Regulatory News:
Global health agency Unitaid has awarded Medincell
(Paris:MEDCL) an extension grant of up to US$ 6 million over three
years to fund the clinical phase 1 activities of long-acting
injectable mdc-STM. If proven safe, effective, and acceptable,
mdc-STM could have a significant impact on transmission of malaria
among vulnerable populations in high-transmission areas.
mdc-STM is an investigational three-month active injectable
formulation of ivermectin using Medincell’s BEPO® technology to
fight malaria transmission. A previous grant of $6.4 million was
awarded in March 2020 by Unitaid to fund the formulation research
phase and preclinical activities of the program conducted by
Medincell and the project consortium members, IRD, IRSS and
CIRDES.
Medincell is committed to the fight against the major global
health threats, such as malaria that remains endemic in 85
countries representing 50% of the world's population. According to
WHO estimates, 249 million people were infected worldwide in 2022,
94% of them in Africa, leading to 580,000 deaths in the
area.
Quiterie de Beauregard, Head of Global Health Development at
Medincell, said: “The 2023 WHO’s World Malaria Report highlights
the significant discrepancies between the objectives outlined in
the Global Technical Strategy and the status of malaria indicators.
This gap is particularly pronounced in the countries initially
identified as high burden, which have seen little to no change in
both malaria incidence and mortality rates. In 2022, these nations
represented 67% of global cases and 73% of deaths. The report
emphasizes the urgent need for additional tools to curb malaria
transmission. Ivermectin emerges as a highly promising solution;
however, logistical challenges associated with its oral
administration may hinder its potential to make a significant
epidemiological impact on malaria. At Medincell, bolstered by the
support of the IVERMEN community and renewed confidence from
Unitaid, we are firmly convinced that a long-acting injectable
formulation could overcome these obstacles.”
Christophe Douat, Medincell’s CEO, added: "We are delighted that
our long-acting injectable technology, which has reached the
commercial stage following the approval of our first treatment by
the US FDA, can address major global health challenges. The renewed
support from Unitaid is crucial for advancing this project. It
enables us to leverage our internal regulatory development
expertise and continue our collaboration with consortium members
IRD, IRSS, and CIRDES to conduct further studies. Our 3-month
active ivermectin, if proven safe and effective, has the potential
to significantly impact populations suffering from malaria."
About mdc-STM program
Ivermectin, a drug designed to combat parasites, could eliminate
mosquitoes upon biting individuals or animals that have been
administered it. The individual receiving the injection will not be
protected against malaria directly, however the number of
mosquitoes will decrease, thus benefiting the whole community by
lowering the risk of transmission of malaria, particularly in
children. This community-based intervention aims to disrupt the
chain of transmission.
Currently in preparation, clinical trials initiation of mdc-STM
is planned by the end of 2024. The product is based on BEPO®, a
Medincell polymer-based injectable technology that enables the
sustained release of ivermectin and has the potential from a single
subcutaneous injection to protect people living in malaria-endemic
areas throughout the rainy season.
This grant extension is funded through Unitaid’s IMPACT project,
which aims to develop a long-acting injectable medicine that could
both interrupt malaria transmission and be easier to administer and
adhere to.
In 2022, Medincell signed a license agreement with The Medicines
Patent Pool (MPP) that enables MPP to support the identification of
suitable partners needed for the development and distribution of
mdc-STM in low- and middle-income countries.
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical
licensing company developing long-acting injectable drugs in many
therapeutic areas. Our innovative treatments aim to guarantee
compliance with medical prescriptions, to improve the effectiveness
and accessibility of medicines, and to reduce their environmental
footprint. They combine active pharmaceutical ingredients with our
proprietary BEPO® technology which controls the delivery of a drug
at a therapeutic level for several days, weeks or months from the
subcutaneous or local injection of a simple deposit of a few
millimeters, entirely bioresorbable. The first treatment based on
BEPO® technology, intended for the treatment of schizophrenia, was
approved by the FDA in April 2023, and is now distributed in the
United States by Teva under the name UZEDY™ (BEPO® technology is
licensed to Teva under the name SteadyTeq™). We collaborate with
leading pharmaceutical companies and foundations to improve global
health through new treatment options. Based in Montpellier,
Medincell currently employs more than 140 people representing more
than 25 different nationalities.
UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals
www.medincell.com
About Unitaid
Unitaid saves lives by making critical health products available
and affordable for people in low- and middle-income countries. We
work with partners to identify innovative treatments, tests and
tools, help tackle the market barriers that are holding them back
and get them to the people who need them most – fast. Since its
creation in 2006, Unitaid has facilitated access to more than 100
groundbreaking health products to help address the world’s biggest
health challenges, including HIV, TB, and malaria; women’s and
children’s health; and pandemic prevention, preparedness and
response. Every year, more than 170 million people benefit from the
products whose deployment Unitaid has supported.
unitaid.org
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version on businesswire.com: https://www.businesswire.com/news/home/20240408925997/en/
David Heuzé Head of Corporate and Financial
Communications, and ESG david.heuze@medincell.com / +33 (0)6 83 25
21 86
Grace Kim Head of US Financial Strategy & IR
grace.kim@medincell.com / +1 (646) 991-4023
Nicolas Mérigeau Media Relations medincell@newcap.eu /
+33 (0)1 44 71 94 94
Louis-Victor Delouvrier/Alban Dufumier Investor Relations
France medincell@newcap.eu / +33 (0)1 44 71 94 94
Medincell (EU:MEDCL)
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Medincell (EU:MEDCL)
過去 株価チャート
から 5 2023 まで 5 2024