Momenta will receive $45 million up front and as much as $200 million in milestone-related payments, with each company sharing the costs and profits for the products. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialization.
This collaboration builds upon Mylan's existing biologics and insulin analog partnership with Biocon, which 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 trials, and four are in Phase III development. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016.
Mylan chief executive officer Heather Bresch said, "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. This collaboration 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."
Craig A. Wheeler, president and chief executive officer of Momenta Pharmaceuticals, said, "We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. 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."