Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (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.

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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:

1. Stocchi F, et al. Parkinsonism Relat Disord. 2014;20(2):204-11
2. Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
3. Marras et al. NPJ Parkinsons Dis. 2018;4:21.
4. NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019. Accessed April 16, 2021.
5. Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
6. John Hopkins Medicine. Young-Onset Parkinson’s disease. Accessed August 17, 2021.
7. Ferreira, J. et al., Eur J Neurol. 2019 Jul;26(7) 953-960
8. Ferreira, J. et al., Neurol Ther. 2022 Sep;11(3):1409-1425

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