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Clinigen licences Novartis drug

27.03.2013 - British Clinigen Group broadens its cancer support therapy focus with the acquisition of Novartis' cardioprotective agent Cardioxane.

The UK specialist for cancer support therapy has licenced Cardioxane (dexrazoxane) from Novartis for US$33m in cash, payable in two tranches. Under the terms of the agreement, Clinigen will lead manufacturing, registration, distribution, and commercialisation in all countries where marketing authorisations for the cardioprotectant have been already granted.

Cardioxane is used to prevent chronic cumulative cardiotoxicity of anthracycline chemotherapy such as doxorubicin or in advanced and metastatic adult breast cancer. The company said it believes there is an opportunity to revitalise Cardioxane, which has no direct licensed competition in the anthracycline therapy cardioprotection space, by establishing new commercialisation, market and indication strategies over the next five years.

Historic revenues for Cardioxane have been about US$11-12m per year with Latin America, where Clinigen wants to expand, as a strong market. Cardioxane is the third addition to Clinigen's Specialty Pharmaceuticals business. It complements Foscavir, an anti-viral compound licenced from AstraZeneca, which fights CMV infections in leukemia patients undergoing bone marrow transplantation. Recently, the British company licensed Vibativ from Theravance. It fights hospital-acquired MRSA infections.

Cardioxane was initially licensed in 1992. Subsequently, Novartis bought the product as part of the 2006 acquisition of Chiron. The compound 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 US.

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No liability assumed, Date: 27.07.2016