The FDA decision on AP Pharma Inc.'s (APPA) lead product candidate APF530 for chemotherapy-induced nausea and vomiting is only a month away, scheduled for March 18.
A majority of patients receiving chemotherapy experience nausea and vomiting. Since CINV (chemotherapy-induced nausea and vomiting) can lead to patients discontinuing chemotherapy, prevention and control of CINV is important in the treatment of cancer patients.
Acute onset CINV occurs within the first 24 hours following chemotherapy treatment, while delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Based on the strength or degree to which chemotherapy treatments cause vomiting, or emesis, they can be classified as moderately emetogenic or highly emetogenic.
The current treatment options for CINV include 5-HT3 antagonists such as palonosetron (Eisai Co.'s Aloxi), ondansetron (GlaxoSmithKline plc's (GSK) Zofran), dolasetron (Sanofi-Aventis' (SNY) Anzemet) and granisetron (Roche's Kytril), as well as aprepitant (Merck & Co. Inc.'s (MRK) Emend), an NK1 antagonist, which is always used in combination with a 5-HT3 antagonist.
Of the above mentioned treatment options, ondansetron and granisetron have lost patent protection.
APF530 that is delivered by a single subcutaneous injection contains 5-HT3 antagonist, granisetron and is designed to provide five days of continuous relief from CINV. Injections and oral tablets containing granisetron are approved for the prevention of acute onset CINV, but not for delayed onset CINV. The unmet need is the greatest with patients receiving highly emetogenic chemotherapy, particularly delayed onset CINV.
AP Pharma submitted its New Drug Application for APF530 in May of 2009 under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the company can rely on the significant clinical data for safety and efficacy of APF530's active ingredient, granisetron.
In a pivotal late-stage study, APF530 was shown to be equally as effective as Aloxi in the prevention of both acute onset and delayed onset CINV.
Aloxi has been available in the United States for intravenous administration since 2003 for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with highly emetogenic chemotherapy.
Similarly, AP Pharma's APF530 has demonstrated that it can prevent acute onset CINV for both moderately and highly emetogenic chemotherapy, and to prevent delayed onset CINV in moderately emetogenic chemotherapy. However, no drug has been approved by the FDA for the prevention of delayed onset CINV in patients receiving highly emetogenic chemotherapy.
The global annual sales of Aloxi are reportedly estimated to be about more than $400 million.
As of September 30, 2009, AP Pharma's cash, cash equivalents and marketable securities were $1.6 million. Last October, the company strengthened its cash position by raising $8.1 million through private equity placement and as recently as January 11, received a final milestone payment of $2.5 million related to the sale of its royalty rights to two dermatological products - Retin-A Micro and Carac. The two dermatological products were sold by AP Pharma to an affiliate of the Paul Royalty Fund in 2006.
AP Pharma regained compliance with the $1.00 minimum closing bid price requirement for continued listing on the Nasdaq last month. Shares touched a two-year intraday high of $2.05 on Wednesday before closing the day's trade at $1.94.
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