Ranbaxy Laboratories and PPD, Inc. have announced that PPD has acquired an exclusive worldwide license to develop, manufacture and market Ranbaxy's novel statin for the treatment of dyslipidemia.
The preclinical toxicology, drug metabolism and pharmacokinetic data suggest that the Ranbaxy statin has the potential to offer an improved safety profile over currently marketed statins. PPD plans to conduct additional preclinical studies and file an investigational new drug application with the U.S. Food and Drug Administration in April 2007.
Under the terms of the agreement, Ranbaxy will be entitled to receive milestone payments upon the occurrence of specified clinical events. In the event of approval to market a drug product, Ranbaxy 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. Ranbaxy has retained co-marketing rights to the compound in India.
"This is yet another milestone in Ranbaxy's evolution as a strong global research company," said Malvinder Singh, chief executive officer and managing director of Ranbaxy. "We are pleased to partner with PPD in taking this potential drug forward promising superior treatment for dyslipidemia and related areas."
In announcing the agreement, Fred Eshelman, chief executive officer of PPD, said, "The opportunity to develop and commercialize Ranbaxy's statin is a logical extension of our compound partnering program. It meets the rigorous requirements for our partnering strategy and further strengthens our metabolic franchise. We look forward to deploying our development expertise and resources to move this compound ahead."
Commenting on the success, Pradip Bhatnagar, vice president, New Drug Discovery Research, at Ranbaxy said, "This is the second compound from Ranbaxy's New Drug Discovery Research and we are glad to have achieved this milestone."
http://www.ppdi.com/ and http://www.ranbaxy.com/