Bharat Serums and Vaccines’ antibody Covid treatment in Phase 2 trials

Biopharmaceutical company Bharat Serums and Vaccines (BSV) has expanded its research and development facilities and capabilities, with its work on Covid-19 antibody development entering Phase 2 trials.

Sanjiv Navangul, MD and CEO, BSV, said the company is carrying out Phase 1 and 2 trials for the equine antibody for treatment of Covid-19. Studies show the product is neutralising the virus and there is a need to expand the R&D programme. The company is working on recruiting patients for the trial and is hopeful of completing it in three to six months. Trials are under way in 20 sites.

Covid-19 cases, especially of the Omicron variant, have been growing in the country and the number of hospitalisations could increase. Need for antibody treatment could go up if hospitalisations increase, and the company could then apply for emergency use authorisation based on Phase 2 trials. The company has been working on the antibody for the last one year and has seen high in-vitro neutralisation, which means Covid-19 could be treated with the antibody and would not need any other drugs, he said.

Rampant use of steroids and Remdesivir had caused an unprecedented outbreak of mucormycosis or black fungus in the country. During the second wave of the pandemic, BSV was among the largest manufacturers of liposomal amphotericin B, accounting for nearly 70% of the country’s amphotericin capacity. It more than doubled its manufacturing capacity to 24 lakh vials a year at its facility in Ambernath, Maharashtra.

BSV is now planning to apply for regulatory approvals for its amphotericin in EU, Russia, Brazil and other countries. This would require further development and would be carried out from the expanded R&D facilities, Navangul said. The company is already exporting amphotericin to 50 countries in Africa, Eastern Europe and South East Asia.

During the last two years, the company has seen the demand for its critical care medicine portfolio go up and this segment now accounts for 50% of the company’s revenue. BSV revenues are in the Rs 1,000-crore range.

BSV is into therapeutic areas of women’s health, critical care and emergency medicine. This includes intensive care medicine with life support for critically ill patients of sepsis, invasive fungal infections, trauma, thrombosis and products around assisted reproductive technology and safe motherhood. BSV spends 7-10% of its revenue on R&D. The expanded R&D facility at Airoli, Navi Mumbai, was inaugurated on Thursday by Maharashtra health minister Rajesh Tope. The R&D centre has 100-plus scientists.