AVANIR to Raise $40.0 Million to Fund Zenvia Through Clinical Development and Regulatory Approval.ALISO VIEJO, Calif. -- AVANIR Pharmaceuticals (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AVNR AVNR Atrioventricular Nodal Reentry ) today announced that it has obtained commitments from a select group of institutional investors led by ProQuest Investments and joined by Clarus Ventures, Vivo Ventures, and OrbiMed Advisors to raise gross proceeds of $40.0 million in a registered direct offering. At closing, AVANIR will issue an aggregate of approximately 35.0 million shares at a price of $1.14 per share unit (the market closing bid price as of March 26, 2008 plus a nominal amount for warrants) with 35% warrant coverage. The warrants, which represent the right to acquire up to approximately 12.2 million shares, are exercisable at 125% of the offering price and have a 5 year exercise term. Net offering proceeds are expected to be approximately $37.9 million. The transaction is expected to close on or about April 4, 2008, subject to customary closing conditions. Piper Jaffray & Co. served as the sole placement agent. The proceeds from this transaction will be used to complete the confirmatory Phase III STAR trial of the investigational drug Zenvia[TM] (dextromethorphan/quinidine) and submit a complete response to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approvable letter for the pseudobulbar affect (PBA PBA Professional Bowlers Association PBA Palm Beach Atlantic University (West Palm Beach, Florida) PBA Partial-Birth Abortion PBA Philippine Basketball Association PBA Public Broadcasting Atlanta (Georgia, USA) ) indication. Top-line PBA data from the STAR trial are expected in the second half of calendar year 2009 with a complete response expected to be submitted to the FDA in the first half of calendar year 2010. Proceeds will also be used for general working capital. The shares are being offered pursuant to the Company's registration statements on Form S-3 declared effective by the U.S. Securities and Exchange Commission (SEC) on August 3, 2005 and February 8, 2008, respectively. The offering is being made by means of a prospectus and prospectus supplement available from the AVANIR website at http://www.avanir.com/ or from the SEC at http://www.sec.gov/. Copies of the prospectus supplement for this offering are available by writing to the Company at 101 Enterprise, Suite 300, Aliso Viejo, California Aliso Viejo is a city in Orange County, California, United States. As of the 2000 census, Aliso Viejo population was 40,166. Aliso Viejo became Orange County's 34th city on July 1, 2001, and has been the only city in Orange County to incorporate since 2000. 92656 or by calling the Investor Relations Investor relations The process by which the corporation communicates with its investors. department at (949) 389-6700. About AVANIR 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 quinidine (kwĭn`ĭdēn'), heart muscle relaxant used to maintain regular heart rhythm patterns. It is an alkaloid chemically similar to quinine and, like quinine, occurs naturally in some species of cinchona trees. 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 Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with Zenvia in patients with diabetic peripheral neuropathic (DPN DPN, in biochemistry, abbreviation for diphosphopyridine nucleotide, a coenzyme now usually called nicotinamide adenine dinucleotide, or NAD. DPN - Decomposed Petri Net ) 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 (1) (Maker Interchange Format) An alternate file format for a FrameMaker document. A MIF file is ASCII text, which can be created in another program and imported into FrameMaker. inhibitor program to Novartis International Pharmaceuticals Ltd and has sold its anthrax monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing program to Emergent BioSolutions. 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. 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 any additional Phase III trial for Zenvia will be successful, that any new doses of Zenvia will be safe and effective, or that the U.S. Food and Drug Administration (FDA) will approve Zenvia for any indication. There can also be no assurance that the proceeds from this offering will be sufficient to fund our clinical trials to completion as expected. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and subsequent Quarterly Reports on Form 10-Q Form 10-Q See 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. To be included on AVANIR's e-mail alert list, click on the link below or visit AVANIR's website: http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0. |
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