Clinigen's 'Totect' gets US FDA approval

Global pharmaceutical and services company Clinigen Group confirmed it had obtained approval from the US Food and Drug Administration for its ‘Totect’ dexrazoxane hydrochloride product on Monday, alongside Cumberland Pharmaceuticals.

The AIM-traded firm described Totect as an “emergency oncology intervention”, which was 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.

Clinigen said Totect could reverse such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment.

“Totect is the second SP product that we have exclusively licensed to Cumberland as part of the Strategic Alliance, and the FDA approval of Totect is an important milestone in its revitalisation strategy,” said Clinigen chief executive officer Shaun Chilton.

“Approval paves the way for launch, which will enable patients to access this vital FDA-approved emergency support therapy.”

In January, Clinigen and Cumberland entered an exclusive US agreement to commercialise Totect, the second such agreement under their strategic alliance established in 2015.

The FDA approval of Totect was an “important milestone” in the preparation for the US launch of the product later this year, Clinigen’s board said.

Totect was acquired by the company’s specialty pharmaceuticals division in March 2016 to expand its dexrazoxane portfolio for the US market.

Clinigen SP was continuing to commercialise its existing dexrazoxane products ‘Savene’ and ‘Cardioxane’ in Europe and other territories outside of the US.

“We are delighted by the FDA approval of Totect for the United States, and we are looking forward to expanding the number of patients that will benefit from this important oncology support product,” commented Cumberland Pharmaceuticals chief executive A.J. Kazimi.

“This is a significant next step for Cumberland as we build our position in oncology supportive care and further strengthen our Strategic Alliance with our partner, Clinigen.”