THE Philippine Board of Investments (BOI) has approved the application for registration of Lloyd Laboratories, Inc. as domestic producer of Molnupiravir, an oral therapy for COVID-19 patients.
“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. In fact, the BOI has been at the forefront of harnessing the Philippine manufacturing capacity in the fight against the pandemic including through the repurposing project for Personal Protective Equipment (PPEs), disinfectants, and ventilators; and industrial coordination to ensure that oxygen is available across all hospitals in the country during the Delta surge,” said Trade Secretary and BOI Chairman Ramon Lopez.
An existing manufacturer of various medicines, Lloyd Laboratories recently expanded its production facility in Malolos, Bulacan, which will be used to produce the drug. With an estimated cost of Php24 million and an annual capacity of one million 400 mg capsules of Molnupiravir, the project is expected to start production this January. 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 IPP as the transitional Strategic Investment Priorities Plan (SIPP) under the Corporate Recovery and Tax Incentives for Enterprises Act (CREATE) 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 at the soonest time.
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 (SOC) 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%.
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. Secretary Lopez, in this connection, added, ”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.”
“We invite other pharmaceutical companies to look at this model and how we can replicate it in order to further fill-in the gaps not only in our fight against the pandemic but also in providing more affordable critical medicines and health products to Filipinos. The project’s approval is, of course, subject to relevant rules and regulations and whatever flexibilities afforded by our laws,” added BOI Managing Head and DTI Undersecretary Ceferino Rodolfo.
The Suggested Retail Price (SRP) of the locally-made Molnupiravir is Php65/pill, which is much lower than its imported counterpart that sells around Php100 to Php150 per pill providing a COVID patient around Php35 to Php85 in savings per pill.
This production of Molnupiravir forms part of BOI’s goal of developing local capacity for the manufacturing of strategic products. For medicines and vaccines, for example, BOI has been linking local industry with vaccine originators through a project with technical support provided by the Asian Development Bank (ADB).
In addition, “the DTI also successfully convinced its international partners to exempt the Philippines from their export bans of key active pharmaceutical ingredients (APIs) needed for the production of critical medicines,” the Secretary said.
The BOI continues to coordinate with other government agencies, particularly Anti-Red Tape Authority (ARTA) 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,” ended Sec. Lopez.