The licence agreement complements the collaboration between
Medincell and the health agency Unitaid that funds the development
of mdc-STM, an investigational long-acting injectable formulation
for the prevention of malaria.
The Medicines Patent Pool (MPP) is a United Nations-backed
public health organisation working to increase access to, and
facilitate the development of life-saving medicines for low- and
middle-income countries.
The licence agreement relates to a 3-Month active injectable
formulation of ivermectin using Medincell’s BEPO® technology to
fight malaria transmission.
The licence agreement aims to ensure that the product be
widely distributed in low- and middle-income countries if proven
effective and safe.
Malaria remains endemic in 91 countries leading to 627,000
deaths in 2020. Children under 5 are the most vulnerable,
accounting for 80% of deaths.
Regulatory News:
The Medicines Patent Pool (MPP) and French pharmaceutical
company MedinCell (Paris:MEDCL) today announced that they have
signed a licence agreement for a candidate long-acting drug
formulation that could be used to fight malaria in low- and
middle-income countries.
This non-exclusive licence agreement, made possible with funding
to both parties from global health agency Unitaid, will enable MPP
to support the identification of suitable partners for the
development and commercialisation of mdc-STM, an injectable
formulation of ivermectin with a three-month action-duration, using
MedinCell’s BEPO® technology. Under the terms of the licence, the
manufacturing can be carried out in any country worldwide, for
distribution in low- and middle-income countries.
Now at a pre-clinical stage, the product is based on BEPO®, a
MedinCell polymer-based injectable technology that enables the
sustained release of ivermectin after a single injection
administered subcutaneously at the beginning of the malaria
transmission season to people living in malaria-endemic areas.
Mosquitoes feeding on persons having received ivermectin injections
will be killed or made less capable of transmitting malaria
parasites further. Through this community-based intervention – the
individual receiving the injection will not be protected against
malaria directly - the number of mosquitoes will be decreased, thus
benefiting the whole community by lowering the risk of transmission
of malaria, particularly in children.
If proven safe, effective and acceptable, this long-acting
injectable candidate could have a significant impact on
transmission of malaria among vulnerable populations in
high-transmission areas, in particular young children who are
adversely affected.
“We are very proud to be partnering with MedinCell to accelerate
the development of such paradigm-changing interventions and ensure
these innovations, if proven safe and effective, are available in
low- and middle-income countries as soon as possible” said Charles
Gore, Executive Director of MPP.
“This long-acting technology offers an exciting new avenue in
the fight against malaria, and this licence is key to allow rapid
access to innovation for those who need it most.”
Malaria remains endemic in 91 countries representing 50% of the
world’s population. According to WHO estimates, 241 million people
were infected worldwide in 2020, 95% of them in Africa, leading to
627,000 deaths. Children under 5 are the most vulnerable,
accounting for 80% of deaths from malaria.
“Collaboration and innovation are key to face major Global
Health challenges, said Christophe Douat, CEO of MedinCell.
Bringing together the best players to move this project forward is
crucial to ensure that this innovative product based on our
long-acting Injectable technology, if proven safe and effective,
can have a positive impact for affected population. We are
delighted to join forces with MPP which could play an essential
role in enabling rapid and global access to this new complementary
tool to fight the malaria scourge.”
This successful early-stage collaboration is part of Unitaid’s
larger strategy to accelerate the development of affordable,
quality, long-acting products for infectious diseases. As part of
that work, Unitaid is funding both MedinCell to develop long-acting
antimalarial products and MPP to facilitate generic production of
the new technologies without delay. “In the fight against malaria,
there is no time to lose. We know that, if proven safe and
effective, this long-acting malaria prevention will hold tremendous
potential. By supporting development and access pathways
simultaneously, Unitaid is investing on all fronts to fast-track
access to new malaria fighting tools,” said Dr Philippe Duneton,
Executive Director of Unitaid.
The licence agreement covers all low- and middle-income
countries and is royalty free in the public sector, with reasonable
royalty in line with industry standards to be agreed in case there
would be a private market for the licensed product in low and
middle- income countries.
Access the licence agreement
The press release is also available in French and Spanish
(translation by MPP).
More on MPP’s work in long-acting therapeutics
About MPP
The Medicines Patent Pool (MPP) is a United Nations-backed
public health organisation working to increase access to, and
facilitate the development of, life-saving medicines for low- and
middle-income countries. Through its innovative business model, MPP
partners with civil society, governments, international
organisations, industry, patient groups, and other stakeholders, to
prioritise and license needed medicines and pool intellectual
property to encourage generic manufacture and the development of
new formulations.
To date, MPP has signed agreements with 16 patent holders for 13
HIV antiretrovirals, one HIV technology platform, three hepatitis C
direct-acting antivirals, a tuberculosis treatment, four
long-acting technologies, two oral antiviral treatments for
COVID-19 and 12 COVID-19 technologies. MPP was founded by Unitaid,
which continues to be MPP’s main funder. MPP’s work on access to
essential medicines is also funded by the Swiss Agency for
Development and Cooperation (SDC). MPP’s activities in COVID-19 are
undertaken with the financial support of the Japanese Government,
the French Ministry for Europe and Foreign Affairs, and SDC.
About MedinCell
MedinCell is a pharmaceutical company at premarketing stage that
develops a portfolio of long-acting injectable products in various
therapeutic areas by combining its proprietary BEPO® technology
with active ingredients already known and marketed. Through the
controlled and extended release of the active pharmaceutical
ingredient, MedinCell makes medical treatments more efficient,
particularly thanks to improved compliance, i.e. compliance with
medical prescriptions, and to a significant reduction in the
quantity of medication required as part of a one-off or chronic
treatment. The BEPO® technology makes it possible to control and
guarantee the regular delivery of a drug at the optimal therapeutic
dose for several days, weeks or months starting from the
subcutaneous or local injection of a simple deposit of a few
millimeters, fully bioresorbable. MedinCell collaborate with tier
one pharmaceuticals companies and foundations to improve Global
Health through new therapeutic options. Based in Montpellier,
MedinCell currently employs more than 150 people representing over
30 different nationalities. www.medincell.com
This press release contains forward-looking statements,
including statements regarding Company’s expectations for (i) the
timing, progress and outcome of its clinical trials; (ii) the
clinical benefits and competitive positioning of its product
candidates; (iii) its ability to obtain regulatory approvals,
commence commercial production and achieve market penetration and
sales; (iv) its future product portfolio; (v) its future partnering
arrangements; (vi) its future capital needs, capital expenditure
plans and ability to obtain funding; and (vii) prospective
financial matters regarding our business. Although the Company
believes that its expectations are based on reasonable assumptions,
any statements other than statements of historical facts that may
be contained in this press release relating to future events are
forward-looking statements and subject to change without notice,
factors beyond the Company's control and the Company's financial
capabilities.
These statements may include, but are not limited to, any
statement beginning with, followed by or including words or phrases
such as "objective", "believe", "anticipate", “expect”, "foresee",
"aim", "intend", "may", "anticipate", "estimate", "plan",
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"could" and other words and phrases of the same meaning or used in
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risks and uncertainties beyond the Company's control that may, if
any, cause actual results, performance, or achievements to differ
materially from those anticipated or expressed explicitly or
implicitly by such forward-looking statements. A list and
description of these risks, contingencies and uncertainties can be
found in the documents filed by the Company with the Autorité des
Marchés Financiers (the "AMF") pursuant to its regulatory
obligations, including the Company's registration document,
registered with the AMF on September 4, 2018, under number I.
18-062 (the "Registration Document"), as well as in the documents
and reports to be published subsequently by the Company. In
particular, readers' attention is drawn to the section entitled
"Facteurs de Risques" on page 26 of the Registration Document.
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why actual results could differ materially from those anticipated
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place undue reliance on these forward-looking statements.
This press release is for information purposes only. The
information contained herein does not constitute an offer to sell
or a solicitation of an offer to buy or subscribe for the Company's
shares in any jurisdiction, in particular in France. Similarly,
this press release does not constitute investment advice and should
not be treated as such. It is not related to the investment
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version on businesswire.com: https://www.businesswire.com/news/home/20220913006009/en/
MPP press@medicinespatentpool.org
MedinCell David Heuzé Communication leader
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Louis-Victor Delouvrier/Mathilde Bohin Investor Relations
medincell@newcap.eu +33 (0)1 44 71 94 94
NewCap Nicolas Merigeau Media Relations medincell@newcap.eu +33
(0)1 44 71 94 94
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