Indevus Receives Approvable Letter From FDA for Valstar for Bladder Cancer Therapy
LEXINGTON, Mass., August 17, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Valstar. Valstar, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder.
Valstar was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List. Indevus solved the impurity issue and submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007. The FDA approvable letter was in response to this chemistry supplement.
In the approvable letter, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process.
"Valstar offers an effective alternative for bladder cancer patients who have failed BCG therapy and are not candidates for immediate cystectomy," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The FDA requests in the approvable letter are easily addressable with existing data and the completion of a few brief process related investigations. We expect to supply the FDA with a complete response within the next two months. We remain on track for a late 2007 or early 2008 re- introduction."
About Valstar
Valstar is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
In clinical trials, when provided after transurethral resection, Valstar patients had a median 21 months to documented recurrence of disease.
Valstar has been shown to induce complete response in only about 1 in 5 patients with BCG-refractory CIS. It is important to note that delaying cystectomy could lead to development of metastatic bladder cancer.
About Indevus
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA XR and SANCTURA for overactive bladder, VANTAS for advanced prostate cancer, SUPPRELIN LA for central precocious puberty and DELATESTRYL to treat male hypogonadism. Indevus currently markets its products through an approximately 100-person specialty sales force. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include Valstar for bladder cancer, NEBIDO for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and pagoclone for stuttering.
Forward Looking Statements
Except for the descriptions of historical facts contained
herein, this press release contains forward-looking statements that
involve risks and uncertainties that could cause the Company's
actual results and financial condition to differ materially from
those anticipated by the forward-looking statements. These risks
and uncertainties are set forth in the Company's filings under the
Securities Act of 1933 and the Securities Exchange Act of 1934
under "Risk Factors" and elsewhere, and include, but are not
limited to: dependence on the success of SANCTURA, SANCTURA
XR, NEBIDO, VANTAS and SUPPRELIN LA; the early state of
products under development; uncertainties relating to clinical
trials, regulatory approval and commercialization of our products,
particularly SANCTURA XR, NEBIDO and Valstar; risks associated
with contractual agreements, particularly for the manufacture and
co-promotion of SANCTURA and SANCTURA XR and the manufacture of
NEBIDO, VANTAS, SUPPRELIN LA and Valstar; dependence on third
parties for supplies, particularly for histrelin, manufacturing,
marketing, and clinical trials; competition; need for additional
funds and corporate partners, including for the development of our
products; failure to acquire and develop additional product
candidates; changes in reimbursement policies and/or rates for
SANCTURA, VANTAS, SUPPRELIN LA, DELATESTRYL and any future
products; history of operating losses and expectation of future
losses; product liability and insurance uncertainties; risks
relating to the Redux- related litigation; the risk that the
businesses of Indevus and Valera Pharmaceuticals, Inc. will not be
integrated successfully during the period following the related
merger; the risk that the cost savings and any other synergies from
the merger may not be fully realized or may take longer to realize
than expected; market acceptance for the merger and approved
products; risks of regulatory review and clinical trials;
disruption from the transaction making it more difficult to
maintain relationships with customers, employees or suppliers;
competition and its effect on pricing, spending, third-party
relationships and revenues; reliance on intellectual property and
having limited patents and proprietary rights; dependence on market
exclusivity, valuation of our Common Stock; risks related to
repayment of debts; risks related to increased leverage; general
worldwide economic conditions and related uncertainties; the effect
of changes in governmental regulations and other risks. Indevus
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
CONTACT: Michael W. Rogers, Executive Vice President and CFO,+1-781-861-8444 or Brooke D. Wagner, VP, Corporate Communications,+1-781-402-3410, both of Indevus Pharmaceuticals, Inc.
Posted: August 2007
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