Opicapone

BRIDGEWATER, N.J. & PORTO, Portugal--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS ® (opicapone) in the U.S. starting on December 18, 2023. Amneal expects to begin distribution of ONGENTYS ® in early 2024. ONGENTYS ® is BIAL’s proprietary once-daily, peripherally-acting, highly-selective catechol-O-methyltransferase inhibitor (COMT inhibitor), approved by the U.S. Food and Drug Administration (“FDA”) in 2020 as an add-on treatment to carbidopa/levodopa (CD/LD) in patients with Parkinson’s disease (PD) experiencing “Off” episodes. Carbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s. As the disease progresses, patients on LD start experiencing motor complications such as the “wearing-off phenomenon,” which are periods where LD is no longer providing enough relief from PD symptoms and people experience what is referred to as “Off” time. Wearing-off is common, with around 50% of patients reporting it in the first five years after PD diagnosis. 1 “Off” time can greatly disrupt a patient’s daily routine by inhibiting their ability to perform tasks or care for themselves. ONGENTYS ® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time. ONGENTYS offers patients living with Parkinson´s disease an effective, once-daily adjunctive treatment option for “Off” episodes. It is the first and only LD optimizer approved for once-daily use. Amneal views ONGENTYS ® as highly complementary to Rytary ® and IPX203. “As a company committed to the Parkinson’s community, Amneal continues to look for more ways to serve and support people with PD, their loved ones, and the physicians who treat them,” said Joe Renda, Senior Vice President, Chief Commercial Officer Specialty. “We understand the importance of minimizing ‘Off’ time and increasing “On” time without troublesome dyskinesia when treating PD. We look forward to working with BIAL to ensure ONGENTYS ® remains available for patients in the U.S. and look to further grow this key adjunctive therapy. This is an exciting complement to our specialty branded portfolio and pipeline of best-in-class treatment options for PD.” “We are fully committed to creating value for people living with severe neurological conditions worldwide, being the U.S. is a key geography for BIAL. Amneal shares our long-term vision for ONGENTYS ® , and our partnership will allow us to expand its accessibility, continuing to make a difference for patients suffering from Parkinson’s disease in the U.S.,” said Max Bricchi, Executive Vice President, Chief Commercial Officer of BIAL. The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance. Important Information Approved Use ONGENTYS ® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson's disease (PD) who are having "OFF" episodes. It is not known if ONGENTYS ® is safe and effective in children. Important Safety Information Do not take ONGENTYS ® if you: take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor. have a tumor that secretes hormones known as catecholamines. Before taking ONGENTYS ® , tell your healthcare provider about all of your medical conditions, including if you: have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy. have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping. have a history of uncontrolled sudden movements (dyskinesia). have had hallucinations or psychosis. have liver or kidney 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. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection). ONGENTYS ® and other medicines may affect each other causing side effects. ONGENTYS ® may affect the way other medicines work, and other medicines may affect how ONGENTYS ® works. What should I avoid while taking ONGENTYS ® ? Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS ® affects you. What are the possible side effects of ONGENTYS ® ? ONGENTYS ® may cause serious side effects, including: Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS ® or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS ® are higher if you take other medicines that cause drowsiness. Low blood pressure or dizziness , light headedness, or fainting. Uncontrolled sudden movements (dyskinesia). ONGENTYS ® may cause uncontrolled sudden movements or make such movements worse or happen more often. Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior. Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges. Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior. The most common side effects of ONGENTYS ® include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss. These are not all the possible side effects of ONGENTYS ® . Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see ONGENTYS ® full Product Information . About Parkinson’s Disease Parkinson’s disease (PD) has become the fastest-growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S. 2,3 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremor, and impaired balance. 4 While PD is not considered a fatal disease, it is associated with significant morbidity and disability. 5 The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades. 2,6 About ONGENTYS ® (opicapone): ONGENTYS ® is a once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the FDA as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The FDA approval of ONGENTYS ® is supported by data from two pivotal trials in patients with Parkinson's disease and end-of-dose motor fluctuations (BIPARK-I and II), and the results demonstrated an acceptable tolerability profile, combined with efficacy in reducing OFF-time in adult patients with Parkinson's disease and end-of-dose motor fluctuations. 7 These studies also led to the approval of opicapone in the European Union, UK, Japan, Korea, Australia, and other countries. 8 About Amneal Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com . About BIAL BIAL is an innovation-driven pharmaceutical company aiming to improve people’s lives worldwide. With 99 years of experience, BIAL is a fully integrated company strongly committed to therapeutic innovation, being neurosciences as its major area of research. Based on its innovative medicines and with a consistent partnering program, BIAL has extended its presence worldwide. The company has affiliates in three different continents – Europe, America, and Africa – and its products are present in fifty countries, including the US, Japan, Germany, Canada, Korea, and Australia, fulfilling its purpose of making a real difference in the lives of people living with severe diseases across the world. For more information about BIAL, please visit: www.bial.com . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our ability to complete the proposed holding company reorganization on the anticipated timeline or at all and to realize the expected benefits of such reorganization; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. References: Stocchi F, et al. Parkinsonism Relat Disord. 2014;20(2):204-11 Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10. Marras et al. NPJ Parkinsons Dis. 2018;4:21. NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019. Accessed April 16, 2021. Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014. John Hopkins Medicine. Young-Onset Parkinson’s disease. Accessed August 17, 2021. Ferreira, J. et al., Eur J Neurol. 2019 Jul;26(7) 953-960 Ferreira, J. et al., Neurol Ther. 2022 Sep;11(3):1409-1425

INGREZZA® (valbenazine) First Quarter Net Product Sales of $410 Million INGREZZA® (valbenazine) 2023 Net Product Sales Guidance Reiterated at $1.67 - $1.77 Billion SAN DIEGO, May 3, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the first quarter ended March 31, 2023 and provided an update on its 2023 financial guidance. "INGREZZA's first quarter results highlight the steady progress we are making to help improve the lives of patients living with tardive dyskinesia, yet we still have a tremendous opportunity to help even more patients for many years to come," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are executing well across our clinical portfolio and anticipate several important milestones in the months ahead including the August 20th PDUFA date for valbenazine for the treatment of chorea associated with Huntington disease. In addition, we remain on-track for top-line data in the second half of this year for several investigational programs, including crinecerfont for the treatment of pediatric and adult congenital adrenal hyperplasia." First Quarter INGREZZA Net Product Sales Highlights: INGREZZA first quarter 2023 net product sales were $410 million and grew 36% compared vs. the first quarter 2022 Record number of new patients received therapy during the first quarter of 2023 First Quarter Financial Highlights: First quarter 2023 GAAP net loss and loss per share of $77 million and $0.79, respectively, compared with first quarter 2022 GAAP net income and earnings per share of $14 million and $0.14, respectively First quarter 2023 non-GAAP net loss and loss per share of $50 million and $0.51, respectively, compared with first quarter 2022 non-GAAP net income and earnings per share of $30 million and $0.30, respectively Differences in first quarter 2023 GAAP and non-GAAP operating expenses compared with first quarter 2022 driven by: Acquired In-Process R&D (IPR&D) expense of $144 million in first quarter 2023 associated with expansion of strategic partnership with Voyager Therapeutics, Inc. (Voyager) Increased R&D expense in support of an expanded and advancing clinical portfolio Increased SG&A expense primarily due to ongoing commercial initiatives, including the deployment of the expanded salesforce in April 2022 At March 31, 2023, the Company had cash, cash equivalents and marketable securities of approximately $1.1 billion A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release. Recent Events: On January 8, 2023, we entered into a new strategic collaboration with Voyager, which became effective on February 21, 2023, to acquire the worldwide rights to Voyager's GBA1 gene therapy program for Parkinson's disease and other GBA1-mediated diseases and three gene therapy programs directed to rare central nervous system targets for up-front consideration of $175 million. In the first quarter of 2023, we provided BIAL with written notice of termination of the license agreement to commercialize and market ONGENTYS® (opicapone), an approved adjunctive therapy for patients with Parkinson's disease, in the United States and Canada. We determined that continued commercialization of ONGENTYS is unsustainable. The termination is anticipated to be effective in December 2023. ONGENTYS is an important, safe and effective adjunctive treatment option for Parkinson's disease patients. We intend to work with BIAL to ensure an orderly transition of the commercialization of ONGENTYS and to ensure patients have continued access to ONGENTYS. Reiterated 2023 INGREZZA Sales and Updated Operating Expense Guidance: 2023 Expected Pipeline Milestones and Key Activities Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; NaV1.6 = Sodium Channel, Voltage-Gated; M1 / M4 = M1 / M4 Muscarinic Receptor; GPR = Orphan G Protein Coupled Receptor Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia; ** In-Licensed from Xenon Pharmaceuticals; † Partnered with Takeda Pharmaceutical Company Limited; ‡ In-Licensed from Sosei Group Corporation Conference Call and Webcast Today at 8:00 AM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences' website under Investors at . 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 Neurocrine Biosciences 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, Parkinson'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, Twitter and Facebook. (*in collaboration with AbbVie) Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following non-GAAP financial measures: non-GAAP R&D expense, non-GAAP SG&A expense, and non-GAAP net income and net income per share. When preparing the non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these non-GAAP financial measures exclude: non-cash stock-based compensation expense, loss on extinguishment of convertible senior notes, non-cash interest expense related to convertible debt, non-cash amortization expense related to acquired intangible assets, acquisition-related transaction costs, changes in fair value of equity security investments, changes in foreign currency exchange rates and certain adjustments to income tax expense. These non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a non-GAAP basis. A reconciliation of these GAAP financial results to non-GAAP financial results is included in the attached financial information. 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 our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. 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 U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; 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, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof. Company Codes: NASDAQ-NMS:NBIX