Ten years after BTG weathered a tempest as the FDA erected a barrier to its new treatment for varicose veins, the British biotech company has finally gained U.S. approval for its product and confidently predicts it can register peak sales of $500 million a year.
Varithena--formerly dubbed VariSolve--is an injectable foam product designed to substitute for surgical interventions for varicose veins. And the company saw its shares shoot up 15% on the upbeat news as executives set the stage for a Q2 launch next year.
"We are delighted to receive US approval for Varithena, which we believe sets a new standard for the treatment of both the symptoms and appearance of varicose veins," says CEO Louise Makin. "We look forward to the commercial US 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."
BTG estimates the full potential market for Varithena at 30 million adults in the U.S., with women far more likely than men to develop varicose veins.
The approval marks a big advance for Makin, who outlined ambitious plans to grow the company in an interview with FierceBiotech earlier this year.
In the spring BTG agreed to pay $180 million in cash and up to $40 million in milestones for Seattle-area company Ekos, which gave it control of EkoSonic, a new technology approved in the U.S. and Europe for treating blood clots. The biotech has been developing the product for use in hospitals--making it a good match for Varithena. Earlier BTG nabbed the targeted therapies division of Nordion for $200 million, getting its hands on Therasphere, which uses radioactive glass beads in a targeted approach to treating liver cancer.
- here's the press release