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) June 18, 2012
A.P. Pharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-33221 | 94-2875566 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. 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
N/A
(Former name or former address, if changed since last report)
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 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On June 18, 2012, the Board of Directors (the “Board”) of the A.P. Pharma, Inc. (the “Company”) increased the size of the Board from four to six and appointed Barry D. Quart and Stephen R. Davis to the Board. In connection with their appointments to the Board, each of Dr. Quart and Mr. Davis were granted an option to purchase an aggregate of 5,000,000 shares of Company common stock under the Company’s 2007 Equity Incentive Plan, which options are subject to vesting provisions and continued service during the vesting period.
Dr. Quart has been president, chief executive officer and a director of Ardea Biosciences, a biopharmaceutical company, since its founding in December 2006. Previously, he was with Pfizer (NYSE: PFE) as senior vice president, Pfizer Global Research and Development and the director of Pfizer’s La Jolla Laboratories, where he was responsible for approximately 1,000 employees and an annual budget of almost $300 million. Prior to Pfizer’s acquisition of the Warner-Lambert Company, Dr. Quart was president of research and development at Agouron Pharmaceuticals, Inc., a division of the Warner-Lambert Company. Dr. Quart had joined Agouron in 1993 and was instrumental in the development and registration of nelfinavir (Viracept®), which went from the lab bench to new drug application approval in 38 months. Dr. Quart received his Pharm.D. from University of California, San Francisco.
Mr. Davis has been executive vice president and chief operating officer of Ardea Biosciences since April 2010. Prior to joining Ardea, Mr. Davis served as president, chief executive officer and a director of Neurogen Corporation, which was acquired by Ligand Pharmaceuticals (NASDAQ: LGND) in December 2009. Prior to his appointment as chief executive officer of Neurogen, Mr. Davis served as its executive vice president and chief operating officer and in several other executive roles. While at Neurogen, Mr. Davis completed numerous collaborations with global pharmaceutical companies. Prior to Neurogen, Mr. Davis practiced as a corporate and securities attorney with Milbank, Tweed, Hadley & McCloy LLP. Previously, he practiced as a Certified Public Accountant with Arthur Andersen & Co. Mr. Davis received his B.S. in Accounting from Southern Nazarene University and his J.D. from Vanderbilt University.
| ITEM 8.01 | Other Events. |
On June 20, 2012, the Company announced that the Company will present patient-satisfaction data from its Phase 3 trial of APF530 at the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) International Symposium. The MASCC/ISOO 2012 International Symposium focuses on the clinical management of supportive care in oncology and will be held in New York City June 28 – 30. 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).
A copy of the press release announcing the presentation is attached hereto as Exhibit 99.1.
| ITEM 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Press Release, dated June 20, 2012 | |
SIGNATURE
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 22, 2012 | /s/ John B. Whelan | |
| John B. Whelan | ||
| President and Chief Executive Officer | ||
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press Release, dated June 20, 2012 | |
Exhibit 99.1
For Immediate Release
A.P. Pharma to Present APF530 Patient-Satisfaction Data from Phase 3 Study
– Poster at the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology International Symposium –
REDWOOD CITY, Calif. – June 20, 2012 – A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that the Company will present patient-satisfaction data from its Phase 3 trial of APF530 at the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) International Symposium. The MASCC/ISOO 2012 International Symposium focuses on the clinical management of supportive care in oncology and will be held in New York City June 28 – 30. 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).
Presentation details are as follows:
| Title: | Patient satisfaction with control of emesis following chemotherapy: comparison of APF530, a subcutaneous extended-release formulation of granisetron versus intravenous palonosetron | |
| Authors: | Rebecca Clark-Snow, Veena Charu, Nashat Gabrail, Ronald Yanagihara, Martin Rosenberg, Erin O’Boyle, John Barr | |
| Abstract No.: | 1109 | |
| Presentation: | June 29, 2012, Poster Session II |
The full abstract is available on the MASCC/ISOO 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
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| A.P. Pharma to Present APF530 Patient-Satisfaction Data from Phase 3 Study | Page 2 |
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 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.
Forward-looking Statements
This news release 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 capital resources and liquidity, timely development and regulatory approval of product candidates, satisfactory completion of clinical studies, progress in research and development programs, launch and acceptance of new products and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.
Contacts
Investor Relations Contact:
Michael Rice
Office Phone: 646-597-6979
Email: mrice@lifesciadvisors.com
and
Corporate Contact:
A.P. Pharma, Inc.
John B. Whelan, President and Chief Executive Officer
Office Phone: 650-366-2626
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