Indevus Initiates Phase II Clinical Trial of Pagoclone for Stuttering

Business Wire, July 14, 2005

LEXINGTON, Mass. -- Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced the initiation of a Phase II trial of pagoclone in patients with persistent developmental stuttering.

The trial is being conducted in 120 adults at 16 investigational sites in the United States. Assessments in the trial include standard measures of speech fluency, as well as ancillary measures to evaluate disability and quality of life of the enrolled stuttering patients. In a subset of the clinical centers, functional brain imaging assessments will be collected as potential biomarkers of the effects of pagoclone in the treatment of stuttering.

Stuttering is defined as a break in the flow of speech, which is disrupted by repetitions, prolongations or abnormal stoppages of sounds and syllables. It can be accompanied by unusual facial and body movements. Persistent developmental stuttering, the most common form of stuttering, affects approximately three million Americans.

"We are very excited to announce the initiation of this important trial for pagoclone. Stuttering is a debilitating condition for which there is no FDA-approved pharmacotherapy." said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "If successful in development, pagoclone has the potential to bring much-needed relief to those patients affected by this disorder.

"For Indevus, the pagoclone opportunity in stuttering leverages the substantial preclinical, clinical, and manufacturing database which has been accumulated over ten years. In addition, this trial represents a further advance of our strategy of focusing on the medical specialist. Looking ahead, we believe pagoclone has the potential to become a significant commercial opportunity which could be marketed effectively in the U.S. by establishing a specialty sales force to introduce the product to adult and pediatric neurologists and psychiatrists. Outside of the U.S., we expect to seek a partner for the commercialization of pagoclone."

Background on Stuttering

According to the National Stuttering Association (NSA), stuttering is defined as a communication disorder involving disruptions, or "disfluencies," in a person's speech. In addition to producing disfluencies, people who stutter often experience physical tension and struggle in their speech muscles, as well as embarrassment, anxiety, and fear about speaking. Together, these symptoms can make it very difficult for people who stutter to say what they want to say, and to communicate effectively with others.

Additionally, according to the NSA, there is now evidence that stuttering is a neurologic, rather than a primary psychological disorder, that affects areas of the brain concerned with hearing and speech. The impact of stuttering is commonly underestimated. Even seemingly "mild" stuttering may have significant long-term psychological and social consequences.

Pagoclone

Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1500 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering.

Stuttering Trial Information

Patients with stuttering who wish to be considered for enrollment in the trial should contact the EXPRESS (EXamining Pagoclone for peRsistent dEvelopmental Stuttering Study) Hotline at 1-866-289-1359 or e-mail at express@matthewsgroup.com.

Indevus

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. The Company currently markets SANCTURA 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.

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(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.