For Sharvil Patel, February 2020 brought back uncanny memories from a decade ago.
The world was battling another pandemic, swine flu—that originated in Veracruz, Mexico, and spread across 74 countries, killing over 18,000 people, according to the World Health Organization (WHO). The unofficial number, though, estimates that the virus may have killed some 500,000 people, between 2009 and 2010. In India, nearly 2,700 people had lost their lives and over 40,000 were affected.
As pharmaceutical companies scrambled for a cure, Ahmedabad-based Zydus Cadila emerged as a dark horse, becoming the third pharmaceutical firm in the world to bring out a vaccine.
“We were able to bring the H1N1 vaccine to market in less than 10 months,” Sharvil Patel, managing director of Zydus Cadila, tells Forbes India in a telephone interview. “We brought a vaccine in a short period and were the third company in the world after the global companies to have an H1N1 vaccine.” The vaccine, VaxiFlu-S, was the first one to be made in India, where scientists at Zydus Cadila’s facility in Ahmedabad grew the virus in live, fertilised chicken eggs to develop the vaccine.
Today, it’s that experience that Patel and his team are counting on to drive Zydus’s quest to find a cure for the coronavirus. The pandemic, which began in December 2019, has so far killed over 1.5 million and affected some 68.3 million worldwide. In India, the virus has affected 9.74 million people and killed over 141,000.
Zydus is currently developing an indigenous vaccine, ZyCov-D, which could be made available in the country as early as March 2021, if it meets all the regulatory approvals. The company is in the midst of Phase 2 trials for which data could be made available in December, before it can start Phase 3 trials. “For us, developing a vaccine came naturally because of the H1N1 vaccine. So, we knew we had the capability of developing one,” Patel says.
That meant that as early as February 2020, when the genetic sequence of the coronavirus was made available, Patel’s team in India and Italy began working on two approaches to find a potential vaccine. Of those, the company shortlisted a DNA-based platform that had the potential to meet with any unexpected mutations of the virus.
“We didn’t know enough about the coronavirus and assuming what happened in H1N1, if there was a mutation that happens to the virus, you would have to actually go through the whole redevelopment [for the vaccine],” says Patel. Many other vaccine technology platforms being developed for Covid-19 currently will have to start redevelopment from scratch if the virus mutates in the future, Patel explains, but because the virus’s DNA construct would remain the same, Zydus hopes to repurpose its vaccine in eight weeks.
The plasmid DNA candidate doesn’t use an infectious agent, like other vaccines, and instead introduces the DNA sequence encoding the antigen. Zydus is also the only company in the country to develop a vaccine on the DNA platform and is now awaiting the efficacy results of its Phase 2 trials, involving some 1,000 volunteers.
If the vaccine shows a strong response, the company plans to recruit some 30,000 people to conduct its Phase 3 trial, before it decides on the nature of doses to be administered and even starting manufacturing at risk. For now, the company is making the vaccine in small numbers, before it will be ramped up to produce in millions. “Safety is not a concern,” Patel says. “We don’t know the efficacy yet.”
Perhaps, that’s also why, over the past few months, Patel and Zydus have decided to also gamble on a different vaccine, apart from keeping an eye out for potential partnerships where the company can play a key role in distribution and manufacturing. It is now in the pre-clinical trials of a vaccine being developed on a measles vector platform, similar to the one being developed by a US-based pharmaceutical company, Novavax.
“Irrespective of whether a vaccine works or not, we may still bring one more vaccine because we don’t know which vaccine will have what kind of efficacy for a long period of time,” Patel says. “So, it would be a good thing to work beyond one vaccine. Maybe it’s an investment that doesn’t work out, but I think it would be the right thing to work on two vaccines.”
RISING TO THE CHALLENGE
Much of Zydus’s plan to foray into developing a vaccine—at a time when numerous Indian companies were striking partnerships with global pharmaceutical companies to manufacture or sell in India— comes from a strong belief in taking challenges head-on.
“It is in the DNA of the organisation,” Patel, whose father Pankaj Patel is chairman of the ₹48,000 crore company, says. “Whenever there has been a challenge, we have always stood up to the challenge.” That’s something that had been imbibed in the group since it was founded by his grandfather Ramanbhai B Patel.
Zydus Cadila traces its roots to 1952, when Ramanbhai, a former lecturer at LM College of Pharmacy, founded Cadila Laboratories along with business partner Indravadan Modi.
“If you look at our history, when our founder chairman started, it was the era of multinationals and only a few drugs were available in the country and those were very expensive,” Patel says. “We were the first company to launch a few drugs—which were required [in India] like Vitamin B12—for the first time in the country. We also brought drugs that were expensive at better pricing. Our founder was a pharmacist and he knew the place of science.” Among others, Cadila Laboratories manufactured medicines such as Livirubra, the first of its kind in India, to treat pernicious anaemia.
By 1995, the Patel and Modi families split, with the latter’s share being moved to a new company called Cadila Pharmaceuticals Ltd and Cadila Healthcare (Zydus Cadila) became the Patel family’s holding company. Cadila Healthcare eventually listed on the BSE in 2000, while Cadila Pharmaceuticals is privately held and headed by Indravadan Modi’s son Rajiv Modi.
Since that split, and subsequent listing, Zydus has been rather aggressively pursuing the Indian and US markets. In 1995, Zydus Cadila acquired Indo Pharma, the first among the group’s many acquisitions. Over the next two decades, the company’s acquisitions included Karnatakabased Recon Healthcare, giving it a fillip in the southern markets, Liva Healthcare, a dermatology-focussed pharmaceutical company, Carnation Nutra-Analogue Foods Ltd that manufactured Nutralite, and Mumbai-based Biochem Pharmaceuticals.
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