* 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 British pharmaceutical firm BTG
said U.S. regulators had approved its varicose vein
treatment that uses an injectable foam to dissolve the veins as
an alternative to surgical removal.
Varithena, previously known as Varisolve, has taken more
than a decade to win approval, as the company had to answer
concerns that the active agent in the product polidocanol could
enter the bloodstream.
The company, which had expected a decision from the Food and
Drug Administration (FDA) in the first half of next year, has
previously said global sales of Varithena could reach $500
million a year.
Chief Executive Louise Makin said on Tuesday the product
would set a new standard for the treatment of both the symptoms
and appearance of varicose veins.
"We look forward to the commercial U.S. launch in the second
quarter of 2014, and to continuing to advance our plans to
expand use into other geographies and into non-symptomatic
veins," she said.
Shares in BTG, which also has interventional treatments for
cancer and niche anti-poison drugs, rose to a more than 11 year
high of 527.5 pence after the announcement on Tuesday. They were
up 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 a
multiple upgrade cycle for the stock. He increased his price
target to 610 pence from 490 pence.
"(The approval) removes significant forecast risk and
enables us to increase our forecasts modestly near-term but more
significantly in years FY2017-FY2019," he said.
He said peak sales could be 168 million pounds in 2019, at
the 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 when
standing, affect more than 30 million adults in the U.S. aged
between 18 to 70, with women twice as likely as men to develop
the condition, BTG said.
Current treatments include surgically stripping or closing
the vein using laser or heat treatments.
BTG said Varithena was minimally invasive and avoided the
need for surgery and sedation. Its guidance for the product
focuses on the medical market, rather than any potential
cosmetic use, which analysts say could be a significant
The group decided in 2010 to market the product itself in
the United States rather than sharing development costs with a