Committee Memo - Assignment Example

John Carlisle, President Cc: Richard Bartocelli, Vice President, Department of Research and Development Chair of New Product CommitteeDate: October 24, 2012Subject: Status of Lexivia ProjectThis is to update you regarding the latest status of Lexivia project. In the last monthly meeting, held on October 3, two major facts came to light that might delay the project.William Song, our outside patent attorney had informed that the drug composition of Lexivia and its potential use as heart medication was revealed in an article written by one of the company’s scientists in Journal of Experimental Pharmacology in April 2009 issue.

Article was written before patent application was filed. The issue needs to be investigated thoroughly by law firm as it could invalidate the patent right on Lexivia. The law firm has not given any definite timeframe for completion of the investigation which could delay the project indefinitely.In the second instance, Clinical Project Manager, in charge of FDA application says that as per FDA’s enquiry in the late August meeting that she had with FDA, Lexivia could be approved only as intervention for heart patients who are at very high risk.

This could be a big setback as only 20% of patients undergoing heart surgery come under the category of very high risk patients. This would significantly reduce the market potential. Clinical Project Manager feels that further clinical research is needed for Lexivia to ensure that its approval from FDA is expanded to include larger database of heart patients. But, clinical research is expensive and time consuming that could significantly delay the launch of the drug. In case of further enquiry, please contact Mr Bartocelli or myself.Thank you