Gilead's antiviral drug remedesivir being made in India on trial basis

Gilead's remedesivir is under patent protection till 2035. Representative Image
Inspired by the positive initial responses shown in global studies, India is planning to use a broad spectrum anti-viral drug remedesivir on patients here. A handful of Indian pharma majors have also started working on developing the patented drug that was innovated by US pharma giant Gilead. Moreover, firms like Glenmark have approached the country's drug regulator to do trials on another anti-viral drug favipiravir. 

In fact, India is now working on evaluating about 20 different drugs that can be used as a line of treatment against COVID19. 

Gilead's remedesivir was orginally developed for Ebola and then eventually found to be useful against coronaviruses like SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). Now some recent studies show that if administered at an early stage the drug can stop COVID19 from replicating inside the body. 

Reports suggest that researchers from a Houston Methodist Hospital, Texas, US have seen promising results in patients if administered early, Chinese studies too have shown that remedesivir blocks the novel coronavirus from replicating inside the body. Two Chinese studies have been stopped in the middle of this month after lack of eligible patients as the virus outbreak got contained in the country. 

Another anti-viral drug, that is sold in Japan under the brand name Avigan to treat influenza, is also showing promise. Fujifilm Toyama Chemical Co has, in fact, started a phase 3 trial in Japan to test the drug's efficacy against COVID19. Even the Council of Scientific and Industrial Research (CSIR) has completed synthesis of the anti-retroviral drug favipiravir and handed it over to a private company that has approached the Drug Controller General of India (DCGI) for approvals. 

While Gilead has a patent till 2035 for remedesivir (and it has a patent registration in India), the primary patent protecting favipiravir has expired in 2019. "There are some supplementary patents that now protect the drug in India. But, the government is actively using it on patients," said an industry source. 

Meanwhile, Mumbai's Glenmark Pharmaceuticals has approached the DCGI for approvals, the company acknowledged. It would now test the drug on around 100-150 patients in a phase 3 trial. This should roughly take around one month or so as the drug-course is for 14-days. 

If the results are satisfactory, then the drug can be recommended as a line of therapy and included in the Indian Council of Medical Research's protocol. 

"Making the active pharmaceutical ingredient (API) for favipiravir was the challenge.But, finally it has been cracked, and now it can be made in India. Once the trials are over, other companies too can quickly make the drug if the ICMR recommends it as treatment," said another industry source. 

Indian drug firms are actively working on developing anti-virals. Major firms like Zydus Cadila, Cipla, Glenmark, Dr Reddy's Laboratories are on the forefront. 

As for remedesivir, Ahmedabad's Zydus Cadila is developing it. "It is a complex process and takes long. However, we have the capabilities to make it and we have started developing it. This, however, is not being commercially produced as the drug is under patent. This is now for R&D purpose," said an official in Zydus Cadila. 

Similarly, Cipla is learnt to be working on both remedesivir and favipiravir. A Cipla spokesperson said that they were unable to share a comment at the moment, but would update in case of any development. Pharma companies, however, say that since it is a complex drug, it would not be available as a very cheap option like the hydroxychloroquine which costs around Rs 3 per tablet. 

Government sources indicated that India is now keen to try these drugs on Indian patients. "For this, it is important that the drugs are locally available and not imported. At the moment even Gilead is not making remedesivir commercially," said a senior government official. For COVID19, it is now a race against time, he added. 

The government can always invoke the Indian Patents Act and allow local manufacturing under compulsory license for patented drugs. 

Pharma industry sources highlighted that companies can procure a patented drug in small quantities for research purposes. In the face of a medical emergency like the current pandemic, these drugs can be manufactured by the drug makers under a license from the innovator too. 

Gilead's remedesivir is under patent protection till 2035. That's a long way, but the US biopharmaceutical company is known to have given licenses to drug makers in developing countries to make very expensive drugs, like one for Hepatitis C. A pharma industry source also highlighted, "Gilead is likely to sign compulsory license agreements with Indian majors. The company has done that earlier as well. They are unlikely to divert their R&D efforts in conducting clinical trials in India on remedesivir. Also, they cannot potentially make and supply the drug in quantities required once demand picks up." 

Once local manufacturing starts, the clinicians are likely to administer the drug to COVID19 patients under compassionate use program. A compassionate use program is one where a drug is administered to a patient for a disease for which it has not yet been approved for treatment of that particular disease. 

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