Published: September 26, 2008
Indevus Announces Agreement With Teva to Develop Pagoclone for the Treatment of Stuttering
LEXINGTON, Mass., Sept. 26 /PRNewswire/ -- Indevus Pharmaceuticals, Inc.
(Nasdaq: IDEV) today announced that it has signed a development, license and
commercialization agreement with Teva Pharmaceutical Industries Ltd. for the
exclusive, worldwide rights to pagoclone. Indevus previously announced
promising data from its 8-week, placebo controlled, double-blind, multi-center
Phase II trial in patients with persistent stuttering which showed that
pagoclone produced a statistically significant benefit in multiple primary and
secondary stuttering endpoints compared to placebo. Pagoclone is a novel
member of the cyclopyrrolone class of compounds and acts as a gamma amino
butyric acid (GABA) selective receptor modulator.
Under the terms of the Agreement, which is subject to applicable
regulatory clearances and customary conditions, Indevus will conduct and Teva
will reimburse Indevus for its expenses for a Phase IIb study. The placebo-
controlled study will involve approximately 300 patients with stuttering in
the U.S. treated for a period of six months and is expected to commence
enrollment by Q1 2009.
Following the completion of a successful Phase IIb study, the Agreement
provides for Indevus to participate on a 50/50 basis with Teva in the U.S.,
sharing development and marketing costs, and splitting future profits, in
addition to receiving milestone payments. Under certain circumstances, either
party may convert the Agreement from the 50/50 arrangement to a royalty
structure where Teva will be responsible for all development and commercial
costs in the U.S. and Indevus would receive royalties on net sales, in
addition to milestones. In either case, if the arrangement continues, Teva
will be responsible for the conduct of the Phase III program.
For territories outside of the U.S., Teva will be responsible for all
future development and commercialization and Indevus will receive milestones
and royalties on net sales.
Under the 50/50 participation, Indevus could receive up to $92.5 million
(including the Phase IIb study expenses) in U.S. and European development
milestones and R&D reimbursement. In the event of a conversion to the royalty
structure, in addition to the $92.5 million of milestones and reimbursements,
Indevus could receive up to $50.0 million in U.S. based sales threshold
milestones.
"We are excited that we have partnered pagoclone with a leading
pharmaceutical company with a focus on central nervous system conditions,"
said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus.
"There are currently no approved drugs anywhere in the world for patients with
stuttering. Pagoclone has tremendous potential to become a highly significant
commercial product, as well as to provide a ground-breaking therapy to the
nearly three million Americans and millions of patients around the world who
are afflicted with this condition. The deal we have negotiated with Teva
allows us to conduct a definitive Phase IIb trial, funded by our partner. If
the trial is positive, we believe that both companies will have a unique
opportunity to commercialize the first pharmaceutical product for the millions
of patients who stutter."
About Indevus
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the acquisition, development, and commercialization of products to
treat conditions in urology and endocrinology. The Company's approved products
include SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) for
advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and
DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline
contains multiple compounds within the Company's core therapeutic areas in
addition to several partnered or partnerable programs. The most advanced
compounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R)
for male hypogonadism, PRO 2000 for the prevention of infection by HIV and
other sexually-transmitted pathogens, and the octreotide implant for
acromegaly and carcinoid syndrome.
About Pagoclone
Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor
agonist. In clinical studies in anxiety disorders, it has been shown to reduce
the symptoms of panic disorder and generalized anxiety disorder without
causing the sedation or withdrawal effects seen with benzodiazepine agents.
Pagoclone trials have enrolled over 1,500 patients to date. In early 2005,
Indevus was granted a new U.S. patent covering the use of pagoclone for the
treatment of stuttering.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, this
press release contains forward-looking statements that involve risks and
uncertainties that could cause the Company's actual results and financial
condition to differ materially from those anticipated by the forward-looking
statements. These risks and uncertainties are set forth in the Company's
filings under the Securities Act of 1933 and the Securities Exchange Act of
1934 under "Risk Factors" and elsewhere, and include, but are not limited to:
dependence on the success of SANCTURA, SANCTURA XR, NEBIDO, VANTAS and
SUPPRELIN LA; need for additional funds and corporate partners, including for
the development of our products; effectiveness of our sales force; competition
and its effect on pricing, spending, third-party relationships and revenues;
dependence on third parties for supplies, particularly for histrelin,
manufacturing, marketing, and clinical trials; risks associated with being a
manufacturer of some of our products; risks associated with contractual
agreements, particularly for the manufacture and co-promotion of SANCTURA and
SANCTURA XR and the manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR;
reliance on intellectual property and having limited patents and proprietary
rights; dependence on market exclusivity, changes in reimbursement policies
and/or rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and
any future products; acceptance by the healthcare community of our approved
products and product candidates; uncertainties relating to clinical trials,
regulatory approval and commercialization of our products, particularly
SANCTURA XR, NEBIDO, and VALSTAR; product liability and insurance
uncertainties; risks relating to the Redux-related litigation; history of
operating losses and expectation of future losses; uncertainties relating to
controls over financial reporting; valuation of our Common Stock; risks
related to repayment of debts; risks related to increased leverage; general
worldwide economic conditions and related uncertainties; and other risks.
Indevus undertakes no obligation to publicly update any forward- looking
statement, whether as a result of new information, future events or otherwise.
SOURCE Indevus Pharmaceuticals, Inc.
Copyright © 2012, PRNewswire
Copyright © 2012, NewsBlaze,
Daily News