Gilead’s remdesivir has little or no impact on Covid-19 patients' length of hospital stay, initiation of ventilation, or chances of survival, a clinical trial by the World Health Organization (WHO) has found.
The US biotech giant, however, questioned the findings of the study, saying these were premature and the data appeared inconsistent. Other studies, the firm said, had validated the drug's benefits.
Listed pharmaceutical companies that manufacture remdesivir in India -- Cadila Healthcare, Cipla, and Jubilant Life Sciences -- seemed to defy the negative news, as their shares ended the day in the green. Cadila Healthcare’s stock was, in fact, up 3.4 per cent on the BSE. Indian clinicians indicated that they would continue to prescribe the drug. The antiviral medication was one of the drugs used to treat US President Donald Trump’s coronavirus infection.
The results of the WHO’s Solidarity trial, conducted on 11,266 hospitalised Covid-19 patients across 30 countries, found that remdesivir, along with other repurposed drugs hydroxychloroquine (rheumatoid arthritis drug), lopinavir/ritonavir (used in leprosy), and interferon, “appeared to have little effect on in-hospital mortality”.
Senior officials in Indian pharma firms that have licensing agreements with Gilead to make and sell remdesivir said they did not expect a major fall in demand for the drug as long as doctors continued to prescribe it.
Analysts, too, said that for big pharma firms like Cipla and Cadila Healthcare, there would not be any major downside on the stock prices. “Remdesivir’s contribution to their top lines is not very significant, and we do not expect doctors to suddenly stop prescribing the drug because one study found it is not very useful,” said Sapna Jhawar, vice president (research), Dolat Capital.
Explaining the clinician’s experience, Satyanaryana Mysore, head of department of interventional pulmonology at Manipal Hospitals, said meta-analysis did not necessarily capture the true essence of a drug’s efficacy or impact on the patient. “As part of the task force of remote medical guidance to hospitals across Karnataka, I have seen the difference the drug made. Prior to July 15, when the drug was not available here, morbidities and the severity of cases in government hospitals were much higher. Remdesivir definitely helped doctors to manage the disease well,” he said, adding that while it was no magic bullet, the timing of administering the drug could make all the difference.
“It’s the clinical eye and a doctor’s judgement on when to administer the drug that can make a huge difference,” Mysore said.
Gilead expressed concern that the data from the open-label global trial had not been under a rigorous review. Open-label trial basically means that participants, as well as the investigators, know which drug is given to them. The US-based drug major and the innovator of Veklury, or remdesivir, said it was unclear if any “conclusive” findings could be drawn from the study results.
“The emerging data appears inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir),” the company said in a statement. It added that they were concerned that the data from this trial had not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.
The WHO, however, defended the data. "It's a reliable result, don't let anybody tell you otherwise, because they'll try to," Richard Peto, an independent statistician hired by the WHO to scrutinise its Solidarity trial results, told reporters. "This is real world evidence."
Redesivir, originally developed for Ebola, got emergency use authorisation for treating Covid-19 in May from the US Food and Drug Administration. Following this, Gilead entered into licensing agreements with multiple generic drug makers, most of them in India -- Hetero, Cipla, Dr Reddy's Laboratories, Cadila Healthcare, Jubilant Life Sciences, Mylan, and Syngene. These companies not only supply to the Indian market, but also have the licence to distribute it to 127 countries.
The demand for the drug went up rapidly, creating a supply shortage in India. This led to black-marketing of the drug here and the prices shot up by five to six times. Manufacturers had to not only scale up its production, but also start helpline numbers to guide authentic patients to the drug.
In India, Cadila Healthcare alone is making around 500,000 doses of the drug per month and is selling at Rs 2,800 per dose.
On Thursday the Maharashtra government fixed the price of the drug to make it affordable, and ensure no over-charging happened. Now the price has been fixed at Rs 2,240 per vial at hospitals and Rs 2,360 per vial at chemists. One patient needs six vials.
(With inputs from Reuters)