Cautionary Statement Regarding Forward-Looking Statements
Cambridge, Mass. (PRWEB) October 1, 2009
Merrimack Pharmaceuticals, Inc. and sanofi-aventis announced today the signing of an exclusive worldwide licensing agreement for the development and co-commercialization of MM-121, a first-in-class, fully human monoclonal antibody designed to block signaling of the ErbB3 receptor. MM-121 is currently in Phase 1 clinical testing.
Under the terms of the agreement, sanofi-aventis will make an upfront payment of $60 million and will be responsible for all development costs. Merrimack is eligible for an additional $470 million in milestone payments as well as tiered double-digit royalties on sales of MM-121. Merrimack will execute the development of MM-121 through Phase 2 proof of concept for each indication and sanofi-aventis will be responsible for development thereafter. Merrimack retains the right to co-promote the therapy in the United States.
"Merrimack's expertise along with their knowledge of biologics development has allowed them to successfully identify ErbB3 as a promising target and rapidly bring MM-121 into clinical development", declared Marc Cluzel, Senior Vice-President R&D, sanofi-aventis. "MM-121 is a pioneering monoclonal antibody which brings a new innovative approach to sanofi-aventis' oncology portfolio. We are very excited to collaborate with Merrimack on the development of MM-121, which we believe is a very promising compound that will address a significant gap in treating cancer patients".
The ErbB3 receptor is a novel target known to be a key mediator of signaling in the ErbB pathway (also known as the EGFR or HER pathway) - a signaling network that impacts a broad array of cancers. By targeting ErbB3, MM-121 is believed to have a broad application across cancer as both a monotherapy and in combination with other therapeutics. Research data has also shown that ErbB3 may also play a central role in resistance to both targeted therapies and chemotherapy in a number of tumor types.
"We believe that MM-121 has the potential to serve as an important new treatment for multiple forms of cancer," said Robert Mulroy, President and Chief Executive Officer of Merrimack. "We are pleased to partner with sanofi-aventis, a premier, global pharmaceutical company with broad oncology expertise. Together, we hope to work with the international research community to accelerate the development of MM-121 for the benefit of patients."
Merrimack developed MM-121 after identifying the importance of ErbB3 through its Network Biology approach, a fully integrated drug discovery and development technique that combines biology, engineering, and computational modeling to better understand the underlying complexity of disease pathways. The information derived from Network Biology informs the strategic decisions guiding early pharmaceutical discovery as well as helping to advance candidates through pre-clinical, clinical development and towards commercialization.
The effectiveness of the license and collaboration is subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary regulatory approvals.
Merrimack Pharmaceuticals, Inc. is a biotechnology company focused on the discovery and development of novel treatments for cancer and autoimmune disease. Its first two oncology pipeline candidates, MM-121 and MM-111 are currently in Phase 1 clinical development. The Company's proprietary Network Biology discovery platform, developed with the help of leading scientists from MIT and Harvard, enables the high-throughput profiling of protein networks as a basis for improved validation, lead identification and speed in the development of innovative, effective and well tolerated therapeutics. MM-121 and MM-111 are investigational drugs and have not been approved by the U.S. Food and Drug Administration or any international regulatory agency. Merrimack is a privately-held company based in Cambridge, Massachusetts.
Betsy Stevenson, RaymondStevenson Healthcare Communications, 860-984-1424
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
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