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 Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced 
 the U.S. Food and Drug Administration (FDA) has accepted the New Drug 
 Application (NDA) and granted Priority Review for SD-809 
 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). The FDA 
 has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 
 August 30, 2017.
 
 
 "Teva is committed to advancing new therapeutic options for patients 
 with neurological and movement disorders. There remains a significant 
 unmet medical need in tardive dyskinesia," said Michael Hayden, M.D., 
 Ph.D., President of Global R&amp;D and Chief Scientific Officer at Teva. 
 "SD-809 has the potential to reduce the severity of the abnormal 
 involuntary movements of tardive dyskinesia which lead to social 
 isolation for these patients. Currently there is no approved therapy in 
 the U.S. for TD and this important milestone brings Teva one step closer 
 to making SD-809 available."
 
 
 The NDA for SD-809 is based on results from two Phase III studies, 
 ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD 
 (Addressing Involuntary Movements in Tardive Dyskinesia). A Priority 
 Review is an expedited review granted by the FDA that allows for a 
 faster evaluation of applications for drugs that could be significant 
 improvements in the safety or effectiveness in the treatment of serious 
 conditions. SD-809 was previously granted Breakthrough Therapy 
 Designation by the FDA.
 
 
 About Tardive Dyskinesia
 
 
 Tardive dyskinesia, a condition for which there are no approved 
 therapies in the United States, 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.
 
 
 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 100 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 innovative 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&#39;s net revenues in 2016 were $21.9 billion. For more information, 
 visit <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.tevapharm.com%2F&amp;esheet=51517541&amp;newsitemid=20170228005838&amp;lan=en-US&amp;anchor=www.tevapharm.com&amp;index=1&amp;md5=bec8456f7172a9261559626f924825f5" rel="nofollow" rel="nofollow">www.tevapharm.com</a>.
 
 
 Teva&#39;s Safe Harbor Statement under the U. S. Private Securities 
 Litigation Reform Act of 1995:
 
 
 This press release contains forward-looking statements, 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:
 
 <ul xmlns="http://www.w3.org/1999/xhtml">
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 our generics medicines business, including: that we are 
 substantially more dependent on this business, with its significant 
 attendant risks, following our acquisition of Actavis Generics; our 
 ability to realize the anticipated benefits of the acquisition (and 
 any delay in realizing those benefits) or difficulties in integrating 
 Actavis Generics; the increase in the number of competitors targeting 
 generic opportunities and seeking U.S. market exclusivity for generic 
 versions of significant products; price erosion relating to our 
 generic products, both from competing products and as a result of 
 increased governmental pricing pressures; and our ability to take 
 advantage of high-value biosimilar opportunities;
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 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;
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 our substantially increased indebtedness and significantly 
 decreased cash on hand, which may limit our ability to incur 
 additional indebtedness, engage in additional transactions or make new 
 investments, and may result in a downgrade of our credit ratings;
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 our business and operations in general, including: uncertainties 
 relating to our recent senior management changes; 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 information 
 technology systems or breaches of our data security; the failure to 
 recruit or retain key personnel, including those who joined us as part 
 of the Actavis Generics acquisition; the restructuring of our 
 manufacturing network, including potential related labor unrest; the 
 impact of continuing consolidation of our distributors and customers; 
 variations in patent laws that may adversely affect our ability to 
 manufacture our products; 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;
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 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;
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 other financial risks, including: our exposure to currency 
 fluctuations and restrictions as well as credit risks; the significant 
 increase in our intangible assets, which may result in additional 
 substantial impairment charges; potentially significant increases in 
 tax liabilities; and the effect on our overall effective tax rate of 
 the termination or expiration of governmental programs or tax 
 benefits, or of a change in our business;
 </li>
 </ul>
 
 and other factors discussed in our Annual Report on Form 20-F for the 
 year ended December 31, 2016 ("Annual Report") and in our other filings 
 with the U.S. Securities and Exchange Commission (the "SEC"). 
 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 advised to consult any additional disclosures we make in our reports 
 to the SEC on Form 6-K, as well as the cautionary discussion of risks 
 and uncertainties under "Risk Factors" in our Annual Report. These are 
 factors that we believe could cause our actual results to differ 
 materially from expected results. Other factors besides those listed 
 could also materially and adversely affect us. This discussion is 
 provided as permitted by the Private Securities Litigation Reform Act of 
 1995.
 
 
 
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Press Releases

Teva Announces Priority Review Granted by FDA for SD-809 for Treatment of Tardive Dyskinesia - Teva Pharmaceutical Indus (NYSE:TEVA)

Teva Pharmaceutical Indus

TEVA

Teva Announces Priority Review Granted by FDA for SD-809 for Treatment of Tardive Dyskinesia


 


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