JERUSALEM & SAN FRANCISCO -- (Business Wire)
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/
Contacts:
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Nuvelution:
Sandy Zweifach,
650-866-8065
Source: Teva Pharmaceutical Industries Ltd.
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