Grünenthal, a global leader in pain management, and Mesoblast
Limited (ASX: MSB; Nasdaq: MESO), a world leader in allogeneic
cellular medicines for inflammatory diseases, today announced that
they have entered into a strategic partnership to develop and
commercialise MPC-06-ID, a Phase III allogeneic cell therapy
candidate for the treatment of chronic low back pain due to
degenerative disc disease in patients who have exhausted
conservative treatment options. Under the partnership, Grünenthal
will have exclusive commercialisation rights to MPC-06-ID for
Europe and Latin America.
Mesoblast will receive up to US$150 million in upfront and
milestone payments prior to product launch, as well as further
commercialisation milestone payments. These payments include
commitments up to US$45 million within the first year comprising
US$15 million on signing, US$20 million on receiving regulatory
approval to begin a confirmatory Phase III trial in Europe, and
US$10 million on certain clinical and manufacturing outcomes.
Cumulative milestone payments could exceed US$1 billion depending
on the final outcome of Phase III studies and patient adoption.
Mesoblast will also receive tiered double digit royalties on
product sales.
Mesoblast is completing a Phase III trial for MPC-06-ID in the
U.S. which will read out in 2020. In a previous U.S. Phase II
trial, Mesoblast demonstrated that a single intra-discal injection
of MPC-06-ID using a unit dose of 6 million allogeneic mesenchymal
precursor cells (MPCs) resulted in meaningful and durable
improvements for patients in pain intensity and functionality for
at least three years1.
Grünenthal and Mesoblast have agreed on an overall development
plan for MPC-06-ID to meet European regulatory requirements. As
part of this plan, the companies will collaborate on the study
design for a confirmatory Phase III trial in Europe. The
results of the two Phase III trials are expected to support both
U.S. FDA and European EMA regulatory approvals for MPC-06-ID in
chronic low back pain due to degenerative disc disease.
Grünenthal’s CEO Gabriel Baertschi said: “This is an exciting
day for Grünenthal. Cell-based therapies offer a novel approach in
pain management. They can potentially deliver meaningful lasting
improvements to patients beyond symptomatic treatment by
maintaining or even restoring physiological function. By teaming up
with Mesoblast for the next generation of pain therapies for
chronic low back pain due to degenerative disc disease we are
diligently executing our strategy: leveraging promising new
therapeutic modalities and addressing patients with high unmet
medical needs. This is an important next step in working towards
our vision of a world free of pain.”
Mesoblast Chief Executive Dr Silviu Itescu stated: “We are very
pleased to enter into this strategic partnership with Grünenthal, a
world leader in innovative approaches to pain management. Together
with Grünenthal we plan to bring an important new class of therapy
for pain management to the many patients suffering with
degenerative disc disease. This partnership is in line with
our corporate strategy to team up with best in category commercial
leaders to maximise market access for our innovative cellular
medicines for the treatment of patients suffering from debilitating
or life-threatening inflammatory conditions.”
MPCs have generated great interest in clinical science and
medicine due to their immunomodulatory effects and their role in
tissue repair and regeneration. These cells have been shown to be
effective in reducing inflammation and promoting the regeneration
of host tissues through cell-to-cell interactions and secretion of
a wide range of endogenous analgesic and anti-inflammatory
molecules2,3. Furthermore, in degenerative disc disease, these
cells could contribute to regenerating physiological disc tissue by
promoting the proliferation of host chondrocytes and their
secretion of tissue matrix components4. Among key characteristics
of MPCs 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 well-defined release criteria and batch-to-batch
reproducibility that meet stringent regulatory requirements.
About Chronic Low Back Pain due to Degenerative Disc
Disease (CLBP)Over 7 million patients in Europe are
thought to suffer from CLBP caused by degenerative disc
disease5,6,7,8, a disease which involves inflammation and
degeneration of the intervertebral discs due to various factors
like age, trauma or genetic pre-disposition. The lack of
‘cushioning’ as one of the major physiological functions of the
disc in turn can result in spinal instability, mechanical stress
and bony changes of the spine which finally cause significant pain
and loss of function9. In addition, the inflammation of the disc
can cause severe pain, which is poorly responsive to systemic pain
treatment10. Most existing therapies do not address the underlying
mechanisms of these changes and provide limited symptomatic relief.
Patients would typically suffer for several years already at a
relatively young age, without being able to sufficiently address
their pain11. Invasive therapies, including surgeries like spinal
fusion, are sometimes a last resort for these patients, however,
the limited evidence of their long‐term effects remains a matter of
concern12. If clinical trial results from Phase II are confirmed,
MPC-06-ID could offer a new treatment option to patients otherwise
considered unresponsive to conservative therapy, which can provide
relief for at least 3 years and aims to retain the natural function
and anatomy of the disc. MPCs offer the possibility to support and
promote the existing regenerative potential inherent in host
tissues and are expected to deliver superior long term outcomes
compared to purely symptomatic treatments13.
About GrünenthalGrünenthal is a global leader
in pain management and related diseases. As a science-based,
privately-owned pharmaceutical company, we have a long track record
of bringing innovative treatments and state-of-the-art technologies
to patients worldwide. Our purpose is to change lives for the
better – and innovation is our passion. We are focusing all of our
activities and efforts on working towards our vision of a world
free of pain. Grünenthal is headquartered in Aachen, Germany, and
has affiliates in 30 countries across Europe, Latin America and the
US. Our products are available in more than 100 countries. In 2018
Grünenthal employed around 4,900 people and achieved sales of € 1.3
bn.
More information: www.grunenthal.com
Follow us on:LinkedIn: Grunenthal GroupTwitter:
@grunenthalgroupInstagram: @grunenthal
About MesoblastMesoblast Limited (ASX: MSB;
Nasdaq: MESO) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary technology platform to establish a broad portfolio of
late-stage product candidates with three product candidates in
Phase III trials – acute graft versus host disease, chronic heart
failure and chronic low back pain due to degenerative disc disease.
Through a proprietary process, Mesoblast selects rare mesenchymal
lineage precursor and stem cells from the bone marrow of healthy
adults and creates master cell banks, which can be industrially
expanded to produce thousands of doses from each donor without the
need for tissue matching. Mesoblast has facilities in Melbourne,
New York, Singapore and Texas and is listed on the Australian
Securities Exchange (MSB) and on the Nasdaq (MESO).
www.mesoblast.com
Follow us on:LinkedIn: Mesoblast LimitedTwitter: @Mesoblast
Forward-Looking Statements by MesoblastThis
announcement includes forward-looking statements that relate to
future events or Mesoblast’s future financial performance and
involve known and unknown risks, uncertainties and other factors
that may cause Mesoblast’s 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. Mesoblast makes
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 timing, progress and results of
Mesoblast’s preclinical and clinical studies in CLBP; Mesoblast and
its collaborators’ ability to advance product candidates into,
enroll and successfully complete, clinical studies; the timing or
likelihood of regulatory filings and approvals for CLBP; and the
pricing and reimbursement of Mesoblast and its collaborators’
product candidates, if approved. You should read this press release
together with Mesoblast’s risk factors, in Mesoblast’s most
recently filed reports with the SEC or on Mesoblast’s 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. Mesoblast does not undertake any
obligations to publicly update or revise any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
For further information, please contact:
Štěpán Kráčala, Head Global Communications, GrünenthalTel.: +49 241
569-1335Stepan.Kracala@grunenthal.comGrünenthal GmbH, 52099 Aachen,
GermanyKerstin Nacken, Head Editorial Management & Media
Relations, GrünenthalTel.: +49 241
569-2710Kerstin.Nacken@grunenthal.comGrünenthal GmbH, 52099 Aachen,
Germany |
|
Julie Meldrum, Global Head Corporate Communications, MesoblastTel.:
+61 3 9639 6036julie.meldrum@mesoblast.comMelbourne,
AustraliaSchond Greenway, Investor Relations, MesoblastTel: +1 212
880 2060schond.greenway@mesoblast.comNew York, USA |
|
|
|
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1
https://www.mesoblast.com/product-candidates/spine-orthopedic-disorders/chronic-discogenic-low-back-pain;
https://www.mesoblast.com/clinical-trial-results/mpc-06-id-phase-2 2
Chen et al. J Clin Invest. 2015 Aug;125(8):3226-43 Lantero A et al.
J Neurosci. 2014 Apr;34(15):5385-954 Sharma RR et al. Transfusion.
2014 May;54(5):1418-375 Andersson GBJ. Epidemiological features of
chronic low-back pain. Lancet 1999; 354: 581-856 Freburger et al.
The Rising Prevalence of Chronic Low Back Pain. Arch Intern Med
2009; 169 (3): 251-2587 Malanga G et al. Epidemiology In: Cole
& Herring eds. The Low Back Pain Handbook: A Guide for the
Practicing Clinician. 2nd ed. Philadelphia, Pa.: Hanley and Belfus,
2003: 1-78 DePalma MJ et al. What is the source of chronic low back
pain and does age play a role? Pain Med 2011; 12:224-2339 Rider SM
et al. Spine Surg Relat Res. 2018 Apr;3(1):1-1110 Nguyen QT et al.
ACS Biomater Sci Eng. 2017 Nov11 Grünenthal internal data on file12
Gibson AJN, Waddell G. Spine 2005; 30: 2312– 232013 Fernandez-Moure
J, et al. SAGE Open Med. 2018 Mar;6:2050312118761674
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