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Cumberland Pharmaceuticals, Clinigen sign US commercialization deal for Totect

Published 10 January 2017

Cumberland Pharmaceuticals and Clinigen Group have signed an exclusive agreement to commercialize the oncology support drug, Totect (dexrazoxane hydrochloride) in the US.

This is the second product Clinigen has licensed to Cumberland under the strategic alliance established in 2015, following the launch of Ethyol (amifostine) in the U.S. in September 2016.

Totect is an FDA-approved emergency oncology intervention, which is indicated to reverse the toxic effects of anthracycline chemotherapy in case of extravasation.

Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body causing severe damage and serious complications. Totect can reverse such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment.

Under the terms of the agreement, Cumberland has been granted an exclusive U.S. license and will manage all marketing, promotion, and distribution of Totect in the U.S. Clinigen will retain responsibility for manufacturing, regulatory and clinical management of the product. Preparations are now underway for the U.S. launch of Totect later this year.

Totect was acquired by Clinigen's Specialty Pharmaceuticals (SP) division in 2016 to expand its dexrazoxane portfolio and enter the U.S. market. Clinigen SP will continue to commercialize its existing dexrazoxane products, Savene and Cardioxane, in Europe and other territories outside of the U.S.

Cumberland Pharmaceuticals CEO A.J. Kazimi said: "It's good to see another product emerge from our strategic partnership with Clinigen as we continue to selectively expand our line of marketed hospital brands.

"We are keen to help yet another group of oncology patients with Totect, which reflects our mission of delivering products that help improve patients' quality of care."

Clinigen Group CEO Shaun Chilton said: "This agreement marks an important milestone for Clinigen. Totect is the second Specialty Pharmaceuticals product that we have exclusively licensed to Cumberland as part of the strategic alliance signed in 2015.

"Cumberland is a valuable partner, providing us with the opportunity to expand our dexrazoxane portfolio into the sizable U.S. market and enabling patients to access this vital FDA-approved emergency support therapy."

About Totect (dexrazoxane)

Totect is an anthracycline extravasation agent approved by the United States Food and Drug Administration. Anthracyclines are used to treat many types of cancer and are among the most common cancer therapies.

Anthracycline extravasation occurs when there is accidental leaking of the intravenously-administered medication into the surrounding tissues.  Anthracycline extravasation can result in serious complications for cancer patients including tissue necrosis with skin ulceration. In addition to tissue damage, an anthracycline extravasation may cause damage to the nerves, tendons, muscle and joints.

Source: Company Press Release