File acceptance marks important milestone for
Teva and MedinCell’s commitment to treatments for mental
disorders
Regulatory News:
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext:
MEDCL) announced today that the New Drug Application (NDA) for
TV-46000/mdc-IRM (risperidone extended-release injectable
suspension for subcutaneous use) for the treatment of schizophrenia
has been accepted by the U.S. Food and Drug Administration
(FDA).
The acceptance is based on Phase 3 data from two pivotal
studies: TV46000-CNS-30072 (the RISE Study – The Risperidone
Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the
SHINE Study - A Study to Test if TV-46000 is Safe for Maintenance
Treatment of Schizophrenia). These studies evaluated the efficacy
and long-term safety and tolerability of TV-46000 as a treatment
for patients with schizophrenia. Results will be shared at future
scientific conferences and in peer-reviewed publications.
"The advancements made in managing mental health conditions over
the past decade have been shaped by offering patients new treatment
options. Now, we are taking the same approach with long-acting
treatments, using advanced science to improve disease outcomes for
those living with Schizophrenia," said Dr. Hafrun Fridriksdottir,
Executive Vice President, Global R&D, at Teva. “We’re pleased
to share news of this progress as we move one step closer to
potentially bringing a new treatment option to patients in
need.”
Teva will continue to lead the clinical development and
regulatory process and be responsible for commercialization of this
candidate treatment, with MedinCell eligible for development
milestones, royalties on net sales and future commercial
milestones.
"NDA file acceptance marks a major milestone for MedinCell, for
our extended-release injectable technology, and for patients living
with schizophrenia,” said Christophe Douat, CEO of MedinCell.
Through our strategic collaboration with Teva, we move one-step
closer towards helping patients and care-providers gain access to
our extended-release subcutaneously injectable risperidone.”
About TV46000-CNS-30072 (The RISE Study – The Risperidone
Subcutaneous Extended-Release Study)
The RISE study was a multicenter, randomized, double-blind,
placebo-controlled study to evaluate the efficacy of risperidone
extended-release injectable suspension for subcutaneous use as a
treatment in patients (ages 13-65 years) with schizophrenia. 544
patients were randomized to receive a subcutaneous injection of
TV-46000 once monthly (q1M), once every two months (q2M), or
placebo in a 1:1:1 ratio. The primary endpoint was time to
impending relapse.
About TV46000-CNS-30078 (The SHINE Study)
The second of Teva’s Phase 3 studies; designed to evaluate the
long-term safety, tolerability and effectiveness of TV-46000
subcutaneously administered q1M or q2M for up to 56 weeks in 331
patients (ages 13-65 years) with schizophrenia. The primary
endpoint is the frequency of all adverse events, including serious
adverse events. This study is ongoing; interim results align with
the findings of the RISE study (TV46000-CNS-30072).
About Schizophrenia
Schizophrenia is a chronic, progressive and severely
debilitating mental disorder that affects how one thinks, feels and
acts. Patients experience an array of symptoms, which may include
delusions, hallucinations, disorganized speech or behavior and
impaired cognitive ability. Approximately 1% of the world’s
population will develop schizophrenia in their lifetime, and 3.5
million people in the U.S. are currently diagnosed with the
condition. Although schizophrenia can occur at any age, the average
age of onset tends to be in the late teens to the early 20s for
men, and the late 20s to early 30s for women. The long-term course
of schizophrenia is marked by episodes of partial or full remission
broken by relapses that often occur in the context of psychiatric
emergency and require hospitalization. Approximately 80% of
patients experience multiple relapses over the first five years of
treatment, and each relapse carries a biological risk of loss of
function, treatment refractoriness, and changes in brain
morphology. Patients are often unaware of their illness and its
consequences, contributing to treatment nonadherence, high
discontinuation rates, and ultimately, significant direct and
indirect healthcare costs from subsequent relapses and
hospitalizations.
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.
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 the development, approval and
commercialization of TV-46000/mdc-IRM (risperidone extended-release
injectable suspension for subcutaneous use); our ability to
successfully compete in the marketplace, including our ability to
develop and commercialize biopharmaceutical products, competition
for our specialty products, 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 assume no
obligation to update or revise any forward-looking statements or
other information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
About MedinCell
MedinCell is a clinical stage pharmaceutical company 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. Based in Montpellier, MedinCell
currently employs more than 140 people representing over 25
different nationalities.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210831005953/en/
Teva IR United States Kevin C. Mannix, (215)
591-8912 Yael Ashman, 972 (3) 914-8262
Teva PR United States Doris Li, (973) 265-3752
Israel Yonatan Beker, 972 (54) 888 5898
MedinCell France David Heuzé / Head of
Communication, + 33 (0)6 83 25 21 86 david.heuze@medincell.com
Louis-Victor Delouvrier / Newcap - IR, +33 (0)1 44 71 98 53
medincell@newcap.eu Nicolas Mérigeau / Newcap - Media Relation, +33
(0)1 44 71 94 98 medincell@newcap.eu
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024