Hyderabad-based Bharat Biotech, with its largest multi-product biological facility sin Asia-Pacific conforming to international standards, is aspiring to go global. Established in the year 1996, with an objective to offer affordable, safe and effective healthcare solutions to combat mankind''s most dreaded diseases, Bharat Biotech International Ltd (BBIL), is already operating the world''s second largest facility, after SmithKline, to produce hepatitis-B vaccine with a capacity of 100 million doses per annum, and has produced India''s first probiotic yeast. While the company is all set to launch its typhoid vaccine in January 2003, four other vaccines, insulin, a molecule (Lysostaphin) and a couple of other products are in the pipeline. Taking the genetic engineering and rDNA Technology route to develop and provide next-generation remedies, through original and collaborative research, Bharat Biotech is successfully working in the fields of functional genomics, bioinformatics, proteomics, structural biology, identification of new discovery target and new molecules. And recognition of its achievements came in the form of several national awards and international collaborations and two prestigious grants from Bill and Melinda Gates Foundation for the development of malaria vaccine and Children''s Vaccine Programme through PATH. With several American institutions as its alliance partners, Bharat Biotech is better recognized and known in the US than in India.
And the brain behind this path-breaking thoughts and research activities is Dr Krishna Ella, Chairman and Managing Director of this less than six-year-old biotech prodigy. In an exclusive interview with P N V Nair of Chronicle Pharmabiz, Dr Ella said, "My company is going to be global in the next few years. While we want to offer safe and affordable drugs, we also want to stop imports to this country."
Our products, the equipment, procedures and practices, all meet the stringent quality standards laid down by the US FDA, UK MCA and WHO. The safety and protective efficacy of every product that is rolled out, is what drives all our endeavours. Excerpts:
You have achieved so much in so little time. Could you take us along your discovery trail?
Our total commitment to discovery with a social relevance is more than evident in our intense dedication to providing the best of drugs at the most affordable prices. Our pioneering and incessant research led to the launch of Revac-B, the immensely effective second-generation recombinant vaccine for hepatitis-B, in October 1998. This is the world''s first cesium chloride free (CSCl) vaccine, manufactured using the patented innovative in-house production process - HIMAX Technology. We have also produced Biogit, India''s first probiotic yeast to treat irritable bowel syndrome, children''s viral diarrhoea, antibiotic induced diarrhoea and other common stomach upsets.
We are launching the typhoid vaccine in January 2003. The clinical trials of the vaccine have been completed and we are waiting for its clearance from the Drugs Controller-General of India.
Final clinical trial is going on for r-Streptokinase (US patent filed) and this product to treat heart problems will be in the market in another four to five months. This enzyme is a first line therapy for management of acute myocardial infarction, deep vein thrombosis, arterial occulsion and pulmonary embolism.
Pre-clinical trials have been completed for Vascular Epidermal Growth Factor (VEGF) that stimulates new blood vessel formation in tissues deficient of normal arterial blood flow, thereby bypassing the blockage and resulting in improved organ function, in collaboration with the Centre for Biochemical Technology, New Delhi. VEGF will reduce the burden and trauma of present day cardiac bypass surgery.
What are the other products in the pipeline?
Three products - hepatitis-A vaccine, Rabies vaccine and insulin - are in pilot plant stages. The malaria vaccine, in collaboration with the International Centre for Genetic Engineering, New Delhi, PATH-USA, Global Alliance for Vaccine Initiative, USA, and Malaria Vaccine Initiative, USA, is in pre-clinical stage.
The Rota Virus infection vaccine, in collaboration with Centre for Disease Control, Atlanta, USA, Stanford University and National Institute of Allergy and Infectious Diseases, USA, is in GMP production stage. By March 2003, samples will be handed over to the All-India Institute of Medical Sciences, New Delhi, where clinical trials will be done. The vaccine will be ready for launch by the end of 2004.
What is the present status of Recombinant Lysostaphin, the first molecule to be developed by Bharat Biotech?
We are working with CDRI, Lucknow, on this molecule which is in the pre-clinical stage. A staphylolytic enzyme, it offers the possibility of a novel approach in the treatment and propylaxis of staphylococcal infections. Though we want to further develop and commercialise it on our own, we keep the option of aligning with some US companies or with an Indian pharma company for jointly developing the molecule for other applications.
Are you exporting your products? And how do you propose to go global?
Almost 80 % of our sales are in India. We do export in a limited way to countries in Asia, Africa and Latin America. The two products, hepatitis-B and Biogit, are specific to third world countries and there is no market for these products in the US and also in Europe. In any case US FDA has not yet recognized a single ANDA biogenerics so far. When our other products hit the market, we are planning to go aggressively on the export front. Besides the Asian, African and Latin American countries, we will be exploring the East European market as well.
Since you got a favourable verdict in the hepatitis-B case, what will be your strategy to supply the vaccine to the AP government for its immunization programme?
We have not yet received a copy of the court order. Since the court had struck down the government''s condition of WHO pre-qualification for the tender, it was now for the government to make the next move. However, we would like to avoid any confrontation.
What is the fate of the biotech industry in India? Do you think that India can make it big?
Let me start from the US. Out of the 1,500 odd biotech companies, almost 500-600 companies have been closed down. Europe is also going through the recession. In this year''s Hanover Fair, just 40 companies took part as against more than 800 last year. Venture capital is scarce, the gestation period is long. It takes its own time. Besides, the sector has not delivered yet and no blockbuster has come out of it.
It is going to be tough even in India for the next two to three years. Here we have no alliances, the technology is fragmented. To develop a product, integration at various fields and levels is essential and that is not happening in India. Look at the US, the multinationals co-exist, they share the experiences. Here one company tries to pull down the other and doesn''t allow others to come up.
Does it apply to you as well?
My competitors are not the companies. It is always the infectious diseases. I believe in co-existence and work for the betterment of the society. We must think big.
What is your annual turnover now, and what is your target?
Last year it was Rs 27 crore in sales and Rs 6 crore in net sales. My target is to double it by 2004.