Acadia drug approval could clear way for Axovant dementia therapy

• 29 Apr 2016

REUTERS: An imminent ruling on Acadia Pharmaceuticals Inc's drug for Parkinson's disease psychosis is being closely watched by a Bermuda-based company with a similar treatment for dementia.

Axovant Sciences Ltd's experimental drug for Lewy body dementia - after Alzheimer's, the most common form of progressive dementia - would benefit from the approval of Acadia's drug, Axovant's chief development officer told Reuters.

The decision by the U.S. Food and Drug Administration is due by May 1. Analysts expect a positive ruling after the drug won the backing of an independent panel of experts.

Both companies' drugs are designed to treat conditions that have no specific pharmaceutical therapy approved by the FDA. The drugs target the 5-HT2A receptor in the brain, which is linked with neuropsychiatric disturbances.

But while San Diego-based Acadia's Nuplazid seeks to treat Parkinson's disease psychosis (PDP), Axovant is targeting an oft-misunderstood form of dementia that affects 1.4 million Americans.

Lewy body dementia, or LBD, is characterized by a build-up of abnormal proteins called Lewy bodies in parts of the brain that control cognition, movement and behavior.

Since the symptoms resemble those of better-known diseases such as Alzheimer's and Parkinson's, LBD is underdiagnosed.

In fact, conclusive diagnosis is possible only after death; an autopsy of comedian Robin Williams found the condition.

Dr. Lawrence Friedhoff, Axovant's chief development officer, said approval of Acadia's drug would open a regulatory pathway for a class of drugs that would also include his own company's treatment, called Nelotanserin.

Since the meeting of the panel of experts on March 29, shares of Acadia and Axovant have risen about 25 percent and 17 percent respectively.

"If Acadia is successful with Nuplazid, that would have a positive read-through for Nelotanserin," Friedhoff said in an interview. "It would suggest that we have a good chance."

Friedhoff has decades of experience in the field. A former executive at Bristol-Myers Squibb Co and Eisai Co Ltd, he has sometimes been called the 'Father of Aricept' for his work in developing the top-selling drug for Alzheimer's.

Nelotanserin is being tested in two mid-stage studies to treat visual hallucinations and REM sleep behavior disorder. The earliest the drug be approved is 2019, according to Axovant.

Acadia's Nuplazid is expected to generate peak sales of US$300 million, according to data compiled by Thomson Reuters Cortellis.

The potential for Nelotanserin is even greater.

Piper Jaffray analyst Charles Duncan said the drug's addressable population was about quadruple that of Nuplazid as a treatment for Parkinson's disease psychosis alone. Acadia could also test its drug on LBD patients, he added.

"Lewy body dementia is one of the most interesting, under-recognized disorders," said Duncan. "I suspect you'll see Acadia go there too."

(Reporting by Natalie Grover in Bengaluru; Editing by Robin Paxton and Ted Kerr)

http://www.channelnewsasia.com/news/health/acadia-drug-approval-coul/2741148.html