Endo Pharmaceuticals (Nasdaq: ENDP) today announced the availability of VALSTAR(TM) (valrubicin) for the treatment of a distinct form of bladder cancer. VALSTAR 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. VALSTAR represents a new treatment option for these patients who may otherwise have exhausted all other FDA-approved treatment alternatives, including BCG.
"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."
VALSTAR, 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, VALSTAR 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 VALSTAR treatment. It is important to note that if after VALSTAR treatment 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."