Cadila Pharma expects marketing approval for flu vaccine soon

Post approval, company will be able to produce and sell the drug in India

Ahmedabad-based privately held pharmaceutical company Cadila Pharmaceuticals Ltd is expecting to get marketing approval from the country's drug regulator for its seasonal flu vaccine based on virus-like particle (VLP) technology in another 12-18 months time. Post approval, the company would be able to produce and sell it in India.

The company has also recently tied up with UK-based antibiotic discovery major Helperby Therapeutics on antibiotic drug resistance research and development (R&D) and is working on developing 'antibiotic resistance breakers' (ARBs) for certain classes of antibiotics including those used for treating tuberculosis (TB).

Rajiv Modi, chairman and managing director of Cadila Pharmaceuticals said that the company had started research at its Dholka facility on developing ARBs for several classes of antibiotics.

Cadila already has a popular tuberculosis drug Risorine in the market, which contributes nearly 5 per cent of the company's overall turnover. The company would be looking at conducting R&D to develop ARBs in the area of drug-resistant TB. ARBs are new compounds which when combined with an old and obsolete antibiotic, it can rejuvinate it and make it active against highly resistant bacteria. Modi terms this as a major breakthrough, as several antibiotics have been rendered ineffective on account of microbes responsible for diseases developing resistance against them.

"ARBs are easier, cheaper and faster ways of making old antibiotics effective, rather than developing novel antibiotics. Typically, the lifecycle of an antiobiotic ranges between five to ten years," he explained.

As for the VLP technology based vaccines, Cadila has a joint venture with US-based Novavax Inc. called CPL Biologicals, which is working on developing vaccines based on Novavax's advanced technology, is close to getting the marketing approval from the Drug Controller General of India (DCGI)  for its flu vaccine.

"Seasonal flu vaccine market is largely untapped in India," Modi said. As the influenza virus mutates fast, every year the World Health Organisation (WHO) and US-based Centers for Disease Control and Prevention (popularly known as CDC), comes out with the prevalent strains of virus after conducting a global study. It is after that vaccine makers start making vaccines for the same. In case of pandemic flu, vaccines are readily developed when the disease strikes, and the VLP platform can whip up new vaccines ready to combat new strains as required.

Modi further asserted that while research to develop novel products was risky business, Cadila Pharma would continue to pump in resources into R&D. Around Rs 60-70 crore is invested in R&D activities every year of the company's net turnover of around Rs 1200-1300 crore.