quote.bloomberg.com
AVANIR REPORTS PROGRESS ON FDA'S EVALUATION OF NEW DRUG
Application
For Docosanol
SAN DIEGO, July 26 /PRNewswire/ -- AVANIR Pharmaceuticals (Nasdaq: AVNR) today announced that the FDA, in the course of its ongoing review of the company's New Drug Application, has asked for additional statistical analyses to "assess the consistency of the (clinical) data." In a letter dated July 21, 1999, the FDA stated it reviewed the additional evidence of efficacy of docosanol cream submitted recently, and said it "anticipate(s) that AVANIR can have these analyses performed relatively quickly." Docosanol is a topical treatment for oral-facial herpes, commonly known as cold sores and fever blisters. "We intend to submit the results of the requested analyses to FDA in less than two weeks," stated Gerald J. Yakatan, Ph.D., chief executive officer and president of AVANIR. "The FDA informed us that this is its final request for information regarding our clinical data and that its review can be accomplished relatively quickly."
AVANIR Pharmaceuticals develops novel therapeutic products for the treatment of chronic diseases. On December 22, 1998, the company received a letter from the FDA stating that its New Drug Application for docosanol cream was "not-approvable" based on the information submitted and indicated that additional evidence was needed to substantiate the drug's effectiveness. AVANIR has been in frequent communication with the FDA since submitting additional evidence of efficacy and analyses of data starting in March 1999.
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company's Annual Report on Form 10-K/A and other publicly available information regarding the company, copies of which are available from the company upon request. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Forward-looking statements usually contain the words "anticipate," "intend," "believe" or similar expressions, and are subject to numerous known and unknown risks and uncertainties. In evaluating such statements, prospective investors should carefully review various risks and uncertainties identified in Form 10-K/A. Such publicly available information sets forth many risks and uncertainties related to the company's business and such statements, including risks and uncertainties related to drug development and clinical trials. In addition, the FDA has made no commitment as to whether the re-analyses of prior study data performed to date and to be performed will ultimately provide adequate evidence to establish the effectiveness of docosanol in the treatment of cold sores. SOURCE AVANIR Pharmaceuticals -0- 07/26/99 /CONTACT: Gregory Hanson, CFO of AVANIR Pharmaceuticals, 619-410-2670; or Thomas Redington of Redington, Inc., investors, 203-222-7399; or Bob Stone or Ray McNulty, both of The Dilenschneider Group, media, 212-922-0900, for AVANIR Pharmaceuticals/ /Company News On-Call: prnewswire.com or fax, 800-758-5804, ext. 509050/ (AVNR) CO: AVANIR Pharmaceuticals ST: California IN: MTC SU: -0- Jul/26/1999 7:59 EOS (PRN) Jul/26/1999 07:59 197 -0- (PRN) Jul/26/1999 8:14
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