March 12, 2015
By Mark Terry, BioSpace.com Breaking News Staff
San Diego-based Acadia Pharmaceuticals simultaneously announced Wednesday that it would delay submitting its main product for FDA approval and that the company’s Chief Executive Officer, Uli Hacksell, had resigned, effective immediately. Shortly after the announcement, share prices dropped more than 22 percent in after-hours trading on Wednesday.
Acadia originally planned to submit the New Drug Application (NDA) for Nuplazid (pimavanserin) in the first quarter of 2015. The compound is a selective serotonin inverse agonist that preferentially targets 5-HT2A receptors that are thought to play a role in psychosis. The drug is being developed and tested for the treatment of psychosis related to Parkinson’s disease. On Mar. 11, 2015 the company announced it had shifted its NDA to the second half of 2015.
“We have concluded that additional time is needed to complete the readiness of our commercial manufacturing systems,” said Steve Davis, interim chief executive of Acadia in a statement. “While we are very disappointed with the change in timing, we believe that this is the prudent course of action to take. We are working expeditiously to ensure that our systems are robust and ready for FDA review and commercial launch.”
Acadia also announced on Wednesday that Uli Hacksell had retired as chief executive officer and a member of the board of directors, effective immediately. Steve Davis, executive vice president, chief financial officer and chief business officer, was made interim chief executive officer. Hacksell will act as a special advisor during the transition period.
“Under Uli’s leadership, Acadia has grown from a small startup to a fast growing biopharmaceutical company with innovative drug candidates such as Nuplazid that has the potential to transform the treatment of psychosis in a range of neurological and psychiatric disorders,” said Leslie Iversen, chairman of the company’s board in a statement. “We thank Uli for his significant contributions to the Company over the last 16 years.”
Acadia stock has been on a steady increase since November 2012, when it sold at $2.27. On Tuesday, March 10 at close of day stock prices were $45.88. The dual announcements caused a sudden drop to $34.98. It has recovered, for the most part, currently selling at $44.76.
Observers noted that on Tuesday, March 10, after the company announced it was bailing out of two conferences, its stock jumped, likely because investors expected an imminent acquisition.
Prices dropped when the Nuplazid NDA was delayed. Davis has indicated that the reason for the delay has to do with delays in scaling up quality assurance and manufacturing capabilities, as opposed to any problems with the drug itself.
“This has nothing to do with the formulation or the synthesis of the drug,” Davis said in a statement, and shouldn’t “limit the approval of the drug once [we] have those systems in place.”
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?
