AVANIR Pharmaceuticals Invites Investors to the BIO CEO & Investor Conference Webcast
SAN DIEGO--(BUSINESS WIRE)--Feb. 22, 2005--AVANIR Pharmaceuticals (AMEX:AVN) will be presenting at the Biotechnology Industry Organization (BIO) CEO & Investor Conference being held this week at the Waldorf-Astoria Hotel in New York. AVANIR's President and Chief Executive Officer Dr. Gerald J. Yakatan will present a corporate overview at 11:00 a.m. Eastern Time, on Thursday, February 24, 2005.
The live webcast of the presentation will be accessible through AVANIR's website at www.avanir.com. It is recommended that listeners log on 10 minutes early to register and download any necessary software. If you are unable to listen to the live webcast, a recorded replay of the presentation will be available on the AVANIR website within 24 hours of the presentation and will remain available through March 23, 2005.
AVANIR has successfully completed two Phase III trials with Neurodex(TM) for the treatment of pseudobulbar affect, a neurological disorder that affects approximately one million people in the U.S. AVANIR began submission of a "rolling" new drug application (NDA) to the U.S. Food and Drug Administration (FDA) at the end of 2004 and expects to submit the final module by mid-year. Based on communications with the FDA, AVANIR expects that the final submission will activate a priority review, which is an accelerated six-month review timeline for the NDA.
AVANIR is also in the process of initiating a pivotal Phase III clinical trial for Neurodex in the treatment of diabetic neuropathic pain under a Special Protocol Assessment. The results of a four-week Phase II open-label dose-escalation safety study of Neurodex in patients with diabetic neuropathic pain were reported in November at the 2004 annual meeting of the American Society of Regional Anesthesia and Pain Medicine. Study data demonstrated that Neurodex was well tolerated up to the highest target dose, and patients reported decreased pain intensity that was significantly different from baseline (p less than 0.0001). The degree of pain relief increased with duration of the open-label study.
AVANIR Pharmaceuticals is a drug discovery and development company focused on treatments for chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at 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 most recent Annual Report on Form 10-K and other publicly available information regarding the company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect". There can be no assurance that AVANIR will complete the submission of a new drug application for Neurodex(TM) in the anticipated time period, that the application, when and if completed, will be accepted by the FDA, that Neurodex will receive priority review or regulatory approval, or that even if such regulatory approval is received, that AVANIR will be able to market Neurodex successfully. The Company disclaims any intent or obligation to update these forward-looking statements. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the Company.
CONTACT: AVANIR Pharmaceuticals Patrice Saxon, 858-622-5202 (Investor Relations) firstname.lastname@example.org SOURCE: AVANIR Pharmaceuticals