Box 4. Case study: Transgene Biotek

From the following article

India's health biotech sector at a crossroads

Sarah E Frew, Rahim Rezaie, Stephen M Sammut, Monali Ray, Abdallah S Daar & Peter A Singer

Nature Biotechnology 25, 403 - 417 (2007)

doi:10.1038/nbt0407-403

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Transgene Biotek (TBL; Hyderabad) started out as a strictly diagnostics R&D and manufacturing company in 1991 and had its initial public offering on the Bombay Stock Exchange in 1992. It currently has a number of products and technologies ready to be outlicensed (Table 1) or launched into commercial markets.

TBL's business model relies on technological transfer from other organizations. The company aims to acquire or in-license early-stage technologies with high market potential from research scientists, universities and small research institutes. It then uses in-house expertise and assistance from strategic collaborators to advance these technologies through process improvement and optimization, and preclinical animal studies. The firm has recently completed phase 3 human clinical trials of a quadrivalent Maningococcal vaccine developed in collaboration with JN International Medical (Omaha, NE US). TBL also has several ongoing collaborative projects with partners in India and the United States for some of its other products (Table 4 and 5).

Today, TBL generates revenues primarily through out-licensing novel technologies through strategic marketing partnerships for several products. The company's growth strategy is to bolster its product pipeline by reinvesting revenues generated through contract research into innovative products. It serves its clients by performing preclinical and early-stage clinical trials in India for the purpose of providing early safety and efficacy data for new drug candidates. Early data is meant to help lower the risk for later phase (and more expensive) investments in drug development by companies and researchers from advanced industrialized countries. The technological know-how and revenues acquired by providing contract services helps the company to bolster its own product pipelines.

In 1994–1995, TBL acquired the technology to make Hep-B vaccine and went through significant difficulties in securing capital in the years that followed, with high-interest bank loans (at 21%) being their primary source of financing. The company has since sold its recombinant Hep-B vaccine technology and invested a cumulative sum of approx$4.5 million thus far in shaping itself into a vaccines and biotherapeutics company, with additional capabilities in agricultural biotech applications, for example, for producing recombinant proteins for use in human therapy.