Amneal Awarded Sub-License to Manufacture and Commercialize Generic Version of Co-Packaged Nirmatrelvir and Ritonavir in 95 Low- and Middle-Income Countries
March 17 2022 - 4:05PM
Business Wire
- One of 35 global companies selected to manufacture and
commercialize generic version of COVID-19 treatment
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced it has been awarded a sub-license from
the Medicines Patent Pool (MPP) to manufacture and commercialize a
generic version of nirmatrelvir, co-packaged with ritonavir, in 95
low- and middle-income countries. Nirmatrelvir is an oral protease
inhibitor co-packaged with ritonavir for the treatment of
mild-to-moderate COVID-19.
Pfizer markets co-packaged nirmatrelvir and ritonavir in the
United States and other countries as PAXLOVIDTM. The phase 2/3
Evaluation of Protease Inhibition for COVID-19 in High-Risk
Patients (EPIC-HR) trial conducted by Pfizer demonstrated an 89%
reduction in the risk of COVID-19-related hospitalization or death
from any cause in adults treated with PAXLOVIDTM, compared to
placebo, within three days of symptom onset. The U.S. Food and Drug
Administration (FDA) granted PAXLOVIDTM emergency use authorization
(EUA) in December 2021. The product has been authorized or approved
in many other countries as well.
To increase equitable access for this therapy, Pfizer has
entered into a license agreement with the MPP to sub-license the
manufacture of generic versions of nirmatrelvir, as well as the
commercialization of co-packaged nirmatrelvir and ritonavir, to
multiple pharmaceutical companies committed to providing the
product to 95 low- and middle-income countries. Amneal plans to
manufacture nirmatrelvir in India and already owns an internally
developed, FDA-approved generic version of ritonavir, which will be
manufactured in both the U.S. and India.
“Amneal has always held a deep commitment to provide access to
affordable essential medicines and address unmet patient needs.
This is a distinct opportunity for us to fulfill this mission on a
global basis,” said Chirag and Chintu Patel, Co-Chief Executive
Officers. “Nirmatrelvir and ritonavir have the potential to help
address the pandemic in a way we have not seen before, and we are
honored to contribute to the global manufacture and distribution of
generic versions of these important therapies.”
“As we grow our commercial business in India, we expect this
will be an anchor product for us,” continued Messrs. Patel. “And
the opportunity is even greater than that. The 95 countries in the
license territory represent over half the world’s population. We,
together with other MPP licensees, have the potential to provide
hundreds of millions of doses of this COVID-19 treatment to
patients around the world who need them.”
The global demand for generic versions of co-packaged
nirmatrelvir and ritonavir is expected to be robust. Amneal is
working to bring the co-packaged combination to these impacted
countries starting in 2023.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully integrated essential medicines company.
We make healthy possible through the development, manufacturing,
and distribution of generic and specialty pharmaceuticals,
primarily within the United States. The Company has a diverse
portfolio of approximately 250 products in its Generics segment and
is expanding across a broad range of complex products and
therapeutic areas, including injectables and biosimilars. In its
Specialty segment, Amneal has a growing portfolio of branded
pharmaceutical products 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, please visit
www.amneal.com.
About the Medicines Patent Pool
The Medicines Patent Pool (MPP) is a United Nations-backed
public health organisation working to increase access to, and
facilitate the development of, life-saving medicines for low- and
middle-income countries. Through its innovative business model, MPP
partners with civil society, governments, international
organisations, industry, patient groups, and other stakeholders, to
prioritise and license needed medicines and pool intellectual
property to encourage generic manufacture and the development of
new formulations. To date, MPP has signed agreements with eleven
patent holders for thirteen HIV antiretrovirals, one HIV technology
platform, three hepatitis C direct-acting antivirals, a
tuberculosis treatment, a long-acting technology and an
experimental oral antiviral treatment for COVID-19. MPP was founded
by Unitaid, which continues to be MPP’s main funder. MPP’s work on
access to essential medicines is also funded by the Swiss Agency
for Development and Cooperation (SDC). MPP’s activities in COVID-19
are undertaken with the financial support of the Japanese
Government and SDC. More information at
https://medicinespatentpool.org/ and follow us on Twitter, LinkedIn
and YouTube.
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 or forecasts
for the future, including among other things: product research and
development; anticipated manufacturing, distribution, and supply;
discussions of future operations; expected operating results and
financial performance; the Company’s strategy for growth;
regulatory approvals; market position and expenditures. Words such
as “plans,” “expects,” “will,” “anticipates,” “estimates” and
similar words 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. 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 manufacture, 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; the impact of global economic conditions; direct
or indirect impacts of the ongoing COVID-19 pandemic; our ability
to obtain exclusive marketing rights for our products; the impact
of competition on our ability to set prices; our ability to manage
our growth through acquisitions and otherwise; our dependence on
the sales of a limited number of products for a substantial portion
of our total revenues; 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 FDA product approval requirements; risks related to federal
regulation of arrangements between manufacturers of branded and
generic products; the impact of healthcare reform and changes in
coverage and reimbursement levels by governmental authorities and
other third-party payers; the continuing trend of consolidation of
certain customer groups; our reliance on certain licenses to
proprietary technologies from time to time; our dependence on
third-party suppliers and distributors for raw materials for our
products and certain finished goods; our dependence on third-party
agreements for a portion of our product offerings; our ability to
identify, make and integrate acquisitions or investments in
complementary businesses and products on advantageous terms; legal,
regulatory and legislative efforts by our brand competitors to
deter competition from our generic alternatives; the significant
amount of resources we expend on research and development; 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; and the
impact of severe weather. 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/20220316006088/en/
Anthony DiMeo Senior Director, Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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