AVANIR Pharmaceuticals Provides First Quarter Business Update.Conference Call Begins at 11:00 a.m. Eastern Time Today 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 provided a business update and announced a delay in reporting financial results for the first quarter of fiscal year 2007, ended December 31, 2006. The Company is currently evaluating the appropriate method for revenue recognition related to sales of FazaClo([R]) (clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. , USP USP - unique sales point ). Until this evaluation is complete, the Company has delayed issuing a news release and filing a Form 10-Q Form 10-Q See 10-Q. for the quarter; the Company expects that this evaluation will be completed, and that financial results will be released, by February 14, 2007. Business Results The three months ended December 31, 2006 was highlighted by the following events: * FazaClo net wholesaler shipments of $2.7 million, with 46% growth in total prescription and 67% growth in new prescriptions over the same quarter last year. * Received an approvable letter from 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. ) for Zenvia[TM] for the treatment of involuntary emotional expression disorder (IEED IEED Involuntary Emotional Expression Disorder ). We have a meeting scheduled with the FDA in late February and will provide an update on the Company's development plans for Zenvia once that is determined. * Completed an equity offering raising (net) proceeds of $14.4 million. As required by the note obligation associated with our acquisition of Alamo Alamo Eighteenth-century mission in San Antonio, Texas, site of a historic siege of a small group of Texans by a Mexican army (1836) during the Texas war for independence from Mexico. Pharmaceuticals, we used $2.9 million of the funds raised to repay part of this outstanding debt. * Announced initiatives to reduce ongoing operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , including suspending commercial efforts focused on Zenvia for involuntary emotional expression disorder, placing on hold activities associated with the selective cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). inhibitor clinical development program, and reducing the Company's workforce by 16%. * Enrolled the last patient in the ongoing Zenvia Phase III Noun 1. phase III - 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 FDA painful diabetic neuropathy Diabetic Neuropathy Definition Diabetic neuropathy is a nerve disorder caused by diabetes mellitus. Diabetic neuropathy may be diffuse, affecting several parts of the body, or focal, affecting a specific nerve and part of the body. trial. Data from this trial is currently anticipated by mid-2007. * Entered into an agreement for a financing facility and filed a prospectus supplement with the SEC to enable the Company to sell up to 5.7 million shares of common stock into the open market at the discretion of management. During the quarter, management used this facility to sell 243,060 shares, raising net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of $563,000. Following the end of the quarter, AVANIR: * Announced receipt of an approvable letter from the FDA for a new formulation of its currently marketed antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic drug FazaClo. The Company has responded to the FDA's two chemistry, manufacturing and control data requirements and currently anticipates receiving final approval in the coming months. The new formulation, if approved, will include updated packaging as well as a new 12.5mg dosing strength. * Completed and submitted the briefing package to the FDA in response to the approvable letter received for Zenvia. * Sold an additional 2,329,790 shares of common stock into the open market using the prospectus supplement on file with the SEC, thereby raising net proceeds of $5.4 million. Balance Sheet Highlights As of December 31, 2006, the Company had cash and investments in securities totaling $17.6 million, including cash and cash equivalents of $14.5 million, short and long-term investments in securities of $2.2 million, and restricted investments in securities of $857,000. Conference Call and Webcast Management will host a conference call with a simultaneous webcast today beginning at 8:00 a.m. Pacific time/11:00 a.m. Eastern time to discuss business developments in the first quarter of fiscal 2007. The call/webcast will feature Eric Brandt, President and Chief Executive Officer; Michael Puntoriero, Senior Vice President and Chief Financial Officer; and other members of management. The webcast will be available live via the Internet by accessing AVANIR's website at www.avanir.com. Replays of the webcast will be available for 90 days, and a phone replay will be available through February 14, 2007 by dialing 800-642-1687 (domestic) or 706-645-9291 (international) and entering the passcode 6368181. About AVANIR AVANIR Pharmaceuticals is focused on developing, acquiring 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, cardiovascular disorders, inflammation and infectious diseases. AVANIR currently markets FazaClo([R]), the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder Schizoaffective Disorder Definition Schizoaffective disorder is a mental illness that shares the psychotic symptoms of schizophrenia and the mood disturbances of depression or bipolar disorder. . For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. Zenvia[TM], AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), is the subject of an approvable letter from the FDA and future development plans for this product candidate are under consideration. The Company does not know at this time what impact, if any, the ongoing discussions with the FDA for IEED may have on the development of Zenvia for other indications. Additionally, AVANIR has completed the patient recruitment 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 as a potential treatment for patients with painful diabetic neuropathy. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease; and AstraZeneca for the treatment of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular 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. 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 will continue the clinical development of Zenvia after its planned meeting with the FDA or that Zenvia will receive FDA regulatory approval for any indication. There can also be no assurance that the FDA will not require additional evidence of Zenvia's safety and/or efficacy, notwithstanding the existence of an SPA for the Company's neuropathic pain clinical trials. If regulatory approval is received, there can be no assurance that AVANIR will be able to market Zenvia successfully. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are often unpredictable and outside the influence and control of the Company. Risks and uncertainties 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 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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