SAN DIEGO--(BUSINESS WIRE)--Oct. 6, 2009--
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
utilizing innovative technology to fuel drug discovery and clinical
development of novel treatments for central nervous system disorders,
today provided an update on its Phase III program with pimavanserin for
Parkinson’s disease psychosis (PDP), which is being pursued in
collaboration with Biovail Laboratories International SRL (“Biovail”), a
subsidiary of Biovail Corporation. Following the announcement on
September 1st of disappointing top-line results from the
first Phase III PDP trial, ACADIA and Biovail remain committed to the
successful development of pimavanserin and have established a
development strategy that they believe will strengthen the PDP program.
The parties also intend to pursue adjunctive therapy with pimavanserin
for schizophrenia as a third indication in the collaboration.
“We remain enthusiastic about pimavanserin’s prospects in a number of
specialty CNS indications, including schizophrenia where existing data
for the molecule as co-therapy are compelling,” said Bill Wells,
Biovail’s Chief Executive Officer. “The steps we’re taking today are
designed to fully exploit pimavanserin’s potential and to bring this
novel therapeutic to market as quickly as possible.”
ACADIA has conducted a substantial portion of the analysis of the data
from its first Phase III PDP trial with pimavanserin (-012 Study). While
the -012 Study did not meet its primary endpoint of antipsychotic
efficacy and had a larger than expected placebo response, signals of
antipsychotic efficacy were observed in the pimavanserin 40 mg study
arm. These signals were most prominent in the United States portion of
the study, which comprised nearly one-half of the patients in the trial.
The efficacy signals also were supported by additional secondary and
exploratory measures, including efficacy measures and favorable outcomes
in assessments of sleep and caregiver burden. Several findings from the
-012 Study will be used in the design of future PDP studies to help
mitigate the placebo response and to increase the chances of success.
These findings relate to dose selection, the method and application of
ratings, and other study design elements.
ACADIA and Biovail have agreed on a development strategy for PDP that
involves using the findings from the -012 Study together with those from
the second, ongoing Phase III trial (-014 Study), which is testing 10 mg
and 20 mg doses of pimavanserin, to arrive at an enhanced study design
that may be used in new Phase III trials. Accordingly, the ongoing -014
Study will be concluded at its current enrollment level (about 120
patients) to allow for the analysis of data as soon as practicable.
Meanwhile, the parties will begin planning for a new Phase III PDP trial
using a 40 mg dose of pimavanserin. Consistent with the terms of the
original collaboration agreement, Biovail will be responsible for the
cost of this third Phase III trial. This study is expected to start in
the first half of 2010. ACADIA will continue its ongoing open-label
safety extension studies in patients with PDP.
In addition, Biovail intends to pursue adjunctive therapy with
pimavanserin for schizophrenia as a third indication in the
collaboration. Alzheimer’s disease psychosis (ADP) remains the second
indication provided for in the collaboration. The parties currently
intend to focus their efforts on the PDP and schizophrenia programs, but
also are moving forward with planning for an initial study in ADP.
“Together, ACADIA and Biovail are pursuing a development strategy that
strengthens our path forward in PDP while opening up potential
opportunities for pimavanserin to address unmet medical needs of
patients suffering from other psychiatric and neurological disorders,
including schizophrenia and ADP,” said Uli Hacksell, Ph.D., Chief
Executive Officer of ACADIA.
While pursuing its development strategy for pimavanserin, ACADIA intends
to implement cost-saving measures during October to further streamline
its operations, reduce its internal operating expenses, and provide
added financial flexibility. ACADIA currently anticipates that its cash,
investment securities and payments from its collaborations before taking
any cost-saving measures will be sufficient to fund its operations into
the first half of 2011, and that these measures will further extend
ACADIA’s cash runway.
Pimavanserin is a 5-HT2A receptor inverse agonist in Phase
III development as a treatment for Parkinson’s disease psychosis. This
new chemical entity, which was discovered by ACADIA, is a small molecule
that can be taken orally as a tablet once-a-day. ACADIA and Biovail have
formed a collaboration to co-develop and commercialize pimavanserin for
neurological and psychiatric indications in the United States and
Canada. ACADIA retains rights to pimavanserin in the rest of the world.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, over 1.5 million people
in the United States suffer from Parkinson’s disease. Up to 40 percent
of patients with Parkinson’s disease may develop psychotic symptoms,
commonly consisting of visual hallucinations and delusions. Currently
there is no therapy in the United States approved to treat PDP. The
development of psychosis in patients with Parkinson’s disease is
associated with increased caregiver burden, nursing home placement, and
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to
fuel drug discovery and clinical development of novel treatments for
central nervous system disorders. ACADIA’s product candidates include
pimavanserin in Phase III for Parkinson’s disease psychosis in
collaboration with Biovail, a product candidate in Phase II for chronic
pain and a product candidate in Phase I for glaucoma, both in
collaboration with Allergan, as well as additional compounds in
IND-track development. All of the product candidates in ACADIA’s
pipeline emanate from discoveries made using its proprietary drug
discovery platform. ACADIA maintains a website at www.acadia-pharm.com
to which ACADIA regularly posts copies of its press releases as well as
additional information and through which interested parties can
subscribe to receive email alerts.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company engaged in the
formulation, clinical testing, registration, manufacture, and
commercialization of pharmaceutical products. Biovail is focused on the
development and commercialization of medicines that address unmet
medical needs in niche specialty central nervous system markets. For
more information about Biovail, visit the company’s web site at www.biovail.com.
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include but are
not limited to statements related to the progress and timing of drug
discovery and development programs, including ongoing and future
clinical trials and the results and regulatory approvals resulting
therefrom, the potential of and the benefits to be derived from product
candidates, in each case including pimavanserin, indications to be
pursued under the collaboration, the length of ACADIA’s cash runway, and
the benefits to be provided by cost-saving measures to be undertaken.
These statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties. Actual
events or results may differ materially from those projected in any of
such statements due to various factors, including the risks and
uncertainties inherent in drug discovery, development, commercialization
and collaborations with others, and the fact that past results of
clinical trials may not be indicative of further trial results. For a
discussion of these and other factors, please refer to ACADIA’s annual
report on Form 10-K for the year ended December 31, 2008 as well as
ACADIA’s subsequent filings with the Securities and Exchange Commission
and to Biovail’s annual report on Form 20-F for the year ended December
31, 2008. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. All forward-looking statements
are qualified in their entirety by this cautionary statement and neither
ACADIA nor Biovail undertakes any obligation to revise or update this
press release to reflect events or circumstances after the date hereof,
except as required by law.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director,
Uli Hacksell, Ph.D., Chief Executive