LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of A.P. Pharma, Inc. (OTCQB:APPA), a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s lead product candidate, APF530, is a long-acting antiemetic drug for the prevention chemotherapy-induced nausea and vomiting (CINV). APF530 has already achieved primary efficacy endpoints in both acute-onset and delayed-onset CINV in one of the largest Phase III studies ever undertaken in CINV. A planned NDA resubmission to FDA is targeted for the first half of 2012. “A.P. Pharma’s APF530 is a well-differentiated product that is positioned for success in the $850 Million U.S. CINV market, driven by multiple factors including long-acting efficacy, convenience and favorable reimbursement dynamics,” said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “APF530’s proprietary subcutaneous delivery system confers both rapid onset of action and extended 5-day exposure, thereby helping to prevent the nausea and vomiting cancer patients typically experience following chemotherapy. APF530 will be welcomed at busy infusion centers and by patients themselves because of its ability to decrease total infusion time in patients receiving standard intravenous chemotherapy. In addition, the drug is suitable for patients undergoing oral chemotherapy, in patients who have difficulty swallowing, and in patients that have failed to achieve a complete response in prior treatment with another antiemetic drug.” A.P. Pharma has a strong cash position following recent financing activity, and they now have sufficient cash on hand for activities into 2013. The Company is currently focused on resubmitting the APF530 NDA in response to a Complete Response Letter (CRL) for APF530 received from FDA in March 2010, for which the Company has laid out a detailed plan addressing all points raised by the agency. In a 43-page Initiation Report by LifeSci Advisors, the clinical achievements of APF530 to date are presented, as is a thorough analysis of the CINV market that highlights the positioning of APF530, and an overview of key aspects of the Company’s response to the CRL. APF530 is long-acting formulation of granisetron, a well-known 5-HT3 antagonist widely used for CINV prophylaxis that is now generic. As such, A.P. Pharma is using the streamlined 505(b)(2) regulatory path in seeking approval from FDA.
All work required for A.P. Pharma should be complete in time for a resubmission of the APF530 NDA expected sometime in the first half of 2012, enabling an approval decision from the agency, which is expected before the end of 2012.Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, http://lifesciadvisors.com/clients/ap/. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur. About LifeSci Advisors: LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company’s website, www.lifesciadvisors.com. Important Disclosures: The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, http://lifesciadvisors.com/disclaimer/, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer. Forward-looking statements: This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.