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| ⚫ | {{Infobox company | ||
| {{Refimprove|date=February 2008}} | |||
| | name = Neurocrine Biosciences, Inc. | |||
| ⚫ | {{Infobox company |
||
| |
| logo = Neurocrine Biosciences logo.svg | ||
| | type = ] | |||
| | traded_as = {{ubl|{{NASDAQ|NBIX}}|] component}} | |||
| logo = ] | | |||
| ⚫ | | industry = ] | ||
| foundation = 1992 |Joseph A. Mollica, Chairman | |||
| | founded = {{Start date and age|1992}} | |||
| Gary A. Lyons, CEO/President | |||
| | hq_location = {{nowrap|], U.S.}} | |||
| Paul W. Hawran, CFO/Exec. VP| | |||
| | key_people = ] (]) <br />Kevin C. Gorman (]) | |||
| location = ], ], ] | | |||
| ⚫ | | num_employees = 1,350 (June 30, 2023) | ||
| key_people = ], Chairman <br />], CEO/President | | |||
| | revenue = {{Increase}} {{US$|788 million|link=yes}} (2019) | |||
| ⚫ | |||
| | website = {{URL|neurocrine.com}} | |||
| ⚫ | |||
| | footnotes = <ref name=bb>{{cite web| url=https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=32073| title=Company Overview of Neurocrine Biosciences, Inc.| publisher=Bloomberg Business| access-date=May 13, 2018}}</ref><ref>{{Cite web|url=https://www.macrotrends.net/stocks/charts/NBIX/neurocrine-biosciences/revenue|title = Neurocrine Biosciences Revenue 2006-2021 | NBIX}}</ref> | |||
| homepage = | | |||
| }} | }} | ||
| '''Neurocrine Biosciences, Inc.''' is an American ] company founded in 1992.<ref name=bb/> It is headquartered in ], and led by CEO Kevin Gorman.<ref name=ben>{{cite web| url=https://www.fiercebiotech.com/biotech/neurocrine-submits-valbenazine-nda-early-set-for-2017-approval| title=Neurocrine Submits Valbenazine NDA Early, Set For 2017 Approval| first=Ben| last=Adams| publisher=FierceBiotech| date=August 30, 2016| access-date=May 13, 2017}}</ref> Neurocrine develops treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug ] (Ingrezza) was approved in the US to treat adults with ] (TD).<ref>{{cite web| url=http://www.pharmacytimes.com/product-news/fda-approves-new-strength-for-tardive-dyskinesia-drug| title=FDA Approves New Strength for Tardive Dyskinesia Drug| publisher=Pharmacy Times| date=October 6, 2017| access-date=May 13, 2018}}</ref> | |||
| '''Neurocrine Biosciences''' is a biopharmaceutical company founded in 1992 and located in ], ]. The company tooks its name from the original focus on therapies for ] and ] ]s and disorders. | |||
| The company is also developing treatments that are in various stages of clinical research for ], ], and ]<ref name=gen>{{cite web| url=https://www.genengnews.com/gen-news-highlights/neurocrine-nabs-bials-pd-therapy-opicapone-for-north-america/81253859| title=Neurocrine Nabs BIAL's PD Therapy Opicapone for North America| publisher=Genetic Engineering & Biotechnology News| date=February 10, 2017| access-date=May 13, 2018}}</ref> and with a partner for ] and ]s.<ref name=ela/> | |||
| The company endured a significant setback on May 16, 2006 when the ] (FDA) denied approval for the 15-milligram dose of ], a medication to treat insomnia. Neurocrine had developed the drug and was seeking to market it with partner, ]. Announcement of the setback led to a 62% drop in stock price. Subsequent disclosures related to attempts to overcome this major setback caused a further drop in the stock by 30% in November 2006. | |||
| ==History== | |||
| Lacking approval for Indiplon, the company laid off a 200-member sales force in July, 2006 and 100 employees across all areas of the company on August 7, 2006. It announced a further cut of half the remaining workforce in December 2007, and a fourth quarter loss of $128 million, including a $94 million write-off.<ref>{{cite news |title=Write-Off Swells Neurocrine's 4Q Loss |url=http://money.cnn.com/news/newsfeeds/articles/apwire/449c555bdf80888e2d2b2b9228ea2c18.htm |date=2008-02-05 |publisher=]}}</ref> | |||
| ] | |||
| Neurocrine was founded in ], in 1992. The company's academic founders were ] of the ],<ref>{{cite web| url=https://www.salk.edu/news-release/wylie-vale-salk-scientist-pioneer-and-leader-dies-at-70/| title=Wylie Vale| publisher=SALK| date=January 6, 2012}}</ref> and ] of ].<ref name=sm>{{cite web|url=https://www.the-scientist.com/?articles.view/articleNo/31743/title/Betting-on-Biotech/|title=Betting on Biotech|first=Scott|last=Veggeberg|publisher=The Scientist|date=April 5, 1993}}</ref><ref>{{cite web|url=https://www.bloomberg.com/research/stocks/private/person.asp?personId=1153833&privcapId=35786930| title=Executive Profile Lawrence Steinman| publisher=Bloomberg| access-date=June 5, 2018}}</ref> The company was backed by Avalon Ventures among others.<ref name=sm/> | |||
| In 1995, the company collaborated with Belgium-based ] to develop treatments for psychiatric disorders utilizing ] (CRF) antagonists, a class of compounds to treat psychiatric, neurological and gastrointestinal diseases including anxiety, depression and irritable bowel syndrome.<ref>{{cite web| url=https://www.nytimes.com/1995/02/17/business/company-briefs-641095.htmlrref=collection%2Ftimestopic%2FNeurocrine%20Biosciences%20Inc.&action=click&contentCollection=business®ion=stream&module=stream_unit&version=latest&contentPlacement=6&pgtype=collection| title=Company Briefs| work=The New York Times| date=February 17, 1995}}</ref> The company underwent an ] in May 1996, listing on the ] exchange under the symbol NBIX and raising $34.2 million.<ref>{{cite web|url=https://scrip.pharmaintelligence.informa.com/deals/199630144|title=Neorocrine Biosciences Raises $34.2 mm in IPO of 3.5mm Shares.|publisher=Scrip Pharma Intelligence|date=May 1996}}</ref> | |||
| But recently the company has recovered the long term hope for recovery. All started on the 25th of May, 2010 when the shares jumped nearly 25% after the company announced its drug to treat endometriosis had achieved its main and secondary goals in a study. | |||
| The drug, called elagolix, reportedly showed statistically significant reductions in dysmenorrhea, or pelvic pain during menstruation as well as painful intercourse. And the shares of the company were up 69 cents to $3.40 on May the 25th trading, hitting a 52-week high of $4.23 early in the trading session.<ref>{{cite news |title=Neurocrine Biosciences Shares Soar on Drug Trial |url=http://www.foxbusiness.com/story/markets/industries/health-care/neurocrine-biosciences-shares-soar-drug-trial/ |date=2010-05-25 |publisher=]}}</ref> | |||
| In October 1996, ] 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.<ref>{{cite web| url=https://www.nytimes.com/1996/10/22/business/lilly-paying-for-obesity-and-alzheimer-study.html| title=Lilly Paying for Obesity and Alzheimer Study| work=The New York Times| date=October 22, 1996}}</ref> | |||
| But since that the stock has climbed from $4.23 to $6.16 at 25 June 2010. And the expectatives for NBIX has raised about the elagolix trial success and of the sign for development deal with Boehringer.<ref>{{cite news |title=Neurocrine signs development deal with Boehringer |url=http://biz.yahoo.com/ap/100617/us_neurocrine_biosciences_contract.html?.v=1 |date=2010-06-17 |publisher=]}}</ref> and Abbott Laboratories.<ref>{{cite news |title=Abbott And Neurocrine Ink Endometriosis Drug Deal |url=http://us.rd.yahoo.com/finance/external/forbes/SIG=139b4dhp7/*http%3A//www.forbes.com/2010/06/16/abbott-neurocrine-partner-on-endometriosis-drug-marketnewsvideo.html?partner=yahootix |date=2010-06-16 |publisher=]}}</ref> | |||
| In July 2001, Neurocrine and ] 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.<ref>{{cite web| url=http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=25119| title=Neurocrine Biosciences and GlaxoSmithKline Announce Worldwide Collaboration For CRF Receptor Antagonists INcluding the Phase I Compound NBI-34041| publisher=Evaluate Group| date=July 24, 2001}}</ref> | |||
| In December 2002, Neurocrine reached an agreement with ] for the rights to its experimental ] drug, ].<ref>{{cite news| url=https://www.nytimes.com/2002/06/17/business/patents-insomnia-drug-based-patented-chemical-compound-also-receives-protection.html| title=Patents; An Insomnia Drug, Based on a Patented Chemical Compound, Also Receives Protection| first=Sabra | last= Chartrand| newspaper=The New York Times| date=June 17, 2002}}</ref><ref>{{cite web| url=http://legacy.sandiegouniontribune.com/news/business/biotech/20040323-9999-news_1b23neurocr.html| title=Helping People to Sleep Could Earn Neurocrine Big Bucks| first=Penni| last=Crabtree| work=San Diego Union Tribune| date=March 23, 2004}}</ref> The deal paid Neurocrine $100 million initially with a possible $300 million more if the drug met regulatory and sales goals.<ref>{{cite web| url=https://www.nytimes.com/2002/12/20/business/company-news-pfizer-is-buying-rights-to-experimental-insomnia-drug.html| title=Company News; Pfizer is Buying Rights to Experimental Insomnia Drug| work=The New York Times| date=December 20, 2002}}</ref> In May 2006, the FDA issued a ] for a modified-release 15 mg formulation of indiplon and an ] with stipulations for 5 mg and 10 mg immediate-release formulations. As a result, Pfizer terminated its agreement with Neurocrine.<ref>{{cite web| url=https://www.forbes.com/2006/06/22/pfizer-neurocrine-indiplon-cx_pk_0622nbix.html#586f98b6a102| title=Pfizer Dumps Neurocrine, Shares Plunge| work=Forbes| date=June 22, 2006}}</ref> Following a resubmission of the 5 mg and 10 mg formulations in December 2007, Neurocrine's ] was deemed 'approvable' but the FDA requested additional studies.<ref>{{cite web| url=https://www.drugs.com/nda/indiplon_071213.html| title=Neurocrine Receives Approvable Letter for Indiplon Capsules With Additional Safety and Efficacy Data Required by FDA| publisher=Drugs.com |date= December 13, 2007}}</ref> 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.<ref>{{cite web| url=https://www.reuters.com/article/idUSIN20071101071846NBIX20071101| title=Neurocrine Biosciences and Dainippon Sumitomo Pharma Announce Agreement to Develop and Commercialize Indiplon in Japan| publisher=Reuters| date=November 1, 2007}}</ref> | |||
| Kevin Gorman replaced Gary Lyons as ] 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.<ref>{{cite web| url=https://www.biospace.com/article/releases/neurocrine-biosciences-inc-says-ceo-to-step-down-/| title= Neurocrine Biosciences, Inc. Says CEO to Step Down| publisher=BioSpace| date= January 15, 2008}}</ref> | |||
| On June 16, 2010, Neurocrine agreed to a deal with ] (previously ])<ref>{{cite web| url=https://www.fiercebiotech.com/r-d/neurocrine-shares-soar-a-promising-second-take-on-a-phiib-drug| title=Neurocrine Shares Soar with a Promising Second Take on a PhIIb Drug| first=John| last=Carroll| publisher=FierceBiotech| date=January 7, 2014}}</ref> worth up to $575 million with Neurocrine granting AbbVie the worldwide rights to develop and commercialize ], an oral ] to treat ] and ]s.<ref>{{cite web| url=https://www.xconomy.com/san-diego/2010/06/16/neurocrine-inks-deal-with-abbott/| title= Neurocrine Inks Deal with Abbot| first=Denise| last=Gellene| publisher=Xconomy| date=June 16, 2010}}</ref> The deal paid Neurocrine $75 million up front.<ref>{{cite web| url=https://www.fiercebiotech.com/biotech/abbott-and-neurocrine-announce-global-agreement-to-develop-and-commercialize-elagolix-for| title= Abbot and Neurocrine Announce Global Agreement to Develop and Commercialize Elagolic for the Treatment of Endometriosis| publisher=FierceBiotech| date=June 16, 2010}}</ref> | |||
| 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.<ref>{{cite web| url=https://www.fiercebiotech.com/biotech/after-disappointing-2016-new-drug-approvals-roared-back-to-life-2017| title=After Disappointing 2016, New Drug Approvals Roared Back to Life in 2017| first=Amirah| last=Al Idrus| publisher=FierceBiotech| date=January 2, 2018}}</ref> Neurocrine is also studying valbenazine in clinical trials for the treatment of Tourette Syndrome. In October 2017, Neurocrine announced that it had been granted ] status from the FDA for valbenazine for the treatment of pediatric patients with Tourette syndrome.<ref>{{cite web| url=https://www.reuters.com/article/brief-neurocrine-granted-fda-orphan-drug/brief-neurocrine-granted-fda-orphan-drug-designation-for-valbenazine-idUSASB0BO6B| title=Brief-Neurocrine Granted FDA Orphan Drug Designation for Valbenazine| publisher=Reuters| date=October 23, 2017}}</ref> | |||
| In February 2017, Neurocrine announced an exclusive licensing agreement for the development and commercialization of the Parkinson's disease drug, ], in North America with the Portugal-based pharmaceutical company ]. 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.<ref name=gen/><ref>{{cite web| url=https://www.reuters.com/article/idUSFWN1FU12N| title=Brief-Neurocrine and Bial Reports Exclusive North American Licensing Agreement for Opicapone| publisher=Reuters| date=February 9, 2017}}</ref> | |||
| 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.<ref>{{cite web|url=https://endometriosisnews.com/2017/09/07/abbvive-files-for-fda-approval-of-elagolix-to-treat-endometriosis-linked-pan/| title=AbbVie Files for FDA Approval of Elagolix to Treat Endometriosis-associated Pain| first=Alice| last=Melao| publisher=Endometriosis News| date=September 7, 2017}}</ref><ref>{{cite news|url=http://endometriosisnews.com/2016/08/25/endometriosis-therapy-candidate-elagolix-meeting-phase-3-clinical-trial-targets/|title=Endometriosis Therapy Candidate Elagolix Meeting Phase 3 Clinical Trial Primary Targets|last=Moore|first=Charles|date=August 25, 2016|work=Endometriosis News|accessdate=14 October 2016}}</ref> 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.<ref>{{cite web| url=http://www.4-traders.com/ABBVIE-12136589/news/AbbVie-FDA-moves-the-goal-line-on-AbbVie-s-endometriosis-drug-elagolix-26319520/| title=AbbVie : FDA moves the goal line on AbbVie's endometriosis drug elagolix| publisher=4-traders| date=April 11, 2018}}</ref> The companies are also developing elagolix for the treatment of uterine fibroids which is in Phase III development.<ref name=ela/> | |||
| In 2021,{{ill|Nexera Pharma|ja|ネクセラファーマ}}<nowiki/>in Japan licensed out its investigational schizophrenia drug,], to Neurocrine Biosciences for development.<ref name=":1">{{Cite web |date=2021-11-22 |title=ニューロクライン社との統合失調症およびその他の精神神経疾患を対象とした新規ムスカリン受容体作動薬に関するライセンス契約締結のお知らせ |url=https://prtimes.jp/main/html/rd/p/000000065.000036794.html |access-date=2024-09-17 |website=プレスリリース・ニュースリリース配信シェアNo.1｜PR TIMES |publisher=PR TIMES}}</ref> | |||
| In August 2024, Neurocrine announced the results of a Phase II clinical trial of NBI-1117568 .<ref name=":22">{{Cite web |last=日経バイオテクONLINE |date=2024-09-02 |title=ネクセラファーマ、統合失調症治療薬候補 NBI-1117568の第II相臨床試験の良好な結果によりニューロクライン社より35百万米ドルのマイルストンを受領 |url=https://bio.nikkeibp.co.jp/atcl/release/24/09/02/21467/ |access-date=2024-09-17 |website=日経バイオテクONLINE |publisher=日本経済新聞社}}</ref><ref name=":32">{{Cite web |date=2024-08-29 |title=ネクセラ---大幅反落、ニューロクラインの株価下落に追随売り {{!}} 個別株 - 株探ニュース |url=https://kabutan.jp/news/marketnews/?&b=n202408290437 |access-date=2024-09-17 |website=kabutan.jp |publisher=MINKABU THE INFONOID, Inc.}}</ref><ref name=":0">{{Cite web |last=Priyan |first=Vishnu |date=2024-08-29 |title=Neurocrine reports positive data from Phase II schizophrenia treatment trial |url=https://www.clinicaltrialsarena.com/news/neurocrine-schizophrenia-treatment-trial/ |access-date=2024-09-21 |website=Clinical Trials Arena |language=en-US}}</ref> The drug demonstrated a 7.5-point improvement in the ] (PANSS), which was lower than the 8.4-point improvement seen with ] (developed by ]) and the 12.7-point improvement seen with ] (developed by ]), both of which were also in clinical trials at the time. Additionally, the study found no dose-dependent response to NBI-1117568.<ref>{{Cite web |date=2024-09-02 |title=Nxera Pharma Official IR Blog 「ニューロクライン社から35百万米ドルのマイルストン受領」 |url=https://soseiheptares.blogspot.com/?ctry=jp |access-date=2024-09-19 |website=soseiheptares.blogspot.com |publisher=ネクセラファーマ}}</ref> As a result, Neurocrine's stock price fell 19% the following day as investors were disappointed by the results.<ref>{{Cite web |date=2024-08-29 |title=Neurocrine Stock Down 19% on Mixed Schizophrenia Study Results |url=https://www.zacks.com/stock/news/2329161/neurocrine-stock-down-19-on-mixed-schizophrenia-study-results?cid=CS-YAHOO-FT-analyst_blog%7Ccompany_news_medical_sector-2329161&t=BMY |access-date=2024-09-17 |website=Zacks Investment Research |publisher=Zacks Investment |language=en}}</ref> | |||
| ==Product pipeline== | |||
| *] – gonadotropin-releasing hormone receptor antagonist undergoing FDA review for the treatment of endometriosis and in clinical trials for uterine fibroids<ref name=ela>{{cite web|url=https://endometriosisnews.com/2017/11/13/endometriosis-elagolix-improves-uterine-fibroid-symptoms-phase-2-trials-show/| title=Elagolix Improves Uterine Fibroid Symptoms With and Without Add-Back Therapy, Trials Show| first=Patricia| last=Inacio| publisher=Endometriosis News| date=November 13, 2017| access-date=May 13, 2018}}</ref> | |||
| *] – A once daily ] inhibitor in trials for Parkinson's disease<ref name=gen/> | |||
| *NBI-74788 – ] (CRF) receptor agonist<ref name=cah>{{cite web| url=http://bciq.biocentury.com/products/nbi-74788| title=NBI-74788| publisher=Biocentury| access-date=May 13, 2018}}</ref> | |||
| *] - A drug that stimulates muscarinic receptors and is used to treat schizophrenia.<ref name=":22" /><ref name=":32" /><ref name=":0" /> | |||
| ==References== | ==References== | ||
| {{Reflist}} | {{Reflist}} | ||
| ==External links== | |||
| ⚫ | ] | ||
| *{{Official website|https://www.neurocrine.com}} | |||
| ⚫ | ] | ||
| {{Finance links | |||
| ⚫ | ] | ||
| | name = Neurocrine Biosciences, Inc. | |||
| ⚫ | ] | ||
| | symbol = NBIX | |||
| | reuters = NBIX.O | |||
| | bloomberg = NBIX:US | |||
| | sec_cik = 914475 | |||
| | yahoo = NBIX | |||
| | google = NBIX:NASDAQ | |||
| }} | |||
| {{S&P 400 companies}} | |||
| {{Authority control}} | |||
| ⚫ | ] | ||
| {{med-company-stub}} | |||
| ⚫ | ] | ||
| ⚫ | ] | ||
| ] | |||
| ] | |||
| ⚫ | ] | ||
Latest revision as of 01:49, 30 October 2024
 | |
| Company type | Public |
|---|---|
| Traded as | |
| Industry | Biotechnology |
| Founded | 1992; 32 years ago (1992) |
| Headquarters | San Diego, California, U.S. |
| Key people | William Rastetter (chairman) Kevin C. Gorman (CEO) |
| Revenue |  US$788 million (2019) |
| Number of employees | 1,350 (June 30, 2023) |
| Website | neurocrine |
| Footnotes / references | |
Neurocrine Biosciences, Inc. is an American biopharmaceutical company founded in 1992. It is headquartered in San Diego, California, 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 (TD).
The company is also developing treatments that are in various stages of clinical research for Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia and with a partner for endometriosis and uterine fibroids.
History
Neurocrine was founded in San Diego, California, in 1992. The company's academic founders were Wylie Vale 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 for the rights to its experimental insomnia drug, indiplon. 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 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, an oral gonadotropin-releasing hormone (GnRH) antagonist to treat endometriosis and uterine fibroids. 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 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, 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.
In 2021,Nexera Pharma [ja]in Japan licensed out its investigational schizophrenia drug,NBI-1117568, to Neurocrine Biosciences for development.
In August 2024, Neurocrine announced the results of a Phase II clinical trial of NBI-1117568 . The drug demonstrated a 7.5-point improvement in the Positive and Negative Syndrome Scale (PANSS), which was lower than the 8.4-point improvement seen with KarXT (developed by Karuna Therapeutics) and the 12.7-point improvement seen with Emraclidine (developed by Cerevel Therapeutics), both of which were also in clinical trials at the time. Additionally, the study found no dose-dependent response to NBI-1117568. As a result, Neurocrine's stock price fell 19% the following day as investors were disappointed by the results.
Product pipeline
- Elagolix – gonadotropin-releasing hormone receptor antagonist undergoing FDA review for the treatment of endometriosis and in clinical trials for uterine fibroids
- Opicapone – A once daily catechol-O-methyl transferase inhibitor in trials for Parkinson's disease
- NBI-74788 – Corticotropin-releasing factor (CRF) receptor agonist
- NBI-1117568 - A drug that stimulates muscarinic receptors and is used to treat schizophrenia.
References
- ^ "Company Overview of Neurocrine Biosciences, Inc". Bloomberg Business. Retrieved May 13, 2018.
- "Neurocrine Biosciences Revenue 2006-2021 | NBIX".
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External links
- Official website
- Business data for Neurocrine Biosciences, Inc.: