|Spectrum Pharma (NASDAQ:SPPI) update from the Rodman & Renshaw Health Conference|
|By BioMedReports Staff|
|Thursday, 10 September 2009 11:55|
Presenter Andrew Sandler, M.D., Chief Medical Officer of Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI), announced that the treatable population base for Zevalin is now over 66,000 due in part to the much less restrictive label which was issued by the FDA; as opposed to the more restrictive label which was issued for the drug in Europe.
Dr. Sandler also cleared up several misconceptions about the safety and toxicity of the drug. The numbers and efficacy data for the drug are quite impressive and the drug has been given a Top Level 1 Category status.
He also reports that the company has been contacted by the FDA and were told that the agency would like to remove the Bioscan requirement, which currently exists. This is a very positive development. SPPI officials and scientists have been working very closely with the government on reimbursement issues and they feel very confident about positive news coming about that in November. They are increasing sales and marketing efforts by hiring more staff and they find that the more they talk to and educate the medical community, the more the oncologists and doctors are willing to prescribe the treatment.
As far as Fusilev, the company has new estimated market growth figures that have them very excited, especially given the new potential dollar figures, which are expected to open up as a result of the pending FDA approval in October.
To sum it up, the company is very excited about the re-launch of the Zevalin sales strategy and they feel very good about their chances going in to October's Prescription Drug User Fee Act (PDUFA) date for Fusilev. Company reports no debt and a strong balance sheet. They are actively working to secure a marketing partner in Asia for their drugs.