Valera will be launching its Vantas prostate cancer implant by the end of the year following FDA approval Oct. 12.

Vantas (histrelin) is approved for "the palliative treatment of advanced prostate cancer," ¹ labeling states.

Valera is in the final stages of assembling a 50-rep urology sales force and is building inventory of the luteinizing hormone-releasing hormone.

Valera hopes to differentiate Vantas from the other 12-month LHRH product, Bayer/J&J's Viadur (leuprolide), based on the design of the implant.

Viadur uses Alza's Duros technology and is a 4 mm by 45 mm titanium alloy reservoir housing a polyurethane rate-controlling membrane, an elastometric piston and a polyethylene diffusion modulator. The implant is "osmotically driven," labeling notes.

Vantas, using Valera's Hydron technology, is a 3 cm by 3.5 mm cylindrically shaped hydrogel reservoir which is diffusion controlled.

Company materials have described Vantas as "soft" and "flexible."

Vantas is expected to be priced above Viadur with an average wholesale price of approximately $6,000 as opposed to Viadur's $5,684.

Viadur recently received a warning letter from FDA's ad division for failing to include risk information in a promotional aid (² Also see "J&J Viadur Promotional Aid Omits Risk Information, FDA Warning Letter Says" - Pink Sheet, 28 September, 2004.).

Valera has a Phase IV commitment for Vantas to conduct a 10-patient study of an ultrasound procedure that is used to locate the implant if it cannot be detected by palpation.

Vantas, which was approved on its 10-month user fee date, is the first product for Valera, a privately held firm located in Cranbury, N.J. The firm, formerly known as Hydro Med Sciences, reacquired rights to the product from Shire in 2002.

Valera's CEO is David Tierney, MD, who joined in 2000 and has overseen a shift in focus from technology out-licensing to niche product development. He was previously president of Biovail Technologies, a division of Biovail Corporation.

- M. Nielsen Hobbs

Valera's Vantas Prostate Cancer Implant To Launch By Year-End

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