Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM
19 Abril 2022 - 06:57PM
Business Wire
Regulatory News:
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Paris:MEDCL)
(Euronext: MEDCL) announced that the U.S. Food and Drug
Administration (“FDA”) has issued a Complete Response Letter (CRL)
regarding the New Drug Application (NDA) for TV-46000/mdc-IRM
(risperidone extended-release injectable suspension for
subcutaneous use) for the treatment of schizophrenia.
Teva and MedinCell remain committed to the development of
risperidone and to providing patients with access to the product in
the U.S., as quickly as possible. Teva is reviewing its next steps
based on the letter and will work closely with FDA to address their
recommendations.
The application included 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.
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,
biosimilar 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 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 140 people representing over
25 different nationalities. www.medincell.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
regarding TV-46000/mdc-IRM (risperidone extended-release injectable
suspension for subcutaneous use), 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 develop 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, 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 the governmental and societal responses
thereto; 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, 2021, 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.
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Teva IR Contacts United States Ran Meir 267-638-8167 Yael
Ashman 972 (3) 914-8262 Teva PR Contacts United
States Kelley Dougherty 973-832-2810 Yonatan Beker 973-917-0851
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 Merigeau (NewCap - Media Relations) +33 (0) 1 44 71 94 98
medincell@newcap.eu
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