Merck Announces Supply Agreement

Voluntary licensing: As part of its commitment to broad global access, Merck has already announced that it has entered into a licensing agreement with the Medicines Patent Pool to improve overall access to molnupiravir in low- and middle-income countries. In addition, Merck has already announced that it has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate the availability of molnupiravir in more than 100 low- and middle-income countries following emergency approvals or approvals by local regulatory authorities. Through this agreement, the Government of Canada has secured access to 500,000 patient courses in 2022, with options of up to 500,000 more, subject to Health Canada approval. The new agreement is part of Merck`s commitment to make this investigational drug widely available worldwide, provided it is approved for use by regulatory authorities. KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: HRK), announced outside the U.S. and Canada as MSD, today announced that it has entered into an agreement with the U.S. government to support the development, manufacture, and initial distribution of an investigational biologic (CD24Fc, called MK-7110) following approval or emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held clinical-stage biopharmaceutical company. KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: HRK), announced as MSD outside the United States and Canada, today announced that it has entered into a supply agreement with the U.S. government for molnupiravir (MK-4482). Molnupiravir is currently being studied in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of out-of-hospital patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

As part of its access strategy, Merck has also entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate the availability of molnupiravir in 104 low- and middle-income countries (LMICs) following emergency approvals or approvals by local regulatory authorities. “Merck is pleased to work with the U.S. government on this new agreement that will give Americans access to covid-19 to molnupiravir – an oral trial treatment that will be evaluated at the onset of the disease for outpatient use – if approved or approved,” said Rob Davis, President of Merck. “In addition to this agreement with the U.S. government, we are actively involved in numerous efforts to make molnupiravir available worldwide to fulfill Merck`s commitment to broad access.” Phase 3 (Part 2) of the MOVe-OUT study, which investigates the potential of molnupiravir to reduce the risk of hospitalization or death, is still ongoing. Merck currently expects that, pending the favorable results of MOVe-OUT, the fastest possible emergency authorization application for molnupiravir will be made in the second half of 2021. Merck and Ridgeback Biotherapeutics plan to share further results from the ongoing molnupiravir development program with regulatory authorities as they become available. For more information on the clinical trial of molnupiravir, please see merckcovidresearch.com/. Shares of Merck & Co. Inc.

MRK, up 0.15%, rose 0.9% in pre-market trading on Wednesday after the drugmaker announced a supply deal with the United States. Government for molnupiravir, its candidate for the oral antiviral test for the treatment of mild to moderate COVID-19. Molnupiravir, which is being developed in collaboration with Ridgeback Biotherapeutics, is currently in a Phase 3 clinical trial for the treatment of COVID-19 in out-of-hospital patients with at least one risk factor. If molnupiravir receives Emergency Use Authorization (USA) from the Food and Drug Administration, Merck will receive approximately $1.2 billion to provide the government with 1.7 million molnupiravir compounds. The company expects more than 10 million treatment cycles by the end of 2021. Merck shares lost 7.2% year-to-date through Tuesday, while the Dow Jones Industrial Average DJIA, -0.49%, gained 13.1%. For 130 years, Merck, known outside the U.S. and Canada as MSD, has been inventing for life and bringing to market medicines and vaccines for many of the world`s most challenging diseases to fulfill its mission to save and improve lives. We demonstrate our commitment to patient and public health by improving access to health care through broad policies, programs and partnerships. Merck continues to conduct research on the prevention and treatment of diseases that threaten humans and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – and strives to be the world`s first research-intensive biopharmaceutical company.

For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. By agreement when molnupiravir receives Emergency Use Authorization (USA) or approval from the United States. . . .