The Board of Investments said Monday it approved the registration of Lloyd Laboratories Inc. to locally manufacture globally-accepted COVID-19 therapy Molnupiravir.
Lloyd Laboratories Inc., a local company, recently expanded its production facility in Malolos, Bulacan to accommodate the production of Molnupiravir. The P24-million project, which is expected to start in January 2022, can produce 1 million 400-mg capsules of Molnupiravir annually.
“Amid the steep surge of COVID-19 cases exacerbated by the emergence of new variants, it is a crucial and urgent step to produce oral therapies locally to reduce hospitalization, and for those who will be hospitalized—to lessen the period of hospitalization, and to prevent the death of Filipinos who contracted the virus,” said Trade Secretary and BOI chairman Ramon Lopez.
Lopez said the BOI is at the forefront of harnessing Philippine manufacturing capacity in the fight against the pandemic by locally producing personal protective equipment, disinfectants and ventilators and in industrial coordination for oxygen supply.
The project was approved under the “All Qualified Activities Relating to the Fight against the COVID-19 Pandemic – Essential Goods” listing of the 2020 Investment Priorities Plan. The 2020 incentives scheme is transitioning to Strategic Investment Priorities Plan under the Corporate Recovery and Tax Incentives for Enterprises Act Law.
Lloyd Laboratories acquired a direct technology transfer on Molnupiravir production from Optimus Pharma—an integrated pharmaceutical organization in Hyderabad. The laboratory reported that it intends to make the product available locally soon.
Based on the interim results of the Phase III Clinical Trials of Optimus Pharma conducted in India for orally administered Molnupiravir capsules on patients with mild symptoms, the addition of Molnupiravir to the standard of care significantly results in faster clinical improvement in reducing viral load.
It also resulted in a significantly higher proportion of patients achieving RT-PCR negative results on days 5 and 10. In Vietnam, Stella Pharma, which Optimus Pharma also supported in terms of technology transfer, conducted a clinical trial which also showed promising results with RT-PCR negativity on day 5 at 75.4 percent.
Based on these results, the local Food and Drug Administration issued a compassionate special permit to Lloyd Laboratories, limited to supplying Recuenco General Hospital 20,000 400-mg capsules for a year until November 2022.
Lloyd Laboratories also applied for a certificate of product registration with the FDA to make the drug more widely available.
“We coordinated with and received a commitment from DOH Secretary Duque, without prejudice to the FDA action, to look into the CPR application of Lloyd Laboratories,” Lopez said.
Trade Undersecretary and BOI managing head Ceferino Rodolfo said invitations were extended to other pharmaceutical companies to look at how they could replicate Lloyd Laboratories manufacturing model to help fill the gaps in providing affordable critical medicines and health products.
“The project’s approval is, of course, subject to relevant rules and regulations and whatever flexibilities afforded by our laws,” Rodolfo said.
The suggested retail price of the locally-made Molnupiravir is P65 per capsule, which is much lower than its imported counterpart that sells around P100 to P150 per pill.
The BOI said it continues to coordinate with other government agencies, particularly Anti-Red Tape Authority and the FDA, to facilitate issuance of the necessary permits and licenses.
“During times of national emergencies—whether due to natural calamities or global health crises—the importance of having local capability to supply critical and strategic products only serve to remind us of the imperative of ensuring the development of our local manufacturing industry,” Lopez said.
