FDA Sets Aside Approval Of AP Pharma's Lead Drug For Now APPA 03/19 07:35 AM
DOW JONES NEWSWIRES
AP Pharma Inc. (APPA:$2.06,00$0.50,0032.05%) said U.S. regulators need more answers about the company's lead drug candidate, a treatment for chemotheraphy-induced nausea, before they can approve the company's new-drug application.
The Food and Drug Administration said it has some worries about the dosing system, manufacturing of and data about APF530, which would be the second drug on the market for chemotherapy-induced nausea and vomiting if approved. Shares plunged 63% to 76 cents on the news. The stock had doubled the past three months.
AP Pharma (APPA:$2.06,00$0.50,0032.05%) has been waiting on FDA approval before pursuing partnership talks for marketing the drug in earnest. Although the company could market the drug on its own, Chief Executive Ronald Prentki had indicated the company was willing to wait for approval in order to get the best deal.
Friday, the company said the FDA was worried about the drug's two-syringe dosing system, including potential problems transferring material from one syringe to the other or the possible risk of improper administration.
The agency also identified deficiencies at some of AP Pharma's (APPA:$2.06,00$0.50,0032.05%) contract manufacturing facilities, which must be resolved. It wants the company to switch to a terminal sterilization process before approving the drug.
Although it didn't request any more clinical studies, the FDA wanted AP Pharma (APPA:$2.06,00$0.50,0032.05%) to review its existing late-stage trial data and reanalyze it. It requested the company do studies related to bioavailability, metabolism and heart arrhythmia, which AP Pharma (APPA:$2.06,00$0.50,0032.05%) said it expect won't take long. The agency also declined the company's request to waive a thorough QT study, which AP Pharma (APPA:$2.06,00$0.50,0032.05%) also said shouldn't take long.
The company had to cut more than a third of its work force last year and shelve several early-stage development programs to conserve cash, vesting a lot of its future success in APF530. The treatment would compete with Eisai Co.'s (ESALF:$39.3254,$0.0000,0.00%) ( 4523.TO, ESALY) Aloxi.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; joan.solsman@ dowjones.com
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