Indevus Receives Approvable Letter from FDA for NEBIDO(R)

Company Announces Revised Operating Plan to Respond to NEBIDO Delay

LEXINGTON, Mass., June 30 /PRNewswire-FirstCall/ -- Indevus
Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that it has received
an approvable letter from the U.S. Food and Drug Administration (FDA) for
NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in
August 2007. The letter, received on June 27, 2008, indicated that the
application may be approved if the Company is able to adequately respond to
certain clinical deficiencies related to the product. The letter generally
confirmed the Company's previously-announced indications from the FDA based
on telephone discussions.

The FDA has expressed a concern about a relatively small number of
patients in European post-marketing use who have experienced respiratory
symptoms immediately following the intramuscular injection of NEBIDO 1000
mg, 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used
in the United States). The Company believes and the FDA concurs that the
reaction is likely the result of a small amount of the oily solution
immediately entering the vascular system from the injection site, a known,
rare complication of oil-based depot injections.

The phenomenon is characterized by short-term reactions involving an
urge to cough, coughing episodes or a shortness of breath. In rare cases
the reaction has been classified as serious or the patient experiences
other symptoms such as dizziness, flushing or fainting. In the Company's
U.S. clinical trials of NEBIDO 750 mg (3 cc injection volume), the proposed
dose in the U.S., there was a single, mild, non-serious case of oil-based
cough observed. In addition, the FDA believes that four cases in the
European post-marketing experience may have an allergic, anaphylactoid
component, although the Company believes these cases were improperly
classified and represent the same oil-based phenomenon.

The FDA has requested the Company address these clinical deficiencies
by providing detailed safety information from clinical studies to determine
the precise incidence of serious post-injection oil-based reactions and
allergic reactions. Specifically, the FDA has requested follow-up data from
the on-going U.S. and European studies in which patients are being treated
with NEBIDO on an extended basis. A majority of these trials are scheduled
to be completed within twelve months. The FDA stated that depending on the
findings, the number of subjects and the number of injections of
testosterone undecanoate from the studies listed above, the safety database
may need to include data from additional clinical studies. They have
requested that the Company propose the size of the safety database (i.e.,
total number of subjects exposed to testosterone undecanoate intramuscular
injection and total number of injections) and the rationale for the size of
the proposed safety database.

FDA has also requested the Company provide a 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 and has requested certain in vitro and skin-testing
data to exclude an allergic component to the drug or some of its
excipients.

Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus
stated, "We believe that NEBIDO is a safe and effective drug for its
intended use and continue to be disappointed that the FDA was not willing
to approve the drug at this time with adequate labeling of the oil-based
reactions and how to minimize them with proper injection technique.
However, we are encouraged that this approvable letter provides a road map
for the product's eventual approval. We will work with the FDA and our
partner, Bayer Schering Pharma AG, to respond to the approvable letter and
devise a plan to address the deficiencies. While the FDA has not
specifically requested additional clinical studies, we believe that an
additional study will likely be required to demonstrate that NEBIDO 750 mg
(3 cc volume) administered with careful and proper intramuscular injection
technique, has an acceptably low incidence of oil-based reactions to gain
approval. In addition, we are pleased that FDA has provided guidance on how
we can demonstrate that the product does not cause allergic reactions. We
hope to be able to articulate a development plan to address FDA concerns
within the next few months, and for now are maintaining our previous
guidance that it may take the Company approximately 18 months to re-submit
the revised NDA. We will communicate specific guidance on clinical plans
and timelines when they are available."

Revised Operating Plan

In view of the NEBIDO regulatory delay, the Company's Board of
Directors has approved a revised operating plan that more appropriately
aligns the cost structure to the Company's revenue projections and
development opportunities. The new operating plan provides for 1)
aggressive support and top-line growth of marketed products, VANTAS(R) and
SUPPRELIN(R) LA, 2) aggressive support for the launch of VALSTAR(TM) for
bladder cancer later this year, 3) continued co-promotion with Allergan of
SANCTURA(R) and SANCTURA XR(TM) with the urology sales force through March
2009, 4) initiation of Phase III trials for the six-month octreotide
implant for acromegaly, and 5) significant reduction in operating expenses
through a combination of headcount reductions of approximately 12 percent
of employees, primarily at the corporate and administrative levels at the
Lexington, Massachusetts headquarters, and reduction of other operating
expenses.

Dr. Cooper said, "We have made the difficult but necessary decision to
reduce the operating expenses and cash burn of the Company and intend to be
vigilant in managing expenses through this difficult period. Under our
revised plan, in fiscal 2009 we expect that our operating cash burn will
fall to approximately $10 million per quarter on total revenues for the
year of approximately $88 to $95 million. This is a significant improvement
compared to our recent average operating cash burn of approximately $18 to
$20 million per quarter and our expected revenues for fiscal 2008 of
approximately $70 million. Our current revised plan does not give effect to
additional NEBIDO studies as their size, duration and expense are not yet
final. In conjunction with implementation of this revised operating plan,
the Company anticipates recording an aggregate restructuring charge of
approximately $3 to $4 million in the third fiscal quarter.

"While the NEBIDO delay is unfortunate, the Company remains strong and
is committed to the patients and physicians who use and prescribe our
products for urological and endocrine disorders. We are highly focused on
driving revenue growth for our marketed products SANCTURA XR, VANTAS and
SUPPRELIN LA and our organization is also preparing to launch VALSTAR,
another important urology product, subject to FDA approval. In addition to
NEBIDO, we are focused on our octreotide implant, a high-value Phase 3
product which we believe can reach the market, assuming approval, by the
end of 2010. Also, we are actively exploring the acquisition of late-stage
or marketed products which can further leverage our experienced urology and
endocrinology field sales force.

"The Company is also moving forward to strengthen its balance sheet,"
continued Dr. Cooper. "In addition to potential out-licensing transactions
for the Company's partnerable products, we are also exploring opportunities
for the monetization of the royalties we receive from sales of SANCTURA and
SANCTURA XR. Our financial goals are to secure adequate non-dilutive
capital to fund the Company's operations for the foreseeable future and to
retire the Company's outstanding convertible debt which matures in July
2009."

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.

About NEBIDO

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 VANTAS

VANTAS(R) is a soft and flexible 12-month hydrogel implant that
provides histrelin, a luteinizing hormone-releasing hormone (LHRH) agonist,
for the palliative treatment of advanced prostate cancer. VANTAS is
contraindicated in patients with hypersensitivity to GnRH, GnRH agonist
analogs, or any components in VANTAS.

About SUPPRELIN LA

SUPPRELIN(R) LA is a subcutaneous implant indicated for the treatment
of central precocious puberty (CPP), the premature onset of puberty in
children. It utilizes the HYDRON(R) Polymer Technology and is specifically
designed to provide a continuous release over 12 months of the gonadotropin
releasing hormone (GnRH) agonist, histrelin. SUPPRELIN LA is
contraindicated in patients with hypersensitivity to GnRH or GnRH analogs.

About SANCTURA and SANCTURA XR

SANCTURA(R) and SANCTURA XR(TM) belong to a class of anticholinergic
compounds known as muscarinic receptor antagonists. These compounds relax
detrusor smooth muscle tissue found in the bladder, thus decreasing bladder
contractions. Overactive or unstable detrusor muscle function is believed
to be the cause of overactive bladder.

SANCTURA and SANCTURA XR possess a quaternary ammonium structure that
may be instrumental in the low incidence of CNS side-effects. At
therapeutic concentrations in vitro, SANCTURA does not interact with drugs
metabolized by the Cytochrome P-450 system, a metabolic pathway commonly
associated with drug-drug interactions, and the majority of the absorbed
dose is excreted largely unchanged into the urine.

Patients who have urinary retention, gastric retention, uncontrolled
narrow-angle glaucoma or hypersensitivity to SANCTURA should not use
SANCTURA.

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; 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; need for additional funds and corporate
partners, including for the development of our products; history of
operating losses and expectation of future losses; uncertainties relating
to controls over financial reporting; difficulties in managing our growth;
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:
For Indevus
Michael W. Rogers Brooke D. Wagner
Executive Vice President and CFO VP, Corporate Communications
(781) 861-8444 (781) 402-3410

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