BTG's varicose vein treatment wins US approval

Reuters

* Injectable foam treatment approved after long development

* BTG sees sales of $250 million to $500 million

* Shares rise to more than 11-year high

By Paul Sandle

LONDON, Nov 26 (Reuters) - British pharmaceutical firm BTG said U.S. regulators had approved its varicose veintreatment that uses an injectable foam to dissolve the veins asan alternative to surgical removal.

Varithena, previously known as Varisolve, has taken morethan a decade to win approval, as the company had to answerconcerns that the active agent in the product polidocanol couldenter the bloodstream.

The company, which had expected a decision from the Food andDrug Administration (FDA) in the first half of next year, haspreviously said global sales of Varithena could reach $500million a year.

Chief Executive Louise Makin said on Tuesday the productwould set a new standard for the treatment of both the symptomsand appearance of varicose veins.

"We look forward to the commercial U.S. launch in the secondquarter of 2014, and to continuing to advance our plans toexpand use into other geographies and into non-symptomaticveins," she said.

Shares in BTG, which also has interventional treatments forcancer and niche anti-poison drugs, rose to a more than 11 yearhigh of 527.5 pence after the announcement on Tuesday. They wereup 12.5 percent at 516.5 pence by 1342 GMT.

Panmure Gordon analyst Savvas Neophytou, who upgraded BTG to"buy" in May, said the approval should be seen as the start of amultiple upgrade cycle for the stock. He increased his pricetarget to 610 pence from 490 pence.

"(The approval) removes significant forecast risk andenables us to increase our forecasts modestly near-term but moresignificantly in years FY2017-FY2019," he said.

He said peak sales could be 168 million pounds in 2019, atthe bottom of the company's $250-500 million guidance, saying at this stage he preferred to keep the upside as a buffer.

Varicose veins, which can be painful, especially whenstanding, affect more than 30 million adults in the U.S. agedbetween 18 to 70, with women twice as likely as men to developthe condition, BTG said.

Current treatments include surgically stripping or closingthe vein using laser or heat treatments.

BTG said Varithena was minimally invasive and avoided theneed for surgery and sedation. Its guidance for the productfocuses on the medical market, rather than any potentialcosmetic use, which analysts say could be a significantopportunity.

The group decided in 2010 to market the product itself inthe United States rather than sharing development costs with apartner.

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