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MESOBLAST HIGHLIGHTS 2019 KEY PRIORITIES FOR ITS LEADING...

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    MESOBLAST HIGHLIGHTS 2019 KEY PRIORITIES FOR ITS LEADING CELLULARMEDICINES PIPELINE AT BIOTECH SHOWCASE IN SAN FRANCISCONew York, USA; January 7, 2019 and Melbourne, Australia; January 8, 2019:

    MesoblastLimited (ASX:MSB; Nasdaq:MESO), world leader in the development and commercialization of cellularmedicines, today reported on commercial and development plans for its lead cellular therapies toBiotech Showcase 2019 being held this week in San Francisco, CA.


    Mesoblast Chief Executive Dr Silviu Itescu said: "We enter calendar 2019 building upon the successfuladvancement of our late-stage pipeline where we successfully completed a Phase 3 trial in steroidrefractory acute graft versus host disease (aGVHD) which has near-term commercial potential in theUnited States (U.S.), and another product candidate having achieved clinical outcomes in line with theU.S. Food and Drug Administration (FDA) guidance for a registrable clinical indication for marketauthorization, and two additional Phase 3 assets with blockbuster potential. With the momentum ofthese marquee therapies, we are preparing for multiple milestones and inflection points across theseproduct candidates in the coming year.”Dr Itescu told meeting attendees that in 2019 Mesoblast plans to work diligently with the FDA tosubmit a rolling Biologics License Application for use of remestemcel-L in treating aGVHD in children,and will execute on the product candidate’s market access and commercialization strategy.The meeting attendees were also told that 2019 will be a pivotal year for the Company’s heart failureproduct candidate Revascor. Mesoblast will meet with the FDA in the first half of 2019 to discuss apotential approval pathway for Revascor in patients with end-stage heart failure and a left ventricularassist device. This follows the clinically meaningful outcomes of reduction in major gastrointestinalbleeding and related hospitalizations achieved in the 159-patient U.S. National Institutes of Healthfunded trial in these patients. In addition, Dr Itescu provided the key takeaways on the Phase 3 trial ofRevascor for patients with advanced heart failure which has completed recruitment of approximately570 patients.A webcast of the presentation will be available viahttps://event.webcasts.com/starthere.jsp?ei=1226368&tp_key=1f4916da2 and as an archivedwebcast for 90 days on the Investors & Media section of the Company’s website atwww.mesoblast.com 

 
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