- ONGENTYS® (opicapone) is a leading adjunctive therapy for the
treatment of Parkinson’s Disease
- Complements Amneal’s existing Parkinson’s franchise and further
expands specialty portfolio
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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the full release here:
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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:
- 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
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Amneal
Investor Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Media Rachel St. Martin Managing Director, Media and
Engagement, Real Chemistry rstmartin@realchemistry.com
Amneal Medical Affairs 888-990-AMRX (2679)
askamrx@amneal.com
BIAL
Media Susana Vasconcelos Senior Manager, Communication
susana.vasconcelos@bial.com
Amneal Pharmaceuticals (NYSE:AMRX)
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