Tomorrow is the last day that Roche's forecast of an approval for T-DM1 can come true, while not impossible, not expected. What I believe is far more possible is approval before the Feb. 26, 2013 PDUFA date.
We now have over two decades of frustrations before the first approval is achieved, but I believe by the time we're into our third decade, a few others will be added to this one. Depending on which drug, under what terms, if IMGN remains independent, they may be ranked among the Giants of Biotech.
We still have many drugs not owned by the company that apparently have the low royalties of T-DM1 deal, but we also have some older drugs that have things such as Opt In provisions which could make them very lucrative. We also have newer partnerships with hundreds of millions in milestone payments and double digit royalties. Finally we have many drugs wholly owned by IMGN, only a few of which are currently in trials. Once IMGN has a solid revenue stream, not only will more drugs enter the clinic, but IMGN will be positioned to take them all the way, if they so choose.
It's a huge step to get approved drugs for others and taking on all manufacturing, distribution and sales for drugs you wholly own, I'm not sure IMGN will take that step alone, but contracts rather than partnerships may prove the answer to getting the job done without taking on a partner. The last 8 years in this decade should certainly prove interesting.
Happy New Year's all,
Gary |
