Heron Therapeutics Inc. (HRTX)

[BooDog]

A.P. Pharma, Inc. (OTCBB:APPA.OB) is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks. The Company's lead product, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. The U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of the New Drug Application (NDA) for APF530, and has set a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013.



A.P. Pharma Highlights

-Lead product candidate, APF530, is long-acting, injectable product for chemotherapy-induced nausea and vomiting (CINV)

-Incorporates widely used 5-HT3 antagonist - granisetron (Kytril®)

-5-day delivery profile

-Reduces both acute- and delayed-onset CINV with single injection

-Patent coverage into 2024

-APF530 shown to be non-inferior to market leader Aloxi®

-1,341-patient, randomized, controlled, Phase 3 study
-FDA PDUFA Action Date of March 27, 2013

-Resubmitted NDA for APF530 in September 2012

-Addressed issues raised in Complete Response Letter

-Product launch planned for 2H 2013

-APF530 targets a $900 million market opportunity in US alone

-Recent competitive setbacks could enhance commercial uptake

-Could be second, long-acting, injectable product on market

-A.P. Pharma has the potential to leverage its Biochronomer™ drug delivery technology into other opportunities

-One of the largest, randomized, controlled clinical studies conducted in the CINV setting

Taken from their Jan 7, 2013 Presentation
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MTY2NzYwfENoaWxkSUQ9LTF8VHlwZT0z&t=1



Summary of APF530 Phase 3 Results
-Bioerodible polymer technology releases granisetron to prevent CINV over 5 days
-Non-inferiority to Aloxi was demonstrated at 10 mg
-For both acute- and delayed-onset CINV
-With both moderately and highly emetogenic chemotherapy
-APF530 was well-tolerated
-Incidence of adverse events comparable to Aloxi
-Good response rates were observed in difficult chemotherapy regimens
-Efficacy was maintained through multiple cycles of chemotherapy


National Cancer Institute

Phase III Randomized Study of APF530 Versus Palonosetron Hydrochloride in Combination With Dexamethasone For Prophylaxis of Acute- and Delayed-Onset, Chemotherapy-Induced Nausea and Vomiting in Cancer Patients Undergoing Moderately or Highly Emetogenic Chemotherapy
http://cancer.gov/clinicaltrials/search/view?cdrid=489413&version=healthprofessional

SEC filings on Edgar
http://www.sec.gov/cgi-bin/browse-edgar?company=&match=&CIK=appa&filenum=&State=&Country=&SIC=&owner=include&Find=Find+Companies&action=getcompany



Appendix A - PDUFA III Information Technology Five-Year Plan
Prescription Drug User Fee Act (PDUFA) III
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm173817.htm