Burton-on-Trent, UK – 26 March 2013 – Clinigen Group plc (‘Clinigen’ or the ‘Group’) (LSE: CLIN) (AIM: CLIN) today announced the acquisition of Cardioxane® (dexrazoxane) from Novartis for US$33 million in cash, payable in two tranches. Under the terms of the agreement, Clinigen will assume responsibility for manufacturing, registration, distribution, and commercialization of the product in countries where current marketing authorizations exist, including key European, Asian and Latin American territories.
Cardioxane, an oncology support therapy, is a cardioprotective agent used to prevent the cardiotoxicity of anthracycline chemotherapy for patients with advanced and/or metastatic breast cancer.
Clinigen believes there is an opportunity to revitalize Cardioxane, which has no direct licensed competition in the anthracycline therapy cardioprotection space, by utilizing new commercialization, market and indication strategies over the next five years. Historic revenues for Cardioxane have been c.US$11-12 million per annum. Latin America is a strong market for Cardioxane which is of particular interest to Clinigen, being a territory in which the Group wishes to expand its reach and which may improve access routes for existing portfolio products such as Foscavir®, as well as products that Clinigen may acquire in the future.
Cardioxane is the third addition to Clinigen’s Specialty Pharmaceuticals (SP) business complementing Foscavir, its anti-viral active against Cytomegalovirus (CMV) and commonly used in the support of leukemia patients undergoing bone marrow transplants, acquired from AstraZeneca in March 2010. Recently, the Group in-licensed VIBATIV®, an anti-bacterial for the treatment of nosocomial pneumonia caused by MRSA, for commercialization in the EU from Theravance. All three are highly specialized, hospital-only drugs which Clinigen SP supplies into licensed markets and Clinigen Global Access Programs (GAP) supplies into pre- or unlicensed markets on a named patient basis.
“Acquiring Cardioxane from Novartis is another major step forward for us,” said Peter George, Chief Executive Officer of Clinigen. “Cardioxane fits particularly well within our portfolio. We have been looking for medicines that complement Foscavir and Cardioxane does this by extending our role in oncology support. Together with our recent addition of VIBATIV, which further builds on our anti-infective capability, we are delivering on our mission to supply the right drug to the right patient at the right time.”
About Cardioxane® (dexrazoxane)
Cardioxane is a cardioprotective agent used to prevent chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300mg/m2 of doxorubicin or 540mg/m2 of epirubicin when further chemotherapy treatment is required. Cardioxane is administered by intravenous infusion. It is believed to work by binding to metal ions, thus decreasing the formation of intracellular superoxide radicals and preventing cardiotoxicity. Cardioxane was initially licensed in 1992. Subsequently, Novartis acquired the product as part of the 2006 acquisition of Chiron. The product is currently licensed for sale in 43 markets around the world, including 18 in Latin America.
Within the European Union Cardioxane underwent a revision to its label in 2011, restricting its licensed use to advanced and/or metastatic breast cancer. The change brought the EU label in line with the dexrazoxane indication that exists within the United States.
About Clinigen Group
Clinigen is a specialty global pharmaceutical products and services business headquartered in the UK, with offices in the US and Japan. The Group has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). The SP business focuses on acquiring and in licensing specialist, hospital-only medicines worldwide and commercializing them within niche markets. For more information, please visit www.clinigengroup.com.
This announcement contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Clinigen Group plc (“Clinigen”). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. The forward-looking statements include statements regarding Cardioxane, its development, potential and financial performance. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Clinigen undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.
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