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IDMI - missed an FDA submission form 9-May-07 06:18 pm

By Christopher Hinton Of DOW JONES NEWSWIRES NEW YORK (Dow Jones)--IDM Pharma Inc. (IDMI) said Wednesday a U.S. Food and Drug Administration advisory committee determined its drug Junovan, which is to be used in the treatment of bone cancer in children and young adults, needed additional evidence of effectiveness. The news is a major blow to the small drug maker, which hoped Junovan would provide its first sales revenue. Junovan is the Irvine, Calif.-based company's only drug candidate. After trading in its shares was halted for most of Wednesday, IDM Pharma stock closed down $1.30, or 32.5%, at $2.70 with trading volume of more than five times its daily average. Earlier Wednesday, the shares hit a new 52- week low at $2.22. Shares were already down about 50% since Monday, when the FDA first posted related documents with advisory comments on its Web site. In a 12-to-2 vote, the FDA's Oncologic Drugs Advisory Committee determined the results of a Phase III trial for Junovan didn't provide substantial evidence of the drug's effectiveness. At issue - in part - was the single large study itself because typically such drug submissions come with two Phase III studies, an FDA spokeswoman said. The FDA usually follows the recommendations of its advisory committees, although it isn't required to do so. IDM said it expects a decision from the agency on the company's new drug application for Junovan in late August. In the meantime, IDM will focus on working with the FDA to address issues raised by the committee in order to complete the evaluation of its application, said Jean-Loup Romet-Lemonne, IDM's president and chief executive, in a statement. During a conference call late Wednesday with analysts, Sylvie Gregoire, executive chairman of IDM's board, said additional data on the drug were submitted to the FDA without a case-support form because the FDA didn't request it. The advisory committee considering Junovan didn't review the additional data because it wasn't accompanied by the form, Gregoire said. The company will now work with the FDA to submit the additional data along with the form, as well as answer other questions the FDA has, ahead of the ruling date on the drug, scheduled for late August, Gregoire said. Junovan is an immune-system stimulant developed for the treatment of osteosarcoma, a rare aggressive bone tumor that occurs primarily in adolescents and young adults. Current standard therapy includes surgical removal of the primary tumor and systemic chemotherapy. -By Christopher Hinton, Dow Jones Newswires; 201-938-5285; [e-mail]