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MacroGenics Achieves Milestone as Servier Exercises Option to Develop and Commercialize DARTbased Candidate, MGD00605/02/2014
Successful Advancement of Lead DART Molecule and Option Exercise Triggers $20 Million in Payments MacroGenics Retains Full Rights to MGD006 in Multiple Major Markets
ROCKVILLE, Maryland, and SURESNES, France, February 5, 2014 – MacroGenics, Inc. (NASDAQ: MGNX), a clinical‐stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody‐based therapeutics for the treatment of cancer and autoimmune diseases, today announced that Servier, France’s largest privately‐held pharmaceutical company, has exercised its exclusive option to develop and commercialize MGD006, a DART‐based product candidate developed by MacroGenics. Servier will gain exclusive development and commercial rights in all countries outside of the U.S., Canada, Mexico, Japan, South Korea, and India. In those countries, MacroGenics will retain development and commercialization rights. As a result of the exercise, MacroGenics will receive a $15 million payment from Servier. In addition, the Investigational New Drug (IND) application for MGD006 has cleared the 30-day review period by the U.S. Food and Drug Administration (FDA), triggering an additional $5 million payment to MacroGenics by Servier.
MGD006 is a humanized Dual‐Affinity Re‐Targeting (DART®) molecule in development for hematologic malignancies that recognizes both CD123 and CD3. In preclinical studies, the results of which were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in November 2013, MGD006 was shown to redirect T cells via their CD3 component to kill CD123‐expressing leukemia cells at very low concentrations of the DART. MacroGenics expects to initiate a Phase 1 study in the second quarter of 2014 for the treatment of relapsed and refractory acute myeloid leukemia (AML), representing the initial execution of an important strategic effort by the company to apply T‐cell directed cancer immunotherapy in significant areas of unmet clinical need, including both hematologic malignancies and solid tumors.
“Servier is committed to bringing novel targeted therapies to patients with cancer, and the MacroGenics team has shown preliminary evidence of the successful application of its proprietary DART platform to multiple promising product candidates for the treatment of solid and hematologic cancers,” said Dr Emmanuel Canet, President of Research and Development at Servier. “In particular, MGD006 has shown the ability to kill AML blasts in vitro and in vivo at very low doses. We are committed to moving this candidate into clinical development in collaboration with MacroGenics and continuing to build our longterm partnership.”
Under the September 2012 agreement, Servier was granted options to obtain three separate exclusive licenses to develop and commercialize novel anticancer DART‐based molecules, consisting of MGD006 and MGD007, as well as a third DART‐based molecule, in all countries other than the U.S., Canada, Mexico, Japan, South Korea and India. In addition to the $20 million upfront payment and $20 million related to the option exercise and IND clearance, MacroGenics may be eligible to receive up to approximately $1 billion in additional license grant fees, and clinical development, regulatory and sales‐based milestones. Both parties will share the clinical development costs for each program following the exercise of such option. Finally, MacroGenics may receive tiered, double‐digit royalties on future net sales.
“We are thrilled that Servier has exercised its option to develop MGD006 and we share their belief that next generation bispecific antibodies are a critical new frontier in medicine,” commented Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We believe DART‐based molecules have the potential to provide a significant impact on the treatment paradigm for patients with cancer and autoimmune disorders and look forward to continuing our relationship with Servier.”
Background on DART Platform
MacroGenics’ DART platform enables the targeting of multiple antigens or cells by using a single molecule with an antibody‐like structure. The Company has created over 100 DARTbased molecules, or DARTs, which have been configured for the potential treatment of cancer, autoimmune disorders, and infectious disease. These DARTs can be tailored for either short or prolonged pharmacokinetics and have demonstrated good stability and attractive manufacturability. The Company has completed in vitro and in vivo proof of concept preclinical studies with multiple candidates and expects to advance its first two DARTs into clinical development in 2014.
About MacroGenics, Inc.
MacroGenics is a clinical‐stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody‐based therapeutics for the treatment of cancer and autoimmune diseases. The company generates its pipeline of product candidates from its proprietary suite of next‐generation antibody technology platforms, which it believes improve the performance of monoclonal antibodies and antibody‐derived molecules. The company creates both differentiated molecules that are directed to novel cancer targets, as well as "bio‐betters," which are drugs designed to improve upon marketed medicines. The combination of MacroGenics' technology platforms and antibody engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies.
About the Servier Group
Founded in 1954, Servier is the first independent French pharmaceutical research company. Its development is based on relentless pursuit of innovation in the following therapeutic areas: cardiovascular diseases, metabolic diseases, neurologic diseases, psychiatric diseases, bone and joint diseases, and oncology. In 2012, the company reported a turnover of 3.9 billion euros. 92% of Servier medicines are prescribed internationally. 25% of turnover from Servier drugs is reinvested in R&D every year. Servier has a strong international presence in 140 countries and employs more than 22 000 people worldwide. The Servier Group contributed 57% to the 2012 French trade surplus in the pharmaceutical sector. For further information, please visit www.servier.com.
Cautionary Note on ForwardLooking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone, or opt‐in payments from the Company's collaborators, the Company's anticipated milestones and future expectations, and plans and prospects for the Company and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward‐looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward‐looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates, and other risk factors described in the Company's filings with the Securities and Exchange Commission. In addition, the forward‐looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward‐looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forwardlooking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
Jim Karrels, Vice President, CFO
Karen Sharma, Vice President
MacDougall Biomedical Communications