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Posted by BooDog on :
 
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=UGFyZW50SUQ9MTY2NzYwfENoaWxkSUQ9L TF8VHlwZT0z&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=healthprofessi onal

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

AP Pharma Inc. (APPA)-OTC BB
0.62 Mar 22, 3:59PM EDT|

Key Statistics

Data provided by Capital IQ, except where noted.
Valuation Measures
Market Cap (intraday)5: 190.71M
Enterprise Value (Mar 25, 2013)3: 136.48M
Trailing P/E (ttm, intraday): N/A
Forward P/E (fye Dec 31, 2014)1: 12.48
PEG Ratio (5 yr expected)1: N/A
Price/Sales (ttm): N/A
Price/Book (mrq): 3.65
Enterprise Value/Revenue (ttm)3: NaN
Enterprise Value/EBITDA (ttm)6: -5.78

Share Statistics
Avg Vol (3 month)3: 1,625,430
Avg Vol (10 day)3: 2,457,000
Shares Outstanding5: 305.63M
Float: 143.22M
% Held by Insiders1: 88.98%
% Held by Institutions1: 9.10%
Shares Short (as of Mar 31, 2011)3: 267.98K
Short Ratio (as of Mar 31, 2011)3: 1.80
Short % of Float (as of Mar 31, 2011)3: 3.00%
Shares Short (prior month)3: 274.42K


PDUFA 27 March 2013
 
Posted by BooDog on :
 
CRL issued, tanked. Be about another year befor they'll be ready again. IF they get it together and to market and probably RS along the way.... if, if, if.
http://www.sec.gov/cgi-bin/browse-edgar?company=&match=&CIK=appa&filenum=&State= &Country=&SIC=&owner=exclude&Find=Find+Companies&action=getcompany

Keeping it on my list. Out for now but i'll be watching. May be a rough ride while they get things under control. The dilution will take away from the end game imo.

PROSPECTUS SUPPLEMENT NO. 4

A.P. PHARMA, INC.

240,000,011 shares of Common Stock

This prospectus supplement amends the prospectus dated April 2, 2012 (as supplemented on May 10, 2012, August 9, 2012 and November 5, 2012) to allow certain stockholders or their pledgees, donees, transferees, or other successors in interest (the “Selling Stockholders”), to sell, from time to time, up to 240,000,011 shares of our common stock (the “Common Stock”). The Common Stock covered by this prospectus consists of (i) 160,000,006 shares of Common Stock which were issued pursuant to a Securities Purchase Agreement we entered into on June 29, 2011 and (ii) 80,000,005 shares of Common Stock issuable upon exercise of warrants issued pursuant to the Securities Purchase Agreement (the “Warrants”).
--------------------------------------------
PROSPECTUS SUPPLEMENT NO. 4

A.P. PHARMA, INC.

69,600,669 shares of Common Stock

This prospectus supplement amends the prospectus dated April 2, 2012 (as supplemented on May 10, 2012, August 9, 2012 and November 5, 2012) to allow certain stockholders or their pledgees, donees, transferees, or other successors in interest (the “Selling Stockholders”), to sell, from time to time, up to 69,600,669 shares of our common stock (the “Common Stock”), all of which are issuable upon the conversion of our Senior Secured Convertible Notes due 2021 or the “Notes” (such underlying shares being referred to herein as the “Shares”). The number of shares registered in the Registration Statement is based upon the shares potentially issuable under the Notes at maturity in May 2021 (based on the initial outstanding principal balance of $1,500,000 and assuming all interest payments are made in-kind). We note that the actual number of Shares that may be issued under the Notes may be less, if the Notes are converted prior to maturity or if the Note holders elect to receive interest payments in cash.

We would not receive any proceeds from any such sale of these Shares.

This prospectus supplement is being filed to include the information set forth in the Current Report on Form 8-K filed on March 28, 2013, which is set forth below. This prospectus supplement should be read in conjunction with the prospectus dated April 2, 2012 and any supplements thereto, which are to be delivered with this prospectus supplement.

Our Common Stock is quoted on the OTC Bulletin Board under the symbol “APPA.OB”. On March 27, 2013, the last reported sale price per share of our Common Stock on the OTC Bulletin Board was $0.58. Our principal executive offices are located at 123 Saginaw Drive, Redwood City, California 94063, and our telephone number is (650) 366-2626.

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


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