Endo Pharmaceuticals Introduces VALSTAR(TM) (Valrubicin) To Fill Unmet Need In
Aggressive Form of Bladder Cancer
CHADDS FORD, Pa., Sept. 3 /PRNewswire-FirstCall/ -- 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.
About Endo
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.
Forward-Looking Statements
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
Investors/Media: Blaine Davis, +1-610-459-7158, or Jonathan Neely,
+1-610-459-6645, or Media: Kevin M. Wiggins, +1-610-459-7281, all of Endo
Pharmaceuticals
