Norethindrone

Board of Directors appoints Kyle Gano, Ph.D., Chief Business Development and Strategy Officer, as CEO-elect, effective October 11, 2024 Kevin Gorman, Ph.D., to continue to serve on the Neurocrine Board of Directors SAN DIEGO, May 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that Kevin Gorman, Ph.D., will retire as Chief Executive Officer of Neurocrine on October 11, 2024. Kyle Gano, Ph.D., currently Neurocrine's Chief Business Development and Strategy Officer, will succeed him in the CEO role. Dr. Gano will also join the Company's Board of Directors at that time, and Dr. Gorman will continue to serve on the Neurocrine Board. Dr. Gorman founded Neurocrine in 1992 and held numerous positions across the Company, including Chief Operating Officer, Chief Business Officer, and Senior Vice President of Business Development, before being appointed CEO in 2008. Under Dr. Gorman's three decades of leadership, Neurocrine has emerged as a fully integrated biopharmaceutical enterprise with a broad, mature pipeline, strong financial position, and highly successful commercial product, INGREZZA® (valbenazine). Dr. Gorman's vision to focus on areas that lack recent innovation or have limited treatment options has provided the Company with meaningful momentum in its mission to discover and develop new medicines that relieve patient suffering. Notably, in late April, Neurocrine submitted to the FDA two New Drug Applications for crinecerfont as a treatment for adult and pediatric patients with classic congenital adrenal hyperplasia (CAH). In addition, the Company now has 17 clinical development programs in its pipeline focusing on helping patients across neurology, neuroendocrinology, and neuropsychology. With a growing multi-billion-dollar medicine in INGREZZA, a rich and diverse pipeline, and a strong financial profile, Neurocrine is well positioned to execute on a bold vision for future growth and impact. "It has been a privilege to lead the Neurocrine team in developing life-changing treatments for patients in need," Dr. Gorman said. "When I took on the role of CEO in 2008, Neurocrine was a clinical stage company with a limited pipeline and no approved products. Together, we have built a diverse pipeline and a leading R&D innovation engine designed to rapidly deliver up to four INDs per year. We successfully launched INGREZZA, which has driven strong financial results while improving the treatment of tardive dyskinesia and chorea associated with Huntington's disease. Importantly, we are working diligently to be prepared to bring crinecerfont to patients with CAH next year, if approved. I couldn't be prouder of all that this team has accomplished, and I have never been more confident in Neurocrine's future." Dr. Gorman continued, "With the foundation of a world-class team, compelling science, and clear vision, it is the right time to initiate this well-planned leadership transition. The Board of Directors is confident Kyle is the ideal CEO to lead Neurocrine's next chapter of growth, as am I. We have worked closely together for more than 20 years. He has been instrumental in Neurocrine's success and is an exceptional leader of the organization. I look forward to supporting him in my continuing role as a member of the Neurocrine Board." "I believe deeply in Neurocrine's values and mission, and I am honored to take the reins from an amazing leader and mentor," Dr. Gano said. "This is an important year for our organization, as we look to help even more patients with tardive dyskinesia and Huntington's disease through INGREZZA, while potentially bringing crinecerfont to CAH patients in 2025 – all while advancing our pipeline. I look forward to continuing to work closely with our leadership team and the Board to capitalize on our momentum and advance our vision to be a true global leader in neuroscience." "On behalf of the Board, I thank Kevin for his unwavering dedication to Neurocrine Biosciences over the past three decades and wish him the very best in his well-deserved retirement," said William H. Rastetter, Ph.D., Chairman of the Board of Neurocrine Biosciences. "Having worked closely with Kevin on succession planning, and knowing Kyle well, we're thrilled to appoint Kyle as Neurocrine's CEO-elect and look forward to welcoming him to the Board. We are confident that, with Kyle's deep substantive expertise, broad experience working with functions throughout the Company, and clear vision for the future, Neurocrine will continue to grow and succeed as a leading neuroscience-focused company for the benefit of patients, employees, and shareholders." About Kyle Gano Kyle W. Gano, Ph.D., is a proven executive who joined Neurocrine Biosciences more than 23 years ago. After beginning his career at Neurocrine in a market research and analytics role, Dr. Gano has spent the better part of the last two decades focused on business and corporate development, assuming the position of Chief Business Development Officer in 2011 and Chief Business Development and Strategy Officer in 2020. In his current role, Dr. Gano oversees the Company's strategic collaborations across multiple therapeutic areas that bring critical treatments to patients suffering from neurological, neuroendocrine, and neuropsychiatric disorders. During his tenure, he has executed and managed many robust partnerships, including those that are currently active with AbbVie, Idorsia Ltd, Mitsubishi Tanabe Pharma, Nxera Pharma (formerly Sosei Heptares), Sanofi S.A., Takeda Pharmaceutical Company Limited, Voyager Therapeutics, and Xenon Pharmaceuticals. He also led the acquisition of Diurnal Group Plc in 2021, expanding Neurocrine's presence to the United Kingdom and European Union. Beyond his business development and strategy portfolio, Dr. Gano has led numerous high-impact operational and business priorities. These include having been the lead inventor on the patent to the valbenazine molecule, having served as Team Lead for both the elagolix development program and VMAT2 Franchise Team, and currently holding oversight responsibility for all muscarinic development teams and activities. He also played key leadership roles in the development of three FDA-approved medicines – INGREZZA® (valbenazine), ORILISSA® (elagolix), and ORIAHNN® (elagolix, estradiol, and norethindrone). Dr. Gano serves on the Board of Directors of California Life Sciences (CLS). He received his B.S. in Chemistry from the University of Oregon, B.S. in Biochemistry from the University of Washington, and his Ph.D. in Organic Chemistry and M.B.A from the University of California, Los Angeles. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The Company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis*, and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie) NEUROCRINE BIOSCIENCES Logo Lockup, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. About INGREZZA® (valbenazine) Capsules INGREZZA is the only one-capsule, once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA selectively targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. Additionally, INGREZZA can be taken as one capsule, once daily together with most psychiatric medications such as antipsychotics or antidepressants. INGREZZA dosages approved for use are 40 mg, 60 mg and 80 mg capsules. INGREZZA is not approved in any other dosage form. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. 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: our pipeline, financial position, commercial product strength, momentum, vision and future growth; the ability of our R&D innovation engine to deliver INDs; the continued success of INGREZZA; the regulatory approval and commercialization of crinecerfont; and the impact of our CEO succession on our future growth and success. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that clinical development activities may not be initiated or completed on time or at all, or 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 that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or 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; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with management transitions; and other risks described in our periodic reports filed with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. View original content to download multimedia: SOURCE Neurocrine Biosciences, Inc. Company Codes: NASDAQ-NMS:NBIX

为落实国务院办公厅《关于改革完善仿制药供应保障及使用政策的意见》有关制定仿制药品目录的部署和要求，2023年，国家卫生健康委、工业和信息化部、国家医保局和国家药品监管局、国家知识产权局等部门组织专家对国内专利即将到期尚未提出注册申请及临床供应短缺（竞争不充分）的药品进行遴选论证，提出了《第三批鼓励仿制药品建议目录》。现予以公示，公示5个工作日。如有异议，请通过以下电话予以反映。电话：（010）68792519     第三批鼓励仿制药品建议目录                    药物政策与基本药物制度司2023年10月30日附件第三批鼓励仿制药品建议目录序号药品名称英文名称剂型规格1贝美替尼binimetinib片剂15mg2伏环孢素voclosporin胶囊剂7.9mg3伊德利塞idelalisib片剂0.1g片剂0.15g4艾曲泊帕乙醇胺eltrombopag 片剂25mg片剂50mg5拉替拉韦raltegravir干混悬剂0.1g6来法莫林lefamulin注射剂15ml:0.15g片剂0.6g7利非司特lifitegrast滴眼剂0.058芦比替定lurbinectedin注射剂4mg9芦曲泊帕lusutrombopag片剂3mg10哌马色林pimavanserin片剂10mg片剂17mg胶囊剂34mg11瑞卢戈利relugolix片剂0.12g片剂40mg12替拉凡星telavancin粉针剂0.25g粉针剂0.75g13妥卡替尼tucatinib片剂50mg片剂0.15g14福他替尼fostamatinib片剂0.1g片剂0.15g15纳洛醇醚naloxegol片剂12.5mg片剂25mg16帕替司兰patisiran注射剂5ml:10mg17芦卡帕利rucaparib片剂0.25g片剂0.3g18替伏扎尼tivozanib胶囊剂0.89mg胶囊剂1.34mg19阿立哌唑aripiprazole缓释注射剂1.6ml:0.441g缓释注射剂2.4ml:0.675g;缓释注射剂3.2ml:0.96g20阿莫非尼armodafinil片剂50mg片剂0.2g21阿塞那平asenapine舌下片2.5mg舌下片5mg舌下片10mg22奥氮平+沙米啡烷，复方olanzapine + samidorphan, combinations片剂15mg:奥氮平5mg,沙米啡烷10mg片剂20mg:奥氮平10mg,沙米啡烷10mg片剂25mg:奥氮平15mg,沙米啡烷10mg片剂30mg:奥氮平20mg,沙米啡烷10mg23贝派度酸bempedoic acid片剂0.18g24凡他尼布vandetanib片剂0.1g片剂0.3g25非达米星fidaxomicin片剂0.2g26加巴喷汀酯gabapentin enacarbil缓释片0.3g缓释片0.6g27卡波替尼cabozantinib胶囊剂20mg胶囊剂80mg片剂20mg片剂40mg片剂60mg28卡替拉韦cabotegravir缓释注射剂3ml:0.6g29瑞维那新revefenacin吸入溶液剂3ml:0.175mg30利右苯丙胺lisdexamfetamine胶囊剂10mg胶囊剂20mg胶囊剂40mg咀嚼片10mg咀嚼片20mg咀嚼片40mg31瑞卢戈利+雌二醇+炔诺酮，复方relugolix + estradiol + norethindrone, combinations片剂41.5mg:瑞卢戈利40mg,雌二醇1mg,炔诺酮0.5mg32依普利酮eplerenone片剂25mg片剂50mg33硝唑沙奈nitazoxanide片剂0.5g混悬剂5ml:0.1g34氯巴占clobazam片剂20mg膜剂5mg膜剂10mg膜剂20mg混悬剂1ml:2.5mg35Ga-68PSMA-11Gallium-68 PSMA-11注射剂10ml:20mCi36Ga-68dotatateGallium-68 dotatate注射剂10ml:20mCi37F-18多巴Fluorine-18 Fluorodopa注射剂10ml:40.5mCi38F-18氟代雌二醇Fluorine-18 fluoroestradiol注射剂10ml:40.5mCi39F-18 氟化钠Fluorine-18 sodium fluoride注射剂10ml:40.5mCi40F-18氟贝他吡/18F-AV1451Fluorine-18 flortaucipir 注射剂10ml:40.5mCi41I-123间碘苄胍/MIBGlodine I-123 iobenguane注射剂10ml:20mCi