Indevus Pharmaceuticals Announces
Second Quarter Fiscal 2005 Results; Investor Conference Call Planned for May 10 2005 9:00 A.M. Eastern
Time
"We are continuing to devote
much of our effort to the sales and marketing of SANCTURA(R
), our
product for overactive bladder, and to the development of our
once-daily version, SANCTURA
XR(TM). "We believe
that SANCTURA has a strong profile, differentiated favorably from its
competition
, and we are optimistic that SANCTURA will perform well as
prescription growth picks up in the coming
months. and Africa. We expect to begin toxicology studies this quarter. The participant passcode is
27496849.ohsu urologists
, co-chair of the NKF work group that developed the guideline. We believe it will improve
patient outcomes and
encourage sorely needed research. "We expect to have results from this study
late this year
or early next year, at which time we will discuss study design for
subsequent trials
with the FDA. We are in the process of
planning the restart of the study later this year.
Marketing
, general, and administrative costs for the three month
period increased to $8,187,000 from $5,782
,000 for the corresponding
period last year, primarily due to costs related to our 85-person
specialty
sales force, as well as other increases in headcount
necessary to support the Company's increased
business activity,
partially offset by a reduction in advertising and promotion costs.
Conference
call and web cast
The Company will hold a conference call and web cast to discuss
these results
at 9:00 a. A replay of the call will be available beginning at 11:00 AM
on May 10, 2005 and lasting
until 12:00 AM on May 30, 2005.8
percent for placebo) and constipation (9.
Except for the
descriptions of historical facts contained herein,
this press release contains forward-looking statements
that involve
risks and uncertainties that could cause the Company's actual results
and financial
condition to differ materially from those anticipated by
the forward-looking statements.
INDEVUS PHARMACEUTICALS, INC.66)$ (0.urologists urological
"We are
proud to partner with the National
Kidney Foundation to sponsor the
development of this guideline.
To obtain more information
about the guideline, call the National Kidney
Foundation at (800) 622-9010 or (212) 889-2210, or
visit http://www.S.
"For aminocandin, we have identified the formulation issues that
caused, we
believe, the local vein irritation that led to the
interruption of our multi-dose Phase I trial.
1 percent for SANCTURA vs.niddk prostate
"Our program for SANCTURA XR is moving ahead as planned.
"We recently
announced promising results from a study in which IP
751 was administered in an animal model of interstitial
cystitis,"
said Dr. For the six-month
period ended March 31, 2005, consolidated costs and expenses
were
$43,412,000, compared to $23,018,000 for the six-month period ended
March 31, 2004. 5.urinary urologic
24
per share, basic, for the
three-month period ended March 31, 2004. "The
3,200 participant, NIH
-sponsored trial was initiated in February with
sites in the U. "IP 751 suppressed the overactivity
in a dose
dependent manner and at the highest dose completely reversed the
excessive bladder contractility
to normal function. The live call
may be accessed by dialing 800-591-6944 from the U.S.genitourinary gynecologic
"
Guideline Work Group
The NKF- K/DOQI Clinical Practice Guidelines for Cardiovascular Disease
in
Dialysis Patients are the culmination of two years' work reviewing evidence
published in peer
-reviewed medical journals by 18 volunteer experts in
nephrology, cardiology, epidemiology, social
work, nutrition, pediatrics,
pharmacology, nursing and internal medicine.org.
About K
/DOQI
The National Kidney Foundation's Kidney Disease Outcomes Quality
Initiative (K/DOQI)
provides evidence-based clinical practice guidelines
developed by volunteer physicians and health
care providers for all phases of
kidney disease and related complications, from diagnosis to monitoring
and
management.
The Company reported a net loss of $9,720,000 or $0. that are due in connection
with the development of the once-a-day program.urologists prostate
More than 300,000
Americans receive dialysis to
treat kidney failure. To access
the replay, please dial 888-286-8010 from the U.prolapse genitourinary
The guidelines,
Cardiovascular Disease in Dialysis Patients, warn
that CVD is also prevalent in the pediatric dialysis
population, dialysis
patients are more prone to side-effects of treatment and that more research
is
needed to help better manage CVD in dialysis patients.49 per share, basic, for the six-month period
ended March 31, 2004. We continue to be on
track for an NDA filing in the second half of 2006. Cooper
. Cooper."
Financial Results
Consolidated revenues were $9,277,000 for the three-month
period
ended March 31, 2005, compared to $876,000 for the three-month period
ended March 31, 2004
.S.S.urgency nighttime
We
continue to make progress for each of our development programs and we
believe the pipeline
is positioned to be a significant value-driver
for the Company over the next twelve months. Cooper
.24) $ (0.niddk voiding
m. For the six-month period
ended March 31, 2005, the Company reported a net loss of $30
,869,000
or $0. This trial will consist of approximately 12,000
participants in four countries
in Africa.
"Other pipeline development plans include a Phase II trial for
pagoclone in stuttering
which is scheduled to begin by mid-year," said
Dr.
"Finally, we continue to be quite active on
the business
development front.indevus.nighttime bladder
At March 31, 2005, the Company had cash, cash equivalents
and
marketable securities totaling approximately $117,465,000.
SANCTURA(R) is indicated for the
treatment of overactive bladder
with symptoms of urge urinary incontinence, urgency and urinary
frequency
.urinary prolapse
"This guideline highlights those aspects of CVD care that are different in
dialysis patients
when compared to the general population," said Alfred K. Additionally, IP
751 appeared to have no
effect on the normal voiding mechanism of the
bladder. An archived version of the call will be
accessible
at the same web address for 20 days following the live
call.6 percent for placebo).tract urologists
, co-chair of
the guideline work group, developed
through the NKF's Kidney Disease Outcomes Quality Initiative
(K/DOQI),
highlighted key findings:
* Pediatric chronic dialysis patients are 1,000 times
more likely to die
from CVD than the general pediatric population
* All dialysis units
should have on-site capability for external cardiac
defibrillation, such as automatic external
defibrillators
* Predialysis and postdialysis blood pressure goals should be less than
140/90 mm Hg and less than 130/80 mm Hg, respectively
* Dialysis patients often have CVD
-related risk factors, including
anemia, hyperparathyroidism, hypoalbuminemia and chronic inflammation
,
among others. Sponsors are not involved in any
aspect of the actual guideline development
process.D. In April, we announced funding of the
Medical Research Council-sponsored trial, scheduled
to begin within
the next few months. As we have stated previously, one of our most
important near
-term goals is to leverage our sales and marketing
infrastructure and capabilities, through the co
-promotion, licensing,
or acquisition of late-stage or marketed urology products. Research and
development
costs for the three month period ended March 31, 2005
increased 17% versus the corresponding period
in fiscal 2004 to
$6,011,000, due to increased pipeline development activities.m.urological niddk
For more
information
, please visit http://www.kidney.
Business Editors/Health Editors
LEXINGTON, Mass. (NASDAQ:
IDEV) today announced its consolidated
results of operations for the three and six-month periods
ended March
31, 2005.21) $ (0.urethra urologists
K/DOQI expands the Dialysis Outcomes Quality Initiative or DOQI
, a
project begun by the National Kidney Foundation in 1995 and recognized
throughout the world
for improving the care of dialysis patients.org.
The Company will host a conference call
today, May 10, 2005,
at 9 a.66 per share, basic, compared with a net loss of $23,394,000, or
$0., chairman, president
and chief executive officer of Indevus.
The Company's consolidated costs
and expenses for the three-month
period ended March 31, 2005 were $17,573,000 compared to $11,133
,000
for the three-month period ended March 31, 2004. 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(R) and SANCTURA XR(TM); the early stage of
products under development; uncertainties
relating to clinical trials,
regulatory approval and commercialization of our products,
particularly
SANCTURA and SANCTURA XR; risks associated with
contractual agreements, particularly for the manufacture
and
co-promotion of SANCTURA and SANCTURA XR; dependence on third parties
for manufacturing and
marketing; competition; need for additional
funds and corporate partners, including for the development
of our
products; failure to acquire and develop additional product
candidates; history of operating
losses and expectation of future
losses; product liability and insurance uncertainties; risks relating
to the Redux-related litigation; limited patent and proprietary
rights; dependence on market exclusivity;
valuation of our Common
Stock; risks related to repayment of debts; risks related to increased
leverage;
and other risks.49)
======== ========= ======== ========
Weighted
average common shares:
Basic and diluted 46,967 47,397 46,946 47,304
======== ========= ======== ========
INDEVUS
PHARMACEUTICALS, INC.gynecologic pituitary
Guideline Sponsors
Satellite Healthcare is Primary Development
Sponsor of the guideline. In addition, findings from a
study of PRO 2000 performed at Mount Sinai
were presented at the 12th
Conference on Retroviruses and Opportunistic Infections in February.com
.
infections laparoscopy
d. eastern time on May 10, 2005. and Canada, and
617-614-4910 from international locations.
Indevus
Pharmaceuticals is a biopharmaceutical company engaged in
the acquisition, development and commercialization
of products
targeting certain medical specialty areas, including urology and
infectious diseases
.
clinical trials were dry mouth (20.bladder fibroids
kdoqi.----Indevus
Pharmaceuticals, Inc.21 per share,
basic
, for the three-month period ended March 31, 2005, compared to a
net loss of $11,370,000, or $0. In
addition, we are very
optimistic about the prospects for our clinical stage pipeline. While several
competitive products have lost market share during the past quarter,
we have been able to maintain
our share," said Dr. To
this end, we are making progress on several opportunities which we
believe
will add significant value for the Company and its
shareholders. Product revenue of $4,238,000
in
the three-month period ended March 31, 2005 included $3,015,000
from sales of SANCTURA to PLIVA,
$799,000 in royalties from PLIVA on
sales of SANCTURA, and $422,000 of royalties from Eli Lilly and
Company for sales of Sarafem. Contract and license fee revenue of
$5,039,000 during the quarter
relates almost entirely to the PLIVA
Agreement. Patients who have urinary retention, gastric
retention
, uncontrolled narrow-angle glaucoma or hypersensitivity to
SANCTURA should not use SANCTURA.urologists gynecologic
The
net loss for the quarter ended March 31, 2005 represents an
$11,429,000 decrease from the net loss
of $21,149,000 for the
three-month period ended December 31, 2004.
"For SANCTURA, I am very pleased
that we have been able to
maintain our market share, despite the introduction of two new
products
into the overactive bladder marketplace.
"We are very pleased to have the Phase III program underway
for
PRO 2000, our compound for the prevention of the sexual transmission
of HIV and other sexually
transmitted diseases," said Dr.
This important study marked the first time the anti-viral activity
of
a microbicide has been demonstrated following human application. For the six-month period ended
March 31, 2005,
consolidated revenues were $15,040,000 compared to $1,803,000 for the
six-month
period ended March 31, 2004. Included is $3,125,000 from the amortization of deferred
revenue and
$1,920,000 for three months of sales force subsidy from
PLIVA.6 percent for SANCTURA vs.nighttime voiding
Cheung
, M."
William Henrich, M. For more information, please visit http://www. Cooper, M. We are
scheduled
to enter Phase III this summer, triggering the first of
three milestone payments from PLIVA d. We
have now completed a second study confirming these
results. The most commonly reported side effects
in Phase III U.
4.genitourinary urology
About the National Kidney Foundation
The National Kidney Foundation
is dedicated to preventing kidney and
urinary tract diseases, improving the health and well being
of individuals and
families affected by these diseases, influencing public policy in support of
the
kidney community and increasing the availability of all organs for
transplantation.
"The past
quarter has been very active for the Company, as we
continue to make steady progress toward the achievement
of our
objectives for 2005," said Glenn L. Cooper.
The press release and the live web cast will
be accessible by
visiting the Investors section of the Company's website,
http://www.gynecologic infections
New National
Kidney Foundation Guidelines Warn Cardiovascular Disease is the Leading Cause of Death Among Dialysis
Patients
D.D.
Additional guideline sponsors include: Amgen and Genzyme Corporation. Amgen is
Founding
and Principal Sponsor of NKF-K/DOQI.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)
March 31, September 30,
2005 2004
------------------
---------
Cash, cash equivalents and marketable
securities
$117,465 $157,008
Other assets 13,970 16,830
---------------------------
Total assets
$131,435 $173,838
===========================
Convertible notes 72,000 72,000
Deferred revenue
137,500 143,750
Other liabilities
15,127 21,126
Capital 306,581 305,865
Accumulated deficit (399,773) (368,903)
---------------------------
Total stockholders' deficit
(93,192) (63,038)
---------------------------
Total liabilities and stockholders'
deficit $131,435
$173,838
===========================
fibroids ohsu
NEW
YORK, Cardiovascular disease (CVD) is the
leading cause of death among dialysis patients, but the
treatment for dialysis
patients with CVD is not as effective as it is in the general population,
according to new guidelines published by the National Kidney Foundation (NKF)
in a supplement
to the April 2005 issue of the American Journal of Kidney
Diseases., eastern time (details follow
below). Distribution of
samples has been quite heavy and consequently, growth in prescriptions
and
new patient starts has slowed considerably.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and six months ended March 31, 2005 and 2004
(Amounts in thousands
except per share data)
(Unaudited)
For the three months For the six months
ended March 31,
ended March 31,
-------------------- -----------------
2005 2004 2005 2004
-------- --------- -------- --------
Total revenues $ 9,277 $ 876
$ 15,040 $ 1,803
Costs and expenses:
Cost of revenues 3,375 209
5,855 524
Research and development 6,011 5,142 11,889 12,696
Marketing
, general and
administrative 8,187 5,782 25,668 9,798
-------- --------- -------- --------
Total costs and expenses 17,573
11,133 43,412 23,018
-------- --------- -------- ----
----
Loss from operations (8,296) (10,257) (28,372) (21,215)
Investment
income 739 180 1,413 406
Interest expense (1,293
) (1,293) (2,585) (2,585)
Impairment of equity securities (175) - (175)
-
-------- --------- -------- --------
Loss before income
taxes (9,025) (11,370) (29,719) (23,394)
Provision for income taxes (695)
- (1,150) -
-------- --------- -------- --------
Net
loss $ (9,720) $ (11,370) $(30,869)$(23,394)
======== ========= ======== ========
Net loss per common share:
Basic and diluted
$ (0.niddk penis
"Because of these differences, practitioners cannot solely rely on existing
CVD
guidelines for the general population to treat CVD in dialysis patients.
"CVD presents unique
challenges to dialysis patients that significantly
impact longevity and quality of life," said Norman
S. Coplon, chairman and
founder of Satellite Healthcare, primary sponsor of the guideline.kdoqi. and
Canada, and
617-801-6888 from international locations, using the passcode
84508753. The Company
currently markets SANCTURA(R) for
overactive bladder and has multiple compounds in clinical development
,
including PRO 2000 for the prevention of infection by HIV and other
sexually transmitted pathogens
, pagoclone for stuttering, aminocandin
for systemic fungal infections, and IP 751 for interstitial
cystitis.Disorders of the genital and urinary organs or their functions.
voiding urologic
org. We believe
we are well
-positioned to capitalize on unique product opportunities
in our core areas of urology, gynecology
, and infectious diseases. Costs of product revenue relate primarily to sales of
SANCTURA to PLIVA
and royalties to Madaus for SANCTURA.penis bladder
A community sponsored library.
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