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."
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.
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.
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.|
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