Conference Call Scheduled for Today, May 4, 2009, at 8:30 a.m. Eastern Time
SAN DIEGO--(BUSINESS WIRE)--May. 4, 2009--
ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) today announced that it has
established a collaboration with Biovail Laboratories International SRL,
a subsidiary of Biovail Corporation, to co-develop and commercialize
pimavanserin, ACADIA’s proprietary and selective 5-HT2A inverse
agonist, in the United States and Canada. ACADIA retains rights to
pimavanserin in the rest of the world. Pimavanserin is a new chemical
entity (NCE) currently in Phase III development as a treatment for
Parkinson’s disease psychosis.
“This agreement provides Biovail with a late-stage NCE product with
strong intellectual property protection that is directly on target with
our specialty central nervous system focus,” said Bill Wells, Biovail’s
Chief Executive Officer. “Pimavanserin addresses a large unmet medical
need, and has the potential to make a significant difference in the
lives of the millions of men and women living with Parkinson’s disease.
We are delighted to be partnering with ACADIA to bring this innovative
treatment to market.”
The collaboration provides for the co-development and commercialization
of pimavanserin for multiple neurological and psychiatric indications,
including Parkinson’s disease psychosis (PDP) and Alzheimer’s disease
psychosis (ADP). ACADIA will continue to manage the ongoing Phase III
trials for PDP. Biovail will lead other development, manufacturing, and
commercialization efforts for pimavanserin, including activities
directed at ADP and other potential indications. Biovail is granted the
right to develop, manufacture, and commercialize pimavanserin in the
United States and Canada, while ACADIA retains rights to pimavanserin in
the rest of the world.
Under the terms of the collaboration, ACADIA is entitled to receive
aggregate payments, excluding royalties, of up to $395 million. These
include an upfront cash payment of $30 million, up to $160 million in
potential milestone payments associated with the successful completion
of clinical trials, regulatory submissions and approvals of pimavanserin
for PDP and ADP, up to $45 million in potential milestones should the
parties pursue a third indication, and up to $160 million in potential
milestones as certain sales thresholds are met. ACADIA also will be
entitled to receive a 15 percent royalty on annual net sales of
pimavanserin up to $100 million and a 20 percent royalty on annual net
sales over $100 million. In addition to product royalties, ACADIA has
the option to co-promote pimavanserin in the United States. Biovail will
be responsible for all future costs associated with the development,
manufacturing, and commercialization of pimavanserin in all indications
with the exception of specified ongoing PDP studies, which will continue
to be funded by ACADIA.
“Our alliance with Biovail not only helps us to advance pimavanserin as
a potential first-in-class therapy for Parkinson’s disease psychosis,
but also enables us to broaden the pimavanserin development program to
Alzheimer’s disease psychosis,” said Uli Hacksell, Ph.D., Chief
Executive Officer of ACADIA. “Biovail’s strong commitment to
establishing a leading North American CNS specialty franchise makes them
an ideal partner for ACADIA. Together with Biovail, we have the
opportunity to improve the lives of patients suffering from neurological
and psychiatric disorders that lack effective therapy options.”
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, May 4, 2009, at
8:30 a.m. Eastern Time to discuss this collaboration. The conference
call can be accessed by dialing 866-277-1181 for participants in the
U.S. or Canada and 617-597-5358 for international callers (reference
passcode 13099931). A telephone replay of the conference call may be
accessed through May 18, 2009 by dialing 888-286-8010 for callers in the
U.S. or Canada and 617-801-6888 for international callers (reference
passcode 92339018). The conference call also will be webcast live on
ACADIA’s website, www.acadia-pharm.com,
under the investors section and will be archived there until May 18,
2009.
About Pimavanserin
Pimavanserin is a new chemical entity discovered by ACADIA and currently
being evaluated in two Phase III pivotal trials as a treatment for PDP.
Pimavanserin blocks the activity of the 5-HT2A receptor, a
drug target that plays an important role in the treatment of various
neuropsychiatric disorders.
About Parkinson’s Disease Psychosis (PDP)
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 often
disrupts their ability to perform many of the activities of daily living
that keeps them independent and active. As a result, PDP is associated
with increased caregiver burden, nursing home placement, and increased
mortality.
About Alzheimer’s Disease Psychosis (ADP)
According to the Alzheimer’s Association, approximately 5.3 million
people in the United States have Alzheimer’s disease. While the criteria
for diagnosing Alzheimer’s disease are mostly focused on cognitive
deficits, it is the behavioral and neuropsychiatric symptoms that are
often troublesome for caregivers and lead to poor quality of life for
patients. Between 25 and 50 percent of patients with Alzheimer’s disease
may develop ADP, which is characterized by disturbing hallucinations and
delusions. There currently is no therapy in the United States approved
for the treatment of ADP. The presence of psychotic symptoms in patients
with Alzheimer’s disease is associated with more rapid cognitive and
functional decline and increased institutionalization.
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 is developing a portfolio
consisting of five product candidates, including pimavanserin in Phase
III for Parkinson’s disease psychosis, a product candidate in Phase II
for chronic pain and a product candidate in Phase I for glaucoma, both
in collaboration with Allergan, and two programs 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. The Company 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.
ACADIA Forward-Looking Statements
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 ACADIA’s
drug discovery and development programs, including clinical trials and
the results therefrom, and the benefits to be derived from ACADIA’s
product candidates, in each case including pimavanserin, the parties’
responsibilities under the collaboration, potential milestone payments
and royalties payable pursuant to the collaboration, the potential
impact of the collaboration on ACADIA’s development programs, and the
development and clinical plans for pimavanserin. 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. 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 ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director,
Investor Relations
Uli Hacksell, Chief Executive Officer
(858)
558-2871