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123 Saginaw Drive
Redwood City, CA 94063 USA
phone:650-366-2626
fax:
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| Symbol |
APPA |
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PINK |
| Founded |
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| www.appharma.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Microfluidic devices for improved drug delivery |
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| Management |
| John Whelan, President and Chief Executive Officer; Michael Adam, Ph.D., Senior VP, Chief Operating Officer; John Barr, Ph.D., Senior VP, Research & Development |
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| Keywords |
| drug delivery technology, pain management, anti-nausea, anti-inflammatory, anti-infective, oncology, ophthalmology , device coatings, DNA delivery, PainManagement, DrugDelivery |
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| Description |
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A.P. Pharma Inc. is a specialty pharmaceutical company that develops products using its proprietary Biochronomer™ technology, a polymer-based drug delivery system. The Company has developed a broad family of unique polymers that bring a number of advantages to drug delivery application such as ease of administration, formulation flexibility, and controlled drug delivery. The Company is currently in the process of resubmitting APF530, its lead product candidate aimed at the prevention of chemotherapy-induced nausea and vomiting, for FDA approval. This later-stage biotechnology company also has additional clinical- and pre-clinical-stage programs underway within the realm of pain management, all of which utilize its bioerodible, injectable, and implantable delivery systems. |
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| Products / Services |
APF530
The Company's lead product, APF530, is being developed for the prevention of CINV in patients receiving either moderately or highly emetogenic chemotherapy. APF530 is delivered by a single subcutaneous injection and contains the 5-HT3 antagonist, granisetron. Granisetron, for infusion and oral tablets, is approved for the prevention of acute onset CINV, but not delayed onset CINV. We selected granisetron because it is a potent drug and the applicable granisetron patent expired in the United States on December 29, 2007.
Granisetron and other 5-HT3 antagonists, as a class, have become the most common antiemetic agents used in chemotherapy. However, no 5-HT3 antagonist formulation is currently approved for the prevention of both acute and delayed onset CINV for both moderately and highly emetogenic chemotherapy. A.P. Pharma's APF530 Phase 3 clinical trial demonstrated that it can deliver therapeutic levels of granisetron to prevent acute onset CINV for both moderately and highly emetogenic chemotherapy, and to prevent delayed onset CINV in moderately emetogenic chemotherapy. The sector efficacy data involving delayed onset CINV in highly emetogenic chemotherapy showed results for the higher dose of APF530 that were numerically better than palonosetron and statistically non-inferior, but did not achieve the statistically significant level of superiority necessary to support a claim in this sector. If A.P. Pharma obtains product approval for all uses except the delayed onset highly emetogenic one, the Company should have a product comparable to palonosetron, which despite the limitation of its claim for prevention of delayed onset CINV to only moderately emetogenic treatments, has achieved considerable commercial success.
APF112
APF112 utilizes A.P. Pharma’s Biochronomer delivery technology to target post-surgical pain relief. The product is designed to provide up to 36 hours of localized pain relief by delivering mepivacaine directly to the surgical site. Mepivacaine is a well-known, short-acting local anesthetic with an excellent safety profile. APF112 is designed to prolong the anesthetic effect of mepivacaine and thus minimize or eliminate the use of opiates. Opiates are currently used in the majority of surgical procedures as a means of managing post-operative pain, and while they are powerful and useful drugs, they may have side effects such as addiction, nausea, disorientation, sedation, constipation, vomiting, urinary retention and, in some situations, life-threatening respiratory depression. If efficacy in treating post-surgical pain can be demonstrated, A.P. Pharma believes that there will be substantial potential for this product, as there are approximately 20 million surgical procedures performed annually in the United States for which the product could potentially be utilized.
APF580
APF580 incorporates an opiate into A.P. Pharma's Biochronomer technology and is designed to provide analgesia lasting at least seven days from a single injection. It is targeted for situations where the intensity and duration of pain require use of an opiate rather than a local anesthetic. APF580 may find use in acute and chronic pain settings, improve patient compliance and reduce the risk of drug abuse. The Company's initial animal pharmacokinetic studies, completed in 2006, present a promising profile, supporting future product development for post-surgical (inpatient) and chronic pain applications (cancer pain). In September 2008, A.P. Pharma filed an IND for APF580 with the FDA. In addition, the Company is working with Merial, a major animal health care company, that is developing a variant of APF580 for use in cats and dogs.
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| Technology / Differentiation |
| Bioerodible polymers are an important class of materials with potential for both drug delivery and devices. The successful application of such polymers requires that stringent criteria are met, such as benign toxicity, ease of manufacturing, surface erosion, essentially neutral internal pH, stability, complete bioerosion and the ability to tailor polymer properties to meet specific purposes.
Specifically, the Company has developed two families of polymers, each with unique attributes. The first family is known collectively as poly(ortho esters) under the trademark Biochronomer; the second family is known collectively as block copolymers of poly(ortho esters) and poly(ethylene glycol) under the trade name Bioerodimer.
The major point of difference, compared to other polymer technologies, is that the A.P. Pharma polymers have been specifically designed as drug delivery vehicles. The Company has demonstrated that erosion times can be varied from days to months and that properties can be adjusted to produce materials ranging from a free-flowing injectable gel at room temperature to hard solids. In addition, the manufacturing of the polymer is simple and reproducible. The polymer is stable at room temperature provided it is stored under anhydrous conditions. |
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