Veloxis Pharmaceuticals A/S Announces Strategic Agreement for Chiesi Farmaceutici S.p.A. to Commercialize and Distribute Its Investigational Drug Candidate LCP-Tacro™ in Europe, Turkey and CIS Countries and Revised Outlook for 2012

HORSHOLM, Denmark, Oct. 5, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that it has entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro in certain countries, including Europe, Turkey and CIS countries.

Under the terms of the agreement, Veloxis will receive up-front and milestone payments of up to USD 47.5 million (in aggregate). The milestone payments are subject to the achievement of certain regulatory milestones and sales targets. Veloxis will supply product to Chiesi for sale in the Territory at a transfer price at a pre-agreed double-digit percentage of the product's sales price. In addition, Chiesi is committed to certain minimum purchases during the term of the agreement. The agreement will extend through expiry of product patents in the territory of the agreement.

"We are thrilled to announce this partnership with Chiesi, a company who we believe to be an ideal partner for Veloxis in Europe and who will effectively launch and sell LCP-Tacro within this critical region of the globe," said William Polvino, M.D., president and chief executive officer of Veloxis Pharmaceuticals.

Chiesi is an international Company with a large distribution network and more than €1 billion revenues per year. According to the agreement, Chiesi will be responsible for the distribution of Veloxis' LCP-Tacro product in Europe, Turkey and CIS countries including promoting the drug and handling pricing and reimbursement for its use in the prevention of rejection in kidney transplant recipients. Chiesi will also have the right, subject to Veloxis' agreement, to develop LCP-Tacro for further indications in the territory of the agreement.

Veloxis is completing two Phase III studies of LCP-Tacro™ in kidney transplant recipients as the basis for its development program for LCP-Tacro™ as a once-daily agent for the prophylaxis of organ rejection in kidney transplantation. The first of these studies, the 3001 Study was a non-inferiority study performed in 326 stable kidney transplant recipients, and this study was successfully completed in 2011, meeting its primary efficacy and safety endpoints when compared to Prograf® (tacrolimus, Astellas Pharma Inc.). The second study, Study 3002 is being undertaken in de novo kidney transplant recipients. This study is a randomized, double-blind, multicenter study that compares once-daily LCP-Tacro™ against twice-daily Prograf® in de novo adult kidney transplant patients. The primary endpoint of the study, a composite endpoint (biopsy proven acute rejection, graft failure, loss to follow up or death), will be evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro™ compared to Prograf®. This study is fully enrolled and Veloxis anticipates filing for regulatory approval of LCP-Tacro in the EU and US in 2013.

Revised outlook for 2012

The content of this release will influence the company's full year outlook as reported in connection with the interim report on 22 August 2012.

The Company's cash and cash equivalents position as at 31 December, 2012 is expected to be in the range of DKK 90–130 million. A range of DKK 240 – 270 million in operating loss is maintained.

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For further information, please visit www.veloxis.com.

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 an investigational drug that it 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.

SOURCE Veloxis Pharmaceuticals A/S