to be the first Medarex antibody-drug conjugate candidate to
enter clinical development in 2008/early 2009.
"We are making great strides in developing potentially important
therapeutics to address a wide range of cancer and inflammatory diseases,"
Geoffrey M. Nichol, M.B.Ch.B., Senior Vice President of Product Development
at Medarex. "We continue to progress towards proof-of-concept for multiple
programs and look forward to advancing our most promising candidates
towards market approval."
Research and Development
Medarex has enhanced its core UltiMAb(R) antibody platform with a suite
of technologies that optimize or enhance the therapeutic activity of
antibodies. One important technology expansion is the company's proprietary
antibody-drug conjugate (ADC) platform. Medarex believes that its ADC
technology overcomes many of the key development challenges of drug
conjugates, including issues of linker stability, potency and multi-drug
resistance while maintaining a wide therapeutic window with minimal
toxicity. Coupled with cutting-edge antibody technologies, Medarex's
sophisticated drug development infrastructure and decision-making processes
engage expertise in the areas of science, clinical development and market
research to maximize efficiency, increase productivity, augment the quality
of our antibody drug development efforts and increase the probability of
success for product candidates.
"We have a world-class antibody drug development platform which allows
us to enrich our pipeline with best-in-class antibody candidates," said
Nils Lonberg, Senior Vice President and Scientific Director at Medarex. "We
are uniquely structured to identify, optimize and channel our most
promising lead candidates into clinical development on a continual basis to
ensure the future growth and value of our pipeline."
Throughout this year and next, Medarex anticipates a strong flow of
research and development milestones, including the goal of moving two or
more antibodies into clinical development.
Financial Guidance Update
Medarex also updated its previously issued guidance for 2008. For the
full year of 2008, Medarex currently expects a cash burn rate per month of
approximately $12.4 million, a decrease from previous guidance for monthly
cash burn rate of approximately $14.5 million. This guidance includes
Medarex's continual investment in its pipeline and the net contributions to
the ipilimumab program.
Also for the full year of 2008, Medarex expects projected revenues to
be in the range of $48 to $52 million; R&D expense in the range of $175 to
$185 million; G&A expense in the range of $31 to $35 million; net interest
income to be approximately $12 million; and capital expenditures to be
approximately $10 million. Estimates for the full year depreciation and
amortization of approximately $13 million, and FAS 123(R) non-cash
stock-based compensation expense in the range of $19 to $23 million remain
unchanged.
"We have consistently managed our resources to invest into the growth
of our pipeline," said Christian S. Schade, Senior Vice President and CFO
of Medarex. "Our commitment to steadily support our research and
development efforts to proof of concept and enhance value under increased
efficiencies remains unchanged."
Factors that may cause variations in Medarex's projected earnings and
financial performance and other risks and uncertainties are discussed in
the section below entitled "Statement on Cautionary Factors" and in our
filings with the U.S. Securities and Exchange Commission.
Webcast
Medarex will be offering an archived webcast of the 2008 R&D Day event
through the Investor Relations section on its website at http://www.medarex.com.
The webcast will be archived and available for replay for at least 14 days
following the event.
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. More than 40 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the subject of regulatory
applications for marketing authorization. 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 http://www.medarex.com.
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,
such as statements preceded by, followed by or including the words
"believe"; "expect"; "may"; "anticipate"; "projected"; "estimated";
"preliminary"; "suggest"; or "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 of ipilimumab
and other product candidates, uncertainties related to the outcome of
clinical trials, slower than expected rates of patient recruitment,
unforeseen safety issues resulting from the administration of antibody
products in patients, uncertainties related to product manufacturing, risks
associated with the enforceability of our patents, as well as risks
detailed from time to time in Medarex's public disclosure filings with the
U.S. Securities and Exchange Commission , including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 and its quarterly
reports on Form 10-Q. There can be no assurance that such development
efforts will succeed or that 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.
SOURCE Medarex, Inc.
 back to top
Related links:
http://www.medarex.com
http://www.prnewswire.com/comp/108265.html /
CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, x2216; Nichol Harber, Corporate Communications
(media), +1-609-430-2880, x2214, both of Medarex, Inc.
|
