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Biotech / Medical : Lidak Pharm. [LDAKA] -- Ignore unavailable to you. Want to Upgrade?

To: Henry Volquardsen who wrote (1112)	3/18/1999 9:33:00 AM
From: Henry Volquardsen	Read Replies (1) \| Respond to of 1115

AVANIR PHARMACEUTICALS ORAL-FACIAL HERPES CREAM WILL 3/18/99 8:14 Receive Further FDA Review AVANIR Meets with FDA to Discuss Additional Data on Docosanol SAN DIEGO, March 18 /PRNewswire/ -- AVANIR Pharmaceuticals (Nasdaq: AVNR) said today that the company representatives met with the Food and Drug Administration (FDA), Division of Dermatological and Dental Products, earlier this week to discuss the company's recently submitted response to the "not-approvable" letter received in December 1998 on docosanol cream, a treatment for oral-facial herpes. Following the company's presentation, the FDA indicated that it will continue its evaluation of the additional effectiveness data submitted and will respond to the company with its findings. The FDA indicated that this process would require at least one additional meeting between the company and FDA scientists. Discussions are currently underway to schedule this meeting as soon as possible. Although not the basis for the "not-approvable" action in December, the FDA had additional questions concerning chemistry, manufacturing and controls, and the pharmacology/toxicology sections of the NDA. These issues were also discussed at this week's meeting. The FDA agreed with the company's responses to these issues and asked that the company formally submit its responses as part of its NDA. Gerald J. Yakatan, Ph.D., chief executive officer and president, said, "The major portion of the FDA discussions centered on the additional evidence of effectiveness for docosanol that AVANIR had recently submitted in response to the issues and questions raised by the FDA last December. As anticipated, the FDA made no final decision regarding its evaluation of the recently submitted data. We believe the meeting produced a very satisfactory exchange of information by both sides and helped clarify the important issues. We will cooperate fully with the FDA on a timely manner to enable them to make a final determination of whether the additional data we supplied will meet the requirements to demonstrate the effectiveness of docosanol cream." AVANIR Pharmaceuticals develops novel therapeutic products for the treatment of chronic diseases. The company also intends to enter Phase II clinical trials of its drug for the treatment of emotional lability in ALS (Lou Gehrig's disease) patients by mid-year, and has a drug research program in pre-clinical development for the treatment of the underlying biological causes of allergy and asthma. 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. The Company can give no assurances that it will be able to provide sufficient additional evidence to the FDA or that the FDA will ultimately grant marketing approval for docosanol cream. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside of the influence and/or control of the Company. SOURCE AVANIR Pharmaceuticals -0- 03/18/99 /CONTACT: Gregory Hanson, CFO of AVANIR Pharmaceuticals, 619-410-2670; or Bob Stone, home, 914-591-5534, or Ray McNulty, both of The Dilenschneider Group, 212-922-0900, for AVANIR Pharmaceuticals/