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morning all. 09:00:34 Today IDEV PRESS RELEASE: Indevus and FDA Agree on Path Forward for NEBIDO(R)


Existing European Data Will Be Used for NDA Resubmission Planned For First
Quarter 2009


LEXINGTON, Mass., Sept. 26 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals,
Inc. (Nasdaq: IDEV) announced today that it has reached agreement with the U.S.
Food and Drug Administration (FDA) with regard to the additional data and risk
management strategy that will lead to re-submission (complete response) of the
New Drug Application (NDA) for NEBIDO(R) in the first quarter of calendar 2009.
The re-submission database will include experience from over 14,000 injections
in more than 2,600 patients, all of which come from existing clinical trials
conducted in the U.S. and post-marketing studies that have been conducted in
Europe. FDA stated that the number of patients and the number of injections of
testosterone undecanoate from these studies appear to provide an adequate size
database to determine the precise incidence of serious post-injection,
oil-based reactions.


Indevus and FDA also agreed on an education plan to minimize the risks
associated with the clinical use of testosterone undecanoate intramuscular
injection, namely, to reduce the incidence and/or severity of the serious oil-
based reactions. Further, Indevus and FDA agreed to obtain skin-testing data
to characterize an allergic component to the drug or any of its excipients in
certain patients. Indevus has also agreed to conduct a large, simple post-
marketing study of the safety of NEBIDO in approximately 10,000 patients.


"We are very pleased that we can provide to FDA additional data from existing
clinical trials to satisfy FDA's desire to understand the incidence of these
rare oil-based reactions, without the need to conduct new clinical trials prior
to resubmission or approval," stated Glenn L. Cooper, M.D., chairman and chief
executive officer of Indevus. "FDA also agreed with our outline of the
proposed risk mitigation plans that included appropriate labeling description
of intramuscular injection technique, adequate labeling information regarding
allergic and oil-based reactions, and the commitment to conduct a large, simple
post-marketing study. Risk mitigation plans are now commonly added to approval
of new drugs and our agreed plans are consistent with FDA's new initiatives for
the management of safety of new drugs. Given a six month FDA review time,
assuming approval, we will be in a position to launch NEBIDO with our sales
force in the fourth quarter of calendar 2009. We remain enthusiastic about the
marketplace opportunity for a long-acting injectable testosterone therapy and
we expect the introduction of NEBIDO to have a significant positive impact on
the Company's business plan."

About NEBIDO(R)


NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate
under development for the treatment of male hypogonadism. NEBIDO is expected to
be the first long-acting testosterone preparation available in the U.S. in the
growing market for testosterone replacement therapies. Indevus acquired U.S.
rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

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.

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.


Contact:
Michael W. Rogers Robin L. DeCarlo
EVP and Chief Financial Officer Director, Corporate Communications
[phone] [phone]


SOURCE Indevus Pharmaceuticals, Inc.


/CONTACT: Michael W. Rogers, EVP and Chief Financial Officer,
[phone], or Robin L. DeCarlo, Director, Corporate Communications,
[phone], both of Indevus Pharmaceuticals, Inc.
/Web site: http://www.indevus.com


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(END) Dow Jones Newswires

09-26-08 0900ET

09:00 092608