Another Setback For Roche Is Bad News For ImmunoGen

For Swiss drug and diagnostics giant Roche (Nasdaq:RHHBY), the hits just keep on coming. Already bruised by setbacks in the Avastin franchise, Roche announced Friday morning that the FDA rejected an accelerated approval application for T-DM1, a potentially major drug for metastatic breast cancer. As the originator of the drug and Roche's partner, ImmunoGen (Nasdaq:IMGN) will also suffer for this surprising FDA decision. 

Precision Munition for Resistant Patients
In very simplified terms, T-DM1 is a derivative of Roche's successful Herceptin drug. ImmunoGen found a way to add a cell-killing compound (DM1) to the HER2 binding antibody trastuzumab that is the active component of Herceptin. What this means in practice is that T-DM1 hones in on the HER2+ cancer cells and delivers a lethal dose, while sparing the sort of system-wide toxicity that so often limits powerful drugs. In early stage studies this drug has shown progression-free survival of five to seven months and Roche had been talking about this drug as a $2-$5 billion/year opportunity.


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