Avanir Pharmaceuticals Inc. is looking to expand use of its core drug overseas.
The Aliso Viejo-based drug maker said last week that it applied for European regulatory approval for Nuedexta.
The drug is used to treat a rare neurological disorder called psuedobulbar affect, which is marked by uncontrollable fits of laughing or crying. About 1.5 million to 2 million people in the U.S. suffer from psuedobulbar affect, and some observers contend it’s underdiagnosed because doctors are unfamiliar with the disorder.
The Food and Drug Administration cleared Nuedexta last year, making it the only federally approved drug for treating the disorder.
Avanir began selling Nuedexta, which was previously known as Zenvia, here in Feburary.
“Important Step”
The drug maker’s new regulatory filing “is an important step toward making Nuedexta available for PBA patients in Europe,” said Joao Siffert, Avanir’s senior vice president of research and development.
The application follows a recent round of clinical trials in Europe.
“The question there was whether the clinical studies that were completed would be sufficient for approval and reimbursement, and then the discussion with the regulators went well,” said Gregory Wade, a San Francisco-based analyst for Los Angeles’ Wedbush Securities, about the timing of the regulatory application.
Nuedexta’s regulatory filing in Europe is still unlikely “to do much for the stock,” Wade said, adding that investors are looking for the drug to bring “top- and bottom-line growth in the United States.”
Avanir’s shares are down some 28% since the beginning of the year with a recent market value of about $353 million.
Guidance
Avanir also gave revenue guidance for Nuedexta.
The company expects revenue of $4.3 million from sales of the drug for the September quarter, up about 95% from the prior period. The drug came on the U.S. market in February.
Analyst estimates put Nuedexta sales at $4.05 million for the quarter.
Wall Street expects Avanir to post a net loss of $61.7 million on revenue of $10 million for the 12 months through Sept. 30, which is the end of the company’s fiscal year.
Avanir said that it had cash, equivalents and security investments of $81.8 million as of Sept. 30.
The drug maker is due to release complete financial results Nov. 28.
Avanir also announced that William Sibold resigned his position as chief commercial officer for personal reasons. Sibold’s last day at Avanir will be Nov. 25.
Sibold, a resident of the Boston area, had been commuting to Southern California, and it “has taken a significant toll on Bill and his family,” Avanir Chief Executive Keith Katkin said.
Sibold joined Avanir in April. He was previously with Cambridge, Mass.-based drug maker Biogen Idec Inc., serving as a senior vice president for U.S. commercial operations.
While Avanir has not announced plans to replace Sibold, the company has “made significant progress in setting the foundation for future growth and a great commercial team is in place” for Nuedexta, Sibold said.
Moving Ahead
Avanir also is moving forward on development of another drug. The company said it remains on track for enrolling its first patient in a study of its AVP-923 drug candidate for treating central neuropathic pain in multiple sclerosis. Avanir said it plans to enroll about 400 patients both in the U.S. and internationally, and that it will start studies in Europe and other markets next year.
