Wockhardt to finish Phase III clinical trials of interferon alpha by year-end
Wockhardt Ltd is engaged in the Phase III clinical trials of its lucrative biotech product interferon alpha used in the treatment of myeloid leukemia, and hepatitis B and C. The company is developing its interferon on yeast Hansenula Polymorpha and bacteria E-Coli. "By the 2003-end, we are confident of finishing the clinical trials," said Dr. M.K. Sahib, Director, Genomics and Biotechnology, Wockhardt.
Currently the three lakh vials per year domestic Interferon market is controlled by Hyderabad-based Shantha Biotech (15 per cent) and ten other players including Fulford, Schering Plough, Roche, LG Chemicals and Zydus Cadila. Two years ago Shantha became the only player in Asia to indigenously manufacture interferon. Rest of the players import the vaccine from countries abroad like Korea, China, Cuba and Argentina.
Shantha has priced its interferon at Rs. 525 per 3 MIU vial and Rs. 625 per 5 MIU vial. "We have got at least 25-30 per cent price advantage compared to our competitors," said Priyadarshi Matruprasad, a brand management executive with Shantha. Shantha develops its interferon on yeast Pichia Pastoris.
Wochardt, which recently launched its human insulin at about 35 per cent cost advantage compared to its competitors have pledged a competitive pricing of interferon, which means the pricing would be on par with Shantha. "Our pricing strategy will always be to grab the market share from our competitors," said Habil Khorakhiwala, Chairman, Wockhardt.
Hoffman La Roche (Switzerland), Novo Nordisk (Denmark), Schering Plough (Germany), Pharmacia Upjohn (US), Rhein Biotech (Germany), and Amgen (US) are the MNCs marketing Interferon across the globe.
Once the clinical trials are over, it will take at least one year for approval from the DCGI for the interferon launch. "From our insulin experience, we would say it would take 1-1.5 years for the DCGI to conduct their studies for the final green signal of launch," said a senior scientist with Wockhardt. This should mean that Wockhardt's interferon launch could be expected only past 2005.