Biocon Biologics Limited (BBL), a subsidiary of Biocon Ltd. and Serum Institute Life Sciences Private Limited (SILS), a subsidiary of Serum Institute of India Pvt. Ltd, have entered into a historic alliance to impact global health. This alliance will complement the strengths and resources of two leading Indian players in addressing inequitable access both in emerging and developed markets for life-saving vaccines and biologics.

Why is the alliance significant for global health?

In the last couple of decades, the world has witnessed a rapid increase in the frequency of viral outbreaks. Besides COVID-19 there have been several other viral outbreaks in different parts of the world such as Dengue, H1N1, Ebola etc, which have had a devastating impact on human life.

In 2002, 36 countries were affected by SARS-CoV virus with more than 8,000 cases and 744 deaths worldwide**.  H1N1 influenza virus caused nearly 575,000 deaths in 2010, while Ebola virus outbreak in West Africa affected 10 countries with more than 28,000 cases and more than 11,000 deaths**. And 2020 witnessed the outbreak of COVID-19, one of the most devastating viral diseases of the 21st century, which has resulted in over 4.7 million deaths globally.

More such viral pandemics are expected to emerge in the future.

With these communicable diseases are increasingly becoming common, there is an urgent need for vaccines and biotherapeutics like monoclonal antibodies, which are humanity’s best bet against viral pandemics.

The COVID-19 pandemic has led pharma companies globally to channelize their resources to develop vaccines, as well as, antibody therapies.

Biocon Biologics had in 2020 repurposed its novel antibody drug, Itolizumab, whose unique mechanism of action helped prevent and treat CRS (cytokine release syndrome), which is a leading cause of death in patients suffering from acute lung inflammation due to COVID-19. Over 27,000 COVID-19 patients in India have benefited from Itolizumab up to the end of June 2021.

Serum Institute of India has been contributing to the fight against the COVID-19 pandemic by developing and manufacturing live-saving vaccines such as COVISHIELD and COVOVAX. It has filled and delivered hundreds of millions of doses to India and the world.

Now, a shared commitment to impact global health has brought together Biocon Biologics and Serum Institute Life Sciences, which have invested in developing global quality products and global scale capabilities, to combine their respective strengths in biologics and vaccines for making a meaningful impact in fighting infectious diseases through a long-term strategic alliance.

What does the alliance seek to deliver?

This alliance provides asset light stakes to both companies in each other’s businesses.

Biocon Biologics, which is a vertically integrated company with established capabilities in R&D, clinical development, manufacturing and quality, has demonstrated success with multiple biosimilar approvals in Europe, U.S. and several other developed and developing countries. It has created global scale capacities for insulins and antibodies that meet the most stringent of regulatory norms. Thus far, Biocon Biologics’ focus had been on providing relatively lower cost access to biologics for treating non-communicable diseases such as diabetes and cancer.

Biocon Biologics’ foray into infectious disease is an expansion into an adjacent domain with strong synergies to its expertise acquired over the many years. The company collaborated with U.S. based Adagio Therapeutics recently, demonstrating its ability to be able to play an important role in addressing growing healthcare needs in the viral disease segment. Vaccines will augment Biocon Biologics’ offering in this segment. Biocon Biologics will have access to 100 million doses annually from Serum Institute’s vaccine portfolio, including COVID-19 vaccines, which the company will commercialize globally.

Serum Institute, which is the world’s largest vaccine producer, will get to strengthen its capabilities in biologics, including monoclonal antibodies, by cross-leveraging R&D knowhow, manufacturing capacities and commercial infrastructure, through the alliance with Biocon Biologics. Serum Institute of Life Sciences will receive 15% stake in Biocon Biologics at a post money valuation of ~$4.9 bn.

Biocon Biologics, which has longstanding expertise in developing biologics, will establish an R&D division for vaccines to support this strategic alliance for the development of both vaccines and biologics for communicable diseases.

In addition to vaccines, the strategic alliance will also develop antibodies targeting infectious diseases like HIV and mosquito-borne infections like malaria and dengue.

The two companies will enter Service Level Agreements (SLAs) for manufacturing and distribution of the vaccines and antibodies.

At a time when the world sadly acknowledges inequitable access to vaccines, this strategic alliance will combine the strengths and resources of two leading players to build a stronger partnership in the viral disease segment and help address inequitable access in emerging and developed markets for life saving vaccines and biologics.

What Biocon Biologics, Serum Institute had to say about this alliance

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon & Biocon Biologics, said:

This alliance will complement the strengths and resources of the two leading players in vaccines and biologics. Our shared vision of building large scale businesses having global impact makes it a unique and synergistic value creation opportunity.

Adar Poonawalla, CEO, Serum Institute of India, commented:

We look forward to complementing each other’s capabilities and capacities in vaccines and biologics, with the objective of addressing inequitable access both in emerging and developed markets for life saving vaccines and biologics.”

What others are saying about this alliance

**Source: Megnak et al, Developing therapeutic approaches for twenty-first-century emerging infectious viral diseases, Nature (2021); Disease Control Priorities: Improving Health and Reducing Poverty (Chapter 17)

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