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Date Posted: 08:36:04 12/12/01 Wed
Author: SmartInvestor
Subject: AVN Gets Another $5 Million!!!

SOURCE: AVANIR Pharmaceuticals
AVANIR Pharmaceuticals Earns Final $5 Million Milestone Payment From GlaxoSmithKline
Preliminary Outlook for Fiscal Fourth Quarter Results And Fiscal First Quarter Performance
SAN DIEGO, Dec. 10 /PRNewswire/ -- AVANIR Pharmaceuticals (Amex: AVN - news) announced today that it has earned its final $5 million milestone payment from GlaxoSmithKline (NYSE: GSK - news) based on the marketing agreement for Abreva(TM), the only cold sore product approved by the U.S. Food and Drug Administration (FDA) available without a prescription. The terms of the agreement provide AVANIR with continuing royalties on product sales through at least 2011. GlaxoSmithKline's consumer health division began marketing Abreva one year ago. The premium priced product leads the category in sales as the number one pharmacist recommended cold sore treatment in the over-the-counter (OTC) market.

``The receipt of this milestone will enable us to achieve profitability for the first fiscal quarter ending December 31,'' said Gerald J. Yakatan, Ph.D., AVANIR's Chief Executive Officer and President. ``We also received a $5 million milestone licensing fee last quarter. We are pleased to note that the milestone payment received last quarter, plus our royalty on product sales, produced a profitable fourth quarter as well.

``In the biotech industry, profitability is difficult to achieve or maintain due to high cost of clinical trials and the challenges associated with successfully bringing products to market,'' Dr. Yakatan continued. ``Successful companies must continuously develop products to remain competitive. AVANIR may have as many as three clinical trials progressing in 2002, with our goal to have the next product in the pipeline, Neurodex, delivered for FDA review in late 2003. We look forward to developing multiple revenue streams in the relatively near future through these and other efforts, while seeking to provide increasing shareholder value.''

AVANIR is in the process of out-licensing Abreva (docosanol) in the rest of the world, and is currently awaiting regulatory approval in three countries in which the Company currently has partners: Canada, Korea and Israel. The Company is seeking non-prescription or OTC status for docosanol in these countries to ensure the product is accessible to cold sore sufferers early in the cold sore cycle, the optimum time to treat outbreaks. AVANIR is also seeking partners in Europe and other parts of Asia, and intends to file for regulatory approval in Europe early next year. Partnership agreements are anticipated in Southern Europe, China and the Middle East late this year and early in 2002.

AVANIR will announce financial results for the fourth fiscal quarter and year ended September 30, 2001 on December 18, 2001, after the market closes. Following the release, management will host a conference call with a simultaneous webcast at 1:30 p.m. Pacific/ 4:30 p.m. Eastern to discuss fourth fiscal quarter and year-end 2001 operating performance and outlook. For those who cannot listen to the live broadcast, the online replays will be available for 90 days, or a phone replay will be available through December 27, 2001, by dialing (888) 266-2086 and entering the passcode # 5710623.

AVANIR Pharmaceuticals, based in San Diego, is a diversified biopharmaceutical company engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The Company's website is www.avanir.com .

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, as amended, and other publicly available information regarding the Company, copies of which are available from the Company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and such statements, including such risks and uncertainties related to drug development and clinical trials. The Company can give no assurances that they will reach a definitive agreement with a pharmaceutical company to license the rights to market docosanol in the European or Asian market. Market acceptance for drug products is unpredictable and substantially outside of the influence and/or control of the Company.

For further information, please contact General Information, Kristen McNally, +1-310-996-7458, kmcnally@webershandwick.com, or Analyst/Investor, Tricia Ross, +1-310-996-7454, tross@webershandwick.com, or Media, Lisa Mueller, +1-310-996-7455, lmueller@webershandwick.com, all of FRB/Weber Shandwick, for AVANIR Pharmaceuticals; or Patrice Saxon, Investor Relations of AVANIR Pharmaceuticals, +1-858-622-5202, psaxon@avanir.com .

SOURCE: AVANIR Pharmaceuticals

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