India’s second largest pharmaceutical company, Dr Reddy’s Laboratories (DRL) plans to now develop new biological entities (NBEs) or new drug molecules from livingorganisms, thereby demonstrating its continuing appetite for risk-taking despite recent investor concerns.
NBE discovery and development will be costlier and riskier vis-a-vis new chemical entities (NCEs) or ‘small molecules’ developed by pharma companies through chemical processes.
DRL already has seven NCEs under various stages of development. It also sells two biosimilars (generic versions of innovative biological drugs) in India – Reditux, a generic version of Roche’s biologic blockbuster Rituxan, and Grafeel (filgrastim).
?We are thinking of developing new molecules through biology (NBEs),? says GV Prasad, vice- chairman and chief executive officer, DRL.
?The probability of success for a biological drug will be much higher. Many of the biologics are therapeutic proteins which are already there in the body, and so are inherently safe.?
Globally, big pharma has placed greater thrust on biological products and are in a rush to acquire early to late-stage biologic products and smaller biologics companies to gain a competitive edge. Moreover, suchproducts are being increasingly approved by the US pharma watchdog, the Food and Drugs Administration (FDA).
In 2006 alone, the FDA approved 24 new molecular entities in all, of which 6 were either biologics or biotechnology-derived products. ?We want to do NBEs largely in the oncology space,? says Prasad.
?Right now, we have it as a concept, which needs to be developed,? Prasad adds.
Earlier this year, Glenmark Pharma entered into a research agreement with Cambridge-based biopharmaceutical company Dyax Corp for the discovery of therapeutic antibodies. Glenmark also purchased two new NBEs from Canada?s Chromos.
Zenotech Laboratories, is also reported to have developed a generic monoclonal antibodies technology platform for NBE development.
?(The travel for the story was sponsored by Dr Reddy?s)