9th Jan 2017 14:51
LONDON (Alliance News) - Clinigen Group PLC on Monday said it has signed an exclusive agreement with specialty pharmaceutical company Cumberland Pharmaceuticals Inc to commercialise the oncology support drug Totect in the US.
The contract represents the second product Clinigen has licensed to Nashville, Tennessee-based Cumberland under the strategic alliance the pair established in 2015.
Totect has been approved by the US Food & Drug Administration and is an 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," Clinigen said.
Under the contract, Cumberland has been given an exclusive US licence and will be responsible for all marketing, promotion, and distribution of Totect in the US. Clinigen will keep on manufacturing the product and will remain responsible for regulatory and clinical management of the product.
The launch of Totect in the US will occur "later this year", Clinigen said.
Totect was acquired by Clinigen's Specialty Pharmaceuticals division in 2016 to expand its dexrazoxane portfolio and enter the US market.
"Cumberland is a valuable partner, providing us with the opportunity to expand our dexrazoxane portfolio into the sizeable US market and enabling patients to access this vital FDA-approved emergency support therapy," said Shaun Clinton, chief executive of Clinigen.
Clinigen shares were trading up 0.4% on Monday at 793.50 pence per share.
By Joshua Warner; [email protected]; @JoshAlliance
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