How Mahima Datla's Biological E is taking on vaccine behemoths in India

Today, Datla is among a handful of women leaders in the Indian pharmaceutical sector, and her company, Biological E, sells vaccines to over 100 countries globally and has supplied more than two billion vaccines in the last decade alone. The company operates four divisions that include branded formulation, specialty generic injectables, vaccines and synthetic biology. Datla owns 83 percent stake in the company.

Last year, the company posted revenues of ₹3,900 crore, a 40 percent growth over the past four years, and currently has eight vaccines prequalified by the World Health Organization (WHO), including those against tetanus, rubella and measles. The company is now looking to launch its pneumonia vaccine for which Datla has won approval from India’s drug regulator for commercialisation and production.

“The tremendous growth we have seen from manufacturing vaccines has allowed us to invest in scaling our vaccine production, while also expanding into the injectables market,” Datla says. “We believe our experience in biologics would help in complex injectables.” Biological E is also the largest producer of Tetanus vaccine in the world and the leading supplier of Pentavalent vaccine. It is among the leading suppliers of Polyvalent Snake Antivenom in India. “The sense of satisfaction you get from knowing your work contributes in some small way to saving millions of lives is immeasurable,” Datla says.

Also read: Mahima Datla: Creating another vaccine powerhouse

From modest beginnings

Biological E was founded by Datla’s grandparents in 1953. GAN Raju and DVK Raju were distant relatives and came together after DVK Raju returned from the UK, where he had studied for a PhD in chemistry at the University of Edinburgh. On returning, he worked briefly with Sarabhai Merck, a pharmaceutical company, before starting his own company. GAN Raju was an agriculturist.

The company started by manufacturing Heparin injections, and by 1962 forayed into DPT (diphtheria, pertussis and tetanus) vaccines, thus becoming India’s first private sector vaccine maker. Four years later, Cyrus Poonawalla set up the Serum Institute of India (SII) in Pune, currently the world’s largest vaccine maker.  

By 1964, UK-based Evans Medicals bought a 40 percent stake in the company, which was renamed Biological Evans. Evans was subsequently taken over in the UK and it became Medeva, and their stake in the company was acquired by GSK. The company, however, retained the ‘E’ in its name. By 1970, Biological E became one of India’s first makers of tuberculosis drugs, and in the 1980s, it diversified into veterinary medicines.  

By 1995, GSK sold its stake in Biological E to the Datlas and by early 2000, Biological E engaged McKinsey to restructure its business and began to divest its stake in numerous businesses, including making tuberculosis drugs. Datla was given charge of putting together a plan for the vaccine business.

Datla joined the business after studying business administration, with a plan to pursue her MBA after a few years of gaining experience in the company. “However, witnessing the restructuring of the firm helped me understand and appreciate what we are doing. This was also the time I came to understand how important vaccination is in the lives of people, and how our company has the power to save lives.”

It was around the same time that the government was firming up plans for nationwide immunisation against hepatitis B and H1 influenza B, offering an opportunity for Biological E to expand in the vaccine category. Until then, although the government had immunisation programmes against measles, BCG and polio, the company had shied away from this category.  

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The Covid-19 game changer

In many ways, Covid-19 has been a game changer for Biological E. Apart from Corbevax, Biological E had also tied up with Janssen Pharmaceuticals, an arm of Johnson & Johnson, to manufacture their single dose Covid-19 vaccine.

“With Covid-19, not just our vaccine, but even Janssen’s vaccine gave us the opportunity to go through the US FDA Inspection for the facilities, which wouldn’t have happened for our routine vaccines because we don’t sell to the US,” Datla says. “But it gave us a lot of confidence that we were able to pull off that partnership and in 18 months we did a tech transfer, scale-up, large-scale manufacturing in hundreds of millions of doses that were ready to use in a single-use system.”

Janssen’s vaccine was planned as a single-dose vaccine, but failed to find takers after concerns of adverse reactions.

“Janssen recognised the value of this partnership and that’s creating other opportunities for us,” Datla says. With the Corebevax vaccine, Biological E made 30 crore vaccines that were contracted to the government.

Now with Covid-19 vaccines on the backburner, the company has turned its attention to its pipeline which includes a pneumococcal conjugate vaccine, hexavalent vaccines, and pentavalent vaccines. The company had managed to licence its pneumococcal conjugate vaccine last year. “It’s a 14 valent vaccine,” Datla says. The company has already received an order from the government to supply the vaccines. The pneumococcal vaccine—which is generally given in four shots to children and at least two shots to adults—protects against several types of bacteria that can cause pneumococcal disease, including bacteraemia, bacterial pneumonia, and meningitis.

There is a polio vaccine portfolio, under its hexavalent vaccine business, that the company has developed in the last few years, particularly through a partnership with Indonesia’s BioFarma. “From not being in the polio franchise at all, we’re going to be dominating that franchise in a couple of years,” Datla says.

Today, about 70 percent of the company’s business comes from vaccines while the remaining 30 percent is from the specialty injectables division. “We have five products approved by the FDA (in the specialty injectables division),” Datla says. “We are still investing, and we should be breaking even very soon and expanding there. We’re also creating a lot of partnership opportunities in that business. We believe that between the two organisations, we’ll have the capability to really deliver not only complex injectables but complex immunotherapies.” Over 40 products are expected to get commercialised in the speciality injectibles segment in the next three to four years.

That means over the next few years, Datla reckons that Biological E will see pivoting towards further developments on the mRNA platform, especially after being selected as a WHO technology partner for mRNA vaccines. “As a company, we are invested in mRNA as a platform,” Datla says. “In fact, I would say vaccines are only a limited part of the deployment for mRNA technologies. mRNA can be deployed both for prevention vaccines, as well as in therapeutics.” Unlike vaccines that use a weakened or inactivated virus, mRNA vaccines use lab-made mRNA to create a protein, or even a piece of it, to trigger an immune response.

To do all that, the company says, it is toying with the idea of raising capital for both its vaccines and specialty generic injectables business, although nothing has been firmed up. “The specialty generic injectable business has a different set of risks,” Datla says. “Vaccines have a different set of risks, and to be honest, our pipeline is extremely well-funded, so it’s not like we need capital to fund our portfolio pipeline, but we are doing some early-stage development in vaccines specifically for the US and European markets.”

The company is in the midst of phase one studies for a PCV 24 valent vaccine, which has the potential for use in regulated markets in addition to WHO, and GAVI markets.  “Should those programmes need risk capital, I think it would be helpful for the company to have the ability to raise that risk capital quickly,” Datla says. The company usually spends around ₹1,200 crore between two and three years for its R&D purposes.

So where does Datla go from here? “We have so much going on in terms of execution,” she says. “On the strategic side, the pivot to new platform technologies will certainly open up avenues in immunotherapies, but are we making a vision to become the next Onco company? I am not sure. That will emerge based on the success of the investments we’re making today.”