Prices of a key drug used to treat hospitalised Covid-19 patients, remdesivir, may rise once the innovator, Gilead, gets a full approval from the US drug regulator, said industry sources. Currently, generic manufacturers make and sell remdesivir in India under a voluntary licensing agreement and are not required to pay any royalty to the innovator.
“This is because remdesivir is an investigational drug and not approved as a therapy for Covid-19. It has an emergency use authorisation from the USFDA and also the Indian regulator in the wake of the pandemic. Gilead had indicated while signing the licensing agreement that they may revisit the royalty payment part once the drug is approved as a treatment,” said one of the license partners of Gilead in India.
In August, Gilead filed an application with the US Food and Drug Administration (USFDA) seeking full approval for remdesivir (Veklury). Speaking at a media event on Thursday, Gilead’s Chairman and CEO Daniel O’ Day said the company had met all requirements for a full authorisation for remdesivir, and expected the approval to come soon.
Gilead is also conducting 36 clinical trials for different formulations of remdesivir and combination therapies with other drugs like tocilizumab.
Prices of remdesivir are very competitive in India. Last month, Ahmedabad-based Zydus Cadila launched, what is perhaps the cheapest remdesivir brand in the world, Remdac, which it has priced at Rs 2,800 per dose. This is 30 per cent cheaper than its closest rival, Cipla’s Cipremi.
Gilead’s remdesivir is priced at $390 per vial (Rs 29,000) for patients on government sponsored insurance and $520 (Rs 38,900) per vial for patients with private insurance. Prices in India have come down since the drug was launched by Hetero at Rs 5,400 per dose thanks to a competitive market here.
Apart from remdesivir, Gilead has licensing agreements with 11 India-based generic pharma manufacturers to develop Hepatitis C compounds (sofosbuvir, ledipasvir, velpatasvir and voxilaprevir) for distribution in 105 developing countries.
According to these agreements, the generic licensees have the right to develop and market generic versions of Gilead’s HCV medicines. While the companies may set their own prices and receive a complete technology transfer of Gilead’s manufacturing process, they have to pay a royalty to Gilead.
Firms did not provide details of the royalty arrangements they have with Gilead. For HCV, Hetero, Zydus Cadila, Cipla etc have agreements with Gilead.
O’Day said at the event that when Gilead started in January, it could make only 5,000 treatment courses (one patient needs 5-6 doses). By the end of 2020, it would have the capacity to manufacture two million treatment courses, a 40-fold increase. The US, however, has booked a bulk of the supplies through September.