New Delhi: Indian drug makers are preparing to develop remdesivir, an experimental drug that failed to cure Ebola but is now being touted as the best shot against Covid-19
Key pharma companies including Cipla, Glenmark and Dr. Reddys, according to the industry sources, have started working on the development of the drug which is under patent protection until 2035.
The companies are hoping that the US-based Gilead Sciences, which owns the drug patent, will grant them licensing provisions, like it did with hepatitis C drug Sovaldi in 2014, so production can then begin.
But for now, according to the “Bolar Provision”, the companies are allowed to formulate the drug, strictly for the research and development purposes. “Due to this, key pharma companies have started the process to develop the drug’s raw material, the active pharmaceutical ingredients (APIs),” an industry source told ThePrint.
The Bolar Provision is a defence against patent infringement. It allows generic drug makers to develop a drug, conduct research on it but they can only launch it in the market after the expiry of the innovator company’s patents. Using this provision, companies file for generic drug approvals many years before the original patent expires.
“We are in the development phase of the drug. We are also working on the development of Japanese flu drug Favipiravir. However, it is strictly for the purpose of R&D and it cannot be marketed as it is covered under the patent,” said the official working at Mumbai-based Cipla, who was not allowed to speak to the media.
Cipla, however, officially refused to comment. “Our spokesperson is unable to respond to your query at present. Will let you know in case there is an update,” it said.
“The key players have started working on the drug already. We can definitely crack this one,” said an official working with the Mumbai-based Glenmark, requesting anonymity. “Once Gilead or the Indian government allows the manufacturing, Indian companies are likely to start supplying the drug within one month.”
Mails sent to Glenmark too did not elicit an official response.
While industry sources indicated that the Hyderabad-based Dr. Reddy’s is also working on the drug, its spokesperson said, “We do not comment on our development pipeline, and have no further comment at this point of time.”
The drug once manufactured by domestic companies can also help apex health research organisation, Indian Council of Medical Research (ICMR), which is involved in designing the treatment protocols for Covid-19.
“Initial data based on an observational study shows that the drug (remdesivir) is effective. We will wait for the results from the WHO solidarity trial and also see if some other companies can work on this to proceed further,” said Raman Gangakhedkar, head scientist at ICMR during the daily briefing Saturday.
This is how India can access the patented remdesivir
Industry experts believe that the US-based Gilead Sciences may announce provisions along the lines it issued in 2014, allowing Indian drug makers to produce the Hepatitis C drug Sovaldi, which was then patented and phenomenally expensive.
If it does allow production of remdesivir, the drug could be made at $9 per treatment, which is less than Rs 700 for 14 days.
“The company (Gilead Lifesciences) is likely to announce a compulsory licensing arrangement with our drug makers that would allow them to produce generic versions of remdesivir. If not, the patent act allows Indian government to evoke laws that would allow Indian firms to manufacture patented drugs in case of epidemics,” said an official from the ministry of health and family welfare.
“Most likely, Gilead will announce licensing provisions but it is premature to initiate any discussion with them (right now) as the drug hasn’t yet reached the final phase of trials,” the official added.
Gilead had in 2014 announced a licensing agreement with firms including India’s Cipla and Ranbaxy Laboratories (now Sun Pharma) clearing the way for the launch of cheap generic versions of Sovaldi in 91 developing countries.
The company’s executive vice president, corporate affairs and general counsel, Brett Pletcher, has hinted at following the same provision of providing licenses to low-cost manufacturing partners.
“We have a long legacy of making our medicines broadly available… This was made possible through our partnerships with low-cost manufacturing partners. We granted the first voluntary licenses for our HIV medications in 2006 and, in 2011, we were the first biopharmaceutical company to donate to the Medicines Patent Pool,” he said in a response to an international humanitarian organisation Médecins Sans Frontières’ open letter that had asked Gilead to immediately take action and ensure access of potential Covid-19 treatment.
“Over the years, we have worked with our manufacturing partners to provide not only a license, but also the technology transfer and support to scale production,” he had said. “While the circumstances are different, it is this legacy that offers us insight into how we can provide remdesivir, should it receive regulatory authorisation, during this pandemic.”
The American research body, National Institutes of Health and Gilead, has published results of the pre-clinical trials of remdesivir based on animals. In a trial involving 12 rhesus macaques, a species of monkey, early treatment of Covid-19 with remdesivir has shown to reduce symptoms of the disease and lung damage.
The study found that when six macaques were treated with the drug, while the others were untreated, within seven days, the macaques treated with remdesivir were significantly healthier than those in the control group.
“…animals treated with remdesivir did not show signs of respiratory disease and had reduced pulmonary infiltrates on radiographs,” said the study. “Virus titers in bronchoalveolar lavages were significantly reduced as early as 12hrs after the first treatment was administered. At necropsy on day 7 after inoculation, lung viral loads of remdesivir-treated animals were significantly lower and there was a clear reduction in damage to the lung tissue.”