Neurocrine Biosciences, Inc. is an American

biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...

company founded in 1992. The company is headquartered in

San Diego, California San Diego ( , ; ) is a city on the Pacific Ocean coast of Southern California located immediately adjacent to the Mexico–United States border. With a 2020 population of 1,386,932, it is the eighth most populous city in the United Stat ...

, and led by CEO Kevin Gorman. Neurocrine develops treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug valbenazine (Ingrezza) was approved in the US to treat adults with

tardive dyskinesia Tardive dyskinesia (TD) is a disorder that results in involuntary repetitive body movements, which may include grimacing, sticking out the tongue or smacking the lips. Additionally, there may be rapid jerking movements or slow writhing movemen ...

(TD). The company is also developing treatments that are in various stages of clinical research for

Parkinson's disease Parkinson's disease (PD), or simply Parkinson's, is a long-term degenerative disorder of the central nervous system that mainly affects the motor system. The symptoms usually emerge slowly, and as the disease worsens, non-motor symptoms becom ...

Tourette syndrome Tourette syndrome or Tourette's syndrome (abbreviated as TS or Tourette's) is a common neurodevelopmental disorder that begins in childhood or adolescence. It is characterized by multiple movement (motor) tics and at least one vocal (phonic) ...

, and

congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is a group of autosomal recessive disorders characterized by impaired cortisol synthesis. It results from the deficiency of one of the five enzymes required for the synthesis of cortisol in the adrenal cort ...

and with a partner for endometriosis and

uterine fibroid Uterine fibroids, also known as uterine leiomyomas or fibroids, are benign smooth muscle tumors of the uterus. Most women with fibroids have no symptoms while others may have painful or heavy periods. If large enough, they may push on the bl ...

History

Neurocrine was founded in San Diego, California, in 1992. The company's academic founders were

Wylie Vale Wylie Walker Vale Jr. (July 3, 1941 – January 3, 2012) was an American endocrinologist who helped identify hormones controlling basic bodily functions. Early life and education Vale was born in Houston, Texas, on July 3, 1941. He completed a B.A ...

of the Salk Institute for Biological Studies, and Lawrence Steinman of Stanford University. The company was backed by Avalon Ventures among others. In 1995, the company collaborated with Belgium-based Janssen Pharmaceutica N.V. to develop treatments for psychiatric disorders utilizing corticotropin releasing factor (CRF) antagonists, a class of compounds to treat psychiatric, neurological and gastrointestinal diseases including anxiety, depression and irritable bowel syndrome. The company underwent an IPO in May 1996, listing on the NASDAQ exchange under the symbol NBIX and raising $34.2 million. In October 1996, Eli Lilly and Company agreed to pay Neurocrine $74 million over five years to develop drugs for obesity and Alzheimer's disease based on its research of CRF-binding protein-ligand inhibitors. In July 2001, Neurocrine and GlaxoSmithKline entered into a worldwide research, development and commercialization agreement, including a collaborative research program for up to five years to identify and develop CRF-R antagonist compounds. The collaboration also included worldwide development and commercialization of NBI-34041 as well as potential backup candidates resulting from the research program. Neurocrine received upfront fees and early milestone payments totaling $25.5 million. In December 2002, Neurocrine reached an agreement with

Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...

for the rights to its experimental

insomnia Insomnia, also known as sleeplessness, is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia is typically followed by daytime sleepiness, low energy, ...

drug,

indiplon Indiplon (INN and USAN) is a nonbenzodiazepine, hypnotic sedative that was developed in two formulations—an immediate-release formulation for sleep onset, and a modified-release (also called controlled-release or extended-release) version fo ...

. The deal paid Neurocrine $100 million initially with a possible $300 million more if the drug met regulatory and sales goals. In May 2006, the FDA issued a non-approvable letter for a modified-release 15 mg formulation of indiplon and an

approvable letter Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs unde ...

with stipulations for 5 mg and 10 mg immediate-release formulations. As a result, Pfizer terminated its agreement with Neurocrine. Following a resubmission of the 5 mg and 10 mg formulations in December 2007, Neurocrine's new drug application was deemed 'approvable' but the FDA requested additional studies. The company discontinued development of the drug in the United States. In 2007, Neurocrine partnered with Dainippon Sumitomo Pharma to develop and commercialize indiplon in Japan. The deal paid Neurocrine $20 million up front with the ability to receive milestone payments and royalties based on the commercialization of indiplon in Japan. Kevin Gorman replaced Gary Lyons as CEO of the company in January 2008. Lyons was CEO and president of the company since its founding and maintained a role on the company's board of directors. On June 16, 2010, Neurocrine agreed to a deal with AbbVie Inc. (previously Abbott Laboratories) worth up to $575 million with Neurocrine granting AbbVie the worldwide rights to develop and commercialize

elagolix Elagolix, sold under the brand name Orilissa, is a gonadotropin-releasing hormone antagonist (GnRH antagonist) medication which is used in the treatment of pain associated with endometriosis in women. It is also under development for the trea ...

, an oral gonadotropin-releasing hormone (GnRH) antagonist to treat endometriosis and

s. The deal paid Neurocrine $75 million up front. In April 2017, the FDA approved valbenazine for the treatment of TD. At the time of approval, it was the first and only drug approved for adults with TD. Neurocrine is also studying valbenazine in clinical trials for the treatment of Tourette Syndrome. In October 2017, Neurocrine announced that it had been granted

orphan drug designation An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...

status from the FDA for valbenazine for the treatment of pediatric patients with Tourette syndrome. In February 2017, Neurocrine announced an exclusive licensing agreement for the development and commercialization of the Parkinson's disease drug,

opicapone Opicapone, sold under the brand name Ongentys, is a medication which is administered together with levodopa in people with Parkinson's disease. Opicapone is a catechol-O-methyltransferase (COMT) inhibitor. The most common side effects are dys ...

, in North America with the Portugal-based pharmaceutical company Bial. As part of the agreement, Neurocrine provided an upfront payment of $30 million and agreed to fund development activities for FDA approval in the United States. Bial is eligible to receive additional milestone payments of up to $115 million and a percentage of net sales. In September 2017, AbbVie submitted a NDA to the FDA for elagolix for the management of endometriosis and associated pain. The submission was supported by two similar Phase 3 clinical studies involving 1,700 women. In October 2017, AbbVie and Neurocrine announced that the FDA granted priority review for the elagolix NDA. A final regulatory decision on the drug will come during the third quarter of 2018. The companies are also developing elagolix for the treatment of uterine fibroids which is in Phase III development.

Product pipeline

Elagolix Elagolix, sold under the brand name Orilissa, is a gonadotropin-releasing hormone antagonist (GnRH antagonist) medication which is used in the treatment of pain associated with endometriosis in women. It is also under development for the trea ...

– gonadotropin-releasing hormone receptor antagonist undergoing FDA review for the treatment of endometriosis and in clinical trials for uterine fibroids *

Opicapone Opicapone, sold under the brand name Ongentys, is a medication which is administered together with levodopa in people with Parkinson's disease. Opicapone is a catechol-O-methyltransferase (COMT) inhibitor. The most common side effects are dys ...

– A once daily

catechol-O-methyl transferase Catechol-''O''-methyltransferase (COMT; ) is one of several enzymes that degrade catecholamines (neurotransmitters such as dopamine, epinephrine, and norepinephrine), catecholestrogens, and various drugs and substances having a catechol struct ...

inhibitor in trials for Parkinson's disease *NBI-74788 – Corticotropin-releasing factor (CRF) receptor agonist

References

External links

* {{Authority control Biotechnology companies of the United States Companies based in San Diego Pharmaceutical companies established in 1992 1995 initial public offerings