Medicines for the modern man

PHARMA: The Indian pharma sector is turning its attention to diabetes, arthritis and other diseases of the developed world.

India is projected to break into the ranks of middle-income countries by the end of the current financial year. Before that can happen, Indian pharmaceutical companies have re-oriented their research and development priorities from infectious diseases found in the under-developed world to chronic lifestyle disorders that threaten the developed world.

Notably, the first possible product patent to be handed out after the patent regime changed in 2005 is likely to belong to the anti-chronic segment.

Last week, Dr Reddy's Laboratory (DRL) announced the beginning of phase III clinical trials of its anti-diabetic drug balagliatzone. Co-developed with Danish firm Rheoscience, the successful completion of the trial could give India its first intellectual property from the pharma sector.

Commenting on the discovery pipeline, Sujay Shetty, associate director (pharmaceutical and life sciences), PricewaterhouseCoopers, says, "Big pharma companies in the country are shifting their R&D to focus on developing drugs to fight chronic illnesses. The move is apparent from the ongoing research of new chemical entities, especially in companies like Glenmark and Torrent pharmaceuticals."

Of the seven potential drug candidates being developed by DRL, six are targeted at the chronic segment.

Nicholas Piramal, a leader in the R&D segment, recently received approval from the US Food and Drug Administration (USFDA) for clinical trials on humans for its lead cancer compound to treat Multiple Myeloma "" an incurable cancer of the plasma cells.

Not only is this the company's first Investigational New Drug application, it is also the first NCE cancer drug from India to be approved by the USFDA. Besides its heavy focus on anti-cancer and anti-diabetes drugs, the company has also begun researching for anti-arthritis drugs.

"Our focus on the chronic segment has gone up because this is a fast growing market. Diabetes alone will affect more than 20 million Indians by 2020 and arthritis is also on the increase. In fact, we have a group working in the area of pain management, particularly using new drug delivery systems," says Swati A Piramal, director, strategic alliances and communications, Nicholas Piramal.

While deaths from infectious diseases and other deficiencies in India are estimated to decrease by 15 per cent in the next ten years, according to the World Health Organisation, the figure for chronic diseases is expected to grow by 18 per cent with diabetes alone witnessing a 35 per cent growth.

Despite investing in combining known molecules to attain new drugs, Cipla, one of the country's largest pharma companies, has started working on putting together known molecules in chronic diseases like cardiovascular and asthma.

Says Cipla joint MD Amar Lulla, "We realise that not enough work is being carried out in developing new chemical entities and that is where we have to start working."

However, D G Shah, secretary general of the Indian Pharmaceutical Alliance, points out that the market for chronic disease drugs is still very small in India. "But," he adds, "If we look at the current pipeline, there is a general perception that cardiovascular and diabetes are research areas where some companies are focusing, though there are no numbers to support this."

In spite of the unavailability of numbers, ongoing trials speak for themselves. Ranbaxy, largely a generics-focused company, has five new compounds in the chronic diseases segment in different stages of trial.

Dr Pradip Bhatnagar, senior vice president, new drug discovery research, Ranbaxy, says, "We have selected a candidate from our GSK collaboration programmes for chronic obstructive pulmonary disease, which is in an early stage of clinical trial. We also initiated research in the metabolic syndrome area few years back."

With Glenmark Pharma also embarking on a search for new chemical entities to combat diseases like diabetes, asthma, oncology and metabolic disorders, the writing on the wall is clear "" chronic diseases will be the new drivers for the market and the industry.

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CHRONIC FOCUS

Nicholas Piramal

Lead compound for cancer in Phase I

Rheumatoid arthritis drug in Phase II

Chronic fungal infection drug in Phase II

Preclinical candidates in Novel Drug Discovery System for diabetes

Ranbaxy

Pre-clinical Type 2 diabetes compound

Compound for dyslipidemia in clinical trial stage

Compound for chronic obstructive pulmonary disorder in clinical trial stage

Investigational New Drug application filed in 2005 for statin NCE (used to lower cholestrol levels), which was later licensed to PPD for clinical development and commercialization. PPD has now completed first-in-man studies, with further development in patients to continue

Dr Reddy's

Type 2 diabetes compound in Phase III

Dyslipidemia compound in Phase II

Diabetes compound in Phase I

Two cardiovascular disorder compounds, one in Phase I and the other in Phase II

Cancer compound in Phase I

Glenmark

Type 2 diabetes drug in Phase II

Molecule for asthma in Phase II

Torrent

Seven discovery projects in the pipeline, all of them in the chronic segment "" three in diabetes and related compilations, one in cerebrovascular, two in obesity and one in cardiovascular.