BTG has finally got the green light in the USA for Varithena, the UK group’s varicose veins treatment.
Varithena (polidocanol) previously known as Varisolve, is a pharmaceutical-grade, low-nitrogen foam dispensed from a proprietary canister device. The approval from the US Food and Drug Administration is based on two Phase III trials where the product achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities.
BTG notes that current treatments include thermal ablation and surgery, whereby Varithena “provides US physicians with the only approved comprehensive therapy to improve symptoms and appearance for a wide range of varicose veins”. Treatment is a minimally invasive, non-surgical procedure “that requires neither tumescent anaesthesia nor sedation”.
Chief executive Louise Makin said the product “sets a new standard for the treatment of both the symptoms and appearance of varicose veins”. She added that a commercial launch in the USA is scheduled for the second quarter of 2014, and the firm will continue “to advance our plans to expand use into other geographies and into non-symptomatic veins”.
The company has been trying to get approval for well over a decade and the green light has been welcomed by investors and analysts. Savvas Neophytou at Panmure Gordon says that the news “should be seen as the start of a multiple upgrade cycle for the stock”. The broker has upgraded its peak sales forecast for the product by 38% to £168 million in 2019.
