AVANIR Receives Nasdaq Staff Determination Letter
Up to 360 Days to Regain Compliance under Nasdaq Marketplace Rules
ALISO VIEJO, Calif., August 15, 2008 - AVANIR Pharmaceuticals (NASDAQ: AVNR) today announced that it has received a Staff Determination Letter from Nasdaq notifying the Company that it is not in compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Global Market pursuant to Marketplace Rule 4450(a)(5). This notification, which was received in a Staff Determination letter dated August 13, 2008, is a standard communication when the bid price of a Nasdaq-listed company closes below the minimum $1.00 per share requirement for 30 consecutive business days. The Staff Determination letter has no effect at this time on the listing of AVANIR Pharmaceuticals' common stock on the Nasdaq Global Market and the Company is expected to continue to trade on the Nasdaq Global Market under the symbol AVNR for at least the next six months.
The letter states that, in accordance with Marketplace Rule 4450(e)(2), the Company will be afforded 180 calendar days, by February 9, 2009, to regain compliance by having the bid price of its common stock close at $1.00 per share or more for a minimum of 10 consecutive business days.
If the Company does not regain compliance with Marketplace Rule 4450(a)(5) by February 9, 2009, Nasdaq will provide written notification that the Company's common stock may be delisted. At that time, the Company may appeal Nasdaq's decision to a Listing Qualifications Panel pursuant to the Marketplace Rule 4800 Series. Alternatively, the Company may consider applying to transfer the listing of its common stock to The Nasdaq Capital Market if it satisfies the requirements for initial inclusion set forth in Marketplace Rule 4310(c), other than the $1.00 minimum bid price requirement of Marketplace Rule 4310(c)(4). If such an application were approved, the Company would be afforded the remainder of a second 180-day compliance period, or until about August 9, 2009, to regain compliance with the $1.00 minimum closing bid price requirement while its common stock trades on The Nasdaq Capital Market.
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. In May 2008 the Company released top-line results of a formal pharmacokinetic (PK) study that identified alternative lower-dose quinidine formulations of Zenvia for DPN pain intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication. AVANIR has licensed its 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 and further information about pseudobulbar affect can be found at www.PBAinfo.org.
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 the Company's securities will remain listed on the Nasdaq Global Market or that they will qualify for listing on the Nasdaq Capital Market or any other securities exchange. There can also be no assurance that the Company will meet development milestones in the coming year, that the results of these milestones will be positive or that even if the results are positive, that such events will have a positive impact on the Company's stock price. 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
Eric Benevich or Brenna Mullen, 949-389-6700
Aug 15, 2008