Neurocrine Biosciences to Present New Data from RE-KINECT, the Largest Real-World Screening Study of Possible Tardive Dyskinesia Patients, at the 2018 American Psychiatric Association Annual Meeting

SAN DIEGO, May 2, 2018 /PRNewswire/ -- Neurocrine Biosciences Inc. (NASDAQ: NBIX) today announced that it will present new data from RE-KINECT, the largest real-world screening study to date of patients with clinician confirmed possible tardive dyskinesia (TD). This study is designed to better understand the potentially broad reaching impact of symptoms of possible TD on patients treated with antipsychotic medications. Neurocrine will also present new data from the KINECT 4 study on long-term treatment with INGREZZA^® (valbenazine) capsules in participants with schizophrenia/schizoaffective disorder or mood disorder. INGREZZA is the first U.S. Food and Drug Administration (FDA) approved treatment for adults with TD. These new data will be presented at the American Psychiatric Association (APA) Annual Meeting in New York City, May 5-9, 2018.

"Neurocrine is committed to understanding tardive dyskinesia and its impact on patients suffering with these symptoms, and improving the clinical care of this potentially underserved patient population," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine. "Data from the RE-KINECT study provide valuable insight into the impact of involuntary movements on the quality of life of patients and the heterogeneity of the patient population receiving antipsychotic medications who have the potential to be affected by tardive dyskinesia."    

TD is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face, which may be disruptive and negatively impact patients. TD is associated with the prolonged use of medications that help control dopamine (a chemical in the brain), such as antipsychotics, used to treat conditions like depression, bipolar disorder and schizophrenia. TD is estimated to affect at least 500,000 people in the U.S.

The seven Neurocrine-sponsored abstracts to be presented at the APA Annual Meeting are:

• A Prospective Real-World Dyskinesia Screening Study and Registry in Patients Taking Antipsychotic Agents (RE-KINECT): Quality of Life Results [P8-152]
  [Poster Session 8; May 8, 2:00 p.m.-4:00 p.m.]
• RE-KINECT: A Prospective Real-World Dyskinesia Screening Study and Registry in Patients Taking Antipsychotic Agents: Caregiver Burden Results [P8-165]
  [Poster Session 8; May 8, 2:00 p.m.-4:00 p.m.]
• Long-Term Valbenazine Treatment in Patients with Schizophrenia/Schizoaffective Disorder or Mood Disorder and Tardive Dyskinesia [P5-131]
  [Poster Session 5; May 7, 10:00 a.m.-12:00 p.m.]
• Characteristics of Patients with Tardive Dyskinesia: Baseline Results from the KINECT 4 Valbenazine Study [P8-153]
  [Poster Session 8; May 8, 2:00 p.m.-4:00 p.m.]
• A Delphi Approach to the Screening, Diagnosis, and Treatment of Tardive Dyskinesia [P5-187]
  [Poster Session 5; May 7, 10:00 a.m.-12:00 p.m.]
• Results of a Depression and Bipolar Support Alliance Survey: Focused Analysis of Tardive Dyskinesia in Patients with Mood Disorders [P8-151]
  [Poster Session 8; May 8, 2:00 p.m.-4:00 p.m.]
• Characteristics of Patients with Mood Disorders Taking Antipsychotics: Data from Depression and Bipolar Support Alliance Survey Respondents [P8-150]
  [Poster Session 8; May 8, 2:00 p.m.-4:00 p.m.]

About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. The condition is caused by treatments that block dopamine receptors in the brain, such as antipsychotics commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression and certain anti-nausea medications. 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 at least 500,000 people in the U.S.

About INGREZZA® (valbenazine) capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.

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 in Neurocrine's laboratories, 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 psychiatric medications such as antipsychotics or antidepressants.

Important Safety Information

Warnings & Precautions
Somnolence 
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see INGREZZA full Prescribing Information at www.INGREZZAHCP.com

About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurological and endocrine related disorders. The Company markets INGREZZA^® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.

Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com.

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 related to the benefits to be derived from INGREZZA and whether results from INGREZZA's clinical trials are indicative of real-world results. 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 Neurocrine's business and finances in general as well as risks and uncertainties associated with the commercialization of INGREZZA; risks that INGREZZA clinical trials results may not be predictive of real-world results or of results in subsequent clinical trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA and the ability of the Company to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that INGREZZA may be alleged to infringe upon the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; 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 March 31, 2018. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

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SOURCE Neurocrine Biosciences, Inc.