Indian drug makers gear up to make Gilead's remdesivir for Covid-19 therapy

Domestic players will be free to price it; Dutch firm Mylan also to make the drug in India; no royalty for Gilead as yet

Three Indian drugmakers, and a Netherlands-based firm that has a majority of its plants here, are readying to make antiviral drug remdesivir, which is under consideration for treating Covid-19, after they signed licensing pacts with US-based Gilead.
 

Gilead Sciences signed non-exclusive licensing agreements with five generic drug makers in India and Pakistan to expand the supply of remdesivir, the re-purposed Ebola drug.
 

According to the agreement, the companies — Cipla, Hetero Labs, Jubilant LifeSciences, Mylan, and Pakistan-based Ferozsons Labs — will manufacture and sell remdesivir in 127 countries.

Under the 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 from regulatory authorities in the respective countries.
 

The firms have said the pricing would be clear in a couple of weeks, once production starts.

 

Besides the three Indian drug majors, Netherlands-based Mylan, too, will make the drug at its Indian plants.
 

The stocks of Jubilant ended the day’s trade on the BSE up about 5 per cent, while Cipla was up only marginally.
 

The drugmakers said they would focus on supplying the Indian market first before looking at exports. The pricing, however, would be decided later.
 

Vamsi Krishna Bandi, managing director of the Hetero Group of Companies, told Business Standard that the pricing aspect would be clear in around two weeks once manufacturing starts. For starters, Hetero is keeping active pharmaceutical ingredients (API) ready for one million doses.

Hetero clarified that at this moment companies do not need to pay a royalty to Gilead as it it not a cure. However, once data from more trials come in and if it's established as cure and gets a final approval, there can be a royalty agreement eventually. 
 

Meanwhile, government sources indicated that fresh clinical trials for India would not be necessary for remdesivir. The source said Indian players have the liberty to price the drug. Drugmakers, however, say pricing would be discussed with government agencies.

 

The injectable drug got an Emergency Use Approval (EUA) from the US drug regulator recently. The EUA basically facilitates use of remdesivir to treat hospitalised patients with severe symptoms of Covid-19.

The EUA is based on available data from two global clinical trials, and multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of the drug. Remdesivir continues to be an investigational drug that has not been approved by the USFDA.

Bandi said the supply to other countries would depend on what treatment protocols they individually adopt and on demand.
 

Hetero said it is fully vertically integrated and does not to import any API. Being one of the largest antiretroviral drugmakers, Hetero has been supplying anti-HIV drugs to European countries. It can also get into manufacturing favipiravir, which is currently under trial in India.
 

Meanwhile, a Mylan India spokesperson confirmed that the company would be making the drug at its Indian plants. Almost 50 per cent of Mylan’s manufacturing plants are in India — it has around 21 plants across seven states.
 

Gilead had earlier indicated it was working to build a global consortium to expand production of remdesivir and make it available across countries.

 

Umang Vohra, MD and global CEO, Cipla, 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 Covid-19.

“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 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 this with its hepatitis C drug sofosbuvir earlier.

In pandemic situations, India can also invoke its Patents Act and grant compulsory licensing provision to allow third-party manufacturing of a patented drug. Pakistan’s Ferozsons Laboratories is Gilead’s partner for making Hepatitis C and HIV drugs.