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Pharma Product Lifecycle Considerations 43 APF530 covered by multiple patents 2 patents covering combination of polymer, excipients and drug expire in 2021 3 patents covering APF530 expire in 2024 Polymer based injectable products are difficult to copy independent of IP ANDA FDA requirements for injectable products Must have same inactive ingredients in the same concentration as the reference listed drug Polymers are complex mixtures of varying length molecules, making characterization for sameness very challenging January 2013 2013.
No single intravenous dose of ondansetron should exceed 16 mg due to the risk of QT prolongation. The lower dose intravenous regimen of 0.15 mg/kg every 4 hours for three doses may be used in adults with chemotherapy induced nausea and vomiting. Results of Zofran tQT study 32 mg IV dose causes 20 ms increase in QTcF 8 mg IV dose causes 6 ms increase in QTcF FDA removed 32 mg dose from market December 4, 2012 Impact on sales may be significant 22 January 2013 2013.
Acute Delayed APF530 10mg Safety Summary 1 APF530 5 mg dose studied in separate arm of the phase 3 study; one pulmonary embolism in morbidly obese patient on day 16 (0.2%); one dyspepsia event (0.2%) 2 90% of injection site reactions were reported as mild; one patient discontinued due to injection site reaction Reported in Cycle 1 12 January 2013 2013.
Pharma has the potential to leverage its Biochronomer drug delivery technology into other opportunities Branded market estimate using 2011 units based on Wolters Kluwer and Aloxi ASP Important APF530 Milestones Milestone Timing Status Successful End of Review Meetings with FDA 1Q 2011 Successful Completion of Thorough QT and Metabolism Studies 1Q 2012 Completed $53.6MM PIPE Financing 3Q 2012 Successful Completion of Human Factors Validation Study 3Q 2012 Successful Completion of CMC Activities 3Q 2012 Resubmitted NDA Sept 2012 Key Commercial Organization Hires 4Q 2012 FDA PDUFA Action Date March 27, 2013 Target Product Launch 2H 2013 * Indicates expected milestone timing 6 January 2013 2013.
Company Overview OTCBB: APPA January 2013 Exhibit 99.1 Legal Disclaimer This presentation contains forward looking statements as defined by the Private Securities Litigation Reform Act of 1995. These forward looking statements involve risks and uncertainties, including uncertainties associated with timely development, approval, launch and acceptance of new products, satisfactory completion of clinical studies, establishment of new corporate alliances, progress in research and development programs and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission.