NovoCure registered for an initial public offering that could fetch as much as $300 million for its tumor-zapping Optune brain cancer treatment as it awaits a decision from the FDA on a new indication for the device.
The federal safety watchdog granted pre-market approval for Optune in April 2011 for adult patients with glioblastoma whose cancer recurred after chemotherapy. Last April, the company applied for another indication, newly diagnosed glioblastoma, under priority review from the FDA.
The Optune device uses NovoCure’s “tumor treating fields,” which use low-intensity, intermediate-frequency alternating electric fields to kill cancer cells. It’s on the market in the U.S., Germany, Switzerland and Japan, NovoCure said.
“Upon FDA approval of Optune for newly diagnosed GBM, we believe TTFields will transform the standard of care for patients with newly diagnosed and recurrent GBM,” NovoCure said in its IPO filing, noting that a Phase III pivotal trial was halted early after it met its endpoints after showing “significant improvements in both progression-free and overall survival” in GBM patients. More than 1,600 patients have been treated using Optune, the company said.
NovoCure said it has clinical programs in place for other types of cancer, including metastases, pancreatic, ovarian, mesothelioma and advanced non-small cell lung cancer.
NovoCure’s losses grew 4.3% to -$80.7 million last year on sales of $15.5 million, for top-line growth of 49.5%, and the company said it expects to be in the red for “at least the next several years.” The company, which is based on Jersey, an island in the English Channel, had deficits of $329.1 million as of June 30, according to the filing.