US drugmaker Gilead Sciences has signed non-exclusive voluntary licensing agreements with five generic pharmaceuticals based in India and Pakistan to speed up the production and supply of its experimental drug to trade severe COVID-19 patients.
Indian companies Mumbai-headquartered Cipla, Hyderabad-based Hetero Labs and Noida-based Jubilant Life Sciences has signed up the agreement to manufacture the drug and to sell it in 127 countries.
Remaining two firms include US-based Mylan which has a strong base in India and a Pakistan-based Ferozsons Laboratories -have also signed licensing agreements with Gilead, which negotiated long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce Remdesivir for developing countries.
Gilead would provide technology transfers to the five drug manufacturers to facilitate production.
A statement from Gilead says these 127 countries nearly all low-income, lower-middle-income as well as several upper-middle and high-income countries.
The statement added that the licenses will also set their respective prices for the generic product they produce.
The licences will remain royalty-free until the WHO declares the end of the public health emergency regarding COVID-19 or a product other than remdesivir or vaccine is approved to treat or prevent coronavirus caused COVID-19, the statement said.
Earlier this month, Gilead’s Remdesivir received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19 symptoms.
Meanwhile, Indian companies were delighted to be a part of the production team.
As part of the agreement, Cipla will be permitted to manufacture the active pharmaceutical ingredient (API) and finished product and market it in 127 countries, including India and South Africa under Cipla’s own brand name.
“At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic,” Umang Vohra, MD and Global CEO, Cipla Limited, said in a statement.
In a statement, Jubilant whose subsidiary Jubilant Generics Ltd inked a pact with Gilead Sciences, said they are very happy to strengthen its partnership with the US giant to license remdesivir, “which, based on initial data, shows promise to be a potential therapy for COVID-19, a pandemic creating unprecedented health and economic crisis globally”.
“We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s Active Pharmaceutical Ingredient (API) in-house helping its cost-effectiveness and consistent availability,” said Jubilant Life Sciences in a stock exchange filing on Tuesday.