Date: 2016-01-08
Type of information: Development agreement
Compound: six of Momenta's current biosimilar candidates, including Momenta's biosimilar candidate Orencia® (abatacept).
Company: Momenta Pharmaceuticals (USA - MA) Mylan (USA -
Therapeutic area:
Type agreement: development collaboration production manufacturing commercialisation
Action mechanism:
Disease:
Details: * On January 8, 2016, Mylan and Momenta Pharmaceuticals, announced that they have entered into an exclusive global collaboration agreement to develop, manufacture and commercialize six of Momenta's current biosimilar candidates, including Momenta's biosimilar candidate, Orencia® (abatacept).,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 in India and other emerging markets.
Financial terms: 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.
Latest news: * On February 10, 2016, Momenta Pharmaceuticals announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the global collaboration agreement executed by the Company on January 8, 2016 with Mylan N.V.'s subsidiary, Mylan Ireland Limited , to develop and commercialize six biosimilar candidates. With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with Mylan is effective as of February 9, 2016 . Under the collaboration agreement, Mylan is obligated to pay Momenta a $45 million upfront cash payment within 30 days of the effective date.
