Start-up biotechnology enterprise Biovel Lifesciences is collaborating with Santiago-based Dowpharma for a technology transfer of Pfenex Expression to manufacture Human Growth Hormone (HGH). With this technology, Biovel will be the first company in India to produce HGH and market at an affordable price world wide.
Dowpharma has already developed a high yield production strain and bench scale process for the production of HCG. The licensing agreement with Dowpharma will allow Biovel to scale up the product from the former's research cell bank and market it globally including the regulated regions of US, Europe and Japan. Within the next three years, Biovel is confident to garner a 5 per cent market share and generate Rs 600 crore turnover, stated Sudhakera Naidu, chairman and managing director at a press conclave.
The HGH technology is based on the specially modified stains of Pseudomonas fluorenscens bacteria which consistently outperforms other microbial systems. By improving quality and boosting yields of difficult-to-express proteins, this technology accelerates speed to market for vaccines and bio-therapeutics and reduces cost when compared to alternatives. Pfenex Expression Technology is recognized in the industry for delivering economical and practical solutions, stated Dr Durgaprasad Annavajjula, director, technical, Biovel Lifesciences.
The company's advanced facility of US FDA standards at Hoskote, Bangalore set up at an investment of Rs 45 crore under the first phase has an R&D centre, pilot plant, two independent production lines with 300 L and 100 L fermenters, two independent filling lines with lyophilisation. The pilot plant contains fully automated 19 L fermenter with a capacity to produce clinical material to meet Biovel's initial marketing requirements. For production of HGH, Biovel will be involved in scale-up, pre-clinical testing, clinical testing, manufacture and global marketing.
Global market for HGH is estimated to be around $3 billion. Patients with human growth hormone problems spend an average between $10,000 to $20,000 annually. Presently, the HGH brands available in India are Humatrope by Eli Lilly, LG Eutropin Inj from LG Chemicals, Saizen from Serum Institute of India and Norditropin NordiLet from Novo Nordisk.
Biovel has manufactured 'Thrombowel' an anticoagulant which is expected to be marketed shortly. The company has already hired 40 filed force for the markets of North and East and is in the process of hiring for southern and western regions.
The plant is also ready to produce vaccines for Typhoid and Haemophilous Influenza-B( for prevention of the fatal brain infection in young children) and recombinant proteins like EGF and Streptokinase. These products are undergoing advanced studies at Central Research Institute, Kasauli.
The Indian market size for typhoid vaccines is Rs 25 crore with GSK being a major player among others. The HiB market value is Rs 100 crore. EGF and Streptokinase markets according to TIFAC reports are valued at Rs 65 crore and Rs 80 crore respectively.
The company's product portfolio covers vaccines, therapeutic molecules, wound management and novel drug delivery systems. It is also actively pursuing in the development of molecules for oncology, dermatology and gynaecology. According to Naidu, Biovel products will have drug delivery systems as one of the key differentiating factors while it competes in the market. "Advanced technologies like Pfenex Expression Technology will allow the company to move from biosimilars to biosuperiors at an affordable pricing," he added.