Valera acquires rights to Valstar for bladder cancer treatment

By Elaine Rigoli

Tampa, Fla., April 3 - Valera Pharmaceuticals, Inc. has completed its acquisition of the New Drug Application and other assets associated with Valstar (valrubicin) and expects to begin marketing the product in the United States by the end of 2006.

Valstar, which is known as Valtaxin in Canada, is a chemotherapeutic anthracyline derivative indicated for use as an intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy (urinary bladder removal) would be associated with unacceptable morbidity or mortality, according to a news release.

Bacillus Calmette Guerin, or BCG, is the most common form of topical treatment of bladder cancer and afflicts nearly 500,000 Americans, the release said.

The company estimates that each year more than 25,000 patients being treated with BCG become unresponsive and are faced with having a cystectomy. Moreover, for about a third of such BCG-refractory patients, surgical removal of the bladder is not considered appropriate.

Valstar is the only product approved by the Food and Drug Administration for patients who have failed other treatment modalities, the release said.

Valera said it plans to sell Valstar directly to urologists to be administered as an office procedure.

Valera, based in Cranbury, N.J., is a specialty pharmaceutical company focused on developing, acquiring and commercializing products to treat urology and endocrinology diseases and disorders.

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