|Optune--Courtesy of Novocure|
It's been a big year for Novocure. In November, the company had an early Phase III trial halt for efficacy for its Optune in combination with chemotherapy for patients with newly diagnosed glioblastoma. Then in April it submitted a PMA application for the device as a first-line treatment; it has been FDA-approved since 2011 for its use as a monotherapy on glioblastoma recurrence after chemotherapy. The application gained priority review status in May--meaning an FDA decision could come before year end.
Now, Novocure has filed for an IPO to raise up to $300 million on the strength of a potential FDA approval for Optune in that newly diagnosed glioblastoma indication.
An exit has been a long time coming. Novocure was founded in 2000--and had already burned through a whopping $329 million at June 30. But it has some deep-pocketed investors who can afford to be patient, including high-profile strategic investors Johnson & Johnson Development Corporation, Pfizer Ventures and Medtronic ($MDT). WFD Ventures and Index Ventures are also among its investors. WFD holds the largest portion of the company, 26.5%, according to the SEC filing.
Novocure had $11.8 million in revenue during the first half of this year, with a net loss of $52.6 million during that period. The company had $106.5 million in cash at June 30.
Optune is already in use at more than 260 cancer centers and has been used on more than 1,600 glioblastoma patients. The first-line study that halted in November found at an interim analysis of the first 315 patients found that it met the endpoints on both progression free survival (PFS) and in overall survival for Optune in combination with standard-of-care temozolomide versus temozolomide alone.
The study found that the two-year survival rate was 48% for the combination group, as compared to 32% for the temozolomide alone group. It found that median PFS was 7.2 months for the combo, as compared to 4 months for temozolomide alone.
About 27,500 patients are diagnosed annually with glioblastoma in the U.S., top EU and Japanese markets. Novocure expects that Optune will become part of the standard-of-care for newly diagnosed glioblastoma patients with an anticipated FDA approval.
Optune is based on Novocure's Tumor Treating Fields, or TTFields, technology to treat solid tumors which "is a low-toxicity anti-mitotic treatment that uses low-intensity, intermediate frequency, alternating electric fields to exert physical forces on key molecules inside cancer cells, disrupting the basic machinery necessary for normal cell division, leading to cancer cell death," according to the SEC filing.
First-line glioblastoma is only the near-term target. Novocure is also planning or conducting TTFields clinical trials in brain metastases, advanced non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
- here is the SEC filing