- Partnering with Strides to commercialize recently U.S. FDA
approved product
- Represents another new product launch for Amneal in 2023
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) and Strides Pharma Science Limited (“Strides”) today
announced the addition of Icosapent ethyl acid soft gel capsules, a
product referencing VASCEPA®. The product has been in-licensed from
Strides, a global pharmaceutical manufacturer, and will be
commercialized by Amneal starting in the fourth quarter of
2023.
Icosapent ethyl acid soft gel capsules 0.5g and 1g is an ethyl
ester of eicosapentaenoic acid (EPA) that is indicated as an
adjunct to diet to reduce triglyceride levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
“We are on-track to launch over 40 new products in 2023,” said
Andy Boyer, Executive Vice President, Amneal Generics. “The launch
of Icosapent ethyl is another essential medicine that we’ve added
to our portfolio.”
“We are thrilled to announce our partnership with Amneal
Pharmaceuticals for Icosapent ethyl acid soft gelatin capsules.
This partnership is a testament to our commitment to excellence and
the pursuit of cutting-edge solutions. By combining our resources,
expertise, and shared passion, we are confident that we will
achieve remarkable outcomes that benefit not only our organizations
but also our valued customer and stakeholders,” said Aditya Kumar,
Vice President Business Development, Strides Pharma Science
Limited.
Important Safety Information: Adverse effects reported
with VASCEPA® include musculoskeletal pain, peripheral edema,
constipation, gout, and atrial fibrillation. For full prescribing
information, see package insert located here.
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 Strides
Strides, listed on the BSE Limited (532531) and National Stock
Exchange of India Limited (STAR), is a global pharmaceutical
company headquartered in Bengaluru, India. The Company mainly
operates in the regulated markets and has an “in Africa for Africa”
strategy along with an institutional business to service
donor-funded markets. The Company’s global manufacturing sites are
located in India (Chennai, Puducherry and two locations in
Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the
United States (New York). The Company focusses on “difficult to
manufacture” products that are sold in over 100 countries.
Additional information is available at the Company’s website at
www.strides.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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231201265945/en/
Amneal Investor Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com Strides Badree Komandur
Executive Director - Finance & Group CFO +91 80 6784 0747
Strides Pharma Science Limited:
CIN: L24230MH1990PLC057062 Regd. Office: 201, ‘Devavrata’, Sector –
17, Vashi, Navi Mumbai – 400 703 Corp. Office: Strides House,
Bannerghatta Road, Bengaluru – 560 076 Corporate Communication: Pallavi Panchmatia
: +91 80 6784 0193, pallavi.panchmatia@strides.com
PR Consultancy: Fortuna PR K
Srinivas Reddy: +91 90005 27213 srinivas@fortunapr.com Boni
Mukherjee: +91 96186 82208 boni@fortunapr.com
Amneal Pharmaceuticals (NYSE:AMRX)
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