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A.P. Pharma, Inc. (OTCBB:APPA.OB) is a specialty pharmaceutical

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Statement of Changes in Beneficial Ownership (4) Edgar (US Regulatory) - 5/23/2019 8:40:33 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 5/21/2019 9:16:32 AM
Heron Therapeutics Announces Publication of Results from Phase 3 EPOCH 1 Study of HTX-011 in Patients Undergoing Bunionectomy PR Newswire (US) - 5/21/2019 9:13:00 AM
Statement of Changes in Beneficial Ownership (4) Edgar (US Regulatory) - 5/16/2019 8:45:48 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 5/14/2019 8:36:20 AM
Heron Therapeutics Presents New Results from Real-world Study Showing 95% of Postoperative Patients Remain Opioid-Free when H... PR Newswire (US) - 5/14/2019 8:30:00 AM
Quarterly Report (10-q) Edgar (US Regulatory) - 5/9/2019 8:45:52 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 5/9/2019 8:40:44 AM
Heron Therapeutics Announces Financial Results for the Three Months Ended March 31, 2019 and Highlights Recent Corporate Prog... PR Newswire (US) - 5/9/2019 8:30:00 AM
Heron Therapeutics to Present at the Bank of America Merrill Lynch 2019 Healthcare Conference PR Newswire (US) - 5/8/2019 4:05:00 PM
Heron Therapeutics Partners with the National Academy of Medicine to Counter the Opioid Epidemic in the United States PR Newswire (US) - 5/7/2019 4:05:00 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 5/1/2019 8:08:05 AM
Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain PR Newswire (US) - 5/1/2019 8:00:00 AM
Additional Proxy Soliciting Materials (definitive) (defa14a) Edgar (US Regulatory) - 4/26/2019 4:58:18 PM
Proxy Statement (definitive) (def 14a) Edgar (US Regulatory) - 4/26/2019 4:54:10 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 4/1/2019 8:37:13 AM
Heron Announces European Medicines Agency Validation of Marketing Authorisation Application for HTX-011 for Postoperative Pai... PR Newswire (US) - 4/1/2019 8:30:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 3/11/2019 8:40:24 AM
77% of Patients Remain Opioid-Free When HTX-011 Is Given with an Over-the-Counter Analgesic Regimen in New Multi-center Posto... PR Newswire (US) - 3/11/2019 8:30:00 AM
Heron Therapeutics to Present at the 39th Annual Cowen Healthcare Conference PR Newswire (US) - 3/4/2019 4:05:00 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 2/26/2019 4:13:24 PM
Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for IV Push PR Newswire (US) - 2/26/2019 4:05:00 PM
Annual Report (10-k) Edgar (US Regulatory) - 2/22/2019 8:50:10 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 2/22/2019 8:42:05 AM
Heron Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2018 and Recent Corporate P... PR Newswire (US) - 2/22/2019 8:30:00 AM
BooDog   Thursday, 03/07/13 06:24:57 AM
Re: None
Post # of 5890 
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



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