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Endo Pharmaceuticals Introduces VALSTAR(TM) (Valrubicin) To Fill Unmet Need In Aggressive Form of Bladder Cancer
Date:9/3/2009

tment a patient does not have a complete response of CIS after three months, or if CIS recurs, surgical bladder removal must be reconsidered.

VALSTAR was approved by the FDA for this indication in 1998 and marketed by Anthra Pharmaceuticals, Inc. In 2002, Anthra voluntarily withdrew VALSTAR from the U.S. market because of a formulation issue with an inactive component. Since market removal, VALSTAR has been on the FDA Drug Shortages List, which was established to address and alleviate shortages primarily of medically necessary drug products, since these can have significant public health consequences. On Feb. 27, 2009, Indevus Pharmaceuticals, Inc., the previous owner of VALSTAR, received FDA approval to re-introduce VALSTAR after modifying the formulation. On March 23, 2009, Endo acquired Indevus Pharmaceuticals and began preparing to re-launch VALSTAR. VALSTAR represents the first product launch by Endo Pharmaceuticals in the urology and oncology therapy markets.

"Patients who have failed multiple courses of BCG have few to no remaining treatment alternatives, in part because many patients cannot undergo surgical bladder removal due to comorbid medical conditions, and the procedure may be associated with significant risk of complications and alteration of lifestyle and body image," said Gary Steinberg, M.D., FACS, Professor and Vice Chairman of Urology, Director of Urologic Oncology at the University of Chicago Medical Center. "Although valrubicin was previously available, it has never been an option for the thousands of people suffering today from this disease, and this reintroduction may bring new hope to many patients."

About Bladder Cancer

Bladder cancer is the fourth most common cancer among men and the 11(th) most common among women in the United States, and approximately 70,000 Americans are newly diagnosed with bladder cancer each year. CIS bladder cancer is a rare and aggressive form
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SOURCE Endo Pharmaceuticals
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