Grünenthal and Mesoblast Enter Strategic Partnership for Europe and Latin America to Develop and Commercialise Innovative Cell Therapy for the Treatment of Chronic Low Back Pain

Aachen, Germany, and Melbourne, Australia (ots) - 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 years (1).

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 molecules
(2,3). 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 components (4). 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 disease (5,6,7,8), 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 function (9). In addition, the inflammation of the
disc can cause severe pain, which is poorly responsive to systemic
pain treatment (10). 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 pain (11). 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 concern (12). 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 treatments (13).

About Grünenthal

Grünenthal 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 EUR 1.3 bn.

More information: www.grunenthal.com
Follow us on:
LinkedIn: Grunenthal Group
Twitter: @grunenthalgroup
Instagram: @grunenthal

About Mesoblast

Mesoblast 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). More
information: www.mesoblast.com

Follow us on:
LinkedIn: Mesoblast Limited
Twitter: @Mesoblast

Forward-Looking Statements by Mesoblast

This 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.

(1) http://ots.de/5o5QsU;
https://www.mesoblast.com/clinical-trial-results/mpc-06-id-phase-2
(2) Chen et al. J Clin Invest. 2015 Aug;125(8):3226-4
(3) Lantero A et al. J Neurosci. 2014 Apr;34(15):5385-95
(4) Sharma RR et al. Transfusion. 2014 May;54(5):1418-37
(5) Andersson GBJ. Epidemiological features of chronic low-back pain.
Lancet 1999; 354: 581-85
(6) Freburger et al. The Rising Prevalence of Chronic Low Back Pain.
Arch Intern Med 2009; 169 (3): 251-258
(7) 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: 1-7
(8) DePalma MJ et al. What is the source of chronic low back pain and
does age play a role? Pain Med 2011; 12:224-233
(9) Rider SM et al. Spine Surg Relat Res. 2018 Apr;3(1):1-11
(10) Nguyen QT et al. ACS Biomater Sci Eng. 2017 Nov
(11) Grünenthal internal data on file
(12) Gibson AJN, Waddell G. Spine 2005; 30: 2312- 2320
(13) Fernandez-Moure J, et al. SAGE Open Med. 2018
Mar;6:2050312118761674

For further information, please contact:
Stepan Krácala,
Head Global Communications, Grünenthal
Tel.: +49 241 569-1335
Stepan.Kracala@grunenthal.com
Grünenthal GmbH, 52099 Aachen, Germany

Kerstin Nacken,
Head Editorial Management & Media Relations, Grünenthal
Tel.: +49 241 569-2710
Kerstin.Nacken@grunenthal.com
Grünenthal GmbH, 52099 Aachen, Germany

Julie Meldrum,
Global Head Corporate Communications, Mesoblast
Tel.: +61 3 9639 6036
julie.meldrum@mesoblast.com
Melbourne, Australia

Schond Greenway,
Investor Relations, Mesoblast
Tel: +1 212 880 2060
schond.greenway@mesoblast.com
New York, USA

Original-Content von: Grünenthal Group, übermittelt durch news aktuell