March 19, 2010 / 11:52 AM / 9 years ago

UPDATE 3-FDA denies approval of AP Pharma nausea drug; shrs sink

* FDA expresses concern about drug’s administration system

* FDA found deficiencies in co’s manufacturing facilities

* FDA asks for more studies

* Shares fall as much as 59 pct (Adds conference call comment; updates share movement)

March 19 (Reuters) - A.P. Pharma Inc APPA.O said U.S. health regulators did not approve its experimental drug for the treatment of nausea and vomiting induced by chemotherapy (CINV), citing concerns regarding the drug’s administration system, and asked for more studies.

Shares of the company fell as much as 59 percent to 85 cents on Nasdaq.

The specialty pharmaceutical company does not expect the commercial launch of the drug, APF530, in 2010, based on the expected time needed for a resubmission.

APF530, being developed to prevent both acute and delayed onset CINV, is a long-acting formulation of the anti-nausea drug granisetron and is delivered by a subcutaneous injection.

The U.S. Food and Drug Administration requested clarification and revision of certain analytical specifications proposed in the drug application and also identified certain deficiencies during inspections of the company and several of its contract manufacturing facilities, the company said.

The FDA’s concerns related to the two-syringe administration system for the drug include issues with the transfer of material from one syringe to another and potential risk of improper administration of the drug, the company said.

The agency did not request additional clinical efficacy studies but requested the company to perform two studies relating to bioavailability and metabolism.

The FDA also did not accept the company’s request to waive the requirement for a thorough QT study to test the drug’s effect on the heart’s electrical cycle. The company expects the study to be of short duration in normal volunteers.

Chief Executive Ronald Prentki, on a conference call, said the company had submitted its response to the agency’s points in recent amendments to the APF530 new drug application, before the FDA’s action date.

“We believe the prior submissions may address many of these issues and in addition may address some of the new issues raised by the FDA,” he said.

If approved, APF530 would have been the second drug in the market to treat delayed onset CINV, and competing with Aloxi, also known as palonosetron, marketed in the United States by Eisai Co Ltd (4523.T).

Prevention of CINV is important because the distress caused by CINV can severely disrupt patient’s quality of life and can lead some patients to delay or discontinue chemotherapy.

Shares of the company were down $1.01 at $1.05 in mid-day trade Friday. (Reporting by Esha Dey and Shailesh Kuber in Bangalore; Editing by Ratul Ray Chaudhuri and Maju Samuel)

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