MSD in Thailand Announces Supply Agreement
with Thailand’s Ministry of Public Health for Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine, Upon Authorization or Approval
Molnupiravir is Currently Being Evaluated for the Treatment of Non-hospitalised Patients with Laboratory-confirmed COVID-19 and At Least One Risk Factor Associated with Poor Disease Outcomes
Bangkok, November 25, 2021 – MSD in Thailand (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) today announced that it has entered into a supply & purchase agreement with Thailand’s Ministry of Public Health (The Ministry) for the supply of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults in the non-hospitalised setting.
Dr. Mary Srethapakdi, Managing Director of MSD Thailand, said “MSD has a long legacy of research and development in infectious diseases. We have been fully committed to developing an effective response to the COVID-19 pandemic since it was first recognized. There is an urgent need to help patients with mild-to-moderate COVID-19 limiting disease progression to severe illness, especially in patients with at least one risk factor associated with poor disease outcomes. We are proud to partner with the Thai Government in the fight against the COVID-19 pandemic. This supply & purchase agreement is another example of Thailand’s forward-looking strategy of pandemic management and the government’s strong commitment to investing in innovative medicines and vaccines to combat the pandemic.”
Dr. Srethapakdi also added: “Our partnership with the Thai government goes beyond today’s supply & purchase agreement. With inputs from the Department of Medical Services and several key experts in Thailand, the country is also one of markets that will be conducting the phase 3 MOVe-AHEAD clinical trial with five trial sites in Thailand. The MOVe-AHEAD study is the second phase 3 study of molnupiravir and a clinical program to evaluate molnupiravir for post-exposure prophylaxis.”
On November 4, 2021, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom for molnupiravir, the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. MSD is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
About the Molnupiravir Clinical Development Program
The MOVe-OUT trial (MK-4482-002) (NCT04575597) is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19. Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes (e.g., older patients, those with obesity and diabetes), and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.
MOVe-AHEAD (MK-4482-013) (NCT04939428) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. The trial will enroll approximately 1,332 participants who will be randomized to receive either molnupiravir (800 mg) or placebo orally every 12 hours for five days. The study will enroll participants who are at least 18 years of age and currently residing in the same household with someone who received a positive test for SARS-CoV-2, has at least one sign or symptom of COVID-19 and has not had those signs and symptoms for more than five days. Participants are not eligible for the trial if they have received the first dose of a COVID-19 vaccine more than seven days prior to enrollment, have previously had COVID-19 or are showing any signs or symptoms of COVID-19.
For more information on molnupiravir clinical trials, including MOVe-OUT and MOVe-AHEAD, please visit https://msdcovidresearch.com/.
Molnupiravir (MK-4482, EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. If authorized or approved, the recommended dose for molnupiravir based on the Phase 3 MOVe-OUT clinical trial would be 800 mg twice daily for five days.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the National Institutes of Health. Molnupiravir is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD 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 MSD and by Wayne and Wendy Holman of Ridgeback.
About MSD’s Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals
MSD is 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; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in 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, MSD has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022.
Supply agreements: Earlier this year, MSD entered into a procurement agreement with the U.S. Government under which the company will supply approximately 3.1 million courses of molnupiravir to the U.S. Government, upon Emergency Use Authorization (EUA) or approval from the U.S. FDA. Additionally, MSD has entered into supply and advance purchase agreements for molnupiravir with governments worldwide and is currently in discussions with additional governments. MSD plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
Voluntary licenses: As part of its commitment to widespread global access, MSD previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries. Additionally, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
MSD continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.
For over 130 years, MSD 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. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD 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.
About MSD in Thailand
In Thailand, MSD’s medicines and vaccines have contributed to improving healthcare for over 70 years and were first supplied through the collaboration with a long-established local partner in 1949.
In 2004, MSD established a wholly owned subsidiary in Thailand. With this establishment in place, MSD has been well positioned to bring more innovative medical solutions to Thailand, conducting clinical research and supporting physicians’ and patients’ needs. With focuses on Oncology, Vaccines, General Medicines and Hospital Specialty, MSD is helping to improve and save lives of Thai People.