By IANS
Mumbai : Nicholas Piramal Research and Development ltd (NRDL), which had recently signed a $100 million drug development and marketing agreement with US-based pharmaceutical major Eli Lilly, Tuesday announced the commencement of Phase I studies of an experimental drug for metabolic disorders.
NRDL, the de-merged research entity of Nicholas Piramal India ltd (NPIL), stated in its official communiqué that the clinical trial application (CTA) on the experimental drug P1201-07 has been submitted to the Central Committee on Research involving Human Subjects (CCMO), the regulatory authority of the Netherlands.
Another set of CTA studies has also been submitted to the Independent Ethics Committee of the foundation Evaluation Of Ethics in Biomedical Research (BEBO), Assen in the Netherlands.
The company in its release claimed that both the bodies had approved the CTA and given a green signal for the initiation of the Phase I study of P1201-07.
P1201-07 is a compound being developed for metabolic disorders. It is the fourth new drug to enter the clinic and the first from the research collaboration of NRDL and Eli Lilly.
As per the company’s projection, NRDL’s compensation, based on the pre-agreed formula, could total $110 million in call back payments and milestones, plus royalties on sales.
The deal also envisages that NRDL will collaborate on development and, in certain regions, commercialise a select group of Lilly’s pre-clinical drug candidates that span multiple therapeutic areas
Swati Piramal, director (Strategic Alliance and Communications) NPIL, said: “We in-licensed this molecule from Lilly only in January 2007, and it has gone to the clinic in just a year.”