Press Release
Source: Indevus Pharmaceuticals, Inc.
Indevus Pharmaceuticals Announces Second Quarter
Fiscal 2003 Results
Tuesday May 13, 8:38 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--May 13, 2003--Indevus Pharmaceuticals, Inc.
(NASDAQ: IDEV - News) today announced its consolidated results of operations for the three
and six-month periods ended March 31, 2003.
The Company reported a net loss of
$2,966,000 or $0.06 per share diluted, for
the three-month period ended March 31,
2003, compared to a net loss of
$4,808,000, or $0.10 per share diluted,
for the three-month period ended March
31, 2002. For the six-month period ended
March 31, 2003, the Company reported a
net loss of $8,397,000, or $0.18 per
share diluted, compared with a net loss
of $6,754,000, or $0.15 per share diluted,
for the six-month period ended March 31,
2002.
At March 31, 2003, the Company had
cash, cash equivalents and marketable
securities totaling approximately
$33,908,000.
"Highlighting recent developments at Indevus were the presentation of Phase III clinical trial data
on trospium for overactive bladder (OAB) and the submission of a New Drug Application (NDA) for
this compound in late April," said Glenn L. Cooper, M.D., chairman, president and chief
executive officer of Indevus.
"The Phase III data, presented at the American Urology Association (AUA) meeting, showed that
trospium met the dual, pre-specified endpoints of the trial, significantly reducing both the
frequency of urination (toilet voids) and the number of urge incontinent episodes among patients
with OAB," said Dr. Cooper. "Treatment with trospium also reduced the severity of urgency,
another defining symptom of OAB, and was well tolerated.
"Following the release of these data at the AUA, the Company submitted an NDA for trospium to
the U.S. Food and Drug Administration (FDA)," said Dr. Cooper. "The NDA includes the results
of 32 clinical studies involving over 2,700 subjects and patients, including 12 double-blind,
placebo- or active-controlled studies, 12 clinical pharmacology and pharmacokinetic studies and
8 uncontrolled studies. In addition to this clinical database, over 10,000 trospium patients have
been followed in post-marketing trials in Europe.
"As part of the ongoing development program for trospium, the Company is conducting additional
clinical trials in the U.S. to explore further certain attributes of trospium," said Dr. Cooper. "We
are also currently evaluating a broad range of commercialization opportunities for trospium in the
U.S.
"In March, the Company signed an exclusive agreement with Shire Laboratories, Inc., to develop
extended release formulations of trospium," said Dr. Cooper. "By applying the proprietary
formulation and drug delivery capabilities of Shire, we expect to improve the highly competitive
attributes of the existing formulation of trospium. Our objective is to introduce once-a-day
trospium at the appropriate time in the life cycle of the twice-a-day product. We expect to begin
clinical trials with a once-a-day formulation later this year.
"The Company added an exciting new compound to our pipeline in April with the licensing of
exclusive, worldwide rights from Aventis SA to aminocandin, a member of a new class of
anti-fungal compounds, echinocandins, for the treatment of a broad spectrum of systemic,
invasive, debilitating and life-threatening infections," said Dr. Cooper. "Based on highly predictive
pre-clinical studies of aminocandin, we believe the profile of this compound is very competitive
with other classes of anti-fungal agents and with other echinocandins. We believe that Aventis
has established a comprehensive pre-clinical dossier on aminocandin, and we plan to initiate our
development activities with aminocandin immediately, including clinical testing with the
intravenous formulation later in 2003. In addition, we plan to vigorously pursue technological
solutions related to an oral formulation of aminocandin."
Consolidated revenues were $2,871,000 for the three-month period ended March 31, 2003,
compared to $86,000 for the three-month period ended March 31, 2002. For the six-month period
ended March 31, 2003, consolidated revenues were $3,693,000 compared to $3,627,000 for the
six-month period ended March 31, 2002. Fiscal 2003 and 2002 revenues were derived primarily
from royalty payments from Eli Lilly & Company on sales of Sarafem(TM), launched by Lilly in
August 2000. Revenue related to Sarafem during the 2003 periods includes $2,184,000 in
accelerated milestone payments and $777,000 in contract and license fee revenue received from
Lilly related to a renegotiated Sarafem agreement.
The Company's consolidated expenses for the three-month period ended March 31, 2003 were
$5,996,000, compared to $5,191,000 for the three-month period ended March 31, 2002. For the
six-month period ended March 31, 2003, consolidated expenses were $12,440,000, compared to
$10,852,000 for the six-month period ended March 31, 2002. Increased expenses during the
fiscal year 2003 three and six-month periods over the comparable fiscal year 2002 periods
include increased research and development expenditures for the clinical testing, NDA
preparation and pre-commercialization activities for trospium.
Indevus Pharmaceuticals is engaged in the development and commercialization of a portfolio of
products and product candidates, including multiple compounds in late-stage clinical
development. The Company's core products under development include trospium for overactive
bladder, pagoclone for panic/anxiety disorders, IP 751 for pain and inflammation, PRO 2000 for
the prevention of infection by HIV and other sexually transmitted pathogens, and aminocandin for
systemic, invasive fungal infections. |
