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Expert Financial Analysis and Reporting

A.P. Pharma: Ondansetron’s Link to QT Interval Prolongation is a Huge Positive for APF530

The FDA issued a safety communication on June 29, 2012 further advising physicians on the link of ondansetron (Zofran) to QT interval prolongation; this condition can cause abnormal heart rhythms that  in some cases may be life threatening. This follows a previous communication on the same concern on September 11, 2011. Because AP Pharma’s competitive product in development, APF530, is not linked to QT interval prolongation, this gives APF530 a meaningful differentiation from ondansetron in terms of safety. In addition, ondansetron can no longer be given as a single 32 mg infusion and will have to given as three infusions spaced over twelve hours. Some contacts I have spoken with think that this will lead to substantial erosion of ondansetron sales. This could be a huge positive for A.P. Pharma as ondansetron currently accounts for 33% of the market. Please refer to my report for more details.

 

A.P. Pharma has been one of the best performing stocks in biotechnology so far this year. Since I published my initiation report on April 25, 2012 in which I recommended purchase, the stock has increased from $0.42 to $0.68 per share, an increase of 60%. This did not result from any single new catalytic event, but rather widening investor awareness of and excitement about the potential of the company’s lead drug APF530 for chemotherapy induced nausea and vomiting or CINV.


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