Valbenazine Tosylate

Nearly 98% of patients experience quality of life impact as a result of tardive dyskinesia (TD) including social, psychological, physical and recreational aspects of daily living Data highlight for the first time that TD has a multidimensional impact on patients including those with mild TD severity IMPACT-TD Registry is the largest-ever study of its kind evaluating the holistic effects of TD over three years along with real-world treatment patterns and outcomes with once-daily AUSTEDO® XR (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO® (deutetrabenazine) tablets TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, reinforcing that TD has a wide-reaching, multidimensional impact on patients’ quality of life. These interim findings from the IMPACT-TD study were presented at the 2024 Psych Congress Elevate Annual Meeting, taking place from May 30 – June 2 in Las Vegas, Nevada. “TD can be a devastating setback for those who have achieved mental stability with their psychiatric medication,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “These interim findings from IMPACT-TD Registry, the largest study of its kind, reveal the profound effect that TD can have on a patient’s life, beyond the clinic. Understanding the full impact of TD and how approved treatment options for TD, like once-daily AUSTEDO XR and twice-daily AUSTEDO, can help treat the condition is critical to improving outcomes for patients and is a driving force in our unwavering commitment to developing meaningful solutions for them.” The two-part IMPACT-TD study is a 3-year longitudinal observational study evaluating how TD progresses over time and impacts a patient’s quality of life (Part A), as well as outcomes related to treatment with once-daily AUSTEDO XR and twice-daily AUSTEDO (Part B). Clinician-reported TD severity and impact is assessed using the IMPACT-TD scale, the AIMS (Abnormal Involuntary Movement Scale) and the CGIS-TD (Clinical Global Impression of Severity of TD) scale. The interim analysis includes 286 patients with varying levels of TD severity and highlights, for the first time, that clinicians reported that TD has a multidimensional impact, even on patients with mild TD severity. Clinician-reported IMPACT-TD findings show: 98% of patients experience the impact of TD in some aspect of their quality of life 83% of patients experience moderate to severe impact across various quality of life domains, including social (59%), psychological/psychiatric (70%), physical (53%) and vocational/educational/recreational (57%) 54% and 61% of patients with “very mild” and “mild” TD severity based on CGIS-TD, respectively, experience moderate to severe impact on their quality of life Patient-reported TD impact is assessed using the novel IMPACT-TD PRO (IMPACT-TD Patient-Reported Outcome) scale. Patient-reported findings, as assessed with the IMPACT-TD PRO, show: 59% and 57% of patients reported that TD caused embarrassment in social situations and impacted their ability to enjoy the things they do for fun, respectively 43% of patients reported that TD impacts their sleep 38-42% of patients reported experiencing the physical impact of TD, including on their ability to hold things, do chores and exercise “These data provide a clearer understanding as to how the abnormal movements of TD significantly impact the daily functioning of patients that cannot be gleaned from looking solely at the severity of the movements,” said Richard Jackson, MD, an Assistant Clinical Adjunct Professor in the University of Michigan School of Medicine’s Department of Psychiatry and the study’s lead investigator. “TD can impact all domains of daily functioning including social, psychological, physical, occupational and recreational aspects of daily living even when the abnormal movements appear to be mild. This emphasizes the need for all clinicians to assess not only the severity of a patient’s TD movements but the impact those movements can have on all aspects of life. Continuing to understand the multifaceted impact of TD and finding ways to alleviate these burdens is crucial to supporting patients on their TD journey.” Also presented at Psych Congress Elevate 2024 were data supporting: The development and internal validation of the IMPACT-TD PRO scale, suggesting that the questionnaire can effectively and reliably characterize the multidimensional impact of TD in adult patients. Final results from the TD cohort of the Phase 4 START study, which investigated real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit. These full START results show that the titration kit successfully helped patients with TD find individualized therapeutic AUSTEDO doses with effectiveness similar to that observed in the pivotal clinical trials, with high adherence and patient satisfaction rates. Findings from a retrospective study comparing healthcare resource utilization (HCRU) in patients with TD treated with benztropine versus non-treated patients with TD suggest that benztropine can result in potential harm and increased cost for the patient if used off-label for the treatment of TD. About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3 About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO. INDICATIONS AND USAGE AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. IMPORTANT SAFETY INFORMATION Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are 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 or valbenazine. Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects. QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and 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 XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems. Akathisia, Agitation, and Restlessness: AUSTEDO XR and 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 XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. Parkinsonism: AUSTEDO XR and 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 XR or 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 XR and 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 XR or 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 XR and 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. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. Please see accompanying full Prescribing Information, including Boxed Warning. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit . 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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” 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. Hauppauge, NY: Nova Science Publishers. 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 Tardive dyskinesia. National Alliance on Mental Illness website. . Accessed May 4, 2023. View source version on businesswire.com: Contacts PR Contacts Kelley Dougherty +1 (973) 832-2810 Eden Klein +972 (3) 906 2645 IR Contacts Yael Ashman +972 (3) 914 8262 Sanjeev Sharma +1 (973) 658 2700 Ran Meir +1 (267) 468-4475 Source: Teva Pharmaceutical Industries Limited View this news release online at:

None  Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please send the good word—or the bad—from your shop to Gabrielle Masson and it will be featured here at the end of each week.  Roche bids adieu to pharma BD vet Sabry Roche It’s the end of an era at Roche as veteran dealmaker James Sabry, Ph.D., hangs up his hat following 14 years at the company. Sabry, whose retirement was announced earlier this week, will be exiting his role as head of Roche Pharma Partnering, which he assumed in 2018.  Sabry started his career at the Swiss pharma giant back in 2010 when he joined Roche’s Genentech as head of partnering. Roche’s current head of group business development, Boris Zaïtra, will take up the baton in Sabry’s absence. July 1, Zaïtra will assume the role of head of corporate business development, a new position that weds the functions of both Roche’s pharma partnering and group business development operations. In his new post, Zaïtra will join Roche’s corporate executive committee. Zaïtra has been with Roche in his current role since 2012. With regards to Sabry’s departure, Roche’s CEO Thomas Schinecker noted in a statement that the executive “has been instrumental in forging important deals for our Pharma R&D pipeline that have led to numerous launches of new medicines,” adding that external innovation would continue to be a critical part of Roche’s business strategy. Release  Vir fills vacant CMO spot Vir Biotechnology  Just a few months after Vir Biotechnology installed Bayer’s Marianne De Backer, Ph.D., as CEO, the company has also named a new chief medical officer. Mark Eisner, M.D., is slated to step on as Vir’s executive vice president and CMO starting June 3. He fills the spot of Phil Pang, M.D., Ph.D., who left the immunology company at the end of March to spend more time with his family. Eisner joins from cell therapy biotech Sonoma Biotherapeutics, where he also served as CMO. The leader has also clocked in time at FibroGen and Roche’s Genentech, where he served as senior vice president and global head of product development immunology, infectious disease and ophthalmology. Eisner’s expertise with late-stage clinical trials and immunology and infectious disease will be key to Vir’s next stage of growth, De Backer said in a May 29 announcement. Release  Neurocrine maps out CEO succession plan Neurocrine Biosciences *Cue the “Succession” theme song.* Neurocrine Biosciences has selected its next leader alongside the announcement that current CEO Kevin Gorman, Ph.D., will retire after nearly 32 years at the company that he helped start in the early '90s. That tenure included shifts as Neurocrine’s chief business officer, chief operating officer and, since January 2008, president and chief executive.  Gorman will step down Oct. 11, when he’ll be succeeded by Kyle Gano, Ph.D., who’s also put in multiple decades at Neurocrine. Since joining in 2001, Gano has held various leadership roles across the company, culminating in his appointment as chief business development officer in 2011 and the addition of the chief strategy officer title in 2020. Gano will take the reins amid a busy time for Neurocrine. As he noted in a statement, “This is an important year for our organization, as we look to help even more patients with tardive dyskinesia and Huntington's disease through INGREZZA, while potentially bringing crinecerfont to CAH patients in 2025–all while advancing our pipeline.” When the CEO baton is passed this fall, Gorman will remain a member of Neurocrine’s board of directors, and Gano will take a board seat of his own. Fierce Pharma  > South San Francisco-based synthetic lethality specialist Ideaya Biosciences is getting ready to welcome a new executive into the fold later this summer. The company has appointed Daniel Simon to serve as its chief business officer starting in August. Simon comes over from Revolution Medicines, where he served in the same role from 2022 to 2024. Prior to that, he was SVP of biopharma business development at Guardant Health. Release > Monte Rosa Therapeutics has rounded out May with a suite of leadership promotions. Sharon Townson, Ph.D., who joined the molecular glue degrader developer as chief technology officer, is being elevated to the role of chief scientific officer. Meanwhile, Monte Rosa’s current general counsel Phil Nickson, Ph.D., is being promoted to chief business and legal officer. And Jennifer Champoux, who joined the company as vice president of operations, has become chief operating officer. Release  > As Nurix Therapeutics plows ahead with development of its small-molecule BTK degrader NX-5948, the San Francisco-based biotech is bulking up in the C-suite. Nurix has enlisted Paula O’Connor, M.D., to serve as its chief medical officer, while Pasit Phiasivongsa, Ph.D., has signed on as chief technical officer. O’Connor joined Nurix in 2022 and most recently served as VP and head of clinical development. Phiasivongsa also joined Nurix in 2022 and most recently held the role as EVP of technical operations. Release > James Ahlers has been removed from his executive officer role at Intensity Therapeutics, a move made “solely in recognition of the reduced scope of [his] responsibilities” rather than any disagreement with the company, according to a regulatory filing. Ahlers originally joined Intensity as CFO in early 2022 before being named executive VP of corporate finance in June 2023. He’ll stay on as a senior consultant to the company. Release > Cardiovascular gene editing company Verve Therapeutics's Chief Scientific Officer Andrew Bellinger, M.D., Ph.D., is stepping down. Starting June 21, Troy Lister, Ph.D., Verve’s senior vice president of research and early development, will take on the CSO role. Release  > Sapreme Technologies has a new CEO: The Dutch biotech has appointed Marco Timmers, Ph.D., former CEO and CSO of Byondis, to replace Guy Hermans, Ph.D., as chief executive. Meanwhile, Sapreme also named the first four members of its newly established scientific advisory board and selected Jeanne Bolger, M.D., previously VP of venture investing for Johnson & Johnson Innovation, to serve as chair of the board of directors. Release > Patrice Matchaba, M.D., is the new CEO of the Bill & Melinda Gates Medical Research Institute, effective June 10. Matchaba previously spent more than two decades in various leadership roles at Novartis, culminating in a term as president of the pharma’s US Foundation. He’ll take over from Emilio Emini, Ph.D., who recently announced his retirement from the institute after nearly three years as CEO following stints at Merck, Pfizer and the Gates Foundation. Release  > Iterum Therapeutics' Chief Medical Officer Sailaja Puttagunta, M.D., is transitioning into a consulting role. Puttagunta will hold the position through the FDA's review of Iterum's resubmitted new drug application for oral sulopenem to treat uncomplicated urinary tract infections in women. A decision is expected by Oct. 25. Release  > On May 28, Compass Therapeutics’ CEO Vered Bisker-Leib, Ph.D., resigned from his role and instead stepped into a consultant position. In his place, the board tapped Thomas Schuetz, M.D., Ph.D., R&D president and vice chair of the board of directors, as CEO and president plus principal executive officer, principal financial and principal accounting officer of Compass. Release > mRNA-focused Omega Therapeutics has tapped Kaan Certel, Ph.D., to lead the biotech’s business development. Most recently, Certel was BioCity Biopharma’s chief business officer, and, before that, served as Sanofi’s global head of oncology external innovation. Release > Precision medicine company Entact Bio has elected Michael Gutch, Ph.D., to serve as chief operating officer. Gutch joins Entact from Noema Pharma, and has past experience at Entasis Therapeutics and AstraZeneca, among others. Release > Alkeus Pharmaceuticals has appointed Eric Trachtenberg as chief legal officer. The leader joins from Kala Bio, where he served as chief legal officer, chief compliance officer and corporate secretary. Release