US drug maker Gilead Sciences Inc has signed non-exclusive licensing agreement with five companies in India and Pakistan for the manufacturing and distribution of antiviral drug remdesivir, said to be a possible treatment for COVID-19 coronavirus.
Indian pharmaceutical manufacturers, Jubilant Life Sciences, Cipla Ltd, Hetero Labs Ltd and Mylan and Pakistani firm Ferozsons Laboratories have signed the commercial agreement that allows the companies to manufacture remdesivir for distribution in 127 countries, including India.
The 127 nations include nearly all low-income, lower middle-income and several upper-middle and high-income countries that face significant obstacles to healthcare access, Gilead Sciences said in a statement.
“The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier,” Gilead said.
Noida-based Jubilant Life Sciences had on Tuesday announced that its subsidiary Jubilant Generics Ltd has entered into a non-exclusive licensing agreement with US-based Gilead Sciences to manufacture and sell anti-viral drug remdesivir, which is under clinical trials globally as a potential treatment of COVID-19 disease.
“We are very happy to strengthen our partnership with Gilead 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,” Shyam S Bhartia, Chairman and Hari S Bhartia, Co Chairman and Managing Director, Jubilant Life Sciences Limited said in a statement.
“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.
Leading pharmaceutical company Cipla on Wednesday announced its deal with Gilead.
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,” said Umang Vohra (MD and Global CEO, Cipla Limited).
Cipla will receive the manufacturing know-how from Gilead Sciences to manufacture the drug at a commercial scale.
Earlier, the US drug maker had said that it is negotiating long-term voluntary licences with several generic drugmakers in India and Pakistan to produce experimental antiviral drug remdesivir.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for remdesivir to treat COVID-19.
Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug was still being studied.
“There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19,” said the FDA.
Remdesivir was shown in a clinical trial to shorten the time to recovery in some people.
There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA, said the agency.
The Union Health Ministry had recently said that it is examining remdesivir, which was used during the Ebola outbreak, as one protocol in the treatment for COVID-19.
Meanwhile, Gilead has said that it will provide appropriate technology transfers to facilitate remdesivir production, adding that it is in active discussions with the Medicines Patent Pool to licence remdesivir for developing countries.