As the world grapples with the fallout of the swine flu pandemic as well as growing concerns on how to control it, Indian pharmaceutical companies, vaccine makers and clinical research organisations are looking to tap new opportunities spawned by the latest outbreak. The World Health Organisation (WHO) has asked the Pune-based Serum Institute of India to develop a vaccine to prevent swine flu. Serum has been working with the WHO for the past two years to develop a vaccine for avian flu.
Scientists at Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) have already characterised the virus causing the influenza. Preliminary research in the area is also underway at other vaccine makers such as Bharat Biotech, who are contemplating the development of a vaccine against swine flu.
?The latest outbreak has given a strong opportunity to Indian drug industry to display its credentials in manufacturing and testing of vaccines,? says Bharat Biotech chairman, Krishna Ella. In the face of a swine flu pandemic, there will be takers for vaccines against the infection. But this opportunity and potential has to be unlocked through direct and indirect support from the government. We require support from the Indian government through incentives, grants, purchase commitments etc, he adds.
Good news is that the government appears to be gung ho in its plans on developing a vaccine for the deadly swine flu. With the number of patients infected by the new strain of virus rapidly increasing in India?mostly from persons who have returned from the US and European countries?the government is engaged in hectic deliberations with the WHO representatives, domestic research institutes such as ICMR, NIV and the National Institute of Communicable Diseases (NICD), and pharmaceutical companies to prepare a scientific framework for manufacturing a vaccine for the dreaded disease.
India has requested the WHO to share the seed virus, which is needed before manufacturing a vaccine for the international market. Healthcare analysts inform that the Centre for Disease Control (CDC), Atlanta, will provide the strain of the H1N1 virus to help in the research work. The government will soon constitute a core team to begin the research work and decide on the requirements of the vaccine makers who would be manufacturing it.
With regard to swine flu, India?s inherent advantages in both contract manufacturing and research make it an attractive destination for clinical research and the production of drugs, informs Ramesh Adige, president?corporate affairs, Ranbaxy Laboratories. ?India has vaccine manufacturers who will be able to develop the vaccine after the seed virus is received from the WHO,? he adds.
But here are some uncomfortable truths. The harsh reality is there is no vaccine as on date for the swine flu. According to IS Gandhi, medical director, Vimta Labs, since the virus strain contains genes from four different flu viruses?North American swine influenza, North American avian influenza, human influenza, and two swine influenza viruses typically found in Asia and Europe?existing vaccines against seasonal flu will not provide any protection.
?Any such vaccine development will require at least 2-3 years for the vaccine to be ready for market,? reveals M Jeevan Kumar, vice-president?domestic business, Shantha Biotech. There are also worries that not everyone will be able to access the drugs and vaccines needed to fight the virus. On the brighter side, Kumar says, ?Indian companies have the expertise and capability to take up both drug development work and clinical trials with regard to swine flu.? There is also widespread consensus that Tamiflu drug from Swiss drug maker Roche and its generic versions?oseltamivir and fluvir?have proved to be effective against swine flu. Predictably, Indian generic manufacturers like Cipla, Ranbaxy and Hetero Drugs are sensing business opportunity in the manufacture of inexpensive generic drugs for the domestic as well as the international market. The health ministry had recently raised a tender for 9 million capsules of oseltamivir and this is now available in the government?s stockpile. Hetero Drugs, the only supplier in India licensed by Roche to make generic versions of Tamiflu, emerged as beneficiary of the government?s largesse.
Hetero claims it has the capacity to produce 80 million doses of oseltamivir per month to treat swine flu cases. The company supplied 200 million doses of the drug in the last three years within India and rest of the world. It is licensed to export to about 100 countries. Cipla, another leading generic major, claims it has the capacity to supply 1.5 million doses of oseltamivir within 4-6 weeks after the drug has been ordered for.
Indian generic companies seem to have taken a cue from the bird flu scare, which had clear financial implications for Roche. The avian flu caused governments of various countries to stockpile Tamiflu as they awaited preparation of pandemic and pre-pandemic influenza vaccines. The sudden increase in Tamiflu demand boosted Roche?s sales by 3% to 5% in 2005, 2006, and 2007, inform healthcare analysts.
In the latest round, Western countries have already committed investments worth more than $1 billion towards procuring 5 billion doses of flu drugs. As they stockpile the flu drugs, Indian generic companies stand to benefit. ?Some pharmaceutical companies in India are maintaining a stock for possible use in the domestic market and any excess capacity can be utilised for exports,? says Adige.
At present, oseltamivir is made available to patients only through hospitals and health centres. But Indian generic companies are seeking permission to sell through chemist stores as a measure to improve accessibility of the anti-flu drug in case of a swine flu outbreak.
Without any doubt, times are good for vaccine players. Only five companies?GSK, Sanofi-Aventis, Merck, Pfizer-Wyeth, and Novartis?command 85% of the $20.6 billion global vaccines market. Because of the high barriers to entry and the sudden shift in the profitability of making vaccines, the major players are enjoying a period of high growth and increasing profitability for their vaccines businesses.
Analysts inform that vaccines have a high probability of R&D success?70% post proof of concept. Once in the market, vaccines have long product life-cycles and no generics market.
At the same time, vaccine manufacturing is a high risk area, with long incubation periods. And governments, including in India, are more concerned about negotiating lower prices than in optimising incentives for investments in vaccines for the future, lament Indian vaccine makers.
Sunita Vaidyanathan, programme manager, South Asia & Middle East, healthcare?pharmaceuticals & biotechnology, Frost & Sullivan says, ?India can benefit from opportunities in the area of vaccine manufacture as there has been a steady decline in production in developed countries. Indian vaccine manufactures would essentially need financial and regulatory support in upgrading their existing facilities to global standards.?
According to Ella, the vaccine industry would require support from the government in suggesting the types of flu vaccines that would be required by them and the quantities they would be interested in procuring, once the vaccine is available. Indian vaccine manufacturers have a long history of supporting WHO and UNICEF in developing and supplying, affordable vaccines such, oral polio, measles, combination vaccines etc, he stresses.
However, vaccine manufacturers have to ascertain whether the swine flu virus will remain in the present form till the vaccine is developed, tested and launched in the market. ?If the government agrees to support research or give some kind of assured returns to the vaccine manufacturers, India will surely succeed in drug development and clinical trials with pandemics as well. In areas of public health, public-private partnership will be a good pathway to achieve desired results in research and drug development,? says Adige.
Looking at disease in a different light, the flight of the virus from birds to human mankind has shaken up the global drug industry to wake up and take remedial measures.
An essential yet critical aspect has been the challenge to develop products that could take on pandemics like the swine flu. Indian pharmaceuticals industry is seeing the crisis as an opportunity too.