Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and
Nuvelution Pharma, Inc. today announced their partnership to
develop AUSTEDO® (deutetrabenazine) tablets for the treatment of
tics associated with Tourette syndrome (TS) in pediatric patients
in the United States. This partnership will accelerate development
of Austedo® in TS, hopefully bringing a much needed new treatment
option to affected young patients more quickly.
This novel agreement provides a creative risk-sharing funding
framework for progressing a promising pipeline opportunity into an
approved product, with a success-based investment return for
Nuvelution. Under the terms of the agreement, Nuvelution will fund
and manage clinical development, driving all operational aspects of
the Phase III program, which is expected to commence later this
year. Teva will lead the regulatory process and be responsible for
commercialization. Upon FDA approval of AUSTEDO® in TS, Teva will
pay Nuvelution a pre-agreed return on its invested capital.
"More than 130,000 children with Tourette syndrome in the US
endure significant distress, stigmatization and isolation due to
their motor and phonetic tics" said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva.
"Nuvelution is the ideal partner to help us realize the potential
of this medication in Tourette syndrome and to help bring it to
patients as quickly as possible."
"Following the successful development programs for AUSTEDO® in
chorea associated with HD and Tardive Dyskinesia, we believe this
partnership represents a win, win, win scenario for patients, Teva
and Nuvelution, and our investors Clarus and Novo Holdings A/S,"
said Sandy Zweifach, President and CEO of Nuvelution Pharma. Inc.
"We are confident, and ready, to rapidly move this program through
Phase III, focused on delivering a successful development
conclusion."
About Tourette Syndrome
Tourette syndrome (TS) is a neurological disorder characterized
by repetitive, stereotyped, involuntary movements and vocalizations
called tics. The early symptoms of TS are typically noticed first
in childhood, with the average onset between the ages of 3 and 9
years. Although TS can be a chronic condition with symptoms lasting
a lifetime, most people with the condition experience their worst
tic symptoms in their early teens, with improvement occurring in
the late teens and continuing into adulthood.
About AUSTEDO®
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease.
Important Safety Information
AUSTEDO® can increase the risk of depression
and suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Anyone considering the use of
AUSTEDO® must balance the risks of depression and
suicidality with the clinical need for treatment of chorea.
AUSTEDO® is contraindicated in patients with
Huntington’s disease who are suicidal, or have untreated or
inadequately treated depression.
AUSTEDO® is also contraindicated in: patients with hepatic
impairment; patients taking reserpine or within 20 days of
discontinuing reserpine; patients taking monoamine oxidase
inhibitors (MAOIs), or within 14 days of discontinuing MAOI
therapy; and patients taking tetrabenazine (Xenazine) or
valbenazine (Ingrezza).
AUSTEDO® may cause a worsening in mood, cognition, rigidity, and
functional capacity in patients with Huntington’s disease.
Tetrabenazine (a closely related VMAT2 inhibitor) causes an
increase in the corrected QT (QTc) interval. A clinically relevant
QT prolongation may occur in some patients treated with AUSTEDO®
who are CYP2D6 poor metabolizers or are co-administered a strong
CYP2D6 inhibitor or other drugs that are known to prolong QTc.
Neuroleptic Malignant Syndrome has been observed in patients
receiving tetrabenazine. AUSTEDO® may increase the risk of
akathisia, agitation, and restlessness. AUSTEDO® may cause
parkinsonism in patients with Huntington’s disease. Sedation is a
common dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated
patients and greater than placebo) in controlled clinical studies
of patients with tardive dyskinesia were nasopharyngitis and
insomnia. The most common adverse reactions (>8% of
AUSTEDO®-treated patients and greater than placebo) in a controlled
clinical study of patients with chorea associated with Huntington’s
disease were somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information,
including Boxed Warning: austedo.com/hcp/pi.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in over 60 markets every day. Headquartered in
Israel, Teva is the world’s largest generic medicines producer,
leveraging its portfolio of more than 1,800 molecules to produce a
wide range of generic products in nearly every therapeutic area. In
specialty medicines, Teva has the world-leading treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
www.tevapharm.com.
About Nuvelution Pharma
Nuvelution leverages its extensive knowledge, experience and
relationships in the Pharma and Biotech industries to deploy
capital in risk-sharing collaborations with companies where product
development can be facilitated by both capital and human resources
with the goal of making this model an essential tool for pharma and
biotech companies to bring products to the market. For more
information, please visit www.nvtpharma.com.
Teva's 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 the collaborative development agreement of AUSTEDO®
(deutetrabenazine) Tablets for use in Tourette Syndrome, 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. Important factors that could
cause or contribute to such differences include risks relating
to:
- the potential that the expected
benefits and opportunities related to the collaboration may not be
realized or may take longer to realize than expected;
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products; our ability to consummate dispositions on terms
acceptable to us; adverse effects of political or economic
instability, major hostilities or terrorism on our significant
worldwide operations; and our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”),
including in the section captioned “Risk Factors,” and in our other
filings with the U.S. Securities and Exchange Commission,
which are available at www.sec.gov and www.tevapharm.com.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170919005780/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, 215-591-8974orNuvelution:Sandy
Zweifach, 650-866-8065
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