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HRTX under $3
HRTX under $3
HRTX bearish 13.525
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HRTX bullish 19.34
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http://www.appharma.com/
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http://lifesciadvisors.com/clients/
MANAGEMENT TEAM / BOD
Kevin Tang
Chairman
Kevin Tang has served as a member of our board of directors since February 2009 and as chairman since July 2012 Mr. Tang is the Managing Director of Tang Capital Management, LLC, a life sciences-focused investment company he founded in 2002. Tang Capital Management holds a significant ownership position in A.P. Pharma's common stock. From 1993 to 2001, Mr. Tang held various positions at Deutsche Banc Alex. Brown, Inc., an investment banking firm, most recently serving as Managing Director and head of the firm's Life Sciences research group. He currently serves as a director of Ardea Biosciences, Inc. and Penwest Pharmaceuticals, as well as two private companies, RadPharm, Inc., and Prospect Therapeutics, Inc. Mr. Tang received a BS degree from Duke University.
Barry D. Quart, Pharm.D.
Chief Executive Officer and Director
Barry D. Quart, Pharm.D. joined A.P. Pharma in May 2013 as Chief Executive Officer and has served as a member of our board of directors since June 2012. Dr. Quart was most recently President and Chief Executive Officer of Ardea Biosciences, Inc., a biopharmaceutical company, since its founding in December 2006. Ardea was acquired by AstraZeneca PLC for $1.26 billion in June 2012. Previously, he was with Pfizer 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. Agouron was acquired by Warner-Lambert for $2.1 billion in 1999. Dr. Quart joined Agouron in 1993 and was instrumental in the development and registration of Viracept, which went from the lab bench to new drug application approval in 38 months. Dr. Quart received his Pharm.D. degree from University of California, San Francisco.
Robert Rosen
President and Director
Robert Rosen joined A.P. Pharma as Senior Vice President and Chief Commercial Officer in October 2012 and was appointed to President in May 2013. Mr. Rosen has also served as a member of our board of directors since July 2012. Prior to joining A.P, Pharma, he served as global head of oncology at Bayer HealthCare, where he was responsible for the development of the global oncology business unit for regions that included the Americas, Europe, Japan, and Asia Pacific from 2005 to 2011. During his tenure at Bayer Healthcare, he led the launch of Nexavar for the treatment of renal cell carcinoma and hepatocellular carcinoma. Nexavar’s worldwide sales in 2011 were $1.0 billion. He also led premarket activities for Stivarga for gastrointestinal stromal tumors and colon cancer and alpharadin for prostate cancer. From 2002 to 2005, Mr. Rosen was vice president of the oncology business unit at Sanofi-Synthèlabo, where he was responsible for the development of Sanofi’s U.S. oncology business and the launch of Eloxatin for colon cancer. Eloxatin U.S. sales in 2005, its third full year on the market, were $1.1 billion, ranking it among the industry’s most successful oncology drug launches. Mr. Rosen received a Bachelor of Science degree in Pharmacy from Northeastern University.
Stephen R. Davis
Executive VP, Chief Operating Officer and Director
Stephen R. Davis joined A.P. Pharma as Executive Vice President and Chief Operating Officer in May 2013 and has served as a member of our board of directors since June 2012. Mr. Davis was most recently Executive Vice President and Chief Operating Officer at Ardea Biosciences, Inc. He has completed numerous strategic transactions between biotechnology and pharmaceutical companies, including the recent $1.26 billion acquisition of Ardea by AstraZeneca PLC. Prior to Ardea, Mr. Davis served as President and Chief Executive Officer of Neurogen Corporation, a biopharmaceutical company acquired by Ligand Pharmaceuticals. Before becoming Neurogen’s Chief Executive Officer, Mr. Davis served in numerous executive roles at Neurogen completing multiple collaboration and asset acquisition and sale transactions with global pharmaceutical companies. Previously, Mr. Davis practiced as a corporate and securities attorney with a Wall Street law firm and as a Certified Public Accountant with a major accounting firm. Mr. Davis received his Bachelor of Science degree in Accounting from Southern Nazarene University and a J.D. from Vanderbilt University.
Mark S. Gelder, M.D.
Senior VP, Chief Medical Officer
Mark S. Gelder, M.D. joined A.P. Pharma as Senior Vice President and Chief Medical Officer in December 2012. Dr. Gelder, most recently, was the vice president and global head of medical affairs and pharmacovigilance at GE Healthcare Medical Diagnostics. During his tenure, he led the global medical affairs strategy, including preparation and execution of medical launch plans. He was also responsible for global Phase IV and other post-approval commitment studies. Prior to GE Healthcare, Dr. Gelder was the vice president, global medical affairs oncology for Bayer Healthcare Pharmaceuticals, and was responsible for the global medical strategy supporting the launch of Nexavar®, Stivarga®, and Alpharadin® global launch programs. Dr. Gelder was also the global therapeutic area director of oncology at Wyeth, with a focus on the commercial launch of Torisel®. Earlier in his career, Dr. Gelder held roles of increasing responsibility at Pfizer, working on Sutent®, and was also a practicing gynecologic oncologist in both the academic and private sectors. Dr. Gelder received a bachelor’s of science degree from Colgate University, and his doctor of medicine from the University of Virginia’s School of Medicine.
Jesse Hollingsworth
VP, Sales
Jesse Hollingsworth joined A.P. Pharma as Vice President of Sales in February 2013. Most recently, Mr. Hollingsworth served as the Senior Director of Group Purchasing Organizations (GPO) and Trade Strategy at Dendreon where he developed and implemented the company’s national GPO strategy. During this time, he was also responsible for building and managing relationships with top community oncologists for the company. Prior to his work at Dendreon, Mr. Hollingsworth was the Senior Director of Strategic Business Development and Marketing at ION Solutions, an Amerisource Bergen Specialty Group where he focused on GPO, payer and practice solutions. Earlier, he worked at Amgen, Inc., where, as the Marketing Director for the oncology business unit, Mr. Hollingsworth was responsible for US reimbursement and access programs for the Neulasta®, Neupogen® and Vectibix® franchises. Mr. Hollingsworth received a Bachelor of Science degree in Journalism and Communications from the University of Florida and a Master of Health Administration from the University of South Florida.
Daniel Martin
VP, Marketing
Daniel Martin joined A.P. Pharma as Vice President of Marketing in December 2012. Mr. Martin brings 14 years of diverse health care industry experience and nearly nine years of oncology marketing experience to A.P. Pharma. Most recently he was the head of US marketing at Dendreon, reporting to the executive vice president and chief commercial officer. Prior to joining Dendreon, Mr. Martin spent 7 years in positions of increasing responsibility within Amgen's Oncology Business Unit. Mr. Martin worked on Amgen’s Aranesp® and Neulasta® franchises and then led the launch of XGEVA® into both oncology and urology. Prior to these roles, Mr. Martin led strategic planning and operations for Amgen’s oncology GPO team. Prior to Amgen, Mr. Martin worked as a management consultant with Deloitte Consulting where he specialized in pharmaceutical marketing and commercial operations. Mr. Martin holds a bachelor's of arts in economics and biology from the University of Virginia and received his master’s in business administration from the University of Pennsylvania’s Wharton School of Business.
Thomas Ottoboni, Ph.D.
VP, Pharmaceutical Development
Thomas Ottoboni, Ph.D. joined A.P. Pharma as Vice President of Pharmaceutical Development in March 2012. Prior to joining us, Dr. Ottoboni was Vice President of Research and Development at Talima Therapeutics, where he worked on the development of a drug delivery implant to treat onychomycosis. Dr. Ottoboni has also served as Executive Vice President of Strategy and Operations at Point Biomedical, where he developed several imaging and drug delivery systems. Previously, Dr. Ottoboni served as Manager of Systems Development and Drug Delivery Research for InSite Vision, where he developed ophthalmic pharmaceutical delivery systems and also served as Director of Drug Delivery at Vitaphore. Dr. Ottoboni is an inventor on more than 19 US patents in organic and macromolecular chemistry and received a B.S. degree in Chemistry as well as a Ph.D. in Organic Chemistry from the University of California, Berkeley.
Thomas Pitler, Ph.D.
VP, Business Development
Thomas Pitler, Ph.D. joined A.P. Pharma as Vice President of Business Development in September 2012. Most recently, Dr. Pitler was vice president of business development at Chimerix, where he was responsible for the company’s interactions with potential partners, leading the due diligence and negotiations process around the licensing of clinical stage programs, preclinical assets and underlying technology. Earlier, Dr. Pitler held the position of senior vice president, chief business and financial officer at Neurogen, Inc. (acquired by Ligand Pharmaceuticals). At Neurogen, Dr. Pitler established research and development collaborations with pharmaceuticals companies, including Merck and Aventis. Dr. Pitler was also a Research Assistant Professor at the University of Maryland School of Medicine and has held other academic positions. He received a B.A. in Biology and a Ph.D. in Physiology from Wake Forest University.
Joel Schaedler
VP, Market Access
Joel Schaedler joined A.P. Pharma as Vice President of Market Access in December 2012. Mr. Schaedler brings over 17 years of specialty pharmaceutical and healthcare distributor experience to A.P. Pharma. Most recently, he was the senior vice president of business development at P4 Healthcare, which was acquired by Cardinal Health in 2010. Prior to his tenure at Cardinal Health, Mr. Schaedler was the regional vice president of sales for Bionicare Medical Technologies where he focused on the development of marketing strategies, physician targeting and creation of operational efficiencies. He has also held positions of increasing responsibilities with Amerisource Bergen Specialty, Centocor (acquired by Johnson & Johnson) and Sanofi-Aventis. Mr. Schaedler has a bachelor's of arts degree in business administration from Kent State University in Kent, Ohio.
A.P. Pharma’s pivotal Phase 3 clinical trial, initiated in May 2006, was a multicenter, randomized, observer-blind, actively-controlled, double-dummy, parallel group study that compared the efficacy of APF530 with palonosetron. The trial stratified patients into two groups, one receiving moderately and the other receiving highly emetogenic chemotherapeutic agents in accordance with the Hesketh algorithm, which assigns emetogenic levels based on the chemotherapy agent, drug dosage and combinations employed. In each group, the patients were randomized to receive in the first chemotherapy treatment cycle either APF530 high dose (10 mg granisetron), APF530 low dose (5 mg granisetron) or the currently approved dose of palonosetron. In subsequent treatment cycles (up to three additional cycles), patients who received palonosetron were re-randomized to either of the two APF530 doses.
During 2006 and the first half of 2007, all patient enrollments were within the U.S. Beginning in the second half of 2007, enrollments were broadened to include sites in India and Poland. A.P. Pharma’s pivotal Phase 3 study, comparing the efficacy of APF530 with palonosetron, completed patient enrollment of 1,395 patients in June 2008, and the Company announced top-line results on September 30, 2008.
The goals of the trial were to demonstrate the safety and efficacy of APF530 in the treatment of CINV following the administration of highly or moderately emetogenic chemotherapy, and to establish an effective dose for APF530. In the trial, 5 mg and 10 mg doses of granisetron were evaluated, and based on the results, the 10 mg dose appears to provide greater efficacy with a side effect profile similar to the 5 mg dose. As such, the APF530 10 mg dose is the proposed therapeutic dose included in the NDA. The NDA was submitted under section 505(b)(2) of the FDCA, whereby A.P. Pharma can rely on the significant clinical data for safety and efficacy of APF530’s active ingredient, granisetron.
The trial was structured to compare the two APF530 doses with palonosetron in four different primary efficacy endpoints, non-inferiority to palonosetron for the prevention of acute and delayed CINV in patients receiving moderately emetogenic chemotherapies, and non-inferiority and superiority to palonosetron for the prevention of acute and delayed CINV, respectively, in patients receiving highly emetogenic chemotherapies. Palonosetron is not FDA approved for the prevention of delayed-onset CINV in patients receiving highly emetogenic chemotherapies; therefore, APF530 needed to be deemed superior to palonosetron for this endpoint to obtain a corresponding label claim. The 10 mg dose of APF530 achieved complete response (CR) rates that were numerically higher than palonosetron across all four assessments. These results achieved non-inferiority to palonosetron for all four assessments, but did not achieve the superiority endpoint for the highly emetogenic delayed-onset assessment. CR was defined as the absence of emetic episodes or use of antiemetic rescue medications during a specified period of time. The time periods studied for CINV onset were acute (0 to 24 hours after chemotherapy) and delayed (24 to 120 hours after chemotherapy).
The results summarized below are the primary endpoints from the study, with such data being drawn from the first cycle of treatment:
APF530 was generally well tolerated, with a side effect profile consistent with previous human use of granisetron and only one serious adverse event reported as possibly attributed to APF530.
Additional data provided herein includes predetermined secondary efficacy endpoints and safety data that were not available at the time the top-line data were released. Review of the clinical data package demonstrates the robustness of the APF530 clinical response within and across chemotherapy cycles. In patients receiving multiple cycles of APF530, CR rates were observed over four cycles of chemotherapy. The data summarized below supports the continued benefits of APF530 over multiple cycles:
Post-hoc analysis of Phase 3 data by chemotherapy regimen showed good response rates for different regimens.
REDWOOD CITY, Calif.--(BUSINESS WIRE)--May. 2, 2013-- A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that its Board of Directors has appointed a new management team to lead the Company. Effective today, Barry D. Quart, Pharm.D. will join the Company as Chief Executive Officer, Robert Rosen, who joined A.P. Pharma in October 2012 as Senior Vice President and Chief Commercial Officer, will be promoted to the role of President, and Steve Davis will join the Company as Executive Vice President and Chief Operating Officer. Each executive joined A.P. Pharma's Board of Directors in 2012 and will continue to serve as directors.
"We are very excited to assemble a team with such extensive industry experience and impressive track records to maximize the value of A.P. Pharma's lead drug candidate, APF530, and capitalize on the Company's BiochronomerTM drug delivery platform," said Kevin C. Tang, Chairman of the A.P. Pharma Board of Directors. "Barry was instrumental in building two biopharmaceutical companies, Ardea Biosciences and Agouron Pharmaceuticals, that were acquired by major pharmaceutical companies for more than $1 billion each. Rob brings deep experience in the commercialization of oncology drugs and was responsible for the launch of two products, Nexavar and Eloxatin, that each achieved sales of more than $1 billion only a few years following market introduction. Steve most recently was the chief architect in the transaction resulting in the sale of Ardea Biosciences to AstraZeneca for more than $1 billion."
"I would also like to extend my thanks to John Whelan and Michael Adam, Ph.D., each of whom made valuable contributions to A.P. Pharma and will be stepping down from their current positions," continued Mr. Tang.
"I am very excited to join A.P. Pharma and to work with the stellar management team the Company has assembled. APF530 and the Biochronomer drug delivery technology, which has the potential to be used for a broad range of drugs, provide a solid platform for building a successful company," said Dr. Quart.
Dr. Quart was most recently President and Chief Executive Officer of Ardea Biosciences, Inc., a biopharmaceutical company, since its founding in December 2006. Ardea was acquired by AstraZeneca PLC for $1.26 billion in June 2012. Previously, he was with Pfizer 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. Agouron was acquired by Warner-Lambert for $2.1 billion in 1999. Dr. Quart joined Agouron in 1993 and was instrumental in the development and registration of Viracept, which went from the lab bench to new drug application approval in 38 months. Dr. Quart received his Pharm.D. degree from University of California, San Francisco.
Prior to joining A.P. Pharma as Senior Vice President and Chief Commercial Officer, Mr. Rosen served as global head of oncology at Bayer HealthCare, where he was responsible for the development of the global oncology business unit for regions that included the Americas, Europe, Japan, and Asia Pacific from 2005 to 2011. During his tenure at Bayer Healthcare, he led the launch of Nexavar for the treatment of renal cell carcinoma and hepatocellular carcinoma. Nexavar's worldwide sales in 2011 were $1.0 billion. He also led premarket activities for Stivarga for gastrointestinal stromal tumors and colon cancer and alpharadin for prostate cancer. From 2002 to 2005, Mr. Rosen was vice president of the oncology business unit at Sanofi-Synthèlabo, where he was responsible for the development of Sanofi's U.S. oncology business and the launch of Eloxatin for colon cancer. Eloxatin U.S. sales in 2005, its third full year on the market, were $1.1 billion, ranking it among the industry's most successful oncology drug launches. Mr. Rosen received a Bachelor of Science degree in Pharmacy from Northeastern University.
Mr. Davis was most recently Executive Vice President and Chief Operating Officer at Ardea Biosciences, Inc. He has completed numerous strategic transactions between biotechnology and pharmaceutical companies, including the recent $1.26 billion acquisition of Ardea by AstraZeneca PLC. Prior to Ardea, Mr. Davis served as President and Chief Executive Officer of Neurogen Corporation, a biopharmaceutical company acquired by Ligand Pharmaceuticals. Before becoming Neurogen's Chief Executive Officer, Mr. Davis served in numerous executive roles at Neurogen completing multiple collaboration and asset acquisition and sale transactions with global pharmaceutical companies. Previously, Mr. Davis practiced as a corporate and securities attorney with a Wall Street law firm and as a Certified Public Accountant with a major accounting firm. Mr. Davis received his B.S. in Accounting from Southern Nazarene University and a J.D. from Vanderbilt University.
http://www.appharma.com/PDFs/03-28-13-APPA-APF530-CRL.pdf
Company Revises Projected Launch Timing from 2H 2013 to 1H 2014 -
- Conference Call to Be Held at 8:30 a.m. Eastern Time -
REDWOOD CITY, Calif.--(BUSINESS
WIRE)-- A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The CRL describes the following issues that must be addressed.
"We appreciate the FDA's thorough review of the APF530 NDA," stated John B. Whelan, A.P. Pharma's president and chief executive officer. "While disappointed in today's notification, we believe that the issues raised in the CRL are addressable, and we remain firmly committed to the successful development of APF530, which we believe will fulfill an important unmet need and improve the lives of patients suffering from CINV. In order to allow us time to carefully address the issues raised in the CRL, we are now projecting product launch for the first half of 2014, versus our prior guidance of the second half of 2013."
Conference Call Details
A.P. Pharma will host a conference call on Thursday, March 28, 2013 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Interested investors may participate in the conference call by dialing (877) 856-1964 (domestic) or (719) 386-0001 (international) and use participant code 135738. In addition, the live conference call is being webcast and can be accessed on the "Calendar of Events" page of the "Investors" section of the Company's website at www.appharma.com. A replay of the webcast will be posted to this same section of the website available approximately two hours after the call.
About APF530
A.P. Pharma's lead product, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV, so this indication represents an area of particular unmet medical need. 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. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for APF530 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 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. A.P. Pharma resubmitted its New Drug Application (NDA) for APF530 to the U.S. Food and Drug Administration (FDA) in September 2012 and received a Complete Response Letter in March 2013. For further information, please visit the Company's web site at www.appharma.com.
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