January 26, 2016
By Alex Keown, BioSpace.com Breaking News Staff
ALISO VIEJO, Calif. – Rohan Palekar, the new chief executive officer of Avanir Pharmaceuticals , has a vision to guide his company forward as Avanir becomes a multi-product provider of central nervous system (CNS) therapies.
Avanir, a division of Otsuka America, has one approved product, Nuedexta, for the treatment of pseudobulbar affect, a neurological disorder often characterized by involuntary crying or uncontrollable laughter. Additionally, the company has a migraine treatment, AVP-825, which is set for review by the U.S. Food and Drug Administration. In an exclusive interview with BioSpace , Palekar said his priorities are focused on bringing strong CNS candidates through clinical trials and into the market place.
“We’re building a pipeline that will set us up to be a long-term CNS company,” Palekar said. “Our focus is to go into indications where there is an unmet need. We’re trying to get to those patients who don’t have anything to go to and are cycling between treatments.”
AVP-825, if approved, will also have a unique delivery mechanism. The mechanism is akin to traditional nasal inhalants, but the delivery actually uses the patient’s own breath to blow the medication up the nose. By using the patient’s breath, Palekar said, more medicine will actually get to where it’s supposed to go rather than ending up in the patient’s throat.
“By using the body’s properties, it will cause the throat to close when blown and deliver more drug to the nasal cavity than traditional nasal sprays,” Palekar said.
Other unmet needs Avanir is targeting include treating agitation in Alzheimer’s and other dementia patients with a new generation of Nuedexta that require lower doses in patients.
“This is a huge unmet area. There are currently no approved drugs on the market. Agitation is the number one cause for institutionalization in the United States,” Palekar said. He added it is difficult for the loved ones of an agitated dementia patient to provide in-home health care, but the new drug, if approved, could help control the level of institutionalization.
Avanir’s parent company, Otsuka, also has a phase III trial for agitation in Alzheimer’s but targets a different function, Palekar said.
“This is allowing us to take multiple shots on goal. If we can do anything to help those patients, what they go through, it’s awful,” he said.
Additionally, the company completed a Phase II trial for a treatment for treatment resistant depression, which Palekar also described as an unmet need. He said most of the current approved treatments target the same mechanism, the glutamate pathway for depression, but Avanir believes it has found a different pathway for treatment. Palekar said the company will have to wait for the trial data to see if they are on the correct path.
The company is also enrolling volunteers in a trial for treating residual symptoms of schizophrenia such as apathy.
Palekar said the goal of Avanir is to build a strong franchise in mood and behavior disorders and he believes the company is well on its way.
Palekar, who has more than 20 years of experience in drug development and commercialization, replaced outgoing CEO Keith A. Katkin, who served as president and CEO since March 2007 and will transition to the board of directors for Avanir. Palekar joined Avanir shortly after the commercial launch of Nuedexta and has since helped the company grow to new levels.
“We now have revenue in the hundreds of millions of dollars. Building this company has been fun and energizing. I’m in a new role now and the question is ‘how do we take Avanir to the next level?’” he said.
With growing revenue streams, the company is also expanding as well. Palekar anticipates the company will have approximately 600 employees by the end of the year. It’s critical for new hires to fit the company culture and are dedicated to achieving treatments for CNS problems, he said.
“It’s all about the patients at the end of the day. I feel pretty strongly about that,” Palekar said.
