Mesoblast Enters Global Collaboration for Development, Manufacture and Commercialization of Remestemcel-L
November 19 2020 - 5:11PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), today announced that it
has entered into an exclusive worldwide license and collaboration
agreement with Novartis for the development, manufacture and
commercialization of Mesoblast’s mesenchymal stromal cell (MSC)
product remestemcel-L, with an initial focus on the development of
the treatment of acute respiratory distress syndrome (ARDS),
including that associated with COVID-19.
Mesoblast Chief Executive Dr Silviu Itescu stated:
“Our collaboration with Novartis will help ensure that
remestemcel-L could become available to the many patients suffering
from ARDS, the principal cause of mortality in COVID-19 infection.
This agreement is in line with our corporate strategy to
collaborate and partner with world-leading major pharma companies
in order to maximize market access for our innovative cellular
medicines.”
The demonstrated ability of Novartis to rapidly
move from clinical to commercial scale with cell-based therapies
will play a role in the successful development and potential
commercialization of remestemcel-L, as will the nearly two decades
of experience Novartis has in delivering first-in-class products
that address areas of unmet respiratory need.
ARDS is an area of significant unmet need, with a
high mortality rate despite current standard of care, which
includes prolonged ICU treatment and mechanical ventilation. As the
potential first ARDS therapy, remestemcel-L will be evaluated to
treat this deadly condition and improve outcomes. Remestemcel-L is
currently being studied in COVID-19-related ARDS in an ongoing
300-patient Phase 3 study, where even with maximal existing
therapies, mortality is estimated to be even higher. Novartis
intends to initiate a Phase 3 study in non-COVID-19-related ARDS
after the anticipated closing of the license agreement and
successful completion and outcome of the current study.
Key transaction terms:
- Novartis will make a US$50 million upfront payment including
US$25 million in equity.
- From the initiation of a Phase 3 trial in all-cause ARDS,
Novartis will fully fund global clinical development for all-cause
ARDS and potentially other respiratory indications.
- Mesoblast may receive a total of US$505 million pending
achievement of pre-commercialization milestones for ARDS
indications.
- Mesoblast may receive additional payments
post-commercialization of up to US$750 million based on achieving
certain sales milestones and tiered double-digit royalties on
product sales.
- Mesoblast will retain full rights and economics for
remestemcel-L for graft versus host disease (GVHD), and Novartis
has an option to, if exercised, become the commercial distributor
outside of Japan.
- For most non-respiratory indications, the parties may co-fund
development and commercialization on a 50:50 profit-share
basis.
- Mesoblast will be responsible for clinical and commercial
manufacturing and Novartis will purchase commercial product under
agreed pricing terms. Novartis will reimburse Mesoblast up to US$50
million on the achievement of certain milestones related to the
successful implementation of its next-generation manufacturing
processes using its proprietary media and three-dimensional
bioreactors aimed at delivering substantial manufacturing
efficiencies. Novartis will be responsible for any capital
expenditure required to meet increased capacity requirements for
manufacture of remestemcel-L.
The closing of the license agreement is subject to
the expiration or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act and certain other
conditions.
About Mesenchymal Stromal Cells
(MSCs) MSCs have immunomodulatory properties which may
facilitate their effective use in life-threatening conditions
associated with systemic inflammation. Key inherent
characteristics of MSCs are their capacity for significant
expansion in culture and their relative lack of immunogenicity.
These properties facilitate their use as allogeneic or
“off-the-shelf” therapeutics with specific release criteria and
batch-to-batch reproducibility.
About
Remestemcel-L Remestemcel-L is an investigational therapy
comprising culture-expanded MSCs derived from the bone marrow of an
unrelated donor. Remestemcel-L is thought to have immunomodulatory
properties to counteract the cytokine storms that are implicated in
various inflammatory conditions by down-regulating the production
of pro-inflammatory cytokines, increasing production of
anti-inflammatory cytokines, and enabling recruitment of naturally
occurring anti-inflammatory cells to involved tissues.
Remestemcel-L is being developed for inflammatory diseases in
children and adults including steroid-refractory acute graft versus
host disease (SR-aGVHD) and moderate to severe acute respiratory
distress syndrome.
About Mesoblast Mesoblast Limited
(Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary mesenchymal lineage cell therapy technology platform to
establish a broad portfolio of commercial products and late-stage
product candidates. Mesoblast has a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 in all major markets. The Company’s
proprietary manufacturing processes yield industrial-scale,
cryopreserved, off-the-shelf, cellular medicines. These cell
therapies, with specific release criteria, are planned to be
readily available to patients worldwide.
Mesoblast is developing remestemcel-L for various
inflammatory conditions, including SR-aGVHD and COVID-19 ARDS, and
rexlemestrocel-L for advanced heart failure and chronic low back
pain. Two products have been commercialized in Japan and Europe by
Mesoblast’s licensees, and the Company has established commercial
partnerships globally and in Europe and China for certain assets.
Mesoblast has locations in Australia, the United
States and Singapore and is listed on the Australian Securities
Exchange (MSB) and on the Nasdaq (MESO). For more information,
please see www.mesoblast.com, LinkedIn: Mesoblast Limited and
Twitter: @Mesoblast
Conference Call There will be a
webcast today beginning at 9.00am AEDT (Friday, November 20);
5.00pm EST (Thursday, November 19, 2020). It can be accessed via
https://webcast.boardroom.media/mesoblast-limited/20201119/NaN5fb59c68f297810019932232
The archived webcast will be available on the
Investor page of the Company’s website: www.mesoblast.com
Mesoblast’s Forward-Looking
Statements This announcement includes forward-looking
statements that relate to future events or our future financial
performance and involve known and unknown risks, uncertainties and
other factors that may cause our actual results, levels of
activity, performance or achievements to differ materially from any
future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. We make
such forward-looking statements pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and other federal securities laws. Forward-looking statements
should not be read as a guarantee of future performance or results,
and actual results may differ from the results anticipated in these
forward-looking statements, and the differences may be material and
adverse. Forward-looking statements include, but are not limited
to, statements about the potential milestone and royalty payments
that may be received pursuant to the agreement with Novartis, the
initiation, timing, progress and results of Mesoblast’s preclinical
and clinical studies, and Mesoblast’s research and development
programs; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory
filings and approvals, manufacturing activities and product
marketing activities, if any; the commercialization of Mesoblast’s
product candidates, if approved; regulatory or public perceptions
and market acceptance surrounding the use of stem-cell based
therapies; the potential for Mesoblast’s product candidates, if any
are approved, to be withdrawn from the market due to patient
adverse events or deaths; the potential benefits of strategic
collaboration agreements and Mesoblast’s ability to enter into and
maintain established strategic collaborations; Mesoblast’s ability
to establish and maintain intellectual property on its product
candidates and Mesoblast’s ability to successfully defend these in
cases of alleged infringement; the scope of protection Mesoblast is
able to establish and maintain for intellectual property rights
covering its product candidates and technology; estimates of
Mesoblast’s expenses, future revenues, capital requirements and its
needs for additional financing; Mesoblast’s financial performance;
developments relating to Mesoblast’s competitors and industry; and
the pricing and reimbursement of Mesoblast’s product candidates, if
approved. You should read this press release together with our
risk factors, in our most recently filed reports with the SEC or on
our website. Uncertainties and risks that may cause Mesoblast’s
actual results, performance or achievements to be materially
different from those which may be expressed or implied by such
statements, and accordingly, you should not place undue reliance on
these forward-looking statements. We do not undertake any
obligations to publicly update or revise any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
Release authorized by the Board.
For further information, please contact:
Media Julie Meldrum T: +61 3 9639 6036
E:julie.meldrum@mesoblast.com |
Kristen
Bothwell T: +1 917 613 5434 E:kbothwell@rubenstein.com |
|
|
Investors Schond Greenway T: +212 880 2060
E: schond.greenway@mesoblast.com |
Paul
Hughes T: +61 3 9639 6036
E: paul.hughes@mesoblast.com |
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