Nicholas Piramal India is likely to license in the new anti-arthritis molecule invented by the UK-based Kennedy Institute of Rheumatology. The company is currently in the advanced stages of negotiations with the Institute to buy the development and marketing rights of the molecule.
The molecule is a recombinant protein designed to block TNF alpha (tumour necrosis factor alpha) produced by the white blood cells, a key factor for the cause of rheumatoid arthritis. The molecule has already been patented by the institute.
"The entire chain of clinical research of the molecule including the preclinical studies and clinical trials will be done by Nicholas Piramal. We are hoping to finish the pre-clinical studies within the next 18-24 months. The molecule is anticipated to enter the market within the next 5-7 years," said Dr. Somesh Sharma, Chief Scientific Officer, Nicholas Piramal India Ltd (NPIL). The pre-clinical studies will be done overseas, said Dr. Sharma. The research is expected to cost the company $ 10-15 million.
The fact that the scientist who was responsible to prove the retardation of arthritis after the administration of TNF alpha-blockers, Dr. Ravinder Maini, is on the scientific advisory board of NPIL, will be advantageous to it. Dr. Maini is currently the head of Kennedy Institute of Rheumatology.
The company is also developing a pharmaceutical pill against rheumatoid arthritis, based on the principle of TNF alpha-blocker.
"Existing TNF-alpha blockers are injectable monoclonal anti-bodies. NPIL, for the first time is trying to develop a blocker in the form of a pill," he said. The molecule is expected to enter toxicology studies in the next 9-12 months.
Embrel (Amgen), Remicade (J&J) and Humira (Abott) are today's widely used injectibles in Rheumatoid Arthritis.
"The current treatment cost with existing drugs is $10-15,000 per year. Our aim is to make it more affordable," said Dr Sharma.
NPIL is emerging as a major player in the field of basic research in India. It is already among the top five companies in the country in terms of turnover.
The company invested Rs 56 crore in financial year 2003-'04 on R&D, which was 4.32 per cent of its total sales of Rs 1,293.38 crore for the year. It had an R&D expenditure of Rs 18.50 crore, the year ago.
For the first quarter ended June 30, 2004, NPIL had invested Rs 9.36 crore in R&D.
NPIL will be shifting its entire research team to its new R&D centre in Goregaon, Mumbai on August 15. The facility has infrastructure to conduct research on pharma, biotech and herbal under a single roof. The company has invested over Rs 100 crore over this facility.