CHADDS FORD, Pa., Sept. 3 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."
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 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."
Bladder cancer patients seeking information about VALSTAR should speak to a healthcare professional that specializes in bladder cancer treatment, typically a urologist. For more information, visit www.ValstarSolution.com.
Endo Pharmaceuticals is a specialty pharmaceutical company 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). Its products include LIDODERM((R)), a topical patch to relieve the pain of postherpetic neuralgia; Percocet((R)) and Percodan((R)) tablets for the relief of moderate-to-moderately severe pain; FROVA((R)) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA((R) )tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA((R)) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; Voltaren((R) )Gel, which is owned and licensed by Novartis AG, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as those of the hands and the knees; SANCTURA((R)) and its XR version for treatment of overactive bladder; VANTAS((R)) for the palliative treatment of advanced prostate cancer; and SUPPRELIN((R)) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the company's financial position, results of operations, market position, product development and business strategy, as well as estimates of future net sales, future expenses, future net income and future earnings per share. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "intend," "guidance" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our annual report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on March 2, 2009. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
SOURCE Endo Pharmaceuticals