TEL AVIV, Israel--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the China National Medical Products Administration (NMPA) has approved AUSTEDO® (Deutetrabenazine Tablets) for the treatment of chorea associated with Huntington's disease (HD) and Tardive Dyskinesia (TD) in adults, after a priority review. China is the second country in the world after the U.S. to have approved AUSTEDO.
As part of the expedited review process, the NMPA placed AUSTEDO on the List of Overseas New Drugs Urgently Needed in Clinical Settings (the First Batch) and granted it priority review, ultimately completing the approval process in four months for the benefit of Chinese patients. This is the second approval and expected launch in China of a Teva specialty medicine, following the recent launch of TREANDA. Teva will commercialize the medicine in China independently.
“The approval of AUSTEDO in China is an exciting milestone for Teva," said Gianfranco Nazzi, Executive Vice President, International Markets, at Teva. "We are delivering on our mission to improve patients’ lives by offering a new treatment option for conditions where the unmet need is significant. We look forward to bringing more of the essential medicines in our portfolio to patients in China, and to fuel organic growth and expand our presence in this important market.”
About Huntington's Disease
A rare and fatal neurodegenerative disorder, Huntington's Disease has an overall prevalence rate in Asia of 0.40/100,000, with an average age at onset of 40 years.1 Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of this disease and occurs in approximately 90% of patients.
About Tardive Dyskinesia
Tardive dyskinesia is a movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The often-debilitating disorder affects about 500,000 people in the United States and is usually a result of treatment with widely used medications for psychiatric conditions such as schizophrenia and bipolar disorder or the gastrointestinal agent, metoclopramide. The prevalence of TD in China is 33.7%2 in individuals with Schizophrenia receiving long-term treatment with antipsychotics and can be caused by certain medications used to treat mental health conditions, which means that up to one third of treated Schizophrenia patients may have TD. The disease not only affects the treatment adherence of patients, but also affects their quality of life and their social functioning. This is the first approved treatment TD in China.
About AUSTEDO® (deutetrabenazine)
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.
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 regarding the launch of AUSTEDO® for treating Chorea associated with Huntington's Disease and Tardive Dyskinesia in adults in China, 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:
- uncertainty of the commercial success of AUSTEDO;
- uncertainty inherent in product development, including the receipt of approval for additional geographies and indications;
- our ability to successfully launch additional products in China;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and 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; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; 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 Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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.
1 Xu M, Wu ZY. Huntington Disease in Asia. Chin Med J (Engl). 2015;128(13):1815–1819. doi:10.4103/0366-6999.159359.
2 Y Z, DC C, LY Q, et al. - Gender differences in the prevalence, risk and clinical correlates of Tardive Dyskinesia in Chinese schizophrenia. Psychopharmacology 2009;205(4):647-654.