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|September 19, 2017 10:00 a.m.|
|Teva and Nuvelution Pharma Partner to Accelerate Development of AUSTEDO® (deutetrabenazine) Tablets for Use in Tourette Syndrome in the United States|
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
"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
"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
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.
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the
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 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:
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.
Teva Pharmaceutical Industries Ltd.