Indonesia reviewing Merck COVID-19 pill, up to 1 mln doses targeted

Indonesia is reviewing a COVID-19 experimental antiviral pill- molnupiravir- produced by Merck for domestic use, its food and drug agency (BPOM) chief said on Monday, ahead of a possible purchase of up to 1 million doses next month.

Britain is the first country to have approved the pill, named molnupiravir, which Merck last month said halved the chance of hospitalisation or death in patients at risk for severe illness.

The United States, Malaysia, South Korea, Singapore, Thailand and the Philippines are among countries interested in buying molnupiravir.

Molnupiravir: Here is what you need to know about COVID-19 pill

Penny K. Lukito, BPOM chief, told a parliamentary hearing the process for registering the drug was underway.

Health Minister Budi Gunadi Sadikin said Indonesia plans to purchase 600,000 to 1 million doses of the Merck pill in December.

State-owned and private companies have been invited to apply for patent licensing to produce the pills at home, he said.

About the COVID-19 pill

Molnupiravir 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.

Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants. Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and is being developed by Merck & Co., Inc. 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 by Wayne and Wendy Holman of Ridgeback.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households.