During election time, it's not uncommon for some important newsworthy stories to get lost in the mix. One of those stories emerged Tuesday when ImmunoGen (IMGN) and partner Roche (RHHBY 0.05%) announced that T-DM1, their experimental drug to treat HER2-positive breast cancer, has been awarded a priority review by the Food and Drug Administration with a decision date expected for, or before, Feb. 26. ImmunoGen also announced that the European Medicines Agency has accepted Roche's marketing application for TDM-1 and put it under review.
T-DM1 has predominantly streamlined through clinical trials, with late-stage data demonstrating a 32% reduction in overall risk of death relative to the current treatment standard. In addition, T-DM1 improved the overall median survival rate to 30.9 months compared with the combination of GlaxoSmithKline's (GSK -0.51%) Tykerb and Roche's Xeloda, which had a median overall survival rate of 25.1 months.
A priority review is an important win for ImmunoGen on multiple fronts. Unlike Roche, ImmunoGen has no FDA-approved drugs, and it will continue to burn through its cash until it does. With $233.6 million in cash as of its latest quarter, that's hardly an immediate worry, but it nonetheless remains a concern on shareholders' minds. It's also worth noting that ImmunoGen's royalty rate on T-DM1 sales isn't nearly as lucrative as many on Wall Street had predicted. As my Foolish colleague Alex Planes noted two weeks ago, ImmunoGen is only expected to receive a 3% royalty on sales of the drug until it generates more than $700 million in sales each year, upon which the rate jumps to 5%. Many analysts were looking for this rate to begin at 5% (or higher), which makes getting this drug to market sooner rather than later all the more important.
This is also an important step for ImmunoGen's antibody-drug conjugate competitor Seattle Genetics (SGEN), which currently has one FDA-approved drug -- Adcetris for the treatment of Hodgkin's lymphoma -- as well as 12 clinical stage ADC treatments focused on solid and blood-based tumors. The FDA appears to be taking a positive stance on bringing ADC drugs to review quickly because of their efficacy, which could bode well for Seattle Genetics in the immediate future.
On top of having a big pipeline like Seattle Genetics', ImmunoGen also has strong collaborative partnerships. In particular, its partnership with Roche in developing T-DM1, and with Sanofi (SNY -1.31%) in developing SAR3419 -- currently a mid-stage trial treatment for diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia -- are its most crucial.
It looks like it's pedal-to-the-metal time for ADC developers, and ImmunoGen appears more than ready to burn some rubber in the fast lane.
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