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Dr Reddy's into biogenerics

Our Bureau

HYDERABAD, July 23

DR Reddy's Laboratories Ltd (DRL), a vertically integrated Hyderabad-based pharmaceutical company, has unveiled a major programme for its biogenerics business.

The company is eying the global market for recombinant proteins, which is currently estimated around $14-billion and the Indian biotechnology market of around Rs 300 crore.

DRL's biogeneric initiatives include setting up of a new formulations facility meeting the US-FDA specifications and entry into the biotechnology market with a robust branded portfolio of leading biogenerics in key therapeutic segments such as cancer, im munology, cardiovascular and diabetes.

Addressing presspersons here on Monday, the DRL Executive Vice-President, Dr Jayaram Chigurupati, said the company would leverage its core competencies and focus on efficiencies along the value chain and strengthen core competencies to develop and market biogenerics in regulated markets.

DRL's core competencies in recombinant proteins technology platform include complete product development from molecular biology, fermentation, protein purification, cell culture to production.

According to Dr Chigurupati, potential entrant would have to fight expensive legal battles since biotechnology related patents were rarely clear-cut. Stating that there was no regulatory framework for biogenerics in place even in the developed markets su ch as the US and Europe, he said companies planning to enter biogenerics should plan and prepare to invest in modest clinical trials.

Admitting that the barriers to entry into biogenerics market were more regulatory in nature and less patent related, he said cost advantage and scale of economy were the crucial factors for success. Vertical integration was essential for gaining cost adv antage and it requires substantial investment for a multi-product facility.

DRL has so far invested over Rs 10 crore on its formulations facility coming up at its Bachupally unit near here. The company, which has recently obtained the approvals of the Drug Controller General of India (DCGI) to market its first biotechnology prod uct Grastim (generic name filgrastim), the human granulocyte colony stimulating factor (hG-CSF), has already completed limited trials on its second product, expected to hit the market before the year-end.

Stating that DRL's third biogeneric product was currently awaiting DCGI's approvals for clinical trials, Dr Chigurupati said there were altogether 10 products in pipeline at various stages of development from DRL's biogenerics stable.

DRL believes that marketing of biogenerics in India was only a warm up act and marketing in emerging markets would give it the competitive edge and image. ``The real stakes are in developed markets,'' Dr Chigurupati said.

While patent on Growth hormone already expired, the patents on Interferon alpha 2b were scheduled to expire in 2001-end, of Erythropoietin (EPO) in 2003 and G-CSF in 2005. DRL has identified significant market opportunity for various biogenerics such as Erythropoietin (sales of $1,759-million in 1998), G-CSF ($1,257-million), Interferon alpha 2b ($1,100-million), Hepatitis Vaccine ($1,012-million), Interferon beta ($350-million), Growth Hormone ($221-million), tPA ($213-million) and Interferon gamma ($1 06-million).

According to Dr Chigurupati, several biogeneric products currently marketed would lose patent protection between 2003 and 2006. ``The sooner these biogenerics are developed and registered the better for an early entrant,'' he said.