Away from the attention that vaccines are getting to tackle Covid-19, there’s much activity in research labs on other tools in the kit to treat those infected by the SARS-CoV-2 virus.
Antivirals, monoclonal antibodies or small molecules (pills) are the “hidden heroes” the biopharmaceutical industry is putting its money on. And here, too, the biggest industry names — Pfizer, Roche and AstraZeneca, for example — are in the fray, as it becomes evident that the world is not out of the woods when it comes to Covid-19.
“Monoclonal antibody treatments are beginning to offer promise for outpatient treatment, as are novel antivirals,” the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said recently, pointing to authorised Covid-19 treatments and hopefuls
And while the biopharmaceutical industry and its suppliers scale up manufacturing, they say rollouts are “dependent on access planning, which involves allocation strategies for patients who will benefit the most, testing, accurate demand forecasting, and country readiness”.
Access and planning are in focus like never before during this pandemic, as inequitable distribution casts a shadow on the success story of the fastest vaccine ever developed. It’s work in progress, say industry watchers, by way of tech transfer, voluntary licensing or intellectual property (IP) waivers. Indian drugmakers, too, are integral to making and supplying these drugs to underserved regions.
Much planning
Roche Pharmaceuticals Chief Executive Bill Anderson says they dedicated their “largest biologics production facility in the world” to produce Covid medicines. Although early studies showed not-so-favourable outcomes for their tocilizumab, the tide turned and it is now recommended by the World Health Organization.
On their partnership with competitor Regeneron to produce an antibody cocktail therapy, Anderson said recently that not many facilities can make such specialised drugs. Scaling up, rather than IP rights, was the challenge, he said. In fact, Roche is not asserting its patent on tocilizumab. And India’s Hetero now has an emergency approval to supply its version here.
On next-generation therapies, Anderson says the “most promising will be pills, small molecules that kill the virus itself”. Unlike tocilizumab, which is given to hospitalised patients, “you want to be able to treat people before they get so sick”, he explains.
Another early planner, Gilead Sciences forged multiple collaborations, including in India, to address access concerns for its antiviral remdesivir.
Merck’s Belén Garijo, Chair of the Executive Board and Chief Executive Officer, points to companies planning ahead — by having regional sites, for example — to deal with export restrictions. She also flags the shortage of consumables, raw materials and so on. Merck supports over 80 vaccination projects with inputs such as cell culture media, bioreactors, and lipids for mRNA vaccines, she said.
More access
Indian Pharmaceutical Alliance’s Sudarshan Jain observes that the industry (domestic and foreign) was working together on vaccines, repurposed drugs and alternatives to tackle the pandemic. He points to the combined clinical trial by five Indian companies on the oral antiviral drug molnupiravir.
Despite the changing regulatory recommendations on drugs like hydroxychloroquine, remdesivir or artesunate, Jain says Indian companies are part of the solution.
Health workers, though, call for greater access, to both existing and new treatment options.