Gilead in talks with Pak drug makers to produce remdesivir

ISLAMABAD: American biopharmaceutical company Gilead is in talks with drug makers in Pakistan and India to produce its new antiviral drug remdesivir for developing countries.

Recently the US Food & Drug Administration (FDA) had issued an Emergency Use Authorisation for remdesivir to treat COVID-19 patients. Gilead Sciences, Inc says in a statement on that its goal is to make remdesivir both accessible and affordable to governments and patients around the world, where authorised by regulatory authorities.

Gilead is in discussions with some of the world’s leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and the developing world through at least 2022. The company is also negotiating long-term voluntary licenses with several generic drug makers in Pakistan and India to produce remdesivir for developing countries. Gilead will provide appropriate technology transfers to facilitate this production.

To further facilitate access in developing countriesduring this acute health crisis, Gilead is in advanced discussions with Unicef to utilise their extensive experience providing medicines to low- and middle-income countries during emergency and humanitarian crises to deliver remdesivir using its well-established distribution networks.

Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the FDA for any use.

A clinical trial of remdesivir showed that patients recovered about 30 percent faster than those on a placebo, in the first proof of successful treatment against the new disease. “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Anthony Fauci, the top US epidemiologist who oversaw the study, told reporters.

Fauci likened the finding to the first retrovirals that worked, albeit with modest success, against HIV in the 1980s. Remdesivir failed in trials against the Ebola virus and a smaller study, released last week by the WHO, found limited effects among patients in Wuhan, China, where the illness was first detected in December.

Senior WHO official Michael Ryan declined to weigh in on the latest findings, saying he had not reviewed the complete study.

“We are all hoping — fervently hoping — that one or more of the treatments currently under observation and under trial will result in altering clinical outcomes” and reducing deaths, he said.

Meanwhile, a Brotish wire service reported that Gilead Sciences Inc faces a new dilemma in deciding how much it should profit from the only treatment so far proven to help patients infected with the novel coronavirus.

The drug maker earned notoriety less than a decade ago, when it introduced a treatment that essentially cured hepatitis C at a price of $1,000 per pill.

Public outrage over the cost of Sovaldi in 2013 - despite that it was a vast improvement over existing equally expensive therapies - ignited a national debate on fair pricing for prescription medicines that the pharmaceutical industry has fought to deflect ever since. That backlash has subsided considerably in the midst of the coronavirus pandemic, during which drugmakers’ efforts to develop vaccines and treatments is considered essential to battling a disease that has infected some 3.7 million people and killed over 258,000 worldwide.

Gilead is now in the spotlight again after data showed its antiviral drug remdesivir helped reduce hospital stays for COVID-19 patients, and the US authorised wide emergency use of the therapy.

Wall Street analysts say remdesivir could generate $750 million or more in worldwide sales next year, and $1.1 billion in 2022, (approx Rs295 billion in 2021-22) assuming the pandemic continues. But Gilead, and other drugmakers, will need to avoid the appearance of taking advantage of a global health crisis to rake in profit, according to pharmaceutical industry consultants and former regulators.

“This is a tremendous opportunity for drug manufacturers,” to improve the industry’s image, said Ed Schoonveld, a drug pricing expert at consulting firm ZS Associates. “There has been an overwhelmingly negative focus on drug prices.”