Conference Call Scheduled for Today, May 4, 2009, at 8:30 a.m.
Eastern Time
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.
