Valera expects to launch Valstar in Q1; says next year will be turning point

By Jennifer Lanning Drey

Portland, Ore., Oct. 23 - Valera Pharmaceuticals, Inc. plans to launch Valstar (valrubicin) by the end of the first quarter of 2007, president and chief executive officer Dr. David S. Tierney said at the Sanders Morris Middle Market Investor Growth Conference in New York on Monday.

"Really, '07 should be a turning point for us as a company. We have a number of new opportunities that are coming through, and we think this will aggressively help grow the business next year," Tierney said.

Valstar has been placed on the Food and Drug Administration's drug shortage list, and Valera has a program in place with the FDA to bring Valstar back to the market, Tierney said.

Valstar was voluntarily taken off the market due to a manufacturing issue in 2002 when it was marketed by Medeva. Valera acquired the New Drug Application and other assets associated with the product in April.

According to Tierney, the FDA said it will not require any additional clinical trials before allowing Valstar to return to the market; however, Valera must take a few additional manufacturing steps, which are currently underway.

Valera is a chemotherapeutic anthracyline derivative indicated for use as an intravesical therapy for BCG-refractory carcinoma of the bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

"These are patients that are basically facing that they need to have bladder removal or cystectomies, so we think this product actually does represent an attractive opportunity for physicians to use as an alternative, or at least precursor, before heading in to taking a patient's bladder out," Tierney said.

In previous studies, Valstar showed a complete response in 20% of patients and the median duration of response was 21 months.

"At first look, this may not look very compelling, but I think it's important to consider you're looking at patients here where this is second- or third-line treatment for bladder cancer," Tierney said.

If returned to market, Valstar will be sold through Valera's existing sales force, he said.

Other expansions in 2007

Valera also expects to launch Supprelin-LA in 2007. The product is a yearlong implant for central precocious puberty and has a target Prescription Drug User Fee Act date of May 3.

In addition, the company is pursing global opportunities to expand its implantable prostate cancer drug Vantas into new markets including Europe, pan Asia and South America.

The company also believes there is an opportunity to expand use of the drug in non-Medicare patients who are less than 65 years old and who represent about 15% to 20% of prostate cancer patients, Tierney said.

Valera is a specialty pharmaceutical company based in Cranbury, N.J., that develops, acquires and commercializes products to treat urology and endocrinology diseases and disorders.

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