AP Pharma, Inc. (APPA)
From ValueWiki
AP Pharma is a specialty pharmaceutical/biotechnology company focused on the discovery and commercialization of drugs mainly using the company's proprietary drug delivery system. The company's lead drug candidate, APF530 is currently undergoing pivotal Phase 3 clinical trial for treatment of emesis (nausea and vomiting), which is serious side effect of many chemotherapy treatments.
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Snapshot
About the Company
A.P. Pharma, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative medical treatments utilizing its proprietary polymer-based drug delivery systems.
The Company's primary emphasis is on advancing its Biochronomer™ technology platform for site-specific and systemic drug delivery. Designed to release drugs over a period of hours, days, weeks or even months, Biochronomer systems can be fabricated into a wide range of solid and gel forms which erode as they deliver the drug.The Company's lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting is expected to enter a Phase 3 clinical trial in the second quarter of 2006. In addition, a variety of injectable and implantable applications are undergoing testing to address major unmet needs in pain management, inflammation, and DNA/RNAI applications. [1].
Products
List of products under development from company's website.
APF530
APF 530 is the company's leading product in development. The drug is a depot injection (extended release for long lasting effect) reformulation of Granisetron to treat both acute and delayed nausea and vomiting, a common side effect of chemotherapy treatment. The drug is currently in Phase III clinical trial. [2]
The company initially targeted to file New Drug Application (NDA) to the FDA by the end of 2007. In December 21, 2006, the company stated that it will not meet the previously announced goal of NDA filing in the year 2007, due to slower than expected enrollment of the trial. [3]
APF112
APF112, is a reformulation of mepivacaine to address the market for post-surgical pain treatment. Mepivacaine is a very well known drug for localized pain relief, and it has an extensive safety protocol. APF112 is designed to minimize the use of opioids (morphine-like drugs) which are currently used in the majority of surgical procedures as a means of managing pain but with unpleasant side effects - nausea, disorientation, sedation, constipation, vomiting, urinary retention and , in some situations, life-threatening respiratory depression. [2]
Recent Events
More News...== Future Events ==- Data from APF530 Pivotal trial: 2H 07 [1]
Leadership
- Paul Goddard, Ph.D., Chairman
- Michael O’Connell, President and CEO
- John Barr, Ph.D., VP, Research & Development
- Jorge Heller, Ph.D., Principal Scientist
- Gordon Sangster, Chief Financial Officer
Bios from company's website
Risks
- Company does not have products in the market yet, and still has negative cash flow.
- Increased cash-burn rate mainly related to clinical trial spending for APF530.
Fundamentals
Official Links
Rumors
Discuss rumors on the Talk Page and link to the topics here.
Message Boards
Notes
- ↑ Company Profile from corporte website. Accessed on March 6, 2007.
- ↑ 2.0 2.1 Product page from company website. Accessed march 6, 2007
- ↑ "A.P. Pharma Resets APF530 NDA Filing Expectations," company press release, December 21, 2007. Accessed on March 6, 2006.
