banter and General Discussion, page-4241

ok now this is not of topic its not advertising and its not about the people that control a certain platform so it should be ok its all to do with mesoblast treatment's

Other Company's Valuations of Graft vs Host Disease are Much More Than Meso's Total Market Cap

In early 2020, Incyte's JAK1 inhibitor itacitinib failed a P3 study in first-line, acute graft vs host disease. With the flop came a $2 billion market cap erasure.

Mesoblast's current full market cap is only $US420m using the last Aussie close or $US454m using the last US closing price. If Meso were worth $US2 billion, the Aussie MSB share price would be $A4.42 and the US MESO ADRs would be $US15.37 JUST FOR GVHD!! ie not taking into account Meso's much bigger potential blockbuster indications of Heart, Back Pain, Ulcerative Colitis (Crohn's Disease and IBD), ARDS and a range of other potential product candidates.

Incyte's GRAVITAS-309 study was testing itacitinib in patients with treatment-naïve chronic GVHD, but the company decided to scrap those plans on Tuesday.
A $2 billion market cap drop didn’t ensue this time around, as Incyte has racked up multiple wins across its other JAK inhibitors: Opzelura, Jakafi and Olumiant. Those drugs helped Incyte reel in $911 million overall in Q2 this year.

So, Incyte is earning nearly $1bn per quarter from its JAK inhibitors, which we know have horrible side effects and a poor track record in treating GVHD. That's $4bn per year!!

Mesoblast is only targeting children's SR-aGvHD in the first instance (a $US120m market in the US treating 400 kids) and the Prof has said that they hope to extend to European children and then into adults in US and EU5 - that's all a $US700m annual market, and then hopefully later extend into Chronic GVHD.

So Meso's plans are much more modest than Incyte's Jakafi markets - hopefully though these figures help put Meso's plans into perspective and show that they are quite modest by comparison. There have been several comments over the past 3 years that Meso is somehow going to bankrupt the US healthcare system by providing dying children with $US120m pa of a life saving drug. There is a 90% death rate for kids with the most severe SR-aGvHD in the skin, liver and gut and if these kids fail to respond to steroids, then there is no other approved treatment. The adult aGvHD market is 3x the kids market in the US (ie $US360m).

This time around, Incyte isn’t even completing a study of itacitinib, because efficacy data from part of a Phase II/III study give the biopharma no signs of hope for a pivotal success.

Incyte had also previously terminated an early-stage study of itacitinib as a prophylaxis for the disease and the drug had received orphan designation from the FDA.

SVB Securities analysts wrote, “Previously, itacitinib was viewed as a significant opportunity for INCY, leveraging Jakafi’s success in GVHD, and moving the company’s reach into earlier lines of treatment”. The oral version of Jakafi was greenlit as a treatment for chronic GVHD after one or two lines of system therapy last September.

It remains a total mystery (!) as to how Mesoblast's much better treatment for aGvHD, both in terms of efficacy and lack of side effects, is still battling to get approval when these other dud treatments have been given the green light. Makes you wonder. The FDA has been forced to lay out their objections to Meso and Meso reckons they have all the answers to these questions. Meso have acquired Dr Philip Krause, senior ex-FDA, who is advising on the BLA submission, Dr Eric Rose has taken over as Meso's Chief Medical Officer, there is desperate need for a treatment for kids, backed by Dr Joanne Kurtzberg (the Jerome S. Harris Distinguished Professor of Pediatrics at Duke University among many other senior positions) and the new FDA Commissioner, Robert M. Califf M.D., formerly worked in Dr Kurtzberg's lab at Duke. Given the FDA's own OTAT committee voted 9:1 to approve Meso's treatment it is hard to believe that Meso won't get approval, especially considering the approvals for Incyte.

Note also that OTAT has indicated that Mesoblast’s approach to address outstanding CMC items is reasonable, that the in vitro immunomodulatory activity of remestemcel-L proposed by Mesoblast as a measure of its potency is a reasonable CQA for the product in the treatment of children with SR-aGVHD, and the relevance of this immunomodulatory activity to clinical outcomes should be established. Mesoblast has now generated substantial new data which it believes establish the relevance of the proposed in vitro immunomodulatory activity of remestemcel-L to the clinical effect of the product in the completed Phase 3 trial in pediatric SR-aGVHD, including to survival outcomes and biomarkers of the product’s in vivo activity. Mesoblast will provide these new data to OTAT and address other remaining CRL items as required for the BLA resubmission.

Only a month or so until the BLA is lodged. I can't believe it won't get up this time.