Business Daily from THE HINDU group of publications Friday, Mar 02, 2007 ePaper |
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PPD, the US-based contract research organisation, will conduct additional pre-clinical studies and file an investigational new drug application with the US Food and Drug Administration in April. Ranbaxy claims that early pre-clinical studies of the second compound from Ranbaxy's New Drug Discovery Research division have suggested that the statin offers improved safety profile over currently marketed statins. Under the terms of the license agreement, Ranbaxy will receive `milestone payments' when specified clinical events occur, and will also receive royalties on sales, when and if the drug gets marketing approval. The company will also have co-marketing rights for India. PPD will bear all costs and expenses of the development, including pre-clinical and clinical studies, and commercialisation of the drug. "We are pleased to partner with PPD in taking this potential drug forward promising superior treatment for dyslipidemia and related areas," said Mr Malvinder Singh, CEO and MD, Ranbaxy, in an official statement.
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