PPD to develop Ranbaxy's statin

MUMBAI: PPD Inc. has acquired an exclusive worldwide license to develop, manufacture and market the Ranbaxy Laboratories Ltd 's statin for the treatment of dyslipidemia.

The preclinical toxicology, drug metabolism and pharmacokinetic data suggest that Ranbaxy’s statin has the potential to offer an improved safety profile over currently marketed statins, Ranbaxy said in a statement.

PPD plans to conduct additional preclinical studies and file an investigational new drug application with the US Food and Drug Administration in April 2007.

Under the terms of the agreement, Ranbaxy will receive milestone payments upon the occurrence of specified clinical events. In the event of approval to market a drug product, it will be entitled to receive royalties on sales of the drug and sales-based milestones.

PPD will be responsible for all costs and expenses associated with the development and commercialization of the compound, including preclinical and clinical studies. The Ranbaxy has retained co-marketing rights to the compound in India.

Malvinder Singh, chief executive officer and managing director of Ranbaxy said the agreement is a milestone in the firm’s evolution as a strong global research company.

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