Mylan N.V. announced that it has entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals, Inc., to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate, ORENCIA® (abatacept).
Mylan CEO, Heather Bresch, commented, “Mylan’s long-stated strategy has been to strategically invest in the long-term drivers of our future growth, both through our strong internal focus on R&D and through external collaboration with industry-leading partners. Biosimilars have long been one of these areas of important future growth, both for our company and our industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these life-saving medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market. This collaboration with Momenta, which is highly complementary to our partnership with Biocon, will position us as a definitive world leader in biosimilars, with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area. Looking forward, Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating us from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring we maintain one of the broadest, highest quality portfolios in our industry.”
“This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar-development experience, operational excellence and expansive global commercial footprint. Importantly, this collaboration builds upon Mylan’s existing successful biologics and insulins collaboration with Biocon, which is focused on more near-term biosimilar opportunities. Through these partnerships, as well as the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world,” continued Bresch.
Craig A. Wheeler, President and CEO of Momenta Pharmaceuticals, said, “We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry-leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them. By combining Momenta’s proven capabilities in complex-product development and Mylan’s world-class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost-effective biosimilar products to markets worldwide, and we believe our success will deliver a strong return to our companies’ stakeholders.”
Under the agreement with Momenta, Mylan will make an up-front cash payment of $45 million and up to $200 million in contingent milestone-related payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialization efforts. All other financial terms and product details remain confidential.
Mylan’s collaboration with Momenta builds upon Mylan’s existing biologics and insulin analog partnership with Biocon. The Biocon partnership includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept, and filgrastim) and three insulin analogs (glargine, lispro, and aspart). Five of these biosimilar programs have successfully completed Phase I clinical trials, and four of the programs are in active Phase III testing. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016. Mylan already has successfully launched its trastuzumab biosimilar product inIndia and other emerging markets.
Mylan President, Rajiv Malik, commented, “Mylan has been fully engaged in the development of biosimilars with our partner Biocon for the last six years. During that time, Mylan has cultivated strong experience and expertise in the development of biosimilar products, and is executing on our programs with the scientific and analytical rigor required to fulfill health-authority expectations. Based upon our proactive and informative interactions with global health authorities on our nine active programs, we are extremely optimistic about the strength of our current development programs with Biocon, and we look forward to deploying our expertise in our collaboration with Momenta.”
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