MSB Trading 2020 - a new dawn, page-12041

Left-e’s comments:

This morning Incyte announced that its small molecule JAK inhibitor ruxolitinib failed in Covid-19. The U.S. brand name of ruxolitinib is Jakafi. Several reasons this is significant for Mesoblast investors. First, Jakafi is already approved for other indications. And it's a blockbuster, traditionally defined as a medication that grosses over $1B in annual sales. Jakafi had $1.7B in 2019 sales growing at a 20% annual clip and helping to lead Incyte to a $20B market cap. The bulk of of those sales came for the treatment of hematologic/bone marrow indications many have not heard of: myelofibrosis, polycythemia vera, thrombocythemia... In May, 2019 Jakafi also received FDA approval for an indication MESO shareholders have heard of: steroid resistant acute Graft-vs-Host Disease. The FDA approval for GvHD thus represented a “label extension” for Jakafi, but note that it was based on a SINGLE-arm, unblinded, open label study involving 49 patients (adults and children above the age of 12). Compare to the rem-L 55-patient study that specifically enrolled children. Hmmm. The Jakafi approval was thus limited to patients 12 years old and above. Toxicities reported included: bone marrow suppression, serious infections, edema, bleeding, and liver inflammation. In short, you know you have a toxic medication when the FDA forbids its use for children under 12 who have an illness that already has a 70%-80% mortality. Second, Jakafi didn't fail in C-19 just a little. It failed a lot. Didn't meet any primary of secondary endpoint and the study is now over. Fini. Third, Novartis distributes Jakafi worldwide outside the U.S. For Novartis the Jakafi failure comes on the heels of the failure of its FDA approved mAb Canakinumab used to treat autoimmune disorders. In early November, Canakinumab also failed its primary and secondary endpoints for treatment of C-19. Hmmm. Anyone else see an interesting paradox setting up for the FDA if rem-L shows “overwhelming” C-19 ARDS efficacy in December... or even just plain old “great” efficacy when the full study completes in Q1 ?