Shares of Redwood City, California-based A.P.Pharma Inc. (APPA) are up nearly 19 percent since the stock was featured on our site in June of this year. Now that the company is moving closer to resubmission of New Drug Application for its lead drug candidate, will investors warm up to this stock?
A.P.Pharma's lead drug candidate is APF530 - a new treatment for Chemotherapy Induced Nausea and Vomiting, or CINV, one of the most distressing side effects of chemotherapy treatment for a majority of cancer patients. The company plans to resubmit the APF530 NDA to the FDA next month (Sept.2012), seeking approval for the prevention of both acute- and delayed-onset CINV.
Some of the approved treatments for CINV include 5-HT3 inhibitors like Aloxi (palonosetron), Zofran (ondansetron) and Kytril (granisetron), as well as Emend, an NK1 antagonist, which is always used in combination with a 5-HT3 antagonist.
A.P.Pharma's APF530, based on its proprietary Biochronomer drug delivery system, contains the 5-HT3 antagonist, Granisetron, as active ingredient whose patent expired in the United States in December, 2007. A.P. Pharma owns worldwide rights to APF530.
Granisetron, for infusion and oral tablets, is approved for the prevention of acute onset CINV, which occurs within the first 24 hours following chemotherapy treatment, and is not approved for delayed onset CINV, which occurs more than 24 hours after chemotherapy treatment.
APF530, if approved, could become the second long-acting product given in a single administration to deal with the delayed onset CINV, according to the company. So far, Aloxi is the only 5-HT3 antagonist that is approved for the prevention of delayed onset CINV in patients receiving moderately emetogenic chemotherapy.
The overall market opportunity for CINV drugs is estimated to be more than $800 million in the U.S. alone.
It will be APF530's second go-around with the FDA when the application is filed and is taken up for review.
A.P.Pharma had initially submitted the NDA for APF530 in May 2009 under 505(b)(2) regulatory pathway that allowed the company to rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, Granisetron. However, the APF530 NDA failed to clear the regulatory muster, and was issued a Complete Response Letter in March 2010. Since then, the company has been working to address the issues raised in the Complete Response Letter and resubmit the NDA.
A quick look at the company's balance sheet...
A.P.Pharma has incurred significant operating losses, and had an accumulated deficit of $169.7 million as of June 30, 2012. The company, which ended the second quarter of this year with $12.4 million in cash, raised $50.7 million in a stock offering last month. A.P.Pharma believes that its current cash resources are sufficient to fund its operations through the anticipated product launch of APF530 in 2013.
Will APF530's second time be a charm? Stay tuned...
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by RTT Staff Writer
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