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Mar 26, 2013

Clinigen Buys Cardioxane from Novartis for $33M

  • Clinigen Group said today it acquired the oncology support therapy Cardioxane® (dexrazoxane) from Novartis for $33 million cash, reasoning that new commercialization, market, and indication strategies over the next five years will revive sales of the cardioprotective agent since it has no direct licensed competitor drugs focused on anthracycline therapy cardioprotection.

    Cardioxane is used to prevent the cardiotoxicity of anthracycline chemotherapy for patients with advanced and/or metastatic breast cancer. A successful revitalization would raise Cardioxane revenues well above their current annual range of $11 million to $12 million.

    Cardioxane is the third addition to Clinigen’s Specialty Pharmaceuticals (SP) business, and is designed to complement Foscavir, the anti-viral active against cytomegalovirus (CMV) acquired from AstraZeneca in March 2010 and commonly used to support leukemia patients undergoing bone marrow transplants. More recently, Clinigen in-licensed Vibativ®, an anti-bacterial for the treatment of nosocomial pneumonia caused by MRSA, for commercialization in the E.U. from Theravance.

    “Acquiring Cardioxane from Novartis is another major step forward for us,” Peter George, Clinigen’s CEO, said in a statement. “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.”

    Clinigen said it will assume responsibility for manufacturing, registration, distribution, and commercialization of Cardioxane in “key European, Asian, and Latin American territories” where current marketing authorizations exist. Clinigen said a potentially strong market for Cardioxane was Latin America, since the group wants to expand its reach within that region, with the goal of improving access for both its existing products and products it may acquire in the future.

    All three Clinigen SP therapies are hospital-only products supplied into licensed markets, with Clinigen Global Access Programs (GAP) supplying the drugs into pre- or unlicensed markets on a named-patient basis.

    Cardioxane is designed 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 300 mg/m2 of doxorubicin or 540 mg/m2 of epirubicin when further chemotherapy treatment is required.

    Initially licensed in 1992, Cardioxane was among Chiron drugs acquired by Novartis when it bought the company in 2006. Cardioxane is now licensed for sale in 43 markets around the world, 18 of them in Latin America.

    One key factor in Cardioxane’s recent sales: In 2011, the European Union revised the drug’s label by restricting its licensed use to advanced and/or metastatic breast cancer. The change brought the E.U. label in line with the dexrazoxane indication in the United States.


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