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Your Daily Pharma Scoop: KPTI Data, Allergan Write-Off, Celgene Down On Delay


  • KPTI is up on strong data from MM study.
  • Allergan writes off its entire Vitae acquisition.
  • Celgene is down on ozanimod resubmission delay.

Analysis focus : KPTI

Karyopharm (NASDAQ:KPTI) slumped 17% in the pre-market yesterday, ahead of data from a mid stage study of selinexor in treatment-resistant multiple myeloma. A couple of years ago, this same drug was pitted against Darzalex in the same indication and showed similar efficacy. An FDA filing was planned in 2018, which seems to be on track. The sell-off was therefore probably profit taking ahead of expected good news.

That is just what has happened after the data was released. The stock was up 22% after news came out that selinexor showed treatment effect in the mid-stage study. The patient group was heavily pre-treated, meaning this was a very sick patient population, so the observed response rate of 25.4% was very good. That included two complete responses as well as 29 partial responses. Response mean duration was 4.4 months. This is comparable with CR in ASCT in MM. As has been shown before, CR is a very good indicator of OS in MM, so the spike on this data is justified.

KPTI will now submit an US NDA in the second quarter, and an EU MAA in 2019. According to published data:

MM is the third most common blood cancer in the U.S. (after lymphoma and leukemia). Men have a higher incidence than women, and African-Americans have more than twice the incidence and mortality rates of whites. In 2014, it was estimated that more than 24,000 people would be diagnosed with MM in the U.S. and that more than 11,000 would die from it.

MM is currently treated by immunomodulatory drugs like Darzalex, Revlimid, and Thalomid, with treatment costs ranging between the high $60 thousands to $100 thousands. There are also Proteasome Inhibitors like Farydak and Kyprolis, which cost almost half the immunomodulatory drugs, and there's also Farydak, a Histone Deacetylase Inhibitor and, of course, the long standard Doxil

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