Indevus Pharmaceuticals,
Inc. (Nasdaq: IDEV) 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.
Indevus Pharmaceuticals, Inc.
indevus
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