@Dowski Perhaps another title is in order, post this presentation, which I am reliably informed included a discussion with a particular focus on the IP estate.
Mesoblast have a US patent granted on Composition of Matter that encompasses all types of Mesenchymal Cells , regardless of type, including
InducedPluripotent, which lasts until 2032 with extensions out to 2037.
No other
operator will have the freedom to operate in the USA using
cryopreserved MSC’s and there is a comparably strong patent running parallel relating to GVHD specifically as well.
This guidance will be further supported by other patent applications many of which are already filed and pending which should take out this IP protection to 2043 if granted .
The US market is critical . As Takeda found out to their cost marketing Alofisel in Europe , reference pricing can be 20-30% of the US price…so essentially companies like CYP need to tread extremely carefully. Of course they may well achieve some good clinical results in the meantime..just don't say you were not warned about potential IP infringement with cryopreserved cells. Takeda were forced into making royalty payments to Mesoblast and investors seldom appreciate that the dominant IP position may well be worth many billions of dollars regardless of whether or not Mesoblast has a product approved.
The correction in Mesoblast shares started in the US before the Bell Potter presentation. It is a healthy pullback. I would expect continued volatility until the BLA application for paediatric sr aGVHD is filed imminently (by quarter end). Once Mesoblast has a PDUFA date for its submission, I am pretty sure the Company will be very active in widening its investor base and the shares may then take another leg up.
Mesoblast has limited resources and cash flow. The sudden, unexpected, advancement in prospects for CHF post FDA guidance, now requires bringing Rexlemestrocel to the same level of clinical documentation as Remestemcel before the end of this year. This should allow an accelerated approval submission as a therapy for destination therapy LVAD patients with ischemic heart disease in early 2025. The guidance from the FDA on a potential accelerated approval pathway for LVAD is stunningly good news but with budget limitations i suspect it has forced Mesoblast to prioritise expenditure on Heart and GVHD, over back, for a month or so. It’s what is generally referred to as “an embarrassment of riches”, but if some of you want to moan and take profits that is your call not mine .
Remember , Mesoblast is in pole position with its IP estate … if you want entrance to the enchanted garden you have to pay the gatekeeper ! OP
Please do not rely on the facts or opinions expressed in this post when making an investment decision. Biotech shares are extremely volatile especially pre approval .
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