Zeev's Turnips Patch-No Politics (ZEEV)

[i_vitale]

Sanctura coming on a screen near you...

"Indevus and Odyssey Announce Initiation of U.S. Distribution of SANCTURA
Wednesday August 11, 8:58 am ET
Launch Date Set for August Companies Provide Update on Launch Activities


LEXINGTON, Mass. & EAST HANOVER, N.J.--(BUSINESS WIRE)--Aug. 11, 2004--Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) and Odyssey Pharmaceuticals, PLIVA d.d.'s specialty branded subsidiary, today announced that U.S. distribution of SANCTURA(TM) (trospium chloride tablets) has begun in preparation for launch later this month. Indevus received approval for SANCTURA by the U.S. Food and Drug Administration (FDA) on May 28, 2004. SANCTURA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
As provided for in their co-promotion and licensing agreement, Indevus and Odyssey have completed the hiring and training of a 480-person sales force, in addition to a managed care and Medical Science Liaisons group, that will launch SANCTURA to primary care physicians, urology specialists, obstetricians and gynecologists. These sales representatives were hired from leading pharmaceutical companies and bring years of urology experience to the launch of SANCTURA.

The pricing and managed care strategy for SANCTURA has been completed. Pricing has been established with a daily average wholesale price of $2.98. Negotiations are well underway with managed care organizations and State Medicaid offices, and a number of initiatives have been put in place to ensure coverage of SANCTURA on these formularies. These initiatives are designed to help maximize the market penetration of SANCTURA in an overactive bladder market that totaled $1.13 billion in 2003.

Additional data from clinical trials with SANCTURA will be presented during the summer at several professional meetings, including the International Continence Society and various national and international urology meetings. These presentations include data from two Phase III trials included in the New Drug Application (NDA) for SANCTURA approved by the FDA and an analysis of long-term use and tolerability. In addition, all of the elements in the branding campaign for the drug have been finalized, including its visual identity and public relations, and a professional print advertising campaign is underway.

SANCTURA is indicated for the treatment of overactive bladder (OAB) 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.

SANCTURA, a quarternary ammonium compound, belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder."