December 13, 2008

Pharma firms shy away from cardio molecule research


Priyanka Golikeri Thursday, December 4, 2008 4:04 IST

MUMBAI: A recent issue of British medical journal The Lancet found that heart diseases kill 3 million people in India annually, accounting for a third of the total deaths in the country. The World Health Organisation (WHO) estimates that by 2010, India will have 60% of the world's heart patients.
Recently, US pharma giant Pfizer, which focused on cardiovascular diseases (CVD) research, decided to stop the development of new drugs for this segment and shift focus to areas such as cancer, diabetes, pain management, Alzheimer's disease and inflammation. Pfizer is the innovator of blockbuster CVD drugs like Lipitor and Norvasc.Hard-hitting facts, these. What's more alarming is that not much research is being done in India for developing new molecules in the area of cardiology.
Tapan Ghose, consultant (cardiology) at Fortis Hospital, said Pfizer's decision may be due to its failure to bring CVD drug torcetrapib into the market.
Several leading domestic players are actively engaged in research to develop new chemical entities (NCE) or new biological entities (NBE). An NCE is a chemical molecule discovered and developed by a pharma company, which can become a drug after undergoing clinical trials. On the other hand, an NBE is derived from plants or animals and could become a drug on completion of clinical trials.
Though Indian pharma companies have NCEs and NBEs in the pipeline, the focus seems to be more on segments such as cancer (oncology), diabetes, pain management, chronic obstructive pulmonary disease (COPD) than on heart ailments, which affect over 20 million Indians.
Players such as Wockhardt and Dr Reddy's Laboratories have 2 and 4 NCEs in the pipeline, respectively, but none in cardiology. Likewise, Piramal Life Sciences and Sun Pharmaceuticals Advanced Research Centre (SPARC) have 14 and 4 NCEs, respectively, but again none for heart ailments.
CK Ponde, consultant cardiologist at PD Hinduja Hospital, said, "Research in cardiology has plateaued. There are hardly any molecules in cardiology at present."
Manjeet Juneja, consultant cardiologist at Wockhardt Hospitals, added that Indian firms are more inclined towards conducting clinical trials and not developing new molecules.
However, Glenmark Pharma has one NBE for CVD, of the 8 NCEs and 5 NBEs it is working on. This molecule is currently in the preclinical stage.
On the other hand, Lupin has some NCEs in the pipeline, and spends 10% of its R&D budget on the cardiovascular space, a spokesperson said.
Bibhuti Bhusan Kar, programme manager (South Asia & Middle East Healthcare) at research and consulting firm Frost & Sullivan, said, "Indian players are less focused on cardiology even though India is becoming a major hub for heart-related ailments.
Though domestic companies have presence in the cardiovascular market, it is more in the area of process development and analytical research."
He added that where innovations are concerned, cardiology is a neglected area. Though there seem to be no clear reasons behind the trend, cost and fear of failure could be a couple of causes, say experts. Ghose said, "About 70-80% of heart diseases are preventable with existing medicines. The failure rate of molecules in cardiology is very high and so, for players, it is a major risk."
He added that the patient pool required for conducting human trials before launching a cardiology drug is quite large compared with other disease segments. "Over 5,000-7,000 patients are needed for phase III trials of a cardiology drug as against 2,000-3,000 for other drugs," Ghose said.

- Source: DNA India, Dec 04, 2008
http://www.dnaindia.com/money/report_pharma-firms-shy-away-from-cardio-molecule-research_1211525