Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today its support of the Pharmaceutical Research Manufacturers of America's (PhRMA) "Code on Interactions with Healthcare Professionals, revised July 2008" (PhRMA Code). Adherence to the Code is voluntary for commercial biotechnology and pharmaceutical companies.
"As CTI prepares for the potential launch of pixantrone to treat patients with relapsed/refractory aggressive non-Hodgkin's lymphoma, we are committed to exchanging information with healthcare professionals in an ethical and responsible manner with the patient's best interests in mind," stated Craig W. Philips, President of CTI. "Our sales representatives will serve as an important resource for healthcare providers and we are focused on providing information about our therapies in a manner that consistently meets or exceeds PhRMA code guidelines."
The PhRMA Code provides guidance on interactions between U.S. healthcare professionals and biotechnology and pharmaceutical companies focusing on appropriate sales and marketing practices and training for company representatives.
The U.S. Food & Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) on February 10, 2010. Pixantrone is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
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