Cheer in Covid times

Recently CDSCO fast-tracked ap­p­roval of Biocon’s Alzumab for the treatment of Covid in India. Serious cases of Covid develop into a “cytokine storm”, which is a debilitating overreaction of the human immune system to the attacking virus. Alzumab had worked miraculously on every one of the trialled Covid patients, albeit only on limited numbers. Wider trials are currently being undertaken. Last week, Fox News reported on this exciting new drug to be launched in the US through Biocon’s partnership with Equillium. Trials in the USA are set to begin. If all works out well, this may be an important, globally relevant innovation from an Indian company. This does not happen frequently.

The backstory of this exciting innovation was narrated in a book published be­fore Covid. (How Kiran Mazumdar-Shaw “fermented” Biocon, R Gopalakrishnan & Sushmita Srivastava, Rupa, 2020). Over the last 35 years, Biocon’s growth identified wi­th a biological way of thinking, distinct from an engineered way of thinking. It was Kiran’s response to the challenge of growing and surviving in a fast-changing and complex global business that made Biocon move from being a big fish in a small pond (enzymes) to a small fish in a big pond (biopharma).

Kiran is a quintessential institution-shaper and believes that with collaboration, one learns faster and better. Institution shapers do so through a highly networked environment; they create new forms of collaboration, whereby they join other ecosystems because they want to be part of the journey. Whether it is through a movement, a company or a community, shapers unite people around them with a shared purpose.

Early in the journey of the company, Biocon began to work on novel molecules, for example, monoclonal antibodies (MAB) and anti-CD-6. This move accelerated the company’s journey into biosimilars in a path-breaking approach. But what at­tracted Kiran to such technologies in the first place? She had long been concerned about chronic diseases and was looking passionately for possible breakthroughs. The technology for producing monoclonal antibodies to develop solutions to fight cancer was available with the Americans. But they would not part with it.

In 2003, when Kiran attended a conference, she met a Cuban scientist from the Cuban Centre of Molecular Im­mu­nology (Centro de Inmunología Molecular or CIM). He had presented his MAB programme. Kiran was impressed. She sensed an opportunity, although most investors in pharma would have ignored technology from Cuba, a country not known for pharmaceutical innovation.

Seemingly on an impulse, she went to Cuba with her husband who could speak Spanish. The laboratory visit, which was to last for only an hour, extended to several hours. The Cubans had fine technology, but did not seem to be developing it purposefully. Kiran asked probing questions that got the Cubans intrigued about further enhancing the value of their technology. She offered to co-invest in the technology of developing monoclonal antibodies. The Cubans appeared reluctant initially, maybe because at that time, Kiran’s was an unknown Indian company. They agreed to in-license the molecule to Biocon for further development and marketing. It was a potential win-win for both and a game changer.

The casual encounter with the Cuban scientist led to a long-term partnership with CIM.

It took 10 years till 2013 for Biocon to develop and commercialise BIOMAb EGFR®, a drug for head and neck cancer, out of this partnership. The Cubans were delighted by this surprising development — to the point that the Cuban government felicitated the scientists from Biocon with a gold medal for their anti-CD6 monoclonal antibody, Itolizumab, which is the generic name for Biocon’s brand, Alzumab.

Biocon’s work on the prognosis of the safety and efficacy of the molecules won the admiration of the Cuban Academy of Sciences. Early and supportive appreciation is important in the difficult and uncertain journey of innovation. Dr M S  Ramakrishnan, vice-president at Biocon Research Limited, had lamented, “Indian Academy of Sciences did not even acknowledge this contribution because Biocon had in-licensed the molecule. They thought this was not an innovation.”

Biocon further developed a version of Itolizumab for psoriasis. When the “cytokine storm” problem of Covid became known, Biocon instinctively felt that the molecule could be repurposed to deal with the problem. And that is the dramatic story of how Alzumab came to be approved by CDSCO and got ready for the US trials. 

Innovative societies applaud innovations early. CDSCO’s fast-track approval without full trials is such a gesture. Competitors and peers may be more cautious, but avoiding snipes and displaying some optimism would be a good ecosystem response.
The writer is an author and corporate advisor. He is a distinguished professor of IIT Kharagpur. 

and a vice-chairman of Hindustan Unilever


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