NBIX Neurocrine Biosciences Inc.

125.37
-0.47  -0%
Previous Close 125.84
Open 125.84
52 Week Low 72.14
52 Week High 131
Market Cap $11,642,500,220
Shares 92,865,121
Float 91,668,224
Enterprise Value $11,414,146,826
Volume 441,464
Av. Daily Volume 910,526
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Upcoming Catalysts

Drug Stage Catalyst Date
Valbenazine
Huntington's disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TAK-041
Anhedonia in depression
Phase 2
Phase 2
Phase 2 trial planned.
TAK-653
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial planned.
TAK-831
Negative symptoms of schizophrenia
Phase 2
Phase 2
Phase 2 trial is ongoing.
Crinecerfont (NBI-74788)
Congenital Adrenal Hyperplasia (CAH) - adults
Phase 2
Phase 2
Phase 3 trial planned for 2H 2020.
Elagolix
Uterine Fibroids
Approved
Approved
FDA approval announced May 29, 2020.
NBI-921352
SCN8A developmental and epileptic encephalopathy (SCN8A-DEE)
Phase 2
Phase 2
Phase 2 trial to commence 2H 2020.
Opicapone
Parkinson's disease
Approved
Approved
FDA Approval announced April 27, 2020.
ACT-709478
Pediatric epilepsy
Phase 2
Phase 2
Phase 2 trial to commence 2H 2020.
Crinecerfont (NBI-74788)
Congenital Adrenal Hyperplasia (CAH) - children
Phase 2
Phase 2
Phase 2a trial ongoing.
Elagolix
Polycystic ovary syndrome (PCOS)
Phase 2
Phase 2
Phase 2 trial initiated 3Q 2019.
INGREZZA - T-Force PLATINUM
Tourette syndrome - pediatric
Phase 2
Phase 2
Phase 2 trial ongoing. Evaluating next steps.
INGREZZA - T-Force GOLD
Tourette syndrome - juvenile
Phase 2b
Phase 2b
Phase 2 top-line data released December 12, 2018 did not meet primary endpoint.
Elagolix
Endometriosis
Approved
Approved
FDA approval announced July 24, 2018.
INGREZZA
Tardive dyskinesia
Approved
Approved
Approved April 11, 2017.
INGREZZA
Tourette syndrome - adults
Phase 2
Phase 2
Phase 2 data released January 18, 2017 did not meet primary endpoint.
INGREZZA
Tardive dyskinesia
Approved
Approved
Approval for sNDA 80 mg capsules announced October 5, 2017.

Latest News

    • Strategic partnership agreement provides Neurocrine Biosciences exclusive worldwide rights to early-to-mid-stage psychiatry pipeline compounds within Takeda's Neuroscience portfolio
    • Collaboration includes three clinical-stage assets with the most advanced molecule in Phase II for negative symptoms of schizophrenia
    • Takeda retains ability to opt in or out of a 50:50 profit share on all clinical programs at certain development events

    Neurocrine Biosciences, Inc. ((NBIX) and Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced a strategic collaboration to develop and commercialize compounds in Takeda's early-to-mid-stage psychiatry pipeline. Specifically, Takeda granted an exclusive license to Neurocrine Biosciences for…

    • Strategic partnership agreement provides Neurocrine Biosciences exclusive worldwide rights to early-to-mid-stage psychiatry pipeline compounds within Takeda's Neuroscience portfolio
    • Collaboration includes three clinical-stage assets with the most advanced molecule in Phase II for negative symptoms of schizophrenia
    • Takeda retains ability to opt in or out of a 50:50 profit share on all clinical programs at certain development events

    Neurocrine Biosciences, Inc. ((NBIX) and Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced a strategic collaboration to develop and commercialize compounds in Takeda's early-to-mid-stage psychiatry pipeline. Specifically, Takeda granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including three clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200616005101/en/

    "We are excited to collaborate with Takeda to bring life-changing therapies to people living with serious, challenging and under-addressed psychiatric disorders who are in need of better treatment options," said Kevin Gorman, Ph.D., Chief Executive Officer at Neurocrine Biosciences. "With our deep understanding in the fields of psychiatry and neurology, we look forward to developing new treatments for schizophrenia, treatment-resistant depression and anhedonia as part of our diverse clinical development pipeline. This strategic partnership enhances our growing pipeline and strengthens our position as a leading neuroscience-focused biopharmaceutical company."

    "With longstanding experience developing and commercializing therapies for serious neurological and psychiatric disorders, Neurocrine Biosciences is the ideal partner to continue to develop our early-to-mid-stage psychiatry portfolio and bring these potential new therapies to patients," said Sarah Sheikh, M.D., M.Sc., MRCP, Head, Neuroscience Therapeutic Area Unit at Takeda. "Takeda is deeply committed to Neuroscience as one of our core therapeutic areas. The strategic partnership with Neurocrine Biosciences allows us to continue to build on our leadership in psychiatry and deliver future medicines for these patients while advancing our clinical assets for rare neurological diseases, such as narcolepsy, developmental and epileptic encephalopathies and neurodegenerative conditions."

    Collaboration Details

    Under the terms of the agreement, Neurocrine Biosciences will be responsible for developing and commercializing all pipeline compounds included in the collaboration. Takeda will receive a total of $120 million USD in upfront cash. Additionally, Takeda will be entitled to development milestones of up to $495 million USD, commercial milestones of up to $1.4 billion USD and up to double-digit royalties on net sales. At certain development events, Takeda may elect to opt in or out of a 50:50 profit share on all clinical programs on an asset-by-asset basis. For any asset in which Takeda is participating in a 50:50 profit share arrangement, Takeda will not be eligible to receive development or commercial milestones.

    Conference Call Information

    Today, Neurocrine Biosciences will host a conference call and webcast at 8:00 a.m. ET to provide commentary on the collaboration. The live call may be accessed by dialing (866) 831-8711 (U.S.) or (203) 518-9883 (International) using the conference ID: 5022. A live audio webcast of the conference call will be available online on the Neurocrine Bioscience website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Programs in the Collaboration Agreement

    TAK-831

    TAK-831 is a potential first-in-class D-Amino Acid Oxidase (DAAO) inhibitor that has completed multiple Phase I studies and is currently in on-going Phase II studies, including the Phase II INTERACT proof-of-concept study in negative symptoms of schizophrenia.

    TAK-653

    TAK-653 is a potential first-in-class Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid (AMPA) potentiator. TAK-653 has completed Phase I studies and is a Phase II study-ready compound with the potential to be developed for treatment-resistant depression.

    TAK-041

    TAK-041 is a potential first-in-class G Protein-Coupled Receptor 139 (GPR139) agonist. TAK-041 has completed multiple Phase I studies and is a Phase II study-ready compound with the potential to be developed for the treatment of anhedonia in depression. Anhedonia is a psychological condition characterized by the inability to experience pleasure.

    Preclinical Programs

    The collaboration includes the rights to four preclinical programs.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease endometriosis* and uterine fibroids* and clinical development programs in multiple therapeutic areas including a gene therapy for Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, epilepsy and polycystic ovary syndrome*. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Takeda's Commitment to Neuroscience

    Takeda's Neuroscience therapeutic area is driven by the immense unmet need of patients suffering from neurological diseases. Our mission is to bring innovative and potentially disease-modifying medicines to these patients. Our commitment to patients extends beyond our research and development efforts by supporting several neuroscience patient and provider organizations to raise awareness, educate and broaden access to therapies.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

    Neurocrine Biosciences 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 transactions with Takeda Pharmaceutical Company Limited; our potential milestone and royalty payments to Takeda; the development of our product candidates and the timing of completion of our clinical, regulatory, and other development activities. 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 the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risks and uncertainties related to any COVID-19 quarantines, shelter-in-place and similar government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our business operations and the business operations of the third parties on which we rely; our future financial and operating performance; risks or uncertainties related to the development of the our product candidates; risks that the FDA or other regulatory authorities may make adverse decisions regarding our product candidates; risks that clinical development activities may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or 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 a product candidate; risks that the benefits of the agreements with Takeda may never be realized; risks that our product candidates may be precluded from commercialization by the proprietary or regulatory 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, 2020. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

    Takeda Pharmaceutical Company Limited Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets," "plans," "believes," "hopes," "continues," "expects," "aims," "intends," "ensures," "will," "may," "should," "would," "could" "anticipates," "estimates," "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

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  1. SAN DIEGO, June 15, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Bank of America Securities 2020 Napa Biopharma Conference at 2:00 p.m. PT (5:00 p.m. ET) on Monday, June 22, 2020. Kevin Gorman, Chief Executive Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, and clinical development programs in multiple therapeutic areas including a gene therapy for Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, epilepsy, and polycystic ovary syndrome*. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-at-the-bank-of-america-securities-2020-napa-biopharma-conference-301076985.html

    SOURCE Neurocrine Biosciences, Inc.

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  2. SAN DIEGO, June 8, 2020 /PRNewswire/ --  Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced positive data from its completed open-label, multiple-dose, dose-finding, Phase II clinical study of crinecerfont (NBI-74788), demonstrating meaningful reductions in all three key disease hormone markers in adult patients with classic congenital adrenal hyperplasia (CAH), a genetic disorder affecting the adrenal glands. Crinecerfont treatment produced meaningful reductions in elevated adrenocorticotropic hormone (ACTH) and 17-hydroxyprogesterone (17-OHP) levels (by 54% to 75%) at all doses studied, together with a dose-related decrease in androstenedione (A4) levels, ranging from 21% to 64% (Figure 1). At the highest dose of crinecerfont…

    SAN DIEGO, June 8, 2020 /PRNewswire/ --  Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced positive data from its completed open-label, multiple-dose, dose-finding, Phase II clinical study of crinecerfont (NBI-74788), demonstrating meaningful reductions in all three key disease hormone markers in adult patients with classic congenital adrenal hyperplasia (CAH), a genetic disorder affecting the adrenal glands. Crinecerfont treatment produced meaningful reductions in elevated adrenocorticotropic hormone (ACTH) and 17-hydroxyprogesterone (17-OHP) levels (by 54% to 75%) at all doses studied, together with a dose-related decrease in androstenedione (A4) levels, ranging from 21% to 64% (Figure 1). At the highest dose of crinecerfont (100 mg twice daily), 75% of patients showed a response of at least 50% reduction from baseline for each of the three hormone markers at day 14 (Table 1). Treatment with crinecerfont was well tolerated with a favorable safety profile with no related serious adverse events reported. Adverse events reported in two or more participants included headache, upper respiratory tract infection, fatigue, contusion, insomnia and nausea. The full data set from the Phase II study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont, an investigational, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist, is available as part of a recorded presentation at the Endocrine Society's ENDO Online 2020 meeting.

    Table 1: Number and Percentage of Participants in Each Cohort Demonstrating a ≥ 50% Reduction from Baseline in ACTH, 17-OHP and Androstenedione (A4)

    ≥ 50% reduction from

    baseline, n/N (%)

    Cohort 1:

    50 mg QHS

    Cohort 2:

    100 mg QHS

    Cohort 3:

    100 mg QPM

    Cohort 4:

    100 mg BID

    ACTH

    4/8 (50.0)

    5/6 (83.3)

    5/7 (71.4)

    6/8 (75.0)

    17-OHP

    4/8 (50.0)

    4/6 (66.7)

    4/7 (57.1)

    6/8 (75.0)

    Androstenedione (A4)

    2/8 (25.0)

    3/6 (50.0)

    3/7 (42.9)

    6/8 (75.0)

    "There continues to be a need for effective treatment options that are well tolerated in patients with classic CAH. Patients with this genetic disorder require glucocorticoid replacement therapy, but often at high doses to manage their excessive adrenal androgen production. At the same time, side effects from chronic treatment with supraphysiologic amounts of glucocorticoids can cause serious long-term health consequences including bone loss and metabolic dysfunction," said Richard Auchus, M.D., Ph.D., the study's lead investigator and Professor of Internal Medicine, Division of Metabolism, Endocrinology & Diabetes at Michigan Medicine. "It is encouraging to see that crinecerfont, a non-steroidal therapy, provided meaningful reductions in three key disease biomarkers in patients with classic CAH. These data suggest that crinecerfont has the potential to improve CAH symptoms and to reduce the burden of daily glucocorticoid exposure for these patients. Hopefully, this approach might provide a new treatment option to better manage the androgen excess of classic CAH while mitigating the adverse consequences of current treatment schemes."

    Neurocrine Biosciences plans to initiate a single, global registrational study of crinecerfont in adult patients with classic CAH in the second half of 2020. Classic CAH is a genetic disorder, in which an enzyme deficiency alters the production of adrenal steroids. Because of this deficiency, the adrenal glands fail to produce enough cortisol and, sometimes, aldosterone, resulting in a potentially life-threatening condition.

    "We are pleased that crinecerfont was effective in producing a meaningful, dose-related reduction of adrenal androgens and other key biomarkers of disease in patients with classic CAH and was well tolerated in this study," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "In addition, data from the study was successful in identifying an effective dosing regimen for further evaluation in a single, global registration study in adults with classic CAH. We hope to demonstrate that crinecerfont is a valuable, non-steroidal, treatment option for patients to manage the burdensome symptoms of classic CAH, while also reducing the need for chronic supraphysiologic dosing with glucocorticoids."  

    Crinecerfont Phase II Study Design

    The Phase II open-label, multiple-dose, dose-finding study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in 18 adults with classic 21-hydroxylase deficiency CAH. The study's sequential-cohort design evaluated four crinecerfont oral dosing regimens: 50 mg at bedtime (Cohort 1; n=8); 100 mg at bedtime (Cohort 2; n=7); 100 mg once-daily with an evening meal (Cohort 3; n=8); and 100 mg twice-daily with meals (Cohort 4; n=8). Participants in Cohorts 1 and 2 could enroll in Cohorts 3 and/or 4. Each regimen was administered for 14 consecutive days. ACTH, 17-OHP and A4, key disease hormone markers in CAH patients, were measured over a 24-hour period at baseline and after 14 consecutive days of dosing.

    About Classic Congenital Adrenal Hyperplasia (CAH)

    Classic CAH is a genetic disorder, in which an enzyme deficiency alters the production of adrenal steroids. Because of this deficiency, the adrenal glands fail to produce enough cortisol and, sometimes, aldosterone, resulting in a potentially life-threatening condition. The lack of cortisol stimulates the release of high levels of adrenocorticotropic hormone (ACTH) from the pituitary gland, leading to excessive adrenal androgen levels. These levels can lead to virilization, menstrual irregularities, hirsutism, acne in females and accelerated growth and precocious puberty in childhood (resulting in short stature and fertility problems in both males and females).

    Corticosteroids, the current standard of care, are used both to correct the endogenous cortisol deficiency and to reduce the high ACTH levels and androgen excess. However, the dose and duration of glucocorticoids required to suppress ACTH are often well above the normal physiological level of cortisol, which can result in serious complications typical of iatrogenic Cushing's syndrome, including metabolic issues, bone loss, growth impairment, and infection risk. Classic CAH is a disease that affects approximately 20,000 to 30,000 people in the United States and approximately 50,000 people in Europe.

    About Crinecerfont

    Crinecerfont is a novel, potent, selective, oral, non-steroidal corticotropin-releasing factor type 1 (CRF1) receptor antagonist under evaluation for the treatment of classic CAH. The blockade of CRF receptors in the pituitary has been shown to decrease the release of adrenocorticotropic hormone (ACTH), which in turn decreases the production of adrenal androgens, and potentially the symptoms associated with CAH. Lowering ACTH and adrenal androgen levels could reduce the amount of glucocorticoid treatment necessary for disease control and thus could avoid the complications associated with long-term supraphysiologic glucocorticoid therapy.

    Neurocrine Biosciences plans to initiate a single, global registrational study of crinecerfont in adult patients with classic CAH in the second half of 2020 and recently restarted enrollment for the Phase IIa pediatric study in adolescents with classic CAH.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, and clinical development programs in multiple therapeutic areas including a gene therapy for Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, epilepsy, and polycystic ovary syndrome*. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    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 statements regarding the potential benefits of crinecerfont to patients and future clinical development plans. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include the risk that crinecerfont will not be found to be safe and/or effective or may not prove to be beneficial to patients; that development activities for crinecerfont may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous and/or interim clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for crinecerfont may not occur or be submitted in a timely manner; risks that crinecerfont may not obtain regulatory approvals; or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding crinecerfont; 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, 2020. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-positive-phase-ii-data-for-crinecerfont-in-adults-with-congenital-adrenal-hyperplasia-at-endo-online-2020-301072072.html

    SOURCE Neurocrine Biosciences, Inc.

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  3. SAN DIEGO, June 4, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast at 9:40 a.m. ET on Thursday, June 11, 2020. Kevin Gorman, Chief Executive Officer, Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences
    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids* and clinical development programs in multiple therapeutic areas including a gene therapy for Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, epilepsy, and polycystic ovary syndrome*. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-at-the-goldman-sachs-41st-annual-global-healthcare-conference-webcast-301070907.html

    SOURCE Neurocrine Biosciences, Inc.

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  4. NORTH CHICAGO, Ill., May 29, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ:NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months.2 ORIAHNN is the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.2 ORIAHNN is expected to be available in the U.S. by the end of June 2020.

    "Women who experience heavy menstrual bleeding as a symptom not only deal with the physical toll of uterine fibroids, but also the burdens surrounding its management…

    NORTH CHICAGO, Ill., May 29, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV), in cooperation with Neurocrine Biosciences, Inc. (NASDAQ:NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months.2 ORIAHNN is the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.2 ORIAHNN is expected to be available in the U.S. by the end of June 2020.

    "Women who experience heavy menstrual bleeding as a symptom not only deal with the physical toll of uterine fibroids, but also the burdens surrounding its management while trying to get through with their day-to-day routines," said Ayman Al-Hendy, M.D., Ph.D., investigator for the ELARIS UF-2 clinical trials, and professor of gynecology and director of translational research at the University of Illinois at Chicago. "This approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way."

    Uterine fibroids, also called leiomyomas, are estrogen and progesterone-dependent non-cancerous tumors of the uterus and are the most common type of benign tumor in women of reproductive age, affecting up to 70 percent of Caucasian women and up to 80 percent of African American women by age 50.1,3,4,5,6,7 Traditionally, uterine fibroids have been primarily managed by surgery and are the leading reason for the hysterectomies performed in the U.S.1,3,5,8 

    "It is always deeply rewarding when the years of development our researchers and scientists dedicate to creating a new way to treat patients is successful," said Michael Severino, M.D., vice chairman and president, AbbVie. "ORIAHNN signifies an important advance in how we can care for women with uterine fibroids."

    In the two, randomized Phase 3 uterine fibroid clinical trials, ELARIS UF-I and ELARIS UF-II, ORIAHNN achieved the primary endpoint of clinically meaningful reduction in bleeding (defined as the proportion of women who achieved both at least a 50 percent reduction in menstrual blood loss at final month of treatment and a total menstrual blood loss amount of less than 80 ml), compared with placebo in final month of study for patients, with seven out of 10 women no longer experiencing heavy menstrual bleeding versus one out of 10 women on placebo (P<0.001 for both trials).9 ORIAHNN also reduced heavy menstrual bleeding due to uterine fibroids by 50 percent within the first month of use.9 The results from these studies were recently published in The New England Journal of Medicine.

    ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are a smoker over 35 years of age with high blood pressure.2 Please see the important safety information below for more information. ORIAHNN is taken twice daily (morning and evening) at approximately the same time each day, with or without food. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.2

    "We have heard from women with fibroids across the country who have been hopeful for a treatment with the potential to address their bleeding effectively," said Jenny Rosenberg, executive director of CARE About Fibroids. "The FDA's approval of an oral treatment for women suffering from heavy menstrual bleeding due to uterine fibroids marks a step forward in women's health."10

    About Uterine Fibroids
    Uterine fibroids (also called leiomyomas or myomas) are non-cancerous, hormonally-responsive muscle tissue tumors of the uterus.1,3 Fibroids are the most common type of abnormal growth in a woman's pelvis and can affect up to 70 percent of Caucasian women and up to 80 of African American women by age 50.1,3,4,5,6,7 Fibroids can range in size, shape, number and location.5 Fibroids can be asymptomatic but, in some women, they can cause symptoms such as heavy menstrual bleeding.3,4,5 Treatment options for uterine fibroids include surgery (hysterectomy, myomectomy), endometrial ablation, uterine artery embolization, magnetic resonance imaging (MRI)-guided focused ultrasound and medical management with treatments such as oral contraceptives, progestins, selective progesterone receptor modulators, and gonadotropin-releasing hormone (GnRH) agonists and antagonists.1,9

    About ORIAHNNTM (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules)
    ORIAHNN is approved by the U.S. Food and Drug Administration (FDA) as an oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women.2 ORIAHNN is an oral combination of elagolix and E2/NETA (estradiol/norethindrone acetate) to help achieve a balance between the reduction of heavy bleeding and associated hypoestrogenic side effects.2

    The full U.S. prescribing information, including the medication guide, for ORIAHNN can be found on rxabbvie.com.

    USE

    ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about ORIAHNN?
    ORIAHNN may cause serious side effects, including:

    • Cardiovascular Conditions
      • ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, or are obese. Stop taking ORIAHNN and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have:
        • Leg pain or swelling that will not go away
        • Sudden shortness of breath
        • Double vision, bulging of the eyes, or sudden blindness (partial or complete)
        • Pain or pressure in your chest, arm, or jaw
        • Sudden, severe headache unlike your usual headaches
        • Weakness or numbness in an arm or leg, or trouble speaking
    • Bone Loss (Decreased Bone Mineral Density [BMD])
      • While taking ORIAHNN, your estrogen levels may be low. Low estrogen levels can lead to BMD loss.
      • If you have bone loss on ORIAHNN, your BMD may improve after you stop taking ORIAHNN, but complete recovery may not occur. It is unknown if these BMD changes could increase your risk for broken bones as you age. For this reason, you should not take ORIAHNN for more than 24 months.
      • Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start taking ORIAHNN and periodically after you start.
      • Your doctor may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle.
    • Effects on Pregnancy
      • Do not take ORIAHNN if you are pregnant or trying to become pregnant, as it may increase the risk of early pregnancy loss.
      • If you think you may be pregnant, stop taking ORIAHNN right away and call your HCP.
      • ORIAHNN can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other pregnancy signs like breast tenderness, weight gain, and nausea.
      • ORIAHNN does not prevent pregnancy. You will need to use effective methods of birth control while taking ORIAHNN and for 1 week after you stop taking ORIAHNN. Examples of effective methods can include condoms or spermicide, which do not contain hormones.
      • Talk to your HCP about which birth control to use during treatment with ORIAHNN. Your HCP may change the birth control you are on before you start taking ORIAHNN.

    Do not take ORIAHNN if you:

    • Have or have had:
      • A stroke or heart attack
      • A problem that makes your blood clot more than normal
      • Blood circulation disorder
      • Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
      • Blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
      • High blood pressure not well controlled by medicine
      • Diabetes with kidney, eye, nerve, or blood vessel damage
      • Certain kinds of headaches with numbness, weakness, or changes in vision, or have migraine headaches with aura if you are over age 35
      • Breast cancer or any cancer that is sensitive to female hormones
      • Osteoporosis
      • Unexplained vaginal bleeding that has not been diagnosed
      • Liver problems including liver disease
    • Smoke and are over 35 years old
    • Are taking medicines known as strong OATP1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix. Ask your HCP if you are not sure if you are taking this type of medicine.
    • Have had a serious allergic reaction to elagolix, estradiol, norethindrone acetate, or any of the ingredients in ORIAHNN. Ask your HCP if you are not sure.
    • FD&C Yellow No. 5 (tartrazine) is an ingredient in ORIAHNN, which may cause an allergic type reaction such as bronchial asthma in some patients who are also allergic to aspirin.

    What should I discuss with my HCP before taking ORIAHNN?
    Tell your HCP about all your medical conditions, including if you:

    • Have or have had:
      • Broken bones or other conditions that may cause bone problems
      • Depression, mood swings, or suicidal thoughts or behavior
      • Yellowing of the skin or eyes (jaundice) or jaundice caused by pregnancy (cholestasis of pregnancy)
    • Are scheduled for surgery. ORIAHNN may increase your risk of blood clots after surgery. Your doctor may advise you to stop taking ORIAHNN before you have surgery. If this happens, talk to your HCP about when to restart ORIAHNN after surgery.
    • Are pregnant or think you may be pregnant.
    • Are breastfeeding. It is not known if ORIAHNN can pass into your breastmilk. Talk to your HCP about the best way to feed your baby if you take ORIAHNN.

    Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Women on thyroid or cortisol replacement therapy may need increased doses of the hormone.

    Keep a list of your medicines with you to show to your HCP and pharmacist when you get a new medicine.

    What should I avoid while taking ORIAHNN?

    • Avoid grapefruit and grapefruit juice during treatment with ORIAHNN since they may affect the level of ORIAHNN in your blood, which may increase side effects.

    What are the possible side effects of ORIAHNN?
    ORIAHNN can cause additional serious side effects, including:

    • Suicidal thoughts, suicidal behavior, and worsening of mood. ORIAHNN may cause suicidal thoughts or actions. Call your HCP or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. Pay attention to any changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings.
    • Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily.
    • High blood pressure. You should see your HCP to check your blood pressure regularly.
    • Gallbladder problems (cholestasis), especially if you had cholestasis of pregnancy.
    • Increases in blood sugar, cholesterol, and fat (triglyceride) levels.
    • Hair loss (alopecia). Hair loss and hair thinning can happen while taking ORIAHNN, and it can continue even after you stop taking ORIAHNN. It is not known if this hair loss or hair thinning is reversible. Talk to your HCP if this is a concern for you.
    • Changes in laboratory tests, including thyroid and other hormone, cholesterol, and blood clotting tests.

    The most common side effects of ORIAHNN include: hot flashes, headache, fatigue, and irregular periods.

    These are not all of the possible side effects of ORIAHNN. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects.

    Take ORIAHNN exactly as your HCP tells you. The recommended oral dosage of ORIAHNN is one yellow/white capsule in the morning and one blue/white capsule in the evening, with or without food.

    This is the most important information to know about ORIAHNN. For more information, talk to your doctor or HCP.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

    If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

    About AbbVie
    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn.

    Forward-Looking Statements
    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    1 De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95(2):100-107.  
    2 ORIAHNN™ (elagolix, estradiol and norethindrone acetate capsules co-formulated) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    3 Office on Women's Health, WomensHealth.gov. Uterine Fibroids. https://www.womenshealth.gov/a-z-topics/uterine-fibroids.
    4 Khan A et al. Uterine fibroids: current perspectives. Int J Women's Health. 2014;6:95-114.
    5 The American College of Obstetricians and Gynecologists: FAQ Uterine Fibroids. https://www.acog.org/patient-resources/faqs/gynecologic-problems/uterine-fibroids.
    Wallach EE et al. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol. 2004;104:393–406.
    7 Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2013;188:100-107.
    8 Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin No. 96. American College of Obstetricians and Gynecologist. Obstet Gynecol 2008; 112:387-400.
    9 Data on file.
    10 Reference to CARE About Fibroids reflects their recognition of the need for medical management options for this patient population, but is not meant to be an endorsement or recommendation of use by this organization of ORIAHNN or AbbVie. 

    Cision View original content:http://www.prnewswire.com/news-releases/fda-approves-the-first-oral-medication-for-the-management-of-heavy-menstrual-bleeding-due-to-uterine-fibroids-in-pre-menopausal-women-301067963.html

    SOURCE AbbVie

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