AVANIR Receives NASDAQ Staff Determination Letter and Outlines Restoration Plan
ALISO VIEJO, Calif., March 27, 2008 - AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced that it has received a Staff Determination Letter from NASDAQ. The Staff Determination Letter notified the Company that the market value of its listed securities had been below the minimum $50 million market value required for inclusion on the NASDAQ Global Market for the previous 10 consecutive trading days. This minimum market value requirement is set forth in Marketplace Rule 4450(b)(1)(a).
In accordance with Marketplace Rule 4450(e)(4) the Staff provided the Company with 30 calendar days, or until April 25, 2008, to regain compliance. The Company expects that upon closing the previously announced registered direct offering the market value of its listed securities will exceed $50 million and therefore it will regain compliance with this continued listing standard within the required 30 day period.
AVANIR Pharmaceuticals is focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, inflammation, and infectious diseases. AVANIR's lead product candidate, Zenvia, is being developed for the treatment of pseudobulbar affect (PBA) and is the subject of an approvable letter from the U.S. Food and Drug Administration (FDA) for that indication. The Company has initiated a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. Additionally, in April 2007 AVANIR announced meeting all primary endpoints in a Phase III clinical trial with Zenvia in patients with diabetic peripheral neuropathic (DPN) pain. The Company is conducting a formal pharmacokinetic (PK) study to assess alternative lower-dose quinidine formulations of Zenvia for DPN pain that are intended to deliver similar efficacy and improve safety/tolerability versus the formulations previously tested for this indication. AVANIR has licensed the MIF inhibitor program to Novartis International Pharmaceuticals Ltd and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, Abreva®, 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.
Forward Looking Statements
Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. There can be no assurance that we will successfully complete our pending offering or that we will regain or maintain compliance with NASDAQ continued listing standards. Risks and uncertainties affecting the Company's financial condition and operations also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.
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AVANIR Investor Contacts
Mar 27, 2008