Glenmark molecule gets USFDA nod
The United States Food and Drug Administration (USFDA) has granted approval to Glenmark Pharmaceuticals to start phase I trials on its biologic molecule GBR 500.
This is the first time that a new biologic entity (NBE) from India has been granted approval to conduct phase I trials. A NBE is a biologic molecule derived from living organisms as opposed to chemicals. It can translate into a drug on completion of the clinical trials.
The Mumbai-based company expects to complete phase I trials by the end of financial year 2008-09 for GBR 500. The molecule can be used for treating multiple sclerosis. Since it is a monoclonal antibody, it has higher efficacy and substantially lesser chances of side effects.
The USFDA nod provides huge opportunities for Glenmark as the market for monoclonal antibody is estimated to touch $40 billion by 2012.
Glenmark's managing director and CEO Glenn Saldanha said the company would now be able to implement relevant learnings to the other biologic molecules. "This will fasten the discovery process for our biologics in the pre clinical stage."
According to an analyst from a leading broking firm, phase I is just the first step in human trials and there is a long way to go for the company. "There is no idea how the trials on patients-that is phase II and III — will go."
Industry experts say the chemical entities pipeline is fast depleting and biopharma is thus assuming importance.
As per an estimate, there are only about 18-20 new chemical entities (NCEs) globally, while a stupendous $80-90 billion is being spent for their development.
"The NCE pipeline is quickly drying up and hence companies need to focus on new biologic entities or NBEs," says Ranjit Kapadia, an analyst with Prabhudas Lilladher.
Moreover, the average cost incurred on developing a NCE is soaring. The research &development spend per NCE has increased from $1.8 billion in 2004 to a staggering $2.3 billion now. In comparison, the expenditure incurred for developing a biopharma product is only about $500-600 million, says Kapadia.
Importantly, biopharma products fetch more margins as compared to chemical products. Kapadia says that in biopharma, the operating margins are around 30-40%. "This is much more than the operating margins of around 10-25% in active pharmaceutical ingredients and 15-30% in formulations — which make up chemical products."
September 17, 2008