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BTG rises on FDA approval of varicose vein therapy

Varithena receives green light in US
FDA headquarters White Oak

UK healthcare company BTG passed a major milestone this week when the US Food and Drug Administration (FDA) approved Varithena, a treatment for varicose veins which has followed a long and tortuous route to market.

Varithena (polidocanol) - formerly known as Varisolve - has been tipped by the company as having the potential to make up to $500m in annual sales at peak, thanks to advantages over current varicose vein treatments.

Varicose veins are typically removed by surgery or thermal ablation using lasers, while Varithena takes the form of a foam that is injected into affected veins, driving out blood and shutting down the vein from within. Its advantages are that it is quicker and less invasive than other procedures, while also reducing the patient's recovery time.

"Treatment is a minimally invasive, non-surgical procedure that requires neither tumescent anaesthesia nor sedation," said BTG in a statement. Shares in the company rose more than 11 per cent yesterday on the announcement to reach an 11-year high.

US approval of the product comes after more than a decade of development, including a four-year period when the product was on an FDA-ordered clinical hold because of concerns that polidocanol might escape into the bloodstream.

In 2010, BTG took the brave decision to market the drug itself in the US rather than seeking a marketing partner, so will garner maximum benefit from sales of the drug.

Analyst Savvas Neophytou of Panmure Gordon points out that BTG has been very prudent in its guidance on the product, focusing on medical, reimbursed applications rather than any potential cosmetic use, which could provide significant upside.

More than 30 million adults in the US aged 18 to 70 have varicose veins, with women twice as likely as men to develop them. Neophytou suggested that approval is only the start of "a multiple upgrade cycle for the stock."

Given that BTG's total revenues were £234 in fiscal 2012/13, Varithena's approval looks set to be a transformative event for the company.

"We believe [Varithena] sets a new standard for the treatment of both the symptoms and appearance of varicose veins," commented BTG's chief executive Louise Makin.

"We look forward to the commercial US launch in the second quarter of 2014."

Article by
Phil Taylor

27th November 2013

From: Sales

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