AVANIR Pharmaceuticals (AVNR) Provides Business Updates and Delays Q1 Earnings Report

February 9, 2007 8:55 AM EST

AVANIR Pharmaceuticals (NASDAQ: AVNR) 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.

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) for Zenvia(TM) for the treatment of involuntary emotional expression disorder (IEED);
Announced initiatives to reduce ongoing operating expenses, including suspending commercial efforts focused on Zenvia for involuntary emotional expression disorder, placing on hold activities associated with the selective cytokine inhibitor clinical development program, and reducing the Company's workforce by 16%.

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 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.

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