Ann: FDA Grants Rare Pediatric Disease Designation for Revascor, page-233

AstraZeneca seems to be synchronized with Mesoblast on the MOA for REVASCOR (Rexlemestrocel-L) in the DREAM HF trial.

In my opinion they would be the perfect partner to be funding the DREAM 2 HF trial with the goal to get Accelerated Approval to allow for earlier approval based on a surrogate endpoint. The FDA and Mesoblast must first be aligned on the surrogate endpoint:

• LVEF improvement at 12 months should be an appropriate early surrogate endpoint.

Targeting the key mechanism of HFrEF which is inflammation must be a major priority.

Understanding mechanisms that drive HFrEF is a key objective of the FDA, and Mesoblast has now provided the FDA with results from three randomized controlled trials in class II/III HFrEF and in end-stage HFrEF with left ventricular assist devices (LVADs), which ALL support the idea of a common mechanism of action (MOA) by which rexlemestrocel-L reverses inflammation-related endothelial dysfunction and reduces adverse clinical outcomes across the spectrum of HFrEF patients.

This is a pivotal year for Mesoblast and I sincerely hope they get Accelerated Approval for CHF, although they may have to wait for the DREAM 2 trial to be fully recruited first.

Remember that Mesoblast reported that effects on LVEF and MACE outcomes were even more pronounced in 301 HFrEF patients with high baseline levels of inflammation as measured by hsCRP.

This should be the Data that pushes the FDA to approve the trial with the surrogate endpoint and recruitment criteria of high baseline levels of inflammation, as the data showed that increased LVEF preceded long-term reduction in major adverse cardiovascular events (MACE) and associated recurrent hospitalizations for non-fatal heart attack or stroke.

What’s a partnership worth for a Multi Billion CHF Blockbuster indication. Mesoblast spent hundreds of millions on the prior trials and research, so I would say a $400 million usd upfront payment is reasonable and then additional payments subject to certain milestones and then a double digit royalty on all sales.

With this payment, Mesoblast can fund all their other trials and programs for future indications.