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Document Preview Indevus Pharmaceuticals Announces Fiscal 2003 Year End and Fourth Quarter Results |
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Title: |
Indevus Pharmaceuticals Announces Fiscal 2003 Year End and Fourth Quarter Results |
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Entities: |
Eli Lilly & Co.; Indevus Pharmaceuticals Inc.; Shire Laboratories Inc. |
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Date: |
2003 |
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13KB total |
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Price: |
$34 |
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ID: |
#274123 |
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FOR IMMEDIATE RELEASE
Contact, at (781) 861-8444:
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Michael W. Rogers |
William B. Boni |
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Exec. VP and Chief Financial Officer |
VP, Corp. Communications |
INDEVUS PHARMACEUTICALS ANNOUNCES FISCAL 2003
YEAR END AND FOURTH QUARTER RESULTS
Year Highlighted by Preparation for Launch of Trospium in 2004
LEXINGTON, MA, December 18, 2003 Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced its consolidated results of operations for the fiscal year and the three-month periods ended September 30, 2003.
The Company reported a consolidated net loss of $31,812,000 or $0.68 per share (basic), for fiscal 2003, compared to a consolidated net loss of $17,586,000, or $0.38 per share (basic), for fiscal 2002. For the three-month period ended September 30, 2003, the Company reported a consolidated net loss of $11,365,000 or $0.24 per share (basic), compared to a consolidated net loss of $4,817,000, or $0.10 per share (basic), for the three-month period ended September 30, 2002.
The increased net loss for fiscal 2003 is primarily the result of increased expenses related to the Companys lead product, trospium, including costs for clinical trials, regulatory submission and review, development of a once-a-day formulation and pre-commercialization activities. Total direct costs related to trospium in fiscal 2003 were approximately $21,400,000, or approximately 58 percent of total costs and expenses for the year.
At September 30, 2003, the Company had consolidated cash, cash equivalents and marketable securities totaling approximately $84,087,000.
We made significant advancements during fiscal 2003 in our lead product development program, trospium for overactive bladder, as well as in other earlier-stage programs and in the expansion of our product pipeline, said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. We also strengthened our cash position during the year through an offering of convertible senior notes. Looking forward, we eagerly anticipate the events of 2004, which we expect will include the launch of trospium and the clinical advancement of several of our other programs.
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The highlight of the past year was the submission to the U.S. Food and Drug Administration (FDA) of the Companys New Drug Application (NDA) for trospium on April 29, 2003, said Dr. Cooper. The NDA includes the results of 34 clinical studies involving over 2,800 subjects and patients, including 12 double-blind, placebo-controlled or active-controlled studies, 14 clinical pharmacology and pharmacokinetic studies and 8 uncontrolled studies.
We have laid a foundation for the product launch of trospium by initiating a broad range of pre-commercialization and market preparation activities, highlighted during the past year by presentations of data from our successful Phase III trial at the annual meetings of the American Urology Association and the International Continence Society, said Dr. Cooper. These data showed that trospium met the dual, pre-specified endpoints of the clinical trial, significantly reducing both the frequency of urination and the number of urge incontinent episodes among patients with OAB. Treatment with trospium also reduced the severity of urgency, another defining symptom of OAB, resulted in onset of therapeutic action within one week after initiation of treatment, and was well tolerated, with the most frequently reported adverse events being dry mouth and constipation.
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