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May 23, 2012

Veloxis Restructures to Focus on Late-Stage Once-Daily Immunosuppressant

  • Veloxis Pharmaceuticals is considering cutting its workforce by 40-50% and pulling the plug on all its pipeline and early R&D projects in order to free up all existing resources for completing development and commercialization of lead immunosuppression candidate LCP-Tacro™, in the U.S. and Europe. The firm says it also aims to build up an in house marketing and sales organization in the U.S. If all the noted restructuring activities are carried out Veloxis could save some DKK 35-40 million a year (about $5.2-$6.0 million) from 2013 onwards. Its employee base would effectively be cut from about 60 to 30-35 personnel.

    LCP-Tacro is a once-daily tablet formulation of tacrolimus, which is currently in Phase III development for preventing organ rejection. Danish firm Veloxis plans to submit a European marketing authorization application for LCP-Tacro later this year, which will be based primarily on the first completed Phase III trial in maintenance switch kidney transplant patients. A second pivotal Phase III study evaluating LCP-Tacro in de novo kidney transplant patients is fully enrolled, and topline data are expected in mid-2013, with a regulatory submission to FDA projected for some time during the second half of 2013.

    “The Veloxis organization will be reorganized to focus completely on the LCP-Tacro program,” notes William Polvino, president and CEO. “We will realign out company to crate the most efficient and capable infrastructure to bring LCP-Tacro through the planned EU and U.S. regulatory filings, and commercialization in the U.S.”

    In the meantime, Veloxis is also making changes to its management organization, which will continue to be headed by William Polvino, and CFO Johnny Stilou.

    The firm is focused on developing new formulations of marketed drug compounds based on its MeltDose® technology platform for enhancing the bioavailability of compounds with low water solubility. Apart from LCP-Tacro, the firm’s clinical pipeline includes the Phase II- and III-ready cardiovascular products AtorFen™, a fixed-dose combination tablet of fenofibrate and atorvastatin, and LCP-Feno™, a generic fenofibrate tablet formulation. Both these products are on developmental hold, as partners are being sought. 

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