HORSHOLM, Denmark, May 23, 2012-- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that it contemplates restructuring the company's operations in order to fully focus its resources on the completion of the development and subsequent commercialization of LCP-Tacro™, Veloxis' product candidate for the prevention of organ rejection. It is planned that a discontinuation of other pipeline activities will take place, including early phase research activities. The basis for the contemplated restructuring of Veloxis is to ensure that optimal resources are placed behind LCP-Tacro™ on its path towards commercialization. This includes working towards filing and regulatory approvals in the US and Europe and the building of an in-house marketing and sales organization in the US.
If the contemplated organizational restructuring - in accordance with the statutory consultation with the employee - is carried through, it is planned to include a staff reduction of approximately 40-50%. The total headcount of the organization will be reduced from approximately 60 to approximately 30-35. This restructuring is expected to reduce the annual cost base of the Veloxis organization by approximately DKK 35-40 million, once the full savings benefits are realized beginning in 2013.
Along with the planned reduction, Veloxis today announces the new management organization. William Polvino and Johnny Stilou continue as CEO and CFO respectively, Johnny Stilou becoming a registered officer of the Company. Dr. John Weinberg is promoted to chief commercial officer and will assume an expanded role in assisting the CEO in oversight of operations. Peter G. Nielsen, the head of CMC and formulation development will be departing from the company. In addition to changes to the management structure, Veloxis also announces the following organizational promotions: Lars Bjorn-Christensen is promoted to the new role of senior vice president, technical operations and in that capacity will lead contract manufacturing responsibilities, supply chain management, and CMC. Christina Sylvest will assume the leadership of global clinical functions via promotion to the position of senior vice president, global clinical operations and development. Similarly, Ron Guido will assume leadership of both global regulatory affairs and quality functions via promotion to senior vice president, global regulatory affairs and quality.
"The Veloxis organization will be reorganized to focus completely on the LCP-Tacro™ program," said William Polvino, president and chief executive officer. "We will realign our Company to create the most efficient and capable infrastructure to bring LCP-Tacro™ through the planned EU and US regulatory filings, and commercialization in the US. We contemplate to make these changes in light of our growing confidence in the LCP-Tacro™ program and in our goal to deliver the highest shareholder value in the most cost-efficient manner. The new management team has been working together successfully for several years and the additional organizational promotions facilitate the efficient organization of our Company. I have complete confidence in each of the team members in their expanded responsibilities."
LCP-Tacro™'s second pivotal Phase III study in de novo kidney transplant patients is fully enrolled and top-line data from this study is expected in mid-2013, allowing for a regulatory submission to the FDA in 2H 2013. In Europe, Veloxis is planning a submission to the EMA later in 2012 based primarily on the completed first Phase III study in maintenance switch kidney transplant patients.
The content of this release will have no influence on Veloxis' financial guidance for 2012 which was provided in March 2012 in connection with the release of the financial results for 2011.
About LCP‐Tacro™ and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP‐Tacro™ is being developed as a once‐daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak‐to‐trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.
About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is LCP‐Tacro™ for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low‐scale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.