NEW DELHI (Reuters) – One of Bangladesh’s largest drugmakers, Beximco Pharmaceuticals, will start production this month of the experimental antiviral drug remdesivir, which has shown promise in fighting the new coronavirus, a senior company executive said on Tuesday.
Remdesivir, a drug developed by Gilead Sciences, has grabbed attention as one of the most promising treatments for COVID-19, the respiratory disease caused by the novel coronavirus that has killed more than 250,000 people.
U.S. drug authorities granted emergency use authorisation last week, paving the way for its broader use in U.S. hospitals, after Gilead provided data showing the drug had helped COVID-19 patients.
The company plans to price the drug, which is given via intravenous infusion, at between 5,000 and 6,000 takas per vial ($59-$71/per vial), Beximco’s Chief Operating Officer Rabbur Reza told Reuters, adding a patient might need anywhere between 5 and 11 vials.
“We will only know exactly how much a patient needs once studies are complete,” Reza said. “We do expect the Bangladesh government will try to cover some of the price of the drug.”
Production will begin this month, initially for domestic use, Reza added.
Beximco’s pricing indicates a course of remdesivir treatment could cost between $295 and $781 per patient in the south Asian country depending on the severity of the case, the number of vials required and the final pricing of the drug.
The figures are a first indication of how the drug will be priced, as countries around the world struggle to control the coronavirus that has infected more than 3.5 million people worldwide.
Gilead has donated an initial batch of 1.5 million vials of to help patients in the United States, but has yet to announce its pricing.
The Institute for Clinical and Economic Review (ICER), which assesses the effectiveness of drugs to determine appropriate prices, put the cost of producing a 10-day course of remdesivir at $10, but suggested the price could rise to $4,500 based on patient benefits shown in clinical trials.
AFFORDABILITY WAIVER
Gilead’s patent on remdesivir in theory means it has exclusive rights to make it, but international trade rules allow nations defined by the United Nations as least-developed countries, including Bangladesh, to ignore such patents and make drugs more affordable in those markets.
Bangladesh would be allowed to export the drug to other least-developed countries and some European countries have also written to Beximco seeking to import the drug, said Reza, declining to name the countries.
“We can seek approval from the government to export it for emergencies,” he said. “But we should be able to supply to our people first, that is number one for us.”
Bangladesh has so far reported 10,929 cases and 183 deaths from the disease, although some experts say the number of cases could be much higher given limited testing in the country.
WILL IT WORK?
Remdesivir was previously developed to treat the Ebola virus and did not work.
Its potential to help COVID-19 patients is based on ability to disable the mechanism by which certain viruses, including the new coronavirus, replicate themselves and potentially overwhelm their host’s immune system.
Data from a trial by the National Institutes of Health (NIH) in the United States showed remdesivir reduced hospitalisation stays by 31% compared to a placebo treatment, but did not significantly improve survival.
Beximco expects to receive marketing approval for remdesivir from Bangladesh authorities by mid-May, following which it plans to launch commercial quantities to be distributed via the government, Reza told Reuters.
“We’ll produce the drug depending on how much the Bangladesh government requires,” he said, adding officials were checking on quantities required by domestic hospitals.
Reza said a Chinese firm was providing the active pharmaceutical ingredients needed to make the drug. That supply deal would allow it to make up to 100,000 units of the drug, he said.
Based in Dhaka, Beximco Pharma exports generic drugs to some 50 countries from the United States to South Africa and makes everything from plain generic drugs to complex molecules.
Seven other Bangladeshi pharma companies including Square Pharmaceuticals and Beacon Pharmaceutical have received government approval to develop the drug, Bangladeshi drug regulatory official Mohammad Salahuddin said.
“For now, we won’t allow the companies to export remdesivir. First, they’ll have to fulfil local demand, then we can consider it,” he told Reuters.
In neighbouring India, drugmaker Cipla Ltd said it was also working on three antivirals, including favipiravir, remdesivir and bolaxavir, which could be used to treat COVID-19. It declined to comment on its launch or pricing plans.
(Reporting by Zeba Siddiqui in New Delhi; additional reporting by Ruma Paul in DHAKA; editing by Euan Rocha and Barbara Lewis)
