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 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. 

AVANIR Pharmaceuticals (NASDAQ:AVNR) today reported financial results for the three months ended December 31, 2007. 

For the first quarter of fiscal 2008, AVANIR reported a net loss of $5.5 million, or $0.13 per share, compared with a net loss of $13.6 million, or $0.39 per share, for the first quarter of fiscal 2007. Total net revenues for the first quarter of fiscal 2008 were $2.1 million. Total operating expenses were $6.6 million in the first quarter of fiscal 2008, compared with $14.6 million in the comparable fiscal 2007 period. Operating expenses for the first quarter of fiscal 2008 included expenses associated with the initiation of the Zenvia (dextromethorphan/quinidine [DM/Q]) Phase III confirmatory STAR trial. Cash used in operations during the first quarter of fiscal 2008 was $4.1 million. 

"We continue to make progress with our Zenvia clinical programs, reflecting our mission to bring this product candidate to market as quickly and safely as possible," said Dr. Randall Kaye, AVANIR's Chief Medical Officer. "Since commencing our confirmatory Phase III clinical trial ("STAR" trial) in pseudobulbar affect (PBA) in mid-December, we continue to gain momentum in activating study sites and enrolling patients. We remain on track to deliver top-line data in the second half of calendar 2009. Our large formal pharmacokinetic (PK) study for the diabetic peripheral neuropathic (DPN) pain program is also well underway. We consider this PK study an important step in identifying an alternative Zenvia formulation for our next Phase III trial in DPN pain. We have initiated dosing for all cohorts in the study and now expect to announce top-line results for this PK study during the second calendar quarter of 2008."

"In addition to advancing our clinical programs, we are also making progress toward improving the Zenvia intellectual property portfolio. In November, AVANIR received official notification from the European Patent Office (EPO) of its intent to grant a new patent, prolonging the protection of Zenvia in Europe for both the PBA and DPN pain indications until 2023. We have a corresponding patent application pending with the U.S. Patent and Trademark Office and based on the outcome in Europe, we are optimistic of a positive response in the U.S. as well," said Keith Katkin, AVANIR's President and CEO. 

RECENT HIGHLIGHTS AND UPCOMING MILESTONES:

CLINICAL PROGRAMS AND PIPELINE 

Zenvia in PBA

Reached a definitive agreement with the U.S. Food and Drug Administration (FDA), under the special protocol assessment (SPA) process, on the design of a single confirmatory Phase III clinical trial with Zenvia in patients with PBA, referred to as the STAR trial. 
Initiated enrollment of PBA patients in the STAR trial. AVANIR is on schedule to complete enrollment in the first half of calendar year 2009 and to report top-line data in the second half of calendar year 2009. 
Zenvia in DPN Pain

Initiated a large, formal PK study to assess alternative lower-dose quinidine formulations of Zenvia for DPN pain intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested. Dosing of the first three cohorts of subjects with varying regimens of dextromethorphan and quinidine has been completed. The last two dosage cohorts have been initiated. AVANIR expects to release top-line results during the second quarter of calendar 2008. 
COMPANY OPERATIONS 

Received official communication from the EPO, under Rule 51(4) EPC, that the EPO intends to grant AVANIR's pending Zenvia patent for both PBA and DPN pain. Issuance of this patent will extend the patent life of Zenvia in Europe through 2023. 
Announced that the Annual Meeting of Shareholders will be held Thursday, February 21, 2008 in Irvine, California. 
BALANCE SHEET HIGHLIGHTS 

As of December 31, 2007, AVANIR had cash and investments in securities totaling $29.4 million, including cash and cash equivalents of $28.3 million, investments of $250,000 and restricted investments in securities of $857,000.