T-DM1

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Roche CEO Severin Schwan--Image courtesy of the Roche Group.

The drug: T-DM1
The disease: Breast cancer
The developers: Roche/Genentech, ImmunoGen
Peak sales potential: $5 billion-plus

Just days ago, we got the final peek at pivotal data on T-DM1, the antibody drug conjugate that helped inspire Roche's ($RHHBY) acquisition of Genentech. With an improved overall survival rate close to 6 months better than standard of care, plus an improved side effect profile, T-DM1 is likely shaping up as another one of those high-profile cancer drugs that gets approved ahead of the PDUFA deadline.

Currently, there is no deadline on T-DM1, but it's likely to be in February of 2013. While Roche and its tech partners at ImmunoGen ($IMGN) wait it out, investigators are bulling ahead with other studies aimed at moving the therapy up the ladder to frontline patients. Analysts like Cowen's Simos Simeonidis believe that TDM-1 could be a bigger earner than Herceptin. Roche is just the kind of company that can find out just what its peak potential is.

Of course, none of this has been ignored by drug developers, which have been eagerly doing deals on more ADCs. Roche says that it has 8 other ADC projects in the clinic, with 17 more brewing in the preclinical sphere. These days, just about every big developer with ambitions in the cancer front has to have a few ADCs in the pipeline to wow analysts. And there's new technology at play that is multiplying the drug payloads--a particularly effective strategy in cancer.

ImmunoGen got this particular ball rolling years ago. And while it stands to earn only mid-single-digit royalties, with the numbers that analysts are kicking around for T-DM1, there's considerable excitement about the future revenue stream.

For more:
In R&D showdown, Genentech beats Roche in a TKO
Roche, ImmunoGen's T-DM1 boosts cancer survival
Roche spotlights top blockbuster bets as it showcases R&D
At ASCO, unique delivery makes T-DM1 a standout