FDA Decision Highlights Significant Unmet Need in the Treatment ofParkinson’s Disease Psychosis
SAN DIEGO—(BUSINESS WIRE)—Sep. 2, 2014—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in neurological and related centralnervous system disorders, today announced that the U.S. Food and DrugAdministration (FDA) has granted Breakthrough Therapy designation toNUPLAZID™ (pimavanserin) for the treatment of Parkinson’s diseasepsychosis. NUPLAZID is a selective serotonin inverse agonist and, ifapproved, will establish a new and distinctly different pharmacologicalapproach to treating psychosis. NUPLAZID has successfully completed apivotal Phase III trial in Parkinson’s disease psychosis, which the FDAhas agreed can serve as the basis, together with supportive data fromother studies, for a New Drug Application (NDA). ACADIA plans to submitthe NUPLAZID NDA to the FDA near the end of this year.
“The hallucinations and delusions in Parkinson’s disease psychosis aredevastating to patients and contribute to a dramatic rise in caregiverburden,” said Joyce Oberdorf, President and Chief Executive Officer ofthe National Parkinson Foundation. “Parkinson’s disease psychosis is aleading cause of nursing home placement for Parkinson’s patients and,with no FDA-approved therapy for this serious condition, there is agreat unmet medical need for an effective, safe, and well-toleratedtreatment option for patients.”
“The Breakthrough Therapy designation for NUPLAZID reinforces the urgentneed for a treatment for patients with Parkinson’s disease psychosis,”said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “NUPLAZIDrepresents a potential new class of psychosis medication and could bethe first drug approved in the United States for patients withParkinson’s disease psychosis.”
The Breakthrough Therapy designation was created by the FDA to expeditethe development and review of drugs that are intended to treat seriousor life-threatening conditions. For indications without an approvedtherapy, drugs qualifying for this designation must show a substantialand clinically meaningful effect on an important outcome when comparedwith placebo. The Breakthrough Therapy designation is distinct frompriority review, which can also be granted to the same drug if therelevant criteria are met. The FDA informs the applicant of a standardor priority review designation within 60 days of the receipt of theoriginal NDA.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2A receptorsbelieved to play an important role in psychosis. ACADIA has reportedpositive Phase III trial results with NUPLAZID, which has the potentialto be the first drug approved in the United States for psychosisassociated with Parkinson’s disease. NUPLAZID is administered orallyonce-a-day. ACADIA discovered NUPLAZID and holds worldwide rights tothis new chemical entity. The trade name NUPLAZID has been provisionallyaccepted by the FDA.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation (www.parkinson.org),about one million people in the United States and from four to sixmillion people worldwide suffer from Parkinson’s disease. Parkinson’sdisease psychosis (PDP) is a debilitating disorder that occurs in anestimated 40 percent of Parkinson’s patients. Currently, there is noFDA-approved therapy to treat PDP in the United States. PDP, whichcommonly consists of visual hallucinations and delusions, substantiallycontributes to the burden of Parkinson’s disease and deeply affects thequality of life of patients. PDP also is associated with increasedcaregiver stress and burden, nursing home placement, and increasedmorbidity and mortality. There is a large unmet medical need for newtherapies that will effectively treat PDP without compromising motorcontrol in patients with Parkinson’s disease.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin neurological and related central nervous system disorders. ACADIA hasa pipeline of product candidates led by NUPLAZID (pimavanserin), forwhich we have reported positive Phase III trial results in Parkinson’sdisease psychosis and which has the potential to be the first drugapproved in the United States for this disorder. We are currentlycompleting NDA-enabling clinical and manufacturing activities forNUPLAZID and are planning to submit an NDA to the FDA near the end ofthis year. Pimavanserin is also in Phase II development for Alzheimer’sdisease psychosis and has successfully completed a Phase II trial inschizophrenia. ACADIA also has clinical-stage programs for chronic painand glaucoma in collaboration with Allergan, Inc. and two preclinicalprograms directed at Parkinson’s disease and other neurologicaldisorders. All product candidates are small molecules that emanate frominternal discoveries. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the timing of the submission of anNDA for NUPLAZID for PDP; the potential for NUPLAZID to be the firstdrug approved in the United States for PDP, if approved at all; theapproval of NUPLAZID for PDP establishing a new and differentpharmacological approach to treating psychosis; the progress, timing andresults of ACADIA’s drug discovery and development programs, eitheralone or with a partner, including the progress and expected timing ofclinical trials; and the progress of ACADIA’s NDA-enabling clinical andmanufacturing activities. These statements are only predictions based oncurrent information and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially from thoseprojected in any of such statements due to various factors, includingthe risks and uncertainties inherent in drug discovery, development,approval, and commercialization, and collaborations with others, and thefact that past results of clinical trials may not be indicative offuture trial results. For a discussion of these and other factors,please refer to ACADIA’s annual report on Form 10-K for the year endedDecember 31, 2013 as well as ACADIA’s subsequent filings with theSecurities and Exchange Commission. You are cautioned not to place unduereliance on these forward-looking statements, which speak only as of thedate hereof. This caution is made under the safe harbor provisions ofthe Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof, except as required by law.
Source: ACADIA Pharmaceuticals Inc.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
UliHacksell, Ph.D., Chief Executive Officer
Lisa Barthelemy,Director of Investor Relations
(858) 558-2871
or
MediaContact:
Chandler Chicco Companies
David Polk
(310)309-1029 or (805) 428-5775