Small molecule candidate Anle138b targets
disease modification for multiple system atrophy and other
neurological disorders
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and
MODAG GmbH today announced a strategic collaboration on the
exclusive worldwide licensing and development of MODAG's lead
compound anle138b and a related compound, sery433.
Anle138b targets pathological alpha-synuclein oligomers and is
being evaluated in patients with neurodegenerative diseases for
potential disease modification. Under the terms of the agreement
and pending regulatory clearance, Teva will receive an exclusive
global license to develop, manufacture and commercialize anle138b
and sery433. The companies will jointly develop the compounds for
the multiple system atrophy (MSA) and Parkinson’s disease (PD)
indications based on early-stage clinical studies, and consider
exploring additional indications based on clinical outcomes.
A Phase 1 (NCT04208152) study examining anle138b in healthy
volunteers completed in July 2020 demonstrated favorable
benefit-risk profile at all dose levels while achieving higher
plasma levels than those required for full therapeutic efficacy in
animal models. Anle138b was initially developed in patients with
MSA and PD and has the potential to be applied to other
neurodegenerative disorders, such as Alzheimer's disease. A Phase
1b (NCT04685265) clinical trial evaluating the safety of the
compound, as well as efficacy measures in patients living with PD,
is currently being conducted.
“With Teva’s strong foundation in neuroscience and our in-house
expertise in neurology and psychiatry, this licensing and
collaboration agreement adds a promising new compound to our
early-stage pipeline as a possible orphan disease treatment for the
growing patient population living with multiple system atrophy, as
well as a potential option for patients living with Parkinson’s
disease,” said Hafrun Fridriksdottir, Executive Vice President,
Global R&D. “We at Teva are excited about collaborating with
the MODAG team and look forward to future developments as we
continue to follow the science and explore additional indications
for both partnered compounds.”
Dr. Matthias, CEO of MODAG added, "We are pleased to partner and
work alongside Teva, an organization that has longstanding,
extensive expertise in the development of therapeutics. In addition
to the previous support we have received from the Michael J.
Fox-Foundation and the Cure Parkinson's Trust, this partnership
further underscores the heightened potential of our lead candidates
to do what no drug is currently capable of: blocking the
progression of synucleinopathies. Building upon our notable
preliminary results, we look forward to the continued development
of anle138b alongside Teva to help patients living with currently
untreatable neurodegenerative diseases, including MSA, PD and
Alzheimer’s disease. With the introduction of small-molecule
medication, we open a new chapter in the fight against
neurodegenerative diseases and have the chance to improve the lives
of millions of patients drastically.”
Multiple System Atrophy
Multiple system atrophy (MSA) is a rare neurodegenerative
disorder classified clinically as "atypical parkinsonism" and
belongs to the group of synucleinopathies. MSA is characterized
histopathologically by abnormal deposits of the α-synuclein
protein, mainly in oligodendroglial cells (glial cytoplasmic
inclusions) and also in certain nerve cells. Typically, there is a
dysfunction of the autonomic nervous system, i.e., disturbances of
bladder function, erectile function, intestinal mobility, or the
regulation of blood pressure in combination with a movement
disorder. The movement disorder often presents with either
Parkinson-like symptoms or a disturbance of cerebellar function,
such as ataxia, gait and speech problems. In the US, EU, and Japan,
MSA affects about 40,000 people (prevalence of 4 per 100,000), with
about 6,000 new cases diagnosed each year (incidence of 0.6 per
100,000). Post-diagnosis life expectancy is about 7-10 years. Due
to the relatively small number of affected patients and lack of
effective therapy, MSA qualifies for orphan status, allowing a
shorter development path. This unmet medical need for MSA disease
modification is the driver to develop new therapies that could
potentially impact the lives of patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
About MODAG
MODAG, a privately held German biotech company, is focused on
the research and development of therapeutics and diagnostics for
neurodegenerative diseases. MODAG's innovative approach offers a
unique combination of early diagnosis and targeted
disease-modifying therapies for severe neurological disorders.
MODAG's collaborations with the top-tier US and European research
institutions, combined with its founders and management team's
interdisciplinary research and development expertise, provide ideal
conditions for accelerated implementation of clinical applications.
Built upon an extensive portfolio of patented active compounds,
MODAG is developing a new oligomer modulator for MSA, PD and other
synucleinopathies such as Alzheimer's disease, intending to deliver
novel, first-in-class drugs with the potential to halt disease
progression. For more information, see www.modag.net.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to; our ability to successfully
compete in the marketplace, including our ability to develop and
commercialize biopharmaceutical products, competition for our
specialty products, including AUSTEDO®, AJOVY and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline, our ability to develop and commercialize additional
pharmaceutical products, and the effectiveness of our patents and
other measures to protect our intellectual property rights; our
substantial indebtedness; our business and operations in general,
including uncertainty regarding the COVID-19 pandemic and its
impact on our business, financial condition, operations, cash
flows, and liquidity and on the economy in general, our ability to
successfully execute and maintain the activities and efforts
related to the measures we have taken or may take in response to
the COVID-19 pandemic and associated costs therewith, costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
compliance, regulatory and litigation matters, including failure to
comply with complex legal and regulatory environments; other
financial and economic risks; and other factors discussed in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the section captioned “Risk Factors.” Forward-looking
statements speak only as of the date on which they are made, and we
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result of new information, future events or otherwise. You are
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IR Contacts United States Kevin C. Mannix (215)
591-8912 Yael Ashman 972 (3) 914-8262 PR Contacts United
States Kelley Dougherty (973) 658-0237 Yonatan Beker (973) 264
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