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CSL and Momenta Announce Collaboration and License Agreement to Develop Fc Multimer Programs

CAMBRIDGE, MA — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) and CSL Limited (ASX:CSL; USOTC:CSLLY) today announced that they have entered into an exclusive research collaboration and worldwide license agreement to develop and commercialize Fc multimer proteins, including Momenta’s M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic in 2017. Momenta will receive a $50 million upfront license fee from CSL and is eligible to receive future milestone and royalty payments for M230. In addition to advancing M230, CSL and Momenta intend to enter into a research collaboration to develop additional Fc multimer proteins that may originate from Momenta’s or CSL’s research.

“This collaboration and license agreement with CSL validates our belief that M230 is an exciting recombinant product candidate for potential use in autoimmune indications. It was developed using our proprietary Fc biology platform and understanding of how intravenous immunoglobulin (IVIg) works in autoimmune diseases,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “As the global leader in immunoglobulin (Ig) therapy, CSL is the ideal development and commercialization partner for us in the area of Fc biology given their expertise in developing plasma-derived medicines and focus on creating disruptive recombinant products in the autoimmune space.”

“We are delighted to announce this collaboration with Momenta, who are leaders in the Fc biology space,” said Paul Perreault, CEO and Managing Director, CSL. “M230 is a very exciting prospect and offers CSL the potential to further grow and expand our long-term global leadership in helping those patients with autoimmune diseases that are treated with immunoglobulins.”

Under the terms of the agreement, Momenta will grant CSL an exclusive, worldwide license to Momenta’s intellectual property relating to M230. Momenta will receive a $50 million upfront license fee payment from CSL and will also be eligible for up to $550 million in contingent clinical, regulatory and commercialization milestone payments. Momenta has the option to elect a cost and profit sharing arrangement, for which Momenta would fund a proportion of global development and commercialization costs in exchange for a share of U.S. profits, and milestones and royalties outside the United States. Momenta has the option to enter into an agreement to co-promote M230 and any other collaboration product in the U.S.

The companies expect to close the transaction in the first quarter of 2017, subject to customary closing conditions including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

 

About M230, Selective Immunomodulator of Fc Receptors (SIF3)
Antigen-autoantibody immune complexes (ICs) are a common pathogenic hallmark of many autoimmune diseases. The multiple Fc domains of ICs aggregate Fcγ receptors (FcγRs), triggering cellular activation processes that play critical roles in inflammation and tissue damage. The rational engineering of therapeutics that broadly antagonize FcγRs has been hampered by a limited understanding of the molecular determinants directing FcγR activation. Through the engineering and characterization of oligomeric Fc structures, Momenta has been able to derive novel insights into FcγR modulation and has generated a unique recombinant Fc multimer therapeutic candidate, referred to as M230, with excellent physiochemical and biological properties. Preclinical studies in animal models of autoimmune disease have shown that M230 matched potency and efficacy of intravenous immunoglobulin at significantly lower doses. M230 is currently in preclinical development and is expected to enter the clinic in 2017.

About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.

Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

About CSL
CSL (ASX:CSL) is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovations, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses CSL Behring and Seqirus – conducts business in more than 60 countries with more than 17,000 employees. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For additional information about CSL, please visit www.CSL.com.au

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