Gilead enters licensing pact with 5 drug firms in India, Pak for remdesivir

US-based Gilead Sciences said that it has signed non-exclusive licensing agreements with five generic drug makers in India and Pakistan to expand the supply of antiviral drug remdesivir. The re-purposed Ebola drug is being considered as a potential therapy for coronavirus (Covid-19).

According to the agreement the companies Cipla, Hetero Labs, Jubilant Life Sciences, Mylan, and Pakistan based Ferozsons Labs, to manufacture and sell remdesivir in 127 countries. The stocks of Cipla and Jubilant were trading high on the BSE in morning trade - Jubilant was up about 5 per cent, Cipla 2.5 per cent.

Most of these 127 countries are low-income and lower-middle-income nations along with some upper-middle and high-income countries that face significant obstacles to healthcare access. Under terms of the licensing agreement, these companies will have the right to receive a technology transfer of the Gilead manufacturing process and can scale up production. This would, however, be subject to approvals by regulatory authorities in the respective countries. 

India can also start using the drug on patients on compassionate grounds. The government was checking with pharma companies on how soon the drug can be manufactured here for trials.

Gilead had earlier indicated that it was working to build a global consortium to expand the production of remdesivir and make it available across countries. The drug, which is an injectable, got emergency approval from the US drug regulator recently. The trials show that patients administered with remdesivir recover faster than others. However, remdesivir remains an investigational drug and has not been approved by the USFDA.

Hetero chairman B Partha Saradhi Reddy said that this agreement illustrates the significance of global collaboration and the need to come together to fight the health crises impacting humanity. "Hetero has developed this product in India and has already been working with the government, ICMR, and DCGI for necessary studies and approvals to bring this product to treat COVID-19 patients in India," he added. It will make remdesivir in its Hyderabad facility which has USFDA and EU approvals. Hetero has developed a fully vertically integrated supply chain for this product.

Hetero is one of the largest producers of anti-retroviral drugs.

Similarly, Umang Vohra, MD, and Global CEO, Cipla Limited said, “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."

Jubilant's chairman Shyam S Bhartia and co-chairman Hari S Bhartia felt that based on initial data remdesivir shows promise to be a potential therapy for Covid19. "We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required approvals. We also plan to produce the drug’s active pharmaceutical ingredient (API) in-house, helping its cost-effectiveness and consistent availability," they added.

Gilead is known for getting into licensing agreements with other drugmakers for its patented drugs – it did the same for its hepatitis C drug sofosbuvir earlier. In pandemic situations, India can also invoke its Patents Act and grant compulsory licensing provisions to allow third party manufacturing of a patented drug.