Neurocrine Biosciences

Neurocrine Biosciences
Public
Traded as NASDAQ: NBIX
Russell 1000 Component
Industry Biotechnology
Founded 1992
Headquarters San Diego, California, U.S.
Key people
 Bill Rastetter, Chairman
Kevin C. Gorman, CEO
Number of employees
 400 (2018)[1]
Website www.neurocrine.com

Neurocrine Biosciences is a publicly traded biopharmaceutical company founded in 1992.[1] The company is headquartered in San Diego, California, and led by CEO Kevin Gorman.[2] Neurocrine develops and discovers treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug INGREZZA (valbenazine) was approved by the Food and Drug Administration (FDA) to treat adults with tardive dyskinesia (TD).[3]

The company is also developing treatments that are in various stages of clinical research for Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia[4] and with a partner for endometriosis and uterine fibroids.[5]

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.[6][7] The company was backed by Avalon Ventures among others.[6][8]

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.[9] The company underwent an IPO in May 1996, listing on the NASDAQ exchange under the symbol NBIX and raising $34.2 million.[10]

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.[11]

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.[12]

In December 2002, Neurocrine reached an agreement with Pfizer for the rights to its experimental insomnia drug, indiplon.[13][14] The deal paid Neurocrine $100 million initially with a possible $300 million more if the drug met regulatory and sales goals.[15] In May 2006, the FDA issued a non-approvable letter for a modified-release 15mg formulation of indiplon and an approvable letter with stipulations for 5 mg and 10mg immediate-release formulations. As a result, Pfizer terminated its agreement with Neurocrine.[16] Following a resubmission of the 5mg and 10mg formulations in December 2007, Neurocrine's new drug application was deemed 'approvable' but the FDA requested additional studies.[17] 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.[18]

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.[19]

On June 16, 2010, Neurocrine agreed to a deal with AbbVie Inc. (previously Abbott Laboratories)[20] 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.[21] The deal paid Neurocrine $75 million up front.[22]

In March 2015, the company announced that it has entered into an exclusive collaboration and licensing agreement for the development and commercialization of valbenazine in Japan and other select Asian markets with Mitsubishi Tanabe Pharma Corporation. Under the terms of the deal, Neurocrine received an upfront payment of $30 million and is eligible to receive up to $85 million in milestone payments associated with the development and commercialization of valbenazine in Asia.[23]

Neurocrine announced it filed a new drug application (NDA) for its once-daily valbenazine drug treating TD on August 29, 2016. Valbenazine received a priority review designation, fast track status and a breakthrough designation from the FDA.[2] In April 2017, the FDA approved INGREZZA (valbenazine) for the treatment of TD. At the time of approval, it was the first and only drug approved for adults with TD.[24][25] 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.[26]

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.[4][27]

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.[28][29] 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.[30] The companies are also developing elagolix for the treatment of uterine fibroids which is in Phase III development.[5]

Product pipeline

  • INGREZZA (valbenazine) capsules – vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of adults with tardive dyskinesia and in clinical trials for the treatment of Tourette’s syndrome in both adult and pediatric patients[2]
  • Elagolix – gonadotropin-releasing hormone receptor antagonist undergoing FDA review for the treatment of endometriosis and in clinical trials for uterine fibroids[5]
  • Opicapone – A once daily catechol-O-methyl transferase inhibitor in clinical trials for the treatment of Parkinson's disease[4]
  • NBI-74788 – Corticotropin-releasing factor (CRF) receptor agonist in clinical trials for the treatment of Congenital Adrenal Hyperplasia (CAH).[31]

References

  1. 1 2 "Company Overview of Neurocrine Biosciences, Inc". Bloomberg Business. Retrieved May 13, 2018.
  2. 1 2 3 Adams, Ben (August 30, 2016). "Neurocrine Submits Valbenazine NDA Early, Set For 2017 Approval". FierceBiotech. Retrieved May 13, 2017.
  3. ↑ "FDA Approves New Strenght for Tardive Dyskinesia Drug". Pharmacy Times. October 6, 2017. Retrieved May 13, 2018.
  4. 1 2 3 "Neurocrine Nabs BIAL's PD Therapy Opicapone for North America". Genetic Engineering & Biotechnology News. February 10, 2017. Retrieved May 13, 2018.
  5. 1 2 3 Inacio, Patricia (November 13, 2017). "Elagolix Improves Uterine Fibroid Symptoms With and Without Add-Back Therapy, Trials Show". Endometriosis News. Retrieved May 13, 2018.
  6. 1 2 Veggeberg, Scott (April 5, 1993). "Betting on Biotech". The Scientist.
  7. ↑ "Executive Profile Lawrence Steinman". Bloomberg. Retrieved June 5, 2018.
  8. ↑ "Wylie Vale". SALK. January 6, 2012.
  9. ↑ "Company Briefs". The New York Times. February 17, 1995.
  10. ↑ "Neorocrine Biosciences Raises $34.2 mm in IPO of 3.5mm Shares". Scrip Pharma Intelligence. May 1996.
  11. ↑ "Lilly Paying for Obesity and Alzheimer Study". The New York Times. October 22, 1996.
  12. ↑ "Neurocrine Biosciences and GlaxoSmithKline Announce Worldwide Collaboration For CRF Receptor Antagonists INcluding the Phase I Compound NBI-34041". Evaluate Group. July 24, 2001.
  13. ↑ Chartrand, Sabra (June 17, 2002). "Patents; An Insomnia Drug, Based on a Patented Chemical Compound, Also Receives Protection".
  14. ↑ Crabtree, Penni (March 23, 2004). "Helping People to Sleep Could Earn Neurocrine Big Bucks". San Diego Union Tribune.
  15. ↑ "Company News; Pfizer is Buying Rights to Experimental Insomnia Drug". The New York Times. December 20, 2002.
  16. ↑ "Pfizer Dumps Neurocrine, Shares Plunge". Forbes. June 22, 2006.
  17. ↑ "Neurocrine Receives Approvable Letter for Indiplon Capsules With Additional Safety and Efficacy Data Required by FDA". Drugs.com. December 13, 2007.
  18. ↑ "Neurocrine Biosciences and Dainippon Sumitomo Pharma Announce Agreement to Develop and Commercialize Indiplon in Japan". Reuters. November 1, 2007.
  19. ↑ "Neurocrine Biosciences, Inc. Says CEO to Step Down". BioSpace. January 15, 2008.
  20. ↑ Carroll, John (January 7, 2014). "Neurocrine Shares Soar with a Promising Second Take on a PhIIb Drug". FierceBiotech.
  21. ↑ Gellene, Denise (June 16, 2010). "Neurocrine Inks Deal with Abbot". Xconomy.
  22. ↑ "Abbot and Neurocrine Announce Global Agreement to Develop and Commercialize Elagolic for the Treatment of Endometriosis". FierceBiotech. June 16, 2010.
  23. ↑ "Neurocrine Partners With Mitsubishi Tanabe on Neurological Drug in Asia". The Pharma Letter. March 4, 2015.
  24. ↑ "Neurocrine Announces FDA Approval of INGREZZA TM (valbenazine) Capsules as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)" (Press release). PR Newswire. April 11, 2017.
  25. ↑ Al Idrus, Amirah (January 2, 2018). "After Disappointing 2016, New Drug Approvals Roared Back to Life in 2017". FierceBiotech.
  26. ↑ "Brief-Neurocrine Granted FDA Orphan Drug Designation for Valbenazine". Reuters. October 23, 2017.
  27. ↑ "Brief-Neurocrine and Bial Reports Exclusive North American Licensing Agreement for Opicapone". Reuters. February 9, 2017.
  28. ↑ Melao, Alice (September 7, 2017). "AbbVie Files for FDA Approval of Elagolix to Treat Endometriosis-associated Pain". Endometriosis News.
  29. ↑ Moore, Charles (August 25, 2016). "Endometriosis Therapy Candidate Elagolix Meeting Phase 3 Clinical Trial Primary Targets". Endometriosis News. Retrieved 14 October 2016.
  30. ↑ "AbbVie : FDA moves the goal line on AbbVie`s endometriosis drug elagolix". 4-traders. April 11, 2018.
  31. ↑ "NBI-74788". Biocentury. Retrieved May 13, 2018.
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