A.P. Pharma says revenue edges lower, net loss tightens in 2005, APF530 phase 3 trial to begin soon

By Angela McDaniels

Seattle, March 15 - A.P. Pharma Inc.'s revenue decreased slightly to $5.39 million for the year ended Dec. 31 from $5.40 million in 2004, according to a company news release.

Revenue in the fourth quarter ended Dec. 31 decreased by 3% to $1.44 million from $1.48 million for the fourth quarter of 2004. Royalty revenue remained steady, but there was no contract revenue during this period, the company said, due to its focus on the development of its APF530 anti-nausea drug.

The net loss for 2005 decreased by 11% to $8.21 million, or $0.33 per share, from a net loss of $9.22 million, or $0.40 per share, for 2004. The net loss for the fourth quarter of 2005 increased by 15% to $2.60 million, or $0.10 per share, from a net loss of $2.26 million, or $0.09 per share, for the fourth quarter of 2004.

APF530 clinical update

A.P. Pharma said it expects to begin enrolling patients in April for its pivotal phase 3 study of APF530, which contains the anti-nausea drug granisetron formulated with the company's proprietary Biochronomer bioerodible drug-delivery system.

The study's primary endpoint is to establish the efficacy of APF530 for the prevention of acute-onset (first 24 hours) and delayed-onset (4-5 days) chemotherapy-induced nausea and vomiting in patients receiving either moderately or highly emetogenic chemotherapy. No other 5HT3 antagonist is currently approved for the prevention of both acute and delayed onset in both moderately and highly emetogenic chemotherapy, the company said.

The proposed phase 3 pivotal trial protocol design divides about 1,200 cancer patients into two groups that will receive either moderately or highly emetogenic chemotherapeutic agents. Patients will receive APF530 with 5 mg or 10 mg of granisetron, which will be compared with the currently approved dose of palonosetron, marketed under the brand Aloxi.

If the pivotal trial of APF530 successfully meets its clinical endpoints, the company said it will submit a New Drug Application to the FDA thereafter.

A.P. Pharma is a specialty pharmaceutical company based in Redwood City, Calif., that develops prescription pharmaceuticals using its proprietary polymer-based drug delivery systems.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.