UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 31, 2012
A.P. PHARMA, INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-33221 | 94-2875566 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 123 Saginaw Drive Redwood City, CA |
94063 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (650) 366-2626
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events.
On May 31, 2012, A.P. Pharma, Inc. announced that an abstract analyzing a subset of efficacy results from its Phase 3 trial of APF530 has been published in conjunction with the American Society of Clinical Oncology’s (ASCO) 2012 Annual Meeting.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Document Description | |
| 99.1 | Press Release issued on May 31, 2012 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| A.P. PHARMA, INC. | ||||||
| Date: June 4, 2012 | By: | /s/ John B. Whelan | ||||
| John B. Whelan | ||||||
| President and Chief Executive Officer | ||||||
Exhibit 99.1
For Immediate Release
A.P. Pharma Announces Study Finding Continuous Exposure to a
5-HT3 Antagonist Using APF530 Provides Better Emetic Control
– Phase 3 Data Abstract Accepted by American Society of Clinical Oncology for
Publication at Annual Meeting –
REDWOOD CITY, Calif. – May 31, 2012 – A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that an abstract analyzing a subset of efficacy results from its Phase 3 trial of APF530 has been published in conjunction with the American Society of Clinical Oncology’s (ASCO) 2012 Annual Meeting. APF530 is the Company’s lead product candidate being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). The abstract concludes that continuous exposure to a 5-HT3 receptor antagonist, through the administration of an extended-release formulation such as APF530, results in better emetic (nausea and vomiting) control than administration of a standard, short-acting 5-HT3 receptor antagonist. The title of the abstract is:
The effect of continuous exposure to serotonin receptor antagonism on delayed emesis: An analysis of 1,535 patients in two randomized clinical trials with granisetron (G), APF530, and palonosetron (palo).
Abstract No.: e19635
Authors: Harry Raftopoulos, Erin O’Boyle, Richard J. Gralla, Martin Rosenberg, John Barr
The full abstract is available on the ASCO website, here.
About APF530
A.P. Pharma’s lead product, APF530, is in development for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in the Company’s proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Intravenous and oral formulations containing granisetron are approved for the prevention of acute-onset CINV, but not delayed-onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s primary focus is on its lead product, APF530, for the prevention of CINV. A.P. Pharma received a Complete Response Letter on the APF530 NDA and is targeting the resubmission of the NDA in mid-2012. The Company has additional research and
- more -
| A.P. Pharma Announces Study Finding Continuous Exposure to a 5-HT3 Anatagonist Using APF530 Provides Better Emetic Control |
Page 2 |
development programs that utilize its bioerodible, injectable and implantable delivery systems. For further information, please visit the Company’s web site at www.appharma.com.
Contacts
Investor Relations Contact:
Michael Rice
Office Phone: 646-597-6979
Mobile Phone: 917-282-3242
Email: mrice@lifesciadvisors.com
and
Corporate Contact:
A.P. Pharma, Inc.
John B. Whelan, President, Chief Executive Officer and Chief Financial Officer
Office Phone: 650-366-2626
###