Merck and Ridgeback Statement on Clinical Trial of Hetero’s Generic Molnupiravir
Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today issued the following statement regarding the clinical trial of Hetero’s generic molnupiravir. Merck is developing molnupiravir, an investigational oral antiviral COVID-19 medicine, in collaboration with Ridgeback Biotherapeutics and it has been authorized for use in more than 10 countries, including in the United States, United Kingdom and Japan. Hetero is developing their own generic version of molnupiravir in India under a voluntary license agreement with Merck.
“We are excited to see that in this clinical trial in more than 1,200 patients in India, generic molnupiravir significantly reduced hospitalizations compared to standard of care alone in patients with mild COVID-19. These data from Hetero add to our understanding of the clinical profile of molnupiravir in the treatment of patients with mild COVID-19,” said Dr. Eliav Barr, senior vice president, Merck Research Laboratories.
“We are grateful to Hetero and these investigators for these important insights, and we continue to accumulate data from clinical trials and real-world studies on the role of molnupiravir in the fight against COVID-19,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.
In April 2021 Merck entered into a non-exclusive licensing agreement with Hetero for the manufacturing and distribution of generic molnupiravir in India and more than 100 low- and middle-income countries to accelerate global access. The Drug Controller General of India (DCGI) granted an emergency use authorization (EUA) for molnupiravir in India for treatment of adult patients with COVID-19 and with SpO2 93% who are at high-risk of progression of the disease in December 2021. Hetero’s randomized, open label study of generic molnupiravir evaluated molnupiravir in addition to standard of care in 1,218 patients with mild COVID-19; the primary efficacy endpoint was reduction in hospitalization at 14 days post randomization.
About Merck’s Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals
Global access has been a priority for Merck and Ridgeback since the inception of their molnupiravir collaboration. The companies are committed to providing timely access to molnupiravir globally through our comprehensive supply and access approach, which includes investing at risk to produce millions of courses of therapy; tiered pricing based on the ability of governments to finance health care; entering into supply agreements with governments; allocating up to 3 million courses of therapy for distribution through UNICEF and the ACT Accelerator Therapeutics Partnership; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in more than 100 low- and middle-income countries following local regulatory authorizations or approvals.
Supply: In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck produced molnupiravir at risk, manufacturing 10 million courses of treatment by the end of 2021, with at least 20 million courses expected to be produced in 2022. To date, Merck has shipped molnupiravir to over 20 countries, including approximately 3.1 million patient courses shipped to the U.S. Government; in countries where it is approved or authorized, patients have begun to receive the drug. To supplement the supply from licensed generic manufacturers, Merck has entered an agreement with UNICEF to allocate up to 3 million courses of therapy to low- and middle-income countries through the first half of 2022.
Supply agreements: Merck entered into a procurement agreement with the U.S. Government under which the company supplied approximately 3.1 million courses of molnupiravir to the U.S. Government, upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration. The U.S. Department of Health and Human Services (HHS) has created a website to help providers locate public locations that have received shipments of Government-procured COVID-19 therapeutics available under Emergency Use Authorization. Merck has also entered into advance purchase and supply agreements for molnupiravir with governments for over 30 markets worldwide, including Australia, Canada, Korea, Japan, Thailand, United Kingdom and United States, pending regulatory authorizations, and is currently in discussions with additional governments. Merck is implementing a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
About Molnupiravir
Molnupiravir (MK-4482) is an investigational, orally administered nucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.
Merck and Ridgeback’s “orange COVID-19 pill” is a Swedish Orange opaque capsule with the Merck corporate logo and “82” printed in white ink, available in certain markets outside of the U.S. as LAGEVRIO.
Results from the Phase 3 MOVe-OUT study demonstrated the efficacy benefit of molnupiravir treatment was generally consistent across patients infected with SARS-CoV-2 variants of concern, Delta, Gamma and Mu. Preclinical data has shown that molnupiravir has antiviral activity against the newly identified variant, Omicron (B1.1.529). Molnupiravir has yet to be evaluated against Omicron in clinical studies.
Molnupiravir was invented at Emory University. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced molnupiravir through IND submission. Emory/DRIVE received some research funding from the U.S. Department of Defense and the U.S. National Institutes of Health. Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and Ridgeback.
Molnupiravir was evaluated in MOVe-OUT, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. The Phase 3 portion of the MOVe-OUT trial was conducted globally in more than 170 sites in locations including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States. For further information about the MOVe-OUT trial, please visit clinicaltrials.gov. Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://merckcovidresearch.com.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. The team at Ridgeback is dedicated to developing life-saving and life-changing solutions for patients and diseases that need champions as well as providing global access to these medicines. In line with Ridgeback’s mission for equitable global access, all Ridgeback services and treatment for Ebola patients in Africa are delivered free of charge.
About Merck
For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world.
February 21, 2022
