Nicholas Piramal''s new drug IND-P276 approved by US FDA

25 Jul 2007

Nicholas Piramal India Limited has announced that the US FDA has approved its investigational new drug (IND) application of its lead cancer compound P 276-00 to treat multiple myeloma (MM), a deadly form of blood cancer. It is the first IND from India for a NCE cancer drug approved by the US FDA.

Multiple myeloma is the second most common haematologic malignancy, and is responsible for at least two per cent of cancer-related deaths. MM remains an incurable disease for most patients, with a median survival of four to five years. High-dose chemotherapy followed by transplantation has resulted in improvement in response rates and survival compared with conventional therapy, but relapse is nearly universal and not all patients are candidates for this option of aggressive treatment.

It is estimated that there would be 16,570 new cases of MM diagnosed in the US and 11,310 deaths attributed to this disease in 2006.More than 20,000 cases of MM are detected every year in India. Despite the availability of novel agents, MM remains incurable and most patients die from disease progression. P 276-00 is a new chemical entity that blocks pathways necessary for cancer cell growth and survival.

Dr Kenneth Anderson, a world-renowned authority in multiple myeloma, will coordinate the clinical studies. The principal investigator of the trial will be Dr. Noopur Raje, MD, at the Dana Farber - Massachusetts General Hospital. Dr. Noopur Raje is part of the Jerome Lipper Cancer centre at the Dana-Farber Cancer Institute. Two additional sites, St. Vincent''s Hospital, New York and Emory University Medical Center in Atlanta will also participate in this study.

Recently former prime minister Chandrasekhar had succumbed to this devastating type of cancer.

Dr. Swati Piramal, director, strategic alliances and communications, NPIL, said, "It is a proud moment for Indian research and an important milestone because a drug discovered in Mumbai India, with global patents is now approved for Clinical studies in world- renowned cancer hospitals in the USA. It is a testament to the world-class quality of the regulatory dossiers and preclinial studies which were completed entirely by the Indian scientific team. It also shows NPIL is delivering on the investments being made in research."