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The Lancet Oncology

Thursday, September 3, 2009

Valrubicin May Fill Unmet Need In Aggressive Form of Bladder Cancer

Specialty pharmaceutical company Endo Pharmaceuticals (100 Endo Boulevard, Chadds Ford, PA 19317, (610)558-9800) engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP), today announced the availability of valrubicin (Valstar™) for the treatment of a distinct form of bladder cancer.

Valrubicin is the only FDA-approved intravesical therapy for patients with Bacille Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks. Valrubicin represents a new treatment option for these patients who may otherwise have exhausted all other FDA-approved treatment alternatives, including BCG.

Bladder cancer is the fourth most common cancer among men and the 11th 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 of cancer with a 50 to 90 percent probability of recurrence in five years.

Standard treatment of CIS of the urinary bladder is transurethral resection of the bladder tumor (TURBT) followed by one or two courses of BCG. Although the initial response rate to BCG is high, recurrence occurs in up to 34 percent of patients.

Patients who don't respond to BCG therapy have few FDA-approved treatment options. The most conservative treatment option for BCG-refractory patients is surgical bladder removal. However, some patients are not candidates for radical surgery due to comorbid disease, and others refuse to consider the change in their lifestyle resulting from surgical bladder removal even when counseled on the risk of cancer progression.

"Bladder cancer is an under recognized disease, and it's important to increase public awareness of bladder cancer and research directed at the diagnosis, treatment and cure of the disease," said Diane Zipursky Quale, co-founder and president of the Bladder Cancer Advocacy Network (BCAN). "We are very encouraged by Endo's commitment to improving outcomes for bladder cancer patients."

"Patients with recurrent carcinoma in situ bladder tumors who fail traditional therapy have been significantly underserved due to the lack of available approved treatment alternatives, and valstar™ will provide a well-tolerated treatment option for these patients," said Dave Holveck, president and chief executive officer of Endo Pharmaceuticals. "Our launch of valstar™ also represents our initial offering in a long-term plan by Endo to deliver multiple therapies to improve and extend the lives of patients with different types of bladder cancer, as evidenced by our recent agreement with Bioniche."

Valrubicin, a sterile solution for intravesical instillation of valrubicin, is placed directly into the bladder through a catheter and is administered once a week for six weeks under the supervision of a physician experienced in the use of intravesical cancer chemotherapeutic agents.
In the pivotal clinical trial, valrubicin was shown to induce a complete response in about one in five patients at six months following initiation of therapy, and 29 percent of patients derived a clinical benefit from valrubicin treatment. It is important to note that if after valrubicin treatment a patient does not have a complete response of CIS after three months, or if CIS recurs, surgical bladder removal must be reconsidered.

Valrubicin was approved by the FDA for this indication in 1998 and marketed by Anthra Pharmaceuticals, Inc. In 2002, Anthra voluntarily withdrew valrubicin from the U.S. market because of a formulation issue with an inactive component. Since market removal, valrubicin 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 valrubicin, received FDA approval to re-introduce valrubicin after modifying the formulation. On March 23, 2009, Endo acquired Indevus Pharmaceuticals and began preparing to re-launch valrubicin. The drug 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."

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