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Medarex Announces Allowance of Investigational New Drug Application for Company’s First Antibody-Drug Conjugate, MDX-1203

January 28, 2009

PRINCETON, N.J., Jan. 28 /PRNewswire-FirstCall/ — Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of an investigational new drug (IND) application filed with the U.S. Food & Drug Administration (FDA) for MDX-1203, the Company’s first Antibody-Drug Conjugate (ADC) candidate generated from its proprietary technology. MDX-1203 is comprised of a potent cytotoxic prodrug chemically linked with a fully human anti-CD70 antibody. CD70 is expressed in renal cell carcinoma (RCC), leukemias, lymphomas, and other cancers. The Phase 1 study will evaluate MDX-1203 for the treatment of advanced/recurrent RCC and relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL).

“Antibody-drug conjugates are another important and innovative therapeutic approach used to fight cancer by effectively and selectively killing tumor cells over-expressing specific tumor antigens, so we are extremely excited in achieving the IND filing for MDX-1203, the first candidate from our proprietary ADC technology platform,” said Howard H. Pien, Chairman and CEO of Medarex. “We developed our ADC technology to have significant competitive advantages over existing technologies and the Phase 1 trial for MDX-1203 will be the first study to evaluate these potential benefits.”

An open-label, multi-dose, dose-escalation Phase 1 clinical trial will be conducted in patients with RCC and NHL. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary distribution, metabolism and pharmacokinetics of MDX-1203.

About Medarex’s Antibody-Drug Conjugate (ADC) Technology

Medarex has enhanced its core UltiMAb(R) antibody platform with a suite of technologies that optimize or augment the therapeutic activity of antibodies, and one important technology expansion is the company’s proprietary Antibody-Drug Conjugate platform. Medarex’s proprietary ADC technology uses a cytotoxic agent that is a potent, synthetically manufactured prodrug (a DNA minor-groove binding alkylating agent) which is attached to an antibody using a stable peptide-based linker. 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.

Medarex has conducted multiple preclinical studies on several investigational antibody-drug conjugate candidates in development demonstrating enhanced anti-tumor activity in xenograft models, even with single doses as low as 0.005 micro mol/kg, when compared to the anti-cancer antibodies alone. Preclinical studies have also demonstrated that anti-tumor activity is maintained in drug-resistant cancer cells. Additionally, Medarex’s activatable prodrug has been shown to accumulate in the targeted tumor cells but not in normal tissue cells, thereby minimizing the toxicity profile but not the anti-tumor activity in animal and primate models.

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. 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 in Phase 3 clinical trials, the subject of regulatory applications for marketing authorization or approved in Canada and Europe. 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.

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 “potential”, “expect”, “believe”, or “may” or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. These risks and uncertainties include those 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, 2007 and its quarterly reports on Form 10-Q. There can be no assurance that MDX-1203 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.

SOURCE Medarex, Inc.


Source: newswire