While maintaing its average growth rate, Bharat Biotech strengthened its position as the producer of quality indigenous vaccines

Bharat Biotech International Limited (BBIL) specializes in product-oriented research, development and manufacturing of vaccines and biotherapeutics. The company registered an annual turnover of 298.34 crore in FY 2010-11 as compared to 271.66 crore in FY 2009-10.

Established in 1996 by Dr Krishna M Ella and Ms Suchitra K Ella, the company is one of the largest manufacturers of Indirab (anti-rabies vaccine) in India. It is a WHO pre-qualified manufacturer of Revac-B (hepatitis-B vaccine) for supply to UNICEF and the only vaccine company in India to manufacture and supply the preservative (thiomersol) free vaccine, Revac-Bmcf.

The company has the largest manufacturing capacity for making hepatitis-B (10 crore doses), typhoid vaccine (five crore doses) and rabies (80 lakh doses). It has product development projects in varying stages for vaccines and therapeutics of several diseases including, malaria, rotavirus, typhoid, Japanese encephalitis, pandemic influenza, chikungunya, and staphylococcus aureus.

On October 18, 2010, the company launched India’s first indigenously developed cell culture H1N1 swine flu vaccine under the brand name, HNVAC. This is the only developing world flu vaccine that has been manufactured in cell culture instead of eggs. HNVAC places Bharat Biotech’s superior, clean, safe and controlled mammalian cell culture technology ahead of several multinational and Indian vaccine manufacturers, all of whom still use eggs for manufacturing. USFDA has discouraged the use of egg-based vaccines due to the adverse reactions generated by egg based proteins, particularly in children.

On February 4, 2011, Bharat Biotech initiated a phase III trial in India with THR-100 in patients suffering from acute myocardial infarction. The trial is expected to recruit approximately 120 patients and the company anticipates that the phase III trial with THR-100 will be completed in the second half of 2011.
In December 2006, Bharat Biotech entered into a license agreement with ThromboGenics for the manufacture, clinical development and commercialization of THR-100 with the objective of potentially commercializing THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase in the developing markets. THR-100, a novel variant of recombinant staphylokinase, is a thrombolytic agent developed by ThromboGenics for the treatment of acute myocardial infarction (AMI) and other vascular diseases.

Rotavac, the first oral rotavirus vaccine developed by Bharat Biotech, is currently under phase III clinical trials. This is one of the largest phase III clinical trial in Indian history, encompassing 10,000 infants. The company has invested 200 crore to 250 crore in the clinical trials and has received funding from the Gates Foundation and the Department of Biotechnology, Government of India (30 crore). The vaccine is expected to hit the market by the end of 2011.