Amneal Awarded Sub-License to Manufacture and Commercialize Generic Version of Co-Packaged Nirmatrelvir and Ritonavir in 95 Low- and Middle-Income Countries


BRIDGEWATER, N.J.–()–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/

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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.

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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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