-APF530 Has No Effect on Cardiac Repolarization-
-APF530 NDA Resubmission Targeted for Mid-2012-
Report is Available for Download at: www.lifesciadvisors.com/clients/ap
Yesterday morning, A.P. Pharma, Inc. (OTC BB: APPA.OB) issued three press releases reporting fourth quarter financial and full year 2011 results, a corporate update and positive thorough QT study results from a study of APF530. Also included in the news flow, was the appointment of a new Vice President of Pharmaceutical Development, Thomas Ottoboni, Ph.D.
The 5-HT3 Antagonist Class of Drugs Has Been Plagued Recently by QT Interval Prolongation Safety Concerns. The single biggest piece of news announced this morning by the Company was the positive results from the thorough QT (tQT) study of APF530. These results were highly anticipated by investors as QT prolongation has plagued the 5-HT3 antagonist class of drugs over the past couple of years.
On December 17, 2010, the FDA issued a note stating that “Anzemet causes a dose-dependent prolongation in the QT, PR, and QRS intervals on an ECG” and the injectable form should no longer be used for preventing chemotherapy-induced nausea and vomiting (CINV). Around this time, the quarter-over-quarter (4Q10/1Q11) units of Anzemet sold dropped off a cliff from 100,000 units sold to virtually zero units sold demonstrating how serious the risk of QT interval prolongation is. Additionally, on September 15, 2011, the FDA issued a drug safety communication announcing that “Zofran (ondansetron) may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.” Label changes for Zofran have already been requested by the FDA. Furthermore, the FDA is now requiring a tQT study for Zofran, which owns approximately a 30% share of the US market.
Positive APF530 tQT Study Results Give a Significant Marketing Advantage. Now that any QT prolongation concerns for APF530 have been extinguished and if the Zofran tQT results are negative, a significant market opportunity for preventing CINV could open up for APF530. Aloxi, the market leader in CINV, with a 50% share (2011 US sales = $425MM), is the only other CINV therapy with a demonstrated clean QT profile.