Company type | Public |
---|---|
Industry | Biotechnology |
Founded | 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 [1] [2] |
Neurocrine Biosciences, Inc. is an American biopharmaceutical company founded in 1992. [1] The company is headquartered in San Diego, California, and led by CEO Kevin Gorman. [3] 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). [4]
The company is also developing treatments that are in various stages of clinical research for Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia [5] and with a partner for endometriosis and uterine fibroids. [6]
Neurocrine was founded in San Diego, California, in 1992. The company's academic founders were Wylie Vale of the Salk Institute for Biological Studies, [7] and Lawrence Steinman of Stanford University. [8] [9] The company was backed by Avalon Ventures among others. [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. [10] The company underwent an IPO in May 1996, listing on the NASDAQ exchange under the symbol NBIX and raising $34.2 million. [11]
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. [12]
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. [13]
In December 2002, Neurocrine reached an agreement with Pfizer for the rights to its experimental insomnia drug, indiplon. [14] [15] The deal paid Neurocrine $100 million initially with a possible $300 million more if the drug met regulatory and sales goals. [16] 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. [17] 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. [18] 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. [19]
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. [20]
On June 16, 2010, Neurocrine agreed to a deal with AbbVie Inc. (previously Abbott Laboratories) [21] 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. [22] The deal paid Neurocrine $75 million up front. [23]
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. [24] 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. [25]
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. [5] [26]
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. [27] [28] 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. [29] The companies are also developing elagolix for the treatment of uterine fibroids which is in Phase III development. [6]
Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, United States specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. Biogen operates in Argentina, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Sweden, and Switzerland.
Gedeon Richter Plc. is a European multinational pharmaceutical and biotechnology company headquartered in Budapest. It is the largest pharmaceutical company in Central and Eastern Europe, with an expanding direct presence in Western Europe, China, Northern America and Latin America. Richter has the largest R&D unit in Central and Eastern Europe and operations in over 100 countries.
INSIGHTEC Ltd., is a privately held medical device company that sells MR guided Focused Ultrasound equipment. The technology can destroy deep tissue in the body without the need for incisions.
Gonadotropin-releasing hormone antagonists are a class of medications that antagonize the gonadotropin-releasing hormone receptor and thus the action of gonadotropin-releasing hormone (GnRH). They are used in the treatment of prostate cancer, endometriosis, uterine fibroids, female infertility in assisted reproduction, and for other indications.
Indiplon is a nonbenzodiazepine, hypnotic sedative that was developed in two formulations—an immediate-release formulation for sleep onset, and a modified-release version for sleep maintenance.
Cetrorelix, or cetrorelix acetate, sold under the brand name Cetrotide, is an injectable gonadotropin-releasing hormone (GnRH) antagonist. A synthetic decapeptide, it is used in assisted reproduction to inhibit premature luteinizing hormone surges The drug works by blocking the action of GnRH upon the pituitary, thus rapidly suppressing the production and action of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). In addition, cetrorelix can be used to treat hormone-sensitive cancers of the prostate and breast and some benign gynaecological disorders. It is administered as either multiple 0.25 mg daily subcutaneous injections or as a single-dose 3 mg subcutaneous injection. The duration of the 3 mg single dose is four days; if human chorionic gonadotropin (hCG) is not administered within four days, a daily 0.25 mg dose is started and continued until hCG is administered.
The National Organization for Rare Disorders (NORD) is an American non-profit organization aiming to provide support for individuals with rare diseases by advocating and funding research, education, and networking among service providers. It was founded in 1983 by Abbey Meyers, along with individuals and rare diseases leaders of rare disease support groups, and it is a 501(c)(3) tax exempt organization.
MorphoSys AG is a German biopharmaceutical company founded in 1992. The company is headquartered near Munich, Germany, and has a wholly owned subsidiary, MorphoSys US Inc., in Boston, Massachusetts, in the US. The company has various antibody, protein and peptide technologies that it uses to discover and develop both proprietary and partnered drug candidates. The company has more than 100 drugs in its wider pipeline that are being investigated for a variety of diseases. While many of these are being developed in partnership with pharma and biotech companies, MorphoSys also has a proprietary pipeline with a focus on cancer and autoimmune diseases.
Ulipristal acetate, sold under the brand name Ella among others, is a medication used for emergency contraception and uterine fibroids. As emergency contraception it should be used within 120 hours of vaginally penetrating intercourse. For fibroids it may be taken for up to six months. It is taken by mouth.
AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois. It is ranked sixth on the list of largest biomedical companies by revenue. In 2023, the company's seat in Forbes Global 2000 was 74. The company's primary product is Humira (adalimumab), administered via injection. It is approved to treat autoimmune diseases including rheumatoid arthritis, Crohn's disease, plaque psoriasis, and ulcerative colitis.
Seagen Inc. is an American biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer. The company, headquartered in Bothell, Washington, is the industry leader in antibody-drug conjugates or ADCs, a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Antibody-drug conjugates are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.
Elagolix, sold under the brand name Orilissa, is a gonadotropin-releasing hormone antagonist medication which is used in the treatment of pain associated with endometriosis in women. It is also under development for the treatment of uterine fibroids and heavy menstrual bleeding in women. The medication was under investigation for the treatment of prostate cancer and enlarged prostate in men as well, but development for these conditions was discontinued. Elagolix is taken by mouth once or twice per day. It can be taken for up to 6 to 24 months, depending on the dosage.
Relugolix, sold under the brand names Orgovyx and Relumina among others, is a gonadotropin-releasing hormone antagonist medication which is used in the treatment of prostate cancer in men and uterine fibroids in women. It is taken by mouth.
Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. The company is the maker of Botox.
Valbenazine, sold under the brand name Ingrezza, is a medication used to treat tardive dyskinesia. It acts as a vesicular monoamine transporter 2 (VMAT2) inhibitor.
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.
Linzagolix, sold under the brand name Yselty, is a medication used in the treatment of uterine fibroids. Linzagolix is a small-molecule, non-peptide, orally active gonadotropin-releasing hormone antagonist developed by Kissei Pharmaceutical and ObsEva.
Elagolix/estradiol/norethisterone acetate, sold under the brand name Oriahnn, is a fixed-dose combination medication used to treat heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It contains elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethisterone acetate, a progestin. It is taken by mouth. Oriahnn is co-packaged as a combination of elagolix/estradiol/norethisterone acetate capsules with elagolix capsules.
Relugolix/estradiol/norethisterone acetate, sold under the brand names Myfembree and Ryeqo, is a fixed-dose combination hormonal medication which is used for the treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and for moderate to severe pain associated with endometriosis. It contains relugolix, an orally active gonadotropin-releasing hormone antagonist, estradiol, an estrogen, and norethisterone acetate, a progestin. The medication is taken by mouth.