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A World Health Organization-led scheme to provide COVID-19 drugs to poor countries is gambling on experimental monoclonal antibody treatments and steroids but is shunning Gilead’s remdesivir blockbuster therapy, an internal document shows.
The WHO draft document, seen by Reuters and dated October 30, states the priorities are to secure monoclonal antibodies in a tight market and to boost purchases and distribution of cheap steroid dexamethasone, of which it has booked almost 3 million courses of treatment for poorer states.
Monoclonal antibodies are manufactured copies of antibodies made by the body to fight an infection.
The newspaper, which for the first time outlines how the strategy would pay donors’ money, does not mention remdesivir among priority drugs – a significant omission as the antiviral is the only other medication along with dexamethasone approved across the world for treating COVID-19.
Gilead Science, the US company that developed remdesivir, said the WHO scheme had not funded its COVID-19 trials and had never approached the company for the possible inclusion of the medication in its portfolio.
The drug-supply scheme is one of the four pillars of the so-called ACT Accelerator, a WHO-led project that also seeks to secure COVID-19 vaccines, diagnostics and protective gear for poorer countries by raising more than $38 billion by the beginning of 2022.
The drug-supply scheme, co-led from the Wellcome Trust, a charity, and Unitaid, a health partnership hosted by the WHO, urgently needs $6.1 billion, $750 million of that by February, out of a total ask of $7.2 billion.
More than half of the money needed urgently would be used to secure and distribute monoclonal antibodies, the document shows, saying these therapeutics might have a”game-changing” impact but are in short supply.
No medication based on monoclonal antibodies has been approved against COVID-19, but the WHO scheme has already invested in research on the new technology and has procured production capacity in a plant of Fujifilm Diosynth Biotechnologies in Denmark.
Fujifilm wasn’t immediately available for a comment.
The scheme wants to spend $320 million to produce antibodies in that facility, the document says, estimating that will be enough to secure at least 4 million antibody courses assuming upper-range procurement prices of $80 per class.
A spokeswoman for Unitaid, speaking on behalf of the co-leaders of the scheme, confirmed that it wanted to raise and invest $320 million in procuring monoclonal antibodies but declined to comment on possible industrial deals citing confidential agreements.
Another $110 million would be used for regulatory approval and other market preparation procedures for monoclonal antibodies in poorer countries, the record shows, while $220 million will fund clinical trials of monoclonal antibodies and COVID-19 drugs projects in poorer countries.
Eli Lilly has agreed to produce antibodies at the Fujifilm plant from April and make them available at”an affordable price” to poorer countries, a company spokeswoman said.
Lilly’s drug is being trialled and is seeking emergency authorisation in the United States.
A US government-run trial of this drug was paused in mid-October over security issues, but other trials continue. In spite of the suspension, the US administration said last week it had sealed a $375-million distribution bargain.
It is unclear how and if the WHO scheme will increase the money needed for the supply of antibodies and other projects.
Regeneron and Novartis weren’t immediately available for comment.
REMDESIVIR? NO, THANKS
Despite being short of funds, the WHO drugs-supply scheme wants to”alter the treatment landscape”, the document states, and distribute hundreds of millions of classes of COVID-19 drugs to poorer countries by 2022.
Aside from monoclonal antibodies and dexamethasone, it’s also planning to develop and secure experimental drugs, such as new antivirals and repurposed drugs.
Medication prepared for people affected by Covid-19, Remdesivir is a selective antiviral prophylactic against virus that is already in experimental use, conceptual image
The scheme wants to spend another $100 million to seal deals with unspecified drugmakers from mid-2021, the record states, and next year plans to spend another $4.4 billion to procure drugs demonstrating positive results in clinical trials.
The Unitaid spokeswoman stated that among repurposed therapeutics, dexamethasone and its alternative, hydrocortisone, were the very promising.
Remdesivir, alternatively called Veklury, is also a repurposed antiviral which was initially trialled against Ebola.
Unitaid confirmed the scheme had not procured or funded remdesivir. It did not comment on whether it may purchase the drug in future or on why remdesivir didn’t appear among priority remedies in the document.
Remdesivir has been authorised in dozens of countries around the world to treat COVID-19. However, preliminary findings of a significant WHO-sponsored trial demonstrated in October the antiviral had little or no gain for COVID-19 patients, contradicting previous positive trials.
Governments however continue to purchase it, with Germany this week announcing the purchase of over 150,000 doses for the next six months.
