Serono and Micromet have signed an exclusive collaboration and license agreement for the development and commercialization of Micromet's fully human monoclonal antibody MT201 (adecatumumab).
MT201 is a pan-carcinoma monoclonal antibody directed against the epithelial cell adhesion molecule Ep-CAM. The product is currently being tested in two multi-centre phase II clinical trials for the treatment of prostate and metastatic breast cancer. Ep-CAM, the target antigen for MT201, is over-expressed with high frequency on most human carcinomas, suggesting that it may have therapeutic potential in the treatment of a broad range of cancers, including prostate, breast, colon, lung, stomach, pancreatic, head & neck, and ovarian cancer.
Under the terms of the agreement, Micromet will be responsible for completing the ongoing phase II clinical trials, and Serono will take over further development and commercialization of the product. Effective immediately, Serono will be responsible for all development costs. Micromet will receive an initial license fee of US$10 million and additional milestone payments of up to US$138 million if the product is successfully developed and registered worldwide in three or more indications. In addition, Micromet will receive royalties based on net sales of the product. Under certain terms and conditions, Micromet may elect to share in the development and commercialization of the product in the US and EU in exchange for a share of profits, a Serono release said.
"With its longstanding history and experience in protein based therapeutics, Serono is an excellent partner for MT201," commented Christian Itin, CEO of Micromet.
Serono's CEO Ernesto Bertarelli said, "MT201 is a promising product with considerable therapeutic potential in the treatment of solid tumours. With this important addition to our pipeline, Serono's portfolio of novel anti-cancer agents is evolving well." Serono is currently evaluating TACI-Ig in two clinical trials for the treatment of B-cell malignancies.
MT201 has been specifically designed to selectively eliminate tumour cells while leaving healthy tissues largely unharmed. Phase I data have demonstrated an excellent safety profile of MT201, and no MT201 neutralizing antibodies have been observed so far in man. An investigational new drug application (IND) for the product was recently cleared by the United States Food and Drug Administration (FDA) for the initiation of phase II studies in the United States.