Date: 2014-03-31
Type of information: Product acquisition
Compound: Savene® (dexrazoxane)
Company: Clinigen (UK) SpePharm (The Netherlands), affiliate of Norgine (The Netherlands)
Therapeutic area: Cancer - Oncology
Type agreement:
Action mechanism: Savene® has two major mechanisms of action: chelation of iron and inhibition of DNA topoisomerase II. Dexrazoxane binds to iron and prevents the formation of free radicals, which are considered to play a major role in the development of extravasation-induced tissue necrosis. In addition, dexrazoxane binds to DNA topoisomerase II at a different step in the catalytic cycle than anthracyclines and locks the enzyme in a form that is no longer affected by the anthracyclines. Savene® has been developed by the Danish company Topotarget. SpePharm Holding acquired the rights to Savene® in March 2010.
Disease: extravasation in anthracycline chemotherapy in adults
Details: * On March 31, 2014, Clinigen Group announced the acquisition of Savene® (dexrazoxane) from SpePharm AG, a majority owned affiliate of Norgine B.V. Savene® is indicated for the treatment of extravasation in anthracycline chemotherapy in adults. Extravasation occurs when anticancer drugs, normally injected into a vein, leak or are accidentally injected into tissue surrounding the vein where they can cause serious damage. Savene® is the only authorized treatment of its kind available. Its use within the first six hours of extravasation occurring is crucial and enables affected patients to continue their anticancer treatment. Under the terms of the agreement, Clinigen will assume full responsibility for Savene®’s manufacturing, registration, distribution, and commercialization in all markets globally excluding the Americas, Israel and South Africa. In Japan, Clinigen will provide Savene® through an existing supply and license agreement with Kissei Pharmaceutical Co. Ltd, the marketing authorization holder. In 2013 the Group also acquired Cardioxane® from Novartis which, like Savene®, has dexrazoxane as its active substance and is also an oncology support therapy; used to prevent the cardiotoxicity of anthracyclines for patients with advanced and/or metastatic breast cancer. The acquisition of SAVENE allows Clinigen to exploit synergies between the two products. Savene® is the fourth product to be added to Clinigen’s Specialty Pharmaceuticals business. In addition to its close strategic fit with Cardioxane® (dexrazoxane hydrochloride), Savene® complements Foscavir® (foscarnet sodium), Clinigen’s anti-viral active against Cytomegalovirus (CMV) commonly used in the support of leukemia patients undergoing bone marrow transplants, acquired from AstraZeneca in March 2010. In addition VIBATIV® (telavancin), an anti-bacterial for the treatment of nosocomial pneumonia caused by MRSA was in-licensed for commercialization in the EU from Theravance in March 2013. All four drugs in Clinigen’s portfolio are highly specialized, hospital-only drugs which Clinigen SP markets into licensed markets and Clinigen GAP supplies into pre- or unlicensed markets on a named patient basis.
Financial terms: Financial terms of the acquisition were not disclosed.
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