Chief Executive Officer of Neurocrine Biosciences, Kevin Gorman, Ph.D., Named EY Entrepreneur Of The Year® 2018 San Diego

The EY awards program recognizes entrepreneurs whose ingenuity, spirit of innovation and discipline have driven their companies' success, transformed their industries and made a positive impact on their communities. Dr. Gorman was selected by an independent panel of judges, and the award was presented at a special gala event at the Fairmont Grand Del Mar on June 7.

"On behalf of the board of directors, I would like to congratulate Kevin on this prestigious award and recognize his leadership in fostering a culture of teamwork and perseverance to fulfill Neurocrine's mission of delivering on hope for patients with neurological and endocrine related disorders," said William H. Rastetter, Ph.D. Chairman of the Board, Neurocrine Biosciences. "This award is also a reflection of the dedication and hard work of each and every member of the Neurocrine team who have made the company that it is today. I look forward to the continued success of Neurocrine in making a difference in the lives of patients."

In April 2017, Neurocrine Biosciences received U.S. Food and Drug Administration (FDA) approval for INGREZZA^® (valbenazine) capsules, becoming the first medicine approved in the United States for the treatment of adults with tardive dyskinesia (TD), a condition 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 characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face, which may be disruptive and negatively impact patients.

"I am honored to accept the Entrepreneur Of The Year award on behalf of the many contributions of our team members at Neurocrine Biosciences over the last 25 years," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Their dedication and commitment has allowed us to join a select group of companies that have discovered, developed and are marketing their own drug. It is the drive, passion and commitment of each employee to relieve patient suffering and enhance lives that inspires me every day."

In addition to INGREZZA, Neurocrine has three late-stage clinical programs: elagolix for women's health (endometriosis and uterine fibroids) that is partnered with AbbVie Inc.; opicapone as adjunct therapy to levodopa/DOPA in Parkinson's patients; and valbenazine for the treatment of Tourette syndrome. Neurocrine also has a compound in development, NBI-74788, for the treatment of congenital adrenal hyperplasia.

As a San Diego award winner, Dr. Gorman is now eligible for consideration for the Entrepreneur Of The Year 2018 National Awards. Award winners in several national categories, as well as the Entrepreneur Of The Year National Overall Award winner, will be announced at the Entrepreneur Of The Year National Awards gala in Palm Springs, California, on November 10, 2018.

About Entrepreneur Of The Year^®
Entrepreneur Of The Year®, founded by EY, is the world's most prestigious business awards program for entrepreneurs, chosen from an independent panel of judges including entrepreneurs and prominent leaders from business, finance, and the local community. The program makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global awards program of its kind, Entrepreneur Of The Year celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 145 cities in more than 60 countries. ey.com/eoy

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 the continued success of Neurocrine in making a difference in the lives of 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 Neurocrine's business and finances in general as well as risks and uncertainties associated with the commercialization of INGREZZA and the development of the Company's product candidates; 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 its product candidates, 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 or a product candidate; 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.

SOURCE Neurocrine Biosciences, Inc.

Related Links

http://www.neurocrine.com