Parkinson Disease, Secondary

U.S. FDA approves new one pill, once-daily AUSTEDO XR tablets (30, 36, 42, 48 mg/day) AUSTEDO XR offers more flexibility with the most once-daily doses of any vesicular monoamine transporter 2 (VMAT2) inhibitor for effective and tolerable tardive dyskinesia (TD) and Huntington’s disease (HD) chorea control1 Patients with TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with HD chorea may experience a significant reduction in Total Maximal Chorea (TMC) score, with three years of the longest TD and HD chorea clinical trials and sustained results to date 1,2,3,4,5 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 that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO XR as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for TD and HD chorea. “Since our launch of AUSTEDO® in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements,” said Dell Faulkingham, Senior Vice President, Head of U.S. Innovative Medicines at Teva. “AUSTEDO, backed by the longest efficacy and tolerability data to date, has continued to evolve – having received approval for AUSTEDO XR, our once-daily extended-release formulation in February 2023. This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility.” Currently more than 57 million Americans are living with a mental illness, 14 million of whom are living with a serious mental health condition.6 For those taking certain mental health medications, one in four may experience the onset of TD, an often-overlooked chronic movement disorder that can have a physical, emotional and psychological impact on patients.7,8 HD is a fatal neurodegenerative disease characterized by cognitive deterioration, behavior and/or psychological problems and uncoordinated and uncontrollable movements known as chorea – a symptom that affects 90% of patients.9,10 Both conditions can pose significant challenges to patients’ everyday lives as simple tasks like eating, talking and walking can be impacted. “Knowing patients living with TD and HD chorea are also managing other underlying concomitant conditions, it is important that treatment options for these chronic movement disorders are not only effective, but keep the patient experience in mind,” said Dr. Rakesh Jain, Clinical Professor of Psychiatry, Texas Tech University School of Medicine. “This latest AUSTEDO XR approval provides patients with the same proven efficacy, but now with the convenience of a one pill, once-daily option for clinically therapeutic doses as established by the pivotal clinical trials to help control involuntary movements that can make carrying out basic daily activities difficult." Patients with TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with HD chorea may experience a significant reduction in TMC score, with three years of the longest TD and HD chorea clinical trials and sustained results to date.1,2,3,4,5 AUSTEDO XR, along with its twice-daily counterpart, AUSTEDO (deutetrabenazine), are the only VMAT2 inhibitor treatments with no restrictions for use with CYP3A4/5 inducers or inhibitors, an important consideration for patients who take a variety of concomitant medications to manage their underlying conditions.11,12 Approximately 90% of patients with insurance coverage are expected to pay $10 or less for their prescription with financial assistance offerings.1 Teva is committed to helping eligible patients who have been prescribed AUSTEDO XR access their medication. Teva continues to support with access, reimbursement, prescription pull-through and patient assistance. Savings on out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility for participation in the co-pay assistance program. For more information regarding cost and coverage options for AUSTEDO XR through Teva Shared Solutions, visit MySharedSolutions.com. 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. 13,14,15 About Chorea Associated with Huntington’s Disease (HD) Huntington’s disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately 90% of patients. Chorea can have a significant impact on daily activities and progressively limit peoples’ lives. 9,10 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 Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 2 Hauser, R. A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia is Associated with Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study. Frontiers in Neurology (2022). 3 Anderson K. E., Stamler D., Davis M. D., et al. Deutetrabenazine for the treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomized, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604 4 Fernandez HH, Factor SA, Hauser RA, et al. Randomised controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 5 Marder S. R., Singer C., Lindenmayer J-P., et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6)620-627. 6 U.S. Department of Health and Human Services. (n.d.). Mental illness. National Institute of Mental Health. . 7 Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. J Clin Psychiatry. 2017;78(3):e264-e278. 8 Hansen TE, Brown WL, Weigel RM, Casey DE. Underrecognition of tardive dyskinesia and drug-induced parkinsonism by psychiatric residents. Gen Hosp Psychiatry. 1992;14(5):340-344. 9 Huntington’s Disease. National Institute of Neurological Disorders and Stroke. -. Accessed May 15, 2023. 10 Thorley, E. M., Iyer, R. G., Wicks, P., Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., & Carlozzi, N. E. (2018). Understanding How Chorea Affects Health-Related Quality of Life in Huntington Disease: An Online Survey of Patients and Caregivers in the United States. The patient, 11(5), 547–559. 11 AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets [current approved prescribing information].Parsippany, NJ: Teva Neuroscience, Inc 12 AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 13 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. 14 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. 15 Tardive dyskinesia. National Alliance on Mental Illness website. . Accessed May 15, 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:

MINNEAPOLIS, Oct. 17, 2023 /PRNewswire/ -- The American Brain Foundation has launched a $10 million cross-disciplinary research initiative that transcends traditional research and philanthropy boundaries by bringing together nonprofit organizations, pharmaceutical and biotech investors, philanthropists, and researchers. The initiative will provide funding for research by top neuroscientists to investigate the role of neuroinflammation in a wide range of brain diseases, both neurologic and psychiatric, including conditions as disparate as Alzheimer's, schizophrenia, long COVID-19, and autism. The research initiative is part of the American Brain Foundation's existing Cure One, Cure Many program, which promotes innovative, cross-cutting approaches to brain disease diagnosis and treatment. Continue Reading The American Brain Foundation has launched a $10 million cross-disciplinary research initiative, bringing together nonprofit organizations, pharmaceutical and biotech investors, philanthropists, and researchers. The initiative will provide research funding for top neuroscientists to investigate the role of neuroinflammation, a contributor to almost every known neurologic and psychiatric brain disease. There are over 600 known brain diseases, and neuroinflammation plays a role in nearly all of them—yet researchers still understand very little about how this common immune response contributes to the development of neurologic disorders. This large-scale, multi-phased initiative will support research to better understand how neuroinflammation acts as an underlying mechanism across nearly all brain diseases and affects people of all ages. Unprecedented Cross-Industry Collaboration The American Brain Foundation is spearheading an unprecedented cross-industry collaboration between scientists, pharmaceutical organizations, venture and private philanthropists, and patient advocacy and nonprofit organizations like the National MS Society, the Encephalitis Society, the NFL Players Association, and the WoodNext Foundation. "The NFLPA proudly joins hands with the American Brain Foundation in advancing this extraordinary $10 million neuroinflammation initiative," said Dr. Thom Mayer, medical director for the NFL Players Association. "We are proud to be part of this historic collaboration, uniting diverse stakeholders to tackle the impact of neuroinflammation on brain health. Together, we aim to improve diagnosis, prevention, treatment, and ultimately discover cures for these conditions." The American Academy of Neurology, the American Brain Foundation's key research partner, will have a central role in the vetting of applications and selecting awardees. Chairing the initiative is Dr. Stephen Hauser, American Brain Foundation board member and director of UCSF Weill Institute for Neurosciences. "Bringing together partners from so many different fields is the fastest, most innovative way to drive forward innovative research and harness the potential of the immune system to treat, repair, and even cure some of the most devastating brain diseases and disorders," said Dr. Hauser. "The research funded by the initiative will impact diseases as widespread and different as Parkinson's, encephalitis, multiple sclerosis (MS), Alzheimer's, brain trauma, autism, and others." This large-scale, coordinated effort to support research from a wide diversity of partners and donors demonstrates both the range of concern about the impact of neuroinflammation on brain health and its significance as an emerging public health issue. "In recent years there has been an increasing interest in neuroinflammation, the role it has to play in the brain, and whether it can be a catalyst in our understanding of so many other diseases and disorders that we know so little about," said Dr. Ava Easton, chief executive of the Encephalitis Society. "Taking a global and collaborative approach is both bold and forward-thinking. By coming together, investing in research, and improving our knowledge of neuroinflammation, we will improve diagnosis and prevention, discover new treatments, and, crucially, find cures." Why Neuroinflammation? Inflammation is the immune system's natural response to injury, illness, and infection. Neuroinflammation—an inflammatory immune response in the brain and spinal cord—plays a role in brain health at all stages of life, from fetal development to aging, and contributes to the formation of nearly every brain disease. Understanding both the protective and detrimental effects of neuroinflammation will allow doctors to more precisely target diseases as varied as Alzheimer's disease and other dementias, stroke, Parkinson's disease, ALS, MS, encephalitis, and COVID-19-associated brain disease. Together, these diseases affect 60% of the U.S. population and at least 3 billion people worldwide, and they attack the essence of what makes us human: thought, speech, emotion, and movement. "We believe in the 'Cure One, Cure Many' ethos of the American Brain Foundation," said donors from a private family foundation that made a $2.2 million donation to the initiative. "This is why we felt it was important to make an investment in the innovative neuroinflammation initiative, which will shed light on a mechanism that is present in almost every brain disease and neurologic condition." Driving Research Advancements Across Multiple Brain Diseases The American Brain Foundation will make phase 1 grants from an initial pool of $5 million in 2025 as it raises an additional $5 million for phase 2 grants. Phase 2 will be an opportunity for the Foundation and its partners to fund new projects and to provide follow-up funding to the most promising Phase 1 projects to advance translation. "We are very pleased to support this novel initiative, which has the potential to uncover common mechanisms across many different brain diseases and disorders of the nervous system, including multiple sclerosis," said Dr. Bruce Bebo, executive vice president of research at the National MS Society. "This venture holds promise for identifying new pathways to stop destructive immune activity in millions of people living with these disorders." The American Brain Foundation will begin soliciting research proposals for the neuroinflammation initiative in spring 2024, and research will begin in 2025. To learn more about the neuroinflammation initiative and other currently funded research, visit AmericanBrainFoundation.org. About the American Brain Foundation The American Brain Foundation promotes and invests in research across the whole spectrum of brain diseases and disorders knowing that when we find a cure for one brain disease, we will find cures for many. Our holistic approach focuses on building bridges between different brain diseases to break new ground in both research and application. Media Contact Emily Christian [email protected] 612-928-6319 SOURCE American Brain Foundation

SAN DIEGO, Oct. 19, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced data on the real-world comorbidities, polypharmacy, and treatment patterns of patients on newly prescribed benztropine who were also being treated with antipsychotic medications. This research will be presented at the 2022 American Psychiatric Nurses Association (APNA) Annual Conference being held October 19–22 both virtually and in Long Beach, CA. The new findings are from a retrospective 24-month observational study of claims between January 1, 2017, and March 30, 2020 (Poster #152; Characteristics, Polypharmacy, and Medication Adherence Among Patients Prescribed Benztropine with a History of Antipsychotic Use). Benztropine is an anticholinergic medication approved as an adjunct for treatment of all forms of parkinsonism, including drug-induced parkinsonism that causes movement problems similar to those seen in Parkinson's disease, such as tremors, slow movement, and stiffness. Benztropine can also be used to control other antipsychotic-induced movement disorders, except for tardive dyskinesia (TD). The analysis found that the patient population, who received at least one new benztropine prescription during the study, often had multiple comorbidities, substantial polypharmacy, and mild, moderate, or severe anticholinergic burden associated with the medications patients were taking prior to initiation of benztropine. After starting benztropine, 38 percent of these patients were on this medication for longer than six months, exceeding recommendations for acute use. These results indicate that regular evaluation of anticholinergic use is clinically warranted, especially in patients who are taking multiple medications with anticholinergic properties and have an increased risk of adverse anticholinergic effects. "The use of benztropine may be appropriate for acute treatment of some antipsychotic-induced movement disorders, but not for tardive dyskinesia," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "In fact, antiparkinson agents like benztropine do not alleviate the symptoms of TD and may even aggravate them. These data help characterize the need for increased education regarding appropriate use of anticholinergic medications." Additional Presentations Include: Global Improvements and Psychiatric Stability in Adults with Tardive Dyskinesia: Post Hoc Analyses of Two Long-Term Valbenazine Studies (Poster #155) Long-Term Valbenazine Is Effective for Tardive Dyskinesia in Elderly Patients (≥65 Years) (Poster #164) The full abstracts being presented by Neurocrine Biosciences at the 2022 APNA Annual Conference can be accessed by registering for the meeting here. About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (like antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia, and schizoaffective disorder, and certain medications to treat upset stomach, nausea and vomiting are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S. About INGREZZA® (valbenazine) Capsules INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts. INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with most psychiatric medications such as antipsychotics or antidepressants. Important Information Approved Use INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). It is not known if INGREZZA is safe and effective in children. IMPORTANT SAFETY INFORMATION Do not take INGREZZA if you: are allergic to valbenazine, or any of the ingredients in INGREZZA. INGREZZA may cause serious side effects, including: Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you. Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation. Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat shortness of breath dizziness or fainting Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint. Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance. Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision. These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. Please see accompanying INGREZZA full Product Information. About Neurocrine Biosciences Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis,* and uterine fibroids,* as well as over a dozen mid- to late-stage clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, Twitter, and Facebook. (*In collaboration with AbbVie). Neurocrine, the Neurocrine logo, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks and uncertainties associated with the commercialization of INGREZZA; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects or adverse reactions; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2022. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof. ©2022 Neurocrine Biosciences, Inc. All Rights Reserved. Company Codes: NASDAQ-NMS:NBIX