Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the
“Company”) today announced that it has entered into an exclusive
licensing agreement with Zambon Biotech SA, part of the Zambon
group (“Zambon”), for IPX203 in the European Union, United Kingdom,
and Switzerland.
IPX203 is a novel, oral formulation of carbidopa/levodopa
(CD/LD) extended-release capsules for the treatment of Parkinson’s
disease (PD) that is under review with the U.S. Food and Drug
Administration. Zambon will seek regulatory approval and
commercialize IPX203 in Europe. Financial terms of the agreement
were not disclosed.
Zambon is a privately held multinational chemical-pharmaceutical
company founded in Italy in 1906. The company continues to be
managed by the family of the original founder. Zambon has extensive
presence in the European neurology space, having launched and
commercialized XADAGO® (safinamide), which is used as add on to LD
to treat fluctuating PD patients. IPX203 is expected to complement
their existing portfolio and PD focus in Europe, where XADAGO® is a
registered trademark of Zambon SpA.
“We believe IPX203 can improve the lives of the more than 10
million people worldwide living with Parkinson’s disease. It has
been a strategic goal of Amneal to ensure that not only U.S.
patients, but also Parkinson’s patients worldwide have access to
our products. Zambon, a family-owned business with whom we share a
long-term vision and commitment toward patient communities, is the
right partner to extend the reach of IPX203 to Europe,” said Chirag
and Chintu Patel, Co-Chief Executive Officers at Amneal.
“Zambon Biotech’s mission is to build a long-term pipeline of
innovative medicines that make patients’ lives better. Given our
group’s capabilities in commercialization and our existing
footprint in neurology, particularly Parkinson’s, we are pleased to
partner with Amneal to bring IPX203 to Parkinson’s patients in
Europe,” said Frank Weber, Chief Executive Officer at Zambon
Biotech.
Today’s announcement of a licensing agreement with a European
partner is part of Amneal’s broader strategy to bring IPX203 to
Parkinson’s patients around the world. Earlier this year, Amneal
also signed a license agreement with Knight Therapeutics Inc.
granting exclusive rights to seek regulatory approval and
commercialize IPX203 in Canada and Latin America.
About IPX203 IPX203 is a novel, oral formulation of CD/LD
extended-release capsules designed for the treatment of Parkinson’s
disease. IPX203 contains immediate-release granules and
extended-release coated beads. The IR granules consist of CD and
LD, with a disintegrant polymer to allow for rapid dissolution. The
ER beads consist of LD, coated with a sustained release polymer to
allow for slow release of the drug a mucoadhesive polymer to keep
the granules adhered to the area of absorption longer, and an
enteric coating to prevent the granules from disintegrating
prematurely in the stomach. This formulation is distinct from
RYTARY® (carbidopa/levodopa) extended-release capsules, Amneal’s
extended-release CD/LD treatment for PD approved by the U.S. FDA in
2015.
About Parkinson’s Disease Parkinson’s disease has become
the fastest growing neurological disorder worldwide, with
approximately 1 million patients diagnosed in the U.S. and over 10
million patients globally1,2,3 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 patients with PD is
60; as people live longer, the number of patients living with PD is
predicted to grow significantly over the coming decades.1,6
About Amneal Amneal Pharmaceuticals, Inc. (NASDAQ: 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 over 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 Zambon Biotech SA Zambon Biotech SA is a
specialized biotech company that aims to build a scientifically
robust and commercially viable portfolio of innovative
patient-oriented drugs through the scouting, acquisition, licensing
and development of new molecules. Zambon Biotech is part of Zambon,
a modern multinational chemical-pharmaceutical company established
in 1906 in Vicenza, whose history is founded on the values of an
Italian family committed to innovating cure and care to improve
patients’ lives. Zambon employs 2,798 people worldwide, is present
in 23 countries in Europe, America and Asia, and has production
facilities in Italy, Switzerland, China, Brazil and in France with
its APIs and CDMO site. Thanks to its innovative, quality products
commercialized in 87 countries, the group reported a revenue of 900
million euros in 2023. Alongside the three historical therapeutic
areas - diseases of the respiratory system, urinary tract
infections and pain treatment – Zambon pharma business is focused
on developing treatments for neurodegenerative diseases such as
Parkinson's or rare diseases such as cystic fibrosis, BOS, to which
is linked the major 2019 acquisition of Breath Therapeutics, and
NCFB. For further information on Zambon please visit
www.zambon.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 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:
- Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
- Marras et al. NPJ Parkinsons Dis. 2018;4:21.
- Parkinson’s Foundation.
https://www.parkinson.org/understanding-parkinsons/statistics.
- NINDS. Parkinson’s disease: challenges, progress, and promise.
Reviewed August 2019.
- Data Monitor: Gibrat et al., 2009; Goldenberg, 2008;
Muangpaisan et al., 2009; Pringsheim et al., 2014.
- John Hopkins Medicine. Young-Onset Parkinson’s disease.
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version on businesswire.com: https://www.businesswire.com/news/home/20240227147740/en/
Amneal Contact Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Zambon Contact media@zambongroup.com
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