-Dr Krishna Ella, chairman & managing director, Bharat Biotech, Hyderabad

Dr Krishna Ella, chairman & managing director, Bharat Biotech, talks to BioSpectrum about the advantages of HNVAC and the company's strategy for this product.

Q How are you planning to promote HNVAC in India?

Bharat Biotech expects the demand for flu vaccines in India to rise, as consumer’s awareness about the disease increases, and concerns about precaution against the flu, than a year ago. HNVAC will be made available in the private market and through government procurement agencies.

Q At what price will the product be sold in the market?

This vaccine, HNVAC, will be competitively priced as Bharat Biotech is committed to ensuring that pricing does not become a barrier for consumers to access its vaccines.

Q How do you see the competition in the swine flu vaccine market?

HNVAC is the only flu vaccine to be manufactured in cell culture in the developing world — a highly sterile and controlled manufacturing process, instead of eggs. HNVAC was tested extensively in one of the largest phase I, II and III clinical trials for flu vaccines in India; and has proved safe and well tolerated.

The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly as required; it also has a much more sterile and faster production cycle, without the external dependence on eggs, thus enabling quicker response times, in the event of a pandemic.

Q How do you look at the market for HNVAC in terms of market share by the end of 2010?

We expect government involvement and increasing awareness on the pandemic to drive the growth of H1N1 vaccines market; thus encouraging market players to gain a better understanding of the market dynamics, technological innovations, product pricing, marketing and regulatory framework.

The total global market for influenza including 2009 H1N1 according to estimates is likely to be 46,000 crore ($10.4 billion) during the current winter (2009-2010). The addition of adjuvant and shift to cell cultures can stretch the present global production capacity to increase protection for world population. The results of clinical trial with tested 2009 H1N1 vaccines indicate that a single dose may offer protection to over 90 percent of the vaccinated subjects.

The global H1N1 influenza vaccine market is expected to show a high compound annual growth rate (CAGR) from 2009 to 2011; but as most of the global population is expected to be immunized by the end of 2011, a more moderate growth is expected in future. The H1N1 vaccines market is classified into intramuscular and intranasal vaccines sub-markets, of which the former holds the major share.

Q In the global market, how are you planning to launch HNVAC?

HNVAC has been launched in India as it is the first country to approve our vaccine. However, we have significant demand from South East Asian countries and other Asian, African and South American countries. Our focus is to launch and support the product in India, followed by regulatory approvals in South East Asia. In other parts of the world, we would register or launch HNVAC as per the requirement, depending on local demand.

Pradeep Kumar in Bangalore