Biotech firms eye novel biological entities

Leading biotech players such as Biocon and Shantha Biotech and pharmaceutical companies such as Glenmark have ushered in a new era of drug research by venturing into the development of new biotech drugs "� novel biological entities (NBEs).

This is in addition to the 50 new pharmaceutical drugs known as new chemical entities (NCEs) under various stages of development with major pharma firms in the country.

Last week, Glenmark, which so far earned $60 million in milestone payments by developing and outlicensing two NCEs, inlicensed two new biotech drugs under development from Chromos Molecular Systems of Canada. It is the first Indian pharmaceutical company to buy NBEs with worldwide rights for further development, registration and commercialisation.

Biocon, which developed an indigenous new biotech drug for cancer - BIOMAb - EGFR, in collaboration with CIMAB - a Cuban Research Institute, has four such NBEs in the pipeline, said Kiran Majumdar Shaw, chairman and managing director of Biocon.

Apart from developing viral vaccines and a pentavalent (five-in-one) vaccine, Shanta Biotech is also working on drugs for heart attack and stroke, cancer and new generation proteins.

"Worldwide, new biotech drugs have immense potential. More than 50 per cent of the new drugs approved last year by the USFDA were biotech drugs and companies such as Amgen and Genetech are among the top drugs firms in the world. We are on the lookout for potential new biotech molecules for further development as they have a bright future," said Glenn Saldanha, managing director and chief executive officer.

"Currently about 10 per cent of the global drug market, worth about $50 billion account for biotech drugs. This share is poised to grow many times in the near future as many new biotech drugs are under development by both pharma and biotech companies," said Sujay Shetty, associate director of PricewaterhouseCoopers.

Experts point out that biologics prescription is growing faster than conventional drugs globally.

"This is mainly because of the efficacy of biotech drugs, since they are targeted at disease causing pathogenetic mechanisms, while conventional drugs are mainly targeted at the symptoms of the disorder. Biologics are molecules which are native to the body whereas conventional drugs are external chemicals agents used for curing diseases," explains K G Rajendran, the R&D head of US Vitamins.

Of the 200 odd biotech companies in India, only about 60 are into serious biotech drug development. Most of the firms such as Reliance Life Science, Bharat Biotech, Serum Institute, pharmaceutical major Wockhardt and Zenotech are into the development of vaccines, biosimilars (generic form of existing biotech drugs) or 'biosuperiors' by developing a new generation of existing drugs with further improvement in efficacy.

India's biotech industry, growing over 30 per cent annually, is currently valued Rs 8,541 crore. Out of this, Rs 5,973 crore account for biopharmaceuticals, which include vaccines worth Rs 3,053 crore, diagnostics worth Rs 950 crore and therapeutics worth Rs 725 crore.

NBE research is totally different from NCE research, and is highly risky with a success rate of only about 10 per cent. The development costs are about ten times that of pharmaceutical molecules, noted Kiran Majumdar Shaw.

"Indian biotech industry faces a huge shortage of skilled manpower and regulatory expertise to take a new biotech drug into the commercialisation stage. The lack of infrastructure and expertise in pre-clinical development stage are major factors that deter the Indian companies from undertaking NBE research," she said.

"Biotech industry itself is not many years old in India and it will take some time to undertake such research," said Venkat Jasti, chairman and managing director of Hyderabad-based Suven Pharmaceuticals.

Technically speaking, novel vaccines under development and new generation biotech products can also be regarded as NBEs, said Rajendran.