Teva Launches 'It's Not OK - It's TD' National Television Advertising Campaign to Increase Awareness of Tardive Dyskinesia and AUSTEDO® (deutetrabenazine) tablets

TEL AVIV, Israel and PARSIPPANY, N.J., May 17, 2021 /PRNewswire/ -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA), today announced the launch of It's Not OK – It's TD, a new national television advertising campaign, which aims to inspire patients with tardive dyskinesia (TD) symptoms to speak up and share the impact of TD with their healthcare provider, start working together to manage their symptoms rather than coping, and ask about how treatment with AUSTEDO^® (deutetrabenazine) tablets may help. Encouraging patients to say, 'It's not OK,' the ad drives awareness of AUSTEDO, a prescription medicine that may help manage TD while patients continue their mental health medication(s) like antipsychotics or antidepressants. 

Tardive dyskinesia is associated with certain prescription medicines used to treat mental health or gastrointestinal conditions.^1,2 One in four people who take certain mental health treatments may develop the uncontrollable movements of TD, including mild-to-severe twitching, shaking or jerking of hands, feet, face or torso, and more. Whether symptoms are mild, moderate, or severe, the impact of TD can be significant, causing physical changes that may lead to functional and emotional changes.^1,2,3 

"As we navigate through a global pandemic, we know there is an increase in individuals reporting symptoms of anxiety or depressive disorder," said Brendan O'Grady, Executive Vice President and Head of North America Commercial at Teva. "Now more than ever, it is important to elevate our efforts to support individuals with TD and mental health conditions. We developed the 'It's Not OK – It's TD' campaign based on valuable insights from patients with TD, allowing us to put a much needed and authentic spotlight on the disorder and how it can truly impact well-being, while driving education about AUSTEDO as a treatment that may help manage their TD symptoms."  

People living with mental health conditions often feel stigmatized and delay seeking treatment.⁴ For some patients, finding the right combination of mental health medications can take several years, and some living with TD would rather cope with their movements than alter their existing treatment regimen and risk relapse.^5,6,7

"TD is already under-diagnosed and under-treated, and with increasing telemedicine visits, it is more challenging to visually identify TD movements, leaving patients to continue coping with the physical and emotional impact of their symptoms," said Rakesh Jain, MD, MPH, Clinical Professor, Department of Psychiatry, Texas Tech Health Sciences Center School of Medicine, Midland. "For patients with mental health conditions, it's critical that we initiate open discussions about their experience with TD and in managing it, we don't take away from their progress and related treatment plan. I'm pleased AUSTEDO can help patients manage their TD symptoms without affecting their mental health treatment regimens."

In one clinical study, AUSTEDO significantly reduced the involuntary movements of TD after 12 weeks of treatment vs. placebo, with improvement beginning to be seen as early as 2 weeks. Additionally, in an open label extension study—the longest TD study to date—symptom control was sustained through 145 weeks, and no new adverse events were observed compared to those in pivotal trials. The most common side effects of AUSTEDO include inflammation of the nose and throat (nasopharyngitis) and problems sleeping (insomnia).^8,9,10

Several informational resources are available on AUSTEDO.com to help individuals throughout the entire process—from learning more about TD to starting and staying on course with treatment:

• TD doctor discussion guide and symptom questionnaire for in-person or telemedicine visits
• AUSTEDO patient brochure
• Daily treatment and activity log to better guide patient discussions with their healthcare provider
• AUSTEDO treatment tracking guide to help establish a dosing routine and taking medication as prescribed by the provider

Additionally, Teva's Shared Solutions^® program is committed to partnering with patients throughout their treatment with AUSTEDO. This includes financial assistance programs where a dedicated team of benefits specialists can help eligible patients gain access to AUSTEDO as soon as possible through: 

• AUSTEDO^® Copay Program, where eligible commercially insured patients may receive the treatment for as little as $0 copay per month
• Assistance with navigating through Medicare Part D
• Additional financial assistance programs that may exist depending on insurance coverage and meeting eligibility requirements

The program's nurse phone support also allows patients to connect with trained nurses to discuss their treatment.

To view the new commercial, please visit YouTube and visit Austedo.com/tardive-dyskinesia for more information on TD and the campaign.

About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is associated with certain prescription medications used to treat mental health or gastrointestinal conditions.^1,2 One in four people who are taking certain mental health medications may develop uncontrollable movements of TD. Long-term use of some medications to treat schizophrenia, bipolar disorder, depression, and some other conditions can lead to TD.^2,3

TD can appear as mild-to-severe twitching, shaking or jerking in the hands, feet, face, or torso, involuntary blinking, tongue movements, and other unintentional movements. The severity of TD symptoms can vary from person to person, but even mild symptoms can be bothersome. The unintentional, uncontrollable movements of TD can impact a person both physically and functionally, making activities like walking, writing, eating, speaking, or swallowing difficult.^1,2,3 

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. Safety and effectiveness in pediatric patients have not been established.

AUSTEDO^® Indications and Usage

AUSTEDO^® is indicated for the treatment of chorea associated with Huntington's disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information About AUSTEDO^®

Depression and Suicidality in Patients with Huntington's Disease:  AUSTEDO^® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO^® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications:  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^®). 

Clinical Worsening and Adverse Events in Patients with Huntington's Disease:  AUSTEDO^® may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO^® in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: AUSTEDO^® may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO^® is administered within the recommended dosage range.  AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO^®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems. 

Akathisia, Agitation, and Restlessness:  AUSTEDO^® may increase the risk of akathisia, agitation, and restlessness.  The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO^® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism:  AUSTEDO^® may cause parkinsonism in patients with Huntington's disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors.  The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO^® dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence:  Sedation is a common dose-limiting adverse reaction of AUSTEDO^®. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO^® and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia:  Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO^®. 

Binding to Melanin-Containing Tissues:  Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions:  The most common adverse reactions for AUSTEDO^® (>8% and greater than placebo) in a controlled clinical study in patients with Huntington's disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO^® (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.

Please see accompanying full Prescribing Information, including Boxed Warning.

About Teva
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 AUSTEDO, 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 commercial success of AUSTEDO;
• 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; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO, AJOVY^® and COPAXONE^®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including: uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; 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; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; 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; and our prospects and opportunities for growth if we sell assets;
• compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); 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;

and other factors discussed in this press release and in our Quarterly Report on Form 10-Q for the first quarter of 2021 and in our Annual Report on Form 10-K for the year ended December 31, 2020, 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 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs: Pharmacology, Side Effects and Abuse Prevention. Hauppauge, NY: Nova Science Publishers, Inc; 2013:235-258. 
² Waln O, Jankovic J. An update on tardive dyskinesia: from phenomenology to treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. 
³ National Alliance on Mental Illness (NAMI). Tardive Dyskinesia. Accessed April 2021. https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Tardive-Dyskinesia.
⁴ American Psychiatric Association. Stigma, Prejudice and Discrimination Against People with Mental Illness. APA website. Accessed April 2021. https://www.psychiatry.org/patients-families/stigma-and-discrimination.
⁵ International Bipolar Foundation. Finding the Right Medication. Accessed April 2021. https://ibpf.org/articles/finding-the-right-medication/#:~:text=Be%20patient%20as%20it%20can,you%20find%20the%20right%20balance.
⁶ Caroff SN. Overcoming barriers to effective management of tardive dyskinesia. Neuropsychiatr Dis Treat. 2019;15:785-794. 
⁷ Fernandez HH, Stamler D, Davis MD, et al. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019;90(12):1317-1323.
⁸ AUSTEDO^® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc. 
⁹ Data on file. Parsippany, NJ. Teva Neuroscience, Inc.
¹⁰ Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604.

SOURCE Teva Pharmaceutical Industries Ltd

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