Clinigen enters into second agreement with Cumberland Pharmaceuticals

Clinigen Group, an AIM listed global pharmaceutical and services company, and Cumberland Pharmaceuticals, a US specialty pharmaceutical company have entered into their second exclusive agreement to commercialise the oncology support drug Totect in the US.

The first product Clinigen licensed to Cumberland, under the strategic alliance established in 2015, was Ethyol in the US in September 2016.

Cumberland has been granted an exclusive US license and will manage all marketing, promotion and distribution of Totect in the US under the agreement. Clinigen will retain responsibility for the manufacturing, regulatory and clinical management of the product.

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.

The drug was acquired by Clinigen’s Specialty Pharmaceuticals division in 2016 to expand its dexrazoxane portfolio and enter the U.S. market. The US launch of Totect later this year is currently being prepared.

Chief executive of Clinigen 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 US market and enabling patients to access this vital FDA-approved emergency support therapy."

Chief executive of Cumberland Pharmaceuticals 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."

The share price of Clinigen rose 0.44% at the close on Monday.