Covid-19: What you need to know today

Is a small brown pill the answer to India’s sudden surge of coronavirus disease (Covid-19, although it seems strange to call it that in 2021) cases? For at least two decades now, a drug called Tamiflu has been used to treat, and in some cases even prevent Avian Influenza or bid flu and H1N1 flu or swine flu. Originally extracted from the Chinese star anise plant, the small molecule oseltamivir has been synthesised since 2006, and is sold under the brand name Tamiflu by Roche (which licensed it from the drug’s discoverer Gilead Sciences). There are generic versions of the drug available in India — including Cipla’s Antiflu — which isn’t surprising. India’s pharmaceutical industry thrives on generic versions of small molecule drugs; the country’s vaccine makers have received a lot of attention over the past year, but India has even more expertise in small molecule drugs than it does in vaccines.

Scientists and pharma companies did try to find a small molecule cure or preventive for Covid-19, an antiviral which can, preferably, be taken orally — but they did not have much luck. With the discovery of a handful of vaccines that work well, interest in such drugs waned even more. But, as a surging second wave threatens to overwhelm the health infrastructure in most large Indian cities — most, reports suggest, have already been overwhelmed — it’s difficult not to think of what might have been if a small molecule therapeutic prophylactic drug for Covid-19 was available. Sure, there’s remdesivir, made affordable by India’s generics companies, and expensive by a thriving black market, but most research studies have shown the drug to be largely ineffective in the treatment of the viral disease. There are also Regeneron’s cocktail of monoclonal antibodies that works well, but the drug is far too expensive, and has also not been approved for sale in India. But there’s the brown pill.

This is molnupiravir, an antiviral drug discovered by Ridgeback Therapeutics and developed by it in partnership with Merck. The drug is currently entering Phase 3 trials for people who have early or mild infections. An April 15 update from Merck said that the drug was linked to a lower rate of hospitalisation and death in such patients — but did not really have any effect on those with infections severe enough to require hospitalisation. Molnupiravir works by messing with the genetic code of the virus, causing a slight alteration in its RNA as it replicates, a process that eventually leaves the virus powerless or ineffective. For those with severe enough infections to require hospitalisation, preventing replication does nothing; by then, there’s a very high probability of other complications. The Phase 3 trials will show the degree of protection from hospitalisation and death that the drug provides to those with mild and (or) early infections. The company also plans to launch, later this year, another clinical trial evaluating molnupiravir’s prophylactic abilities. Together, both trials can answer a simple (but important) question: can it be to Covid-19 what oseltamivir is to Influenza A and B? But how does this help India? In late March, in a conversation with Cipla chairman Yusuf Hamied, I brought up the issue of how patents, and the unwillingness of most western nations, including the US, to back a move by India at the WTO to free up Covid-19 vaccines from patents, were probably hurting the world.

Hamied’s response — the man is also a scientist, so I listened — was that vaccines “are a different ballgame”. “You can pick up a patent of a vaccine manufacturer, and you still won’t be able to produce it. It’s like biotech. Humira, the world’s topselling biotech drug (used to treat various kinds of arthritis), is surrounded by 247 patents. I free the patents, but what are you going to do with that?”

Instead, he added, there was an opportunity in small molecules (also Cipla’s speciality).

According to Hamied, “[Merck has] come to India and given all of us (generics companies) an open licence to produce the drug, which we are planning to do. We have already made 30 kilos in the lab, and we will try to get approval in India. It’s that easy to do.”

Even as India enhances supply of and access to vaccines, and even as several states impose lockdown-like restrictions (without calling them that), the health ministry should work with Merck and Cipla, and also with any other company which has a Covid small molecule in late-stage trials to facilitate local trials, and, if they are successful, accelerate a local launch.