Avanir seeks EMA marketing authorization for NUEDEXTA to treat pseudobulbar affect

Oct 31 2011

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that it has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA).

NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.

The marketing authorization application (MAA) is based on comprehensive clinical data from Avanir's phase 3 studies of NUEDEXTA in patients with PBA, plus data from the company's longer-term safety studies. The MAA filing triggers the initiation of EMA's validation process which is expected to be completed in November.  Once the MAA has passed validation, the scientific assessment and opinion review period will take a minimum of 210 days.

"The regulatory submission announced today represents another significant accomplishment for Avanir," said Joao Siffert, MD, senior vice president research and development at Avanir. "PBA affects millions of people across the globe and imposes a significant health burden on those suffering from this condition. The filing of this application with the EMA is an important step toward making NUEDEXTA available for PBA patients in Europe. The European medical community is looking forward to the day when they can offer the only therapeutic specifically approved for treating patients with PBA."

Financial Update

Based on preliminary results for the fourth fiscal quarter ended September 30, 2011, Avanir estimates gross revenue for NUEDEXTA of $4.3 million. This represents an approximate increase of 95% over the gross revenue for NUEDEXTA of $2.2 million in the third fiscal quarter of 2011.

In addition, based on preliminary results for the fourth fiscal quarter ended September 30, 2011, Avanir estimates that net cash used in operating activities for the fourth fiscal quarter of 2011 was between $13.5 million and $14.5 million, and total operating expenses for the fourth fiscal quarter were between $22.5 million and $23.5 million. Total operating expenses includes start-up costs related to the PRIME study of approximately $1.6 million and non-cash items such as stock-based compensation and depreciation.

As of September 30, 2011, Avanir had cash, cash equivalents and investments in securities totaling approximately $81.8 million, including cash and cash equivalents of approximately $79.5 million and restricted investments in securities of approximately $2.3 million.

Clinical Update

The company remains on track for enrolling the first patient into the PRIME study (Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis) before the end of calendar 2011. Avanir expects to enroll approximately 400 patients both in the U.S. and internationally. In recent weeks, more than 10 U.S. investigator sites have been activated and screening of prospective study patients is currently underway. The company anticipates activating European and other international study sites early in calendar 2012. Full details on the PRIME study can be found at www.clinicaltrials.gov.

Corporate Update

The Company announced that William Sibold, chief commercial officer, has, for personal reasons, tendered his resignation.

"Since starting at Avanir in the beginning of the year, Bill has been commuting from Boston to Southern California.  The commute has taken a significant toll on Bill and his family," said Keith Katkin, president and CEO of Avanir. "Bill's inability to relocate and his desire to spend more time with his family in addition to the opportunity to assume a leadership role at one of the world's largest biopharmaceutical companies led to his decision.  I would like to thank Bill for his contributions and wish him luck in his new role."

"Avanir and NUEDEXTA rival the best of the companies and products that I have worked with in my career. I have every confidence in the long term success of both," said Bill Sibold. "The impact of NUEDEXTA on PBA can be truly remarkable.  Significant progress has been made in setting the foundation for future growth and a great commercial team is in place. Leaving is a very difficult decision but I needed to make my family a priority. I congratulate the entire Avanir team for their accomplishments to date and wish them the best of luck."

Bill's last day with the company will be November 25, 2011.