PGS, AP Pharma - though APF-530 only needed to show statistical non-inferiority to Aloxi for approval, and did, the Phase 3 showed APF-530's complete response rates to be numerically higher than Aloxi's in treatment experienced patient (those with previous chemo) in all instances.
Also, with Cisplatin, a chemo agent with high emetic potential, complete response rates for APF-530 vrs Aloxi were 81.1% vrs 75.5% (acute onset), and 66.0% vrs 60.4% (delayed onset). Also in the Phase 3, APF-530's complete response rates were higher than Aloxi's in all 9 analyses for moderately emetogenic chemo, and in 5 of the 9 analyses for highly emetogenic chemo.
One problem with Aloxi is that for efficacy in delayed onset CINV you need to give it via an IV line, which is fine if the chemo you're giving is also given IV. But if your chemo agent is given orally, then you need to either set up an IV just for Aloxi, or else give the oral form of Aloxi, but the oral form isn't efficacious for delayed CINV, only for acute. APF-530 has the advantage of no IV line being required, just a quick injection.
Compared to the patch version of granisetron, APF-530 has the advantage of being given by a single injection - you give it once at the time of the chemo and forget it. With the patch you have to worry about patient compliance for 5 days, getting it wet, perspiration negating efficacy, etc.
APF-530 will definitely give Aloxi some competition, both clinically and price competition. The single injection option will be preferred by some clinicians for its simplicity, rather than the IV, oral, or transdermal routes.
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