Significantly expanding access to affordable, life-saving opioid
overdose rescue medicine
Entered distribution agreement with California; actively
engaging with other states and municipalities to expand access
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the
“Company”) today announced that it has begun supplying its
over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal
Spray, USP, 4mg to U.S. retail pharmacies and the State of
California. The product is now available for direct distribution to
states and municipalities across the U.S.
The U.S. Food and Drug Administration approved Amneal’s Naloxone
HCI Nasal Spray in April 2024. Amneal’s Naloxone HCI Nasal Spray is
a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication
widely used to help treat opioid drug overdoses. The Company also
entered into a distribution agreement with California to provide
Naloxone HCI Nasal Spray through the CalRx® Naloxone Access
Initiative. Amneal expects to have capacity to produce
approximately ten million two-packs annually at its New Jersey
manufacturing facility, starting in 2025.
“Amneal is an industry leader in complex generics with the
ability to develop, manufacture and commercialize high-quality
medicines that are affordable and accessible. The widespread
availability of OTC naloxone will be a critical tool in the fight
against the ongoing opioid epidemic. Amneal is proud to be part of
the solution,” said Andy Boyer, Executive Vice President, Chief
Commercial Officer – Generics.
“We are pleased to partner with the State of California on a
long-term distribution agreement to make OTC naloxone available to
thousands of communities and millions of people. We are actively
engaging with other states and municipalities to expand access to
this important life-saving product, which is proudly made in
America in one of our New Jersey facilities,” said Maryll
Toufanian, SVP, Regulatory Strategy and Government Affairs.
To learn more about Amneal’s Naloxone HCl Nasal Spray, please
visit https://amnealnaloxone.com/.
About Naloxone Nasal Spray
Naloxone Hydrochloride (Naloxone HCI) Nasal Spray is designed to
rapidly reverse the effects of a life-threatening opioid emergency
by binding to opioid receptors in the brain and blocking the
effects of opioids. It can restore normal breathing within two to
three minutes in a person whose breath has slowed, or even stopped,
as a result of an overdose from opioids including heroin, fentanyl
and prescription opioid medications. Amneal’s Naloxone HCI Nasal
Spray contains the same active ingredient and dose as NARCAN®
Naloxone HCI Nasal Spray, 4 mg. It is available over-the-counter
and is easy to carry, and it can be safely used even if opioids are
not present in the patient.
NARCAN® is a registered trademark of Emergent Operations Ireland
Limited.
When using this product some people may experience symptoms when
they wake up, such as shaking, sweating, nausea or feeling angry.
This is to be expected.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in
Bridgewater, NJ, is a global pharmaceuticals company. We make
healthy possible through the development, manufacturing, and
distribution of a diverse portfolio of over 280 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.
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; expected or estimated operating
results and financial performance; and statements regarding our
positioning, including our ability to drive sustainable long-term
growth, 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 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 impact of a prolonged
business interruption within our supply chain; 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; legal, regulatory and
legislative efforts by our brand competitors to deter competition
from our generic alternatives; our dependence on information
technology systems and infrastructure and the potential for
cybersecurity incidents; our ability to attract, hire and retain
highly skilled personnel; 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 claims brought against us by
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 dependence on
third-party agreements for a portion of our product offerings; 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
potential expansion into additional international markets
subjecting us to increased regulatory, economic, social and
political uncertainties; 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240522229390/en/
Investor and Media Contact Anthony DiMeo VP, Investor
Relations & Media anthony.dimeo@amneal.com
Government Contact Maryll Toufanian SVP, Regulatory
Strategy and Government Affairs maryll.toufanian@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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