The Board of Investments (BOI) has approved the application for registration of Lloyd Laboratories Inc. as domestic producer of Molnupiravir, an oral therapy for patients that contracted the new coronavirus disease 2019 (COVID-19).
An existing manufacturer of various medicines, Lloyd Laboratories is investing P24 million for the project which will have an annual capacity of one million 400-milligram (mg) capsules of Molnupiravir.
The project is expected to start production this month following the completion of the expansion of the company’s production facility in Malolos, Bulacan.
The BOI in a statement said the project was approved for complying with the qualification requirements for “All Qualified Activities Relating to the Fight against the COVID-19 Pandemic – Essential Goods” listing of the 2020 Investment Priorities Plan
The BOI added 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 at the soonest time.
Based on the interim results of the phase 3 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 to 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 has also shown promising results with RT-PCR negativity on day 5 at 75.4 percent.
Based on these results, the local Food and Drug Administration (FDA) issued a compassionate special permit (CSP) to Lloyd Laboratories, limited to supplying Recuenco General Hospital a total of 20,000 400mg capsules for one year or until November 2022.
Lloyd Laboratories also applied for a certificate of product registration (CPR) with the FDA to make the drug more widely available.
Trade Secretary Lopez, BOI managing head, said the agency coordinated with, and received a commitment from Health Secretary Francisco Duque, without prejudice to the FDA action, to look into the CPR application of Lloyd Laboratories.
