Data On SANCTURA for Overactive Bladder Show Treated Patients Do Not Experience Daytime Sleepiness.

LEXINGTON, Mass., EAST HANOVER, N.J. and ZAGREB, Croatia -- Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) and Odyssey Pharmaceuticals, PLIVA d.d.'s specialty branded subsidiary, today announced that new data from a clinical trial with SANCTURA(TM) (trospium chloride) presented at the annual meeting of the International Continence Society (ICS) in Paris, France demonstrated that patients with overactive bladder who were treated with the drug did not experience daytime sleepiness.

A total of 658 patients were studied in this 12-week, randomized, double-blind, placebo-controlled trial, which was included in the New Drug Application (NDA) for SANCTURA approved by the U.S. Food and Drug Administration (FDA) on May 28, 2004. In addition to meeting the endpoints of reduction in the symptoms of OAB, the trial assessed the effect of SANCTURA on daytime sleepiness using the Stanford Sleepiness Scale (SSS). The changes in average SSS scores were minimal and comparable for the SANCTURA and placebo treatment groups at weeks 1, 4 and 12.

"The lack of a difference from placebo in the occurrence of sleepiness is consistent with other human experimental and clinical studies, as well as general clinical use of this compound in Europe," said David R. Staskin, M.D., director, section of voiding dysfunction, New York Presbyterian Hospital and associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College. "As the medical community increasingly views OAB as a treatable disease, tolerability and absence of adverse events such as daytime sleepiness becomes critical, especially for the many elderly patients who are candidates for OAB therapy."

SANCTURA was well tolerated in this trial as well, as evidenced by its adverse event profile that included the most common adverse events associated with the antimuscarinic class of drugs, dry mouth and constipation. The incidence of dry mouth observed in SANCTURA patients was 19.8 percent vs. 5.2 percent for placebo, while constipation was observed in 10.9 percent of these patients versus 5.8 percent for placebo. In addition, the incidence of central nervous system adverse events attributed to SANCTURA was no different than placebo (9.1 percent vs. 8.5 percent, respectively).

SANCTURA is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (20.1 percent for SANCTURA vs. 5.8 percent for placebo) and constipation (9.6 percent for SANCTURA vs. 4.6 percent for placebo). Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.

Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in development: SANCTURA, pagoclone for panic and generalized anxiety disorders, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens and aminocandin for systemic fungal infections.

Odyssey Pharmaceuticals, a subsidiary of PLIVA, is a research-driven, fast growing specialty pharmaceutical company dedicated to the creation of innovative products to improve quality of life. Since 2000, Odyssey has concentrated its core capabilities on key therapeutic categories such as urology, respiratory and CNS. The company's recent alliance with Indevus Pharmaceuticals to co-promote SANCTURA represents a strong strategic fit given Odyssey's existing urological product portfolio, sales force capabilities and proprietary focus.

With more than 80 years of experience in the pharmaceuticals area, PLIVA is a successful multinational corporation with primary focus on generic products, with operations across Central and Eastern Europe, Western Europe and the U.S. PLIVA is the largest Central and Eastern Europe-headquartered pharmaceutical company by sales, whose most prominent discovery is the blockbuster antibiotic azithromycin, sold under the trademarks of Zithromax and Sumamed.

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; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA; 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.