Four pharma firms – Cipla, Jubilant Life Sciences, Hetero and Mylan – have entered into non-exclusive licensing agreements with drug major Gilead Sciences for manufacturing and distribution of remdesivir, a potential therapy for COVID-19.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) to treat COVID-19 patients.
“Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir.
“The agreements allow the companies to manufacture remdesivir for distribution in 127 countries,” Gilead said in a statement.
The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, it added.
“Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly,” Gilead said.
The licensees also set their own prices for the generic product they produce, it added.
“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.
Commenting on the development, Cipla said the agreement is part of its efforts to enhance global access to life-saving treatments for patients affected by the pandemic.
“As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals,” Cipla MD and Global CEO Umang Vohra said.
Commenting on the partnership, Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said: “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”.
The company also plans to produce the drug’s Active Pharmaceutical Ingredient (API) in-house helping its cost effectiveness and consistent availability, they added.
In similar vein, Hetero Group of Companies Chairman B Partha Saradhi Reddy said: “Hetero has developed this product in India and has already been working with the government, Indian Council of Medical Research (ICMR), and Drugs Controller General of India (DCGI) for necessary studies and approvals to bring this product to treat COVID-19 patients in India”.
Mylan said that as part of its ongoing efforts to support patients and public health needs during the COVID-19 pandemic, it has entered into a global collaboration with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19.
Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate, Mylan said adding that the company will manufacture remdesivir in India.