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Agreements

Date: 2013-03-26

Type of information: Product acquisition

Compound: Cardioxane® (dexrazoxane)

Company: Clinigen (UK) Novartis (Switzerland)

Therapeutic area: Cancer - Oncology

Type agreement:

Action mechanism: Cardioxane® (dexrazoxane) 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.

Disease: prevention of the cardiotoxicity of anthracycline chemotherapy for patients with advanced and/or metastatic breast cancer

Details:

* On March 26, 2013, Clinigen Group 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. 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.

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