BTG’s Varicose-Vein Treatment Cleared by U.S. RegulatorAndrea Gerlin
BTG Plc won U.S. regulatory clearance for its varicose-vein treatment, sending shares of the U.K. biotechnology company up the most in more than five years.
The Food and Drug Administration approved the sale of BTG’s Varithena injectable foam for non-surgical treatment of varicose veins in the legs, the London-based company said today in a statement. BTG shares rose 14 percent to close at 522 pence in London, the biggest gain since June 2008.
The removal of uncertainty about U.S. approval “has a great impact on the risk profile” of BTG, Savvas Neophytou, an analyst at Panmure Gordon in London, said in a phone interview. “They do have another product now, which helps them.”
The company expects to begin selling the treatment in the second quarter of 2014, Chief Executive Officer Louise Makin said in the statement. More than 30 million people in the U.S. have varicose veins, with women twice as likely as men to develop the condition, the company said.
BTG foresees the market for the product growing to $250 million and eventually to more than $500 million, Makin said Nov. 20. She said at the time that BTG had 24 sales people in the U.S. and planned to spend 8 million pounds ($13 million) this year and 16 million pounds next year to introduce the medicine.
Initial sales will probably be in the “single-digit millions” of dollars in the current fiscal year and two to three times as much next year with further growth in two years after reimbursement prospects improve, Makin said last week at a conference for investors held by Jefferies.
“We would expect a slow take-up for the first couple of years as the company rolls out the product carefully,” Charles Weston, an analyst at Numis Securities in London, said by e-mail.
BTG expects to eventually expand sales of the treatment to countries including Canada, Brazil and Australia, Makin said last week. The company doesn’t see Europe as a significant potential market, she said.