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 maria.armental@wsj.com
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