Acadia Pharmaceuticals Delays Seeking Approval of Parkinson's Drug; CEO Resigns -- 3rd Update

By Maria Armental

Citing mistakes, Acadia Pharmaceuticals Inc. (ACAD) on Wednesday announced a top management shakeup and said it won't seek regulatory approval for its lead drug candidate until the second half of the year.

Interim Chief Executive Stephen R. Davis, who on Wednesday took the company's reins, said in a conference call with analysts the company needed more time to shore up production and supply operations before seeking approval to commercialize its candidate treatment pimavanserin, which would be sold as Nuplazid to treat Parkinson's disease psychosis. The Food and Drug Administration granted the drug breakthrough therapy designation last year, which means the FDA will act on the application within 60 days of receipt.

Acadia had planned to file a new drug application in the first quarter, a date the company when it released its fourth-quarter results on Feb. 26.

"Just to be clear, this has nothing to do with pimavanserin itself. It has nothing to do with the formulation of the drug or the synthesis of the drug," Mr. Davis said during the conference call Wednesday afternoon. "This is simply a matter of having the correct processes and systems in place" as Acadia transitions from a clinical-stage to a development-stage company.

"Speaking quite frankly, the company didn't start the process early enough to get those things in place," Mr. Davis said.

"Obviously mistakes were made, the company should have been better prepared," he said.

Under the terms of an agreement with longtime Chief Executive Uli Hacksell, who on Wednesday resigned from his post and the company's board effective immediately, Acadia will pay Mr. Hacksell an initial $36,000 and an additional $580,000 in monthly installments for consulting work over the next 1 1/2 years.

No reason was specified for Mr. Hacksell's resignation in a filing with the Securities and Exchange Commission, but in a news release, Acadia said Mr. Hacksell had retired.

Mr. Davis said Mr. Hacksell had discussed with board "for some time" retiring.

Asked about Mr. Hacksell giving up his board seat as well, Mr. Davis said, "When a CEO leaves the organization, it's very common that they also step off the board."

The 53-year-old Mr. Davis, a pharmaceutical industry veteran with more than 20 years of experience, joined Acadia in July as executive vice president, chief financial officer and chief business officer.

Shares plunged nearly 30% to $31.52 in recent after-hours trading.

Write to Maria Armental at [e-mail]

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