Saturday, February 14, 2015 2:06:19 PM
Roche, Kadcyla & biOasis
Perhaps the most recent significant catalysts for biOasis are the hiring of Willow Tree Capital and the failure of Kadcyla (Roche’s T-DM1). Willow Tree has been sufficiently discussed on this forum, but the Kadcyla failure deserves further highlighting. Kadcyla was to be the Herceptin replacement and the new standard of care for the treatment of HER2+ breast cancer (Herceptin off patent in Europe in 2015 and 2019 in the USA). Roche was dealt a nightmare scenario when Kadcyla proved no more efficacious than Herceptin combined with a chemotherapy agent (reference their December 19, 2014 PR).
Many biosimilars for Herceptin are under development (at least 10 that I know of) and approved in some jurisdictions around the globe. Some of the more prominent pharma’s pursuing the Herceptin biosimilar market are Pfizer, Celltrion & Dr. Reddy. Pfizer & Celltrion both have Phase III trials underway around the globe and results should be available in the next 1-2 years. With the failure of Kadcyla in the MARIANNE study, biosimilars for Herceptin just got a “shot in the arm”. It might have been mentioned on this forum before, but many of us remember the Pfizer torcetrapib failure in December 2006 and the significant catalyst that it was for RVX at the time. Only difference being, I think that biOasis actually has something with BT2211 and RVX didn’t.
Roche is very, very exposed on their $6.1 billion dollar annual Herceptin revenue stream at the moment. Roche needs to answer the bell with respect to the Kadcyla failure and soon in my opinion. This is a prime opportunity for one of the biosimilar Herceptin pharma’s to step up to the plate and become a biobetter by engaging biOasis through the BT2211 program. In addition, it should be noted that Pfizer is also pursuing a Rituximab biosimilar (previous posts have discussed Rituximab and I won’t bother repeating it here). Combined annual revenue stream for Rituximab & Herceptin is north of $12 billion. With the ability to treat brain metasteses, would you want to be a physician prescribing Herceptin (that can’t) or BT2211 (that can)? Yes, yes I know, where is the peptide program at for BT2211? That will come in due course, but we have good clues through the efficacy of the SIRNA program.
Well Roche, is your brain shuttle technology up to answering the bell? Perhaps it’s not such an academic question for you anymore, as a significant portion of your livelihood seems to be at stake. Shouldn’t take much to fan the flames at the moment – Should it?
Recent BTI News
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