Europe And Japan Say Yes To ImmunoGen’s Kadcyla For Breast Cancer

ImmunoGen Inc's, (IMGN) Kadcyla, a potential blockbuster and one of the only two FDA approved antibody drug conjugates (ADC) in the market, has been recommended for approval in Europe also.

Committee for Medicinal Products for Human Use (CHMP), the committee of EMA responsible for preparing opinions on drug approvals, recommended the drug for approval in Europe for treatment of metastatic breast cancer. Formal approval from EMA is likely by the end of the year. ImmunoGen Inc. (IMGN), the company that developed the drug, also announced that the drug has been approved for the same indication in Japan as well.

Both events trigger milestone payments of $5 million each for ImmunoGen from Roche (RHHBY), the global pharmaceutical giant that owns global development and commercialization rights for Kadcyla.

Kadcyla is a class of ADC drugs which are highly potent and designed for delivering the cytotoxic agent directly and only to cancerous cells without damaging nearby healthy cells. Kadcyla combines ImmunoGen’s anticancer agent DM1 with Herceptin, the antibody drug of Roche and delivers it using a linker developed by ImmunoGen.

The drug is priced more than double of Herceptin and in its first quarter the company reported sales of $91 million for Kadcyla. Analysts are now estimating peak annual sales between $2 billion and $5 billion. Despite the high price, it is expected that the new drug will take up some of the sales that Herceptin loses because of better efficacy of Kadcyla and compensate for whatever revenue loss occurs due to appearance of biosimilar versions of Roche’s other cancer drugs.

Kadcyla is ImmunoGen’s main compound that uses its linkers developed with ADC technology. The company also has four self-owned drugs in different stages of development and a number of other compounds in clinical and preclinical stages in partnership with Amgen (AMGN), Lilly (LLY), Novartis (NVS) and Sanofi (SNY).