|Second-generation Optune--Courtesy of Novocure|
Europe's Novocure ($NVCR) has won an expanded indication for a 2011 FDA approval of its Optune to treat newly diagnosed glioblastoma in combination with temozolomide, a standard chemotherapy. The company has been on a roll of late, disclosing a CE mark for its second-generation version of Optune on Oct. 5 and pricing a $165 million IPO on Oct. 2.
Now the Jersey Isle-based company will need to turn to reimbursement issues to help it nail down broader U.S. commercialization of Optune. Ultimately, Novocure plans to broaden the use of Optune to other solid tumors, where the device has already shown preclinical utility across the board. Just in the solid tumor indications in which it has ongoing or completed clinical trials, there are about 350,000 new patients diagnosed annually in the U.S.
That could mean billions in revenue--if Novocure is successful in expanding into all those solid tumors and maintaining its price point. The company gets about $14,700 on average for a month of Optune use, which is typically used for several months per patient to extend lifespan.
Novocure bills $21,000 monthly for Optune in the U.S. and commercial third-party payers and privately administered government plans like those for the U.S. military have accounted for about 99% of its patient usage so far. About one-quarter of its active U.S. patients are part of the Medicare fee-for-service program, which has thus far denied coverage claims. Novocure is appealing that decision and this new FDA approval should give it ample ammunition.
In clinical testing, the Optune and temozolomide combo resulted an extension of lifespan for about 3 months for newly diagnosed glioblastoma patients. An average life span from diagnosis for the temozolomide-alone patients was 16.6 months, while the Optune combo achieved 19.4 months.
"Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available," Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement. "While the treatment is not a cure, it can increase survival by several months."
The device is a bit unwieldy and must be worn continuously, although the second-generation version is about half the size and roughly half the weight of its predecessor. Novocure intends to submit an application with the FDA for the next-gen system.
"For a disease for which there are few treatment options, Optune offers new hope for extending survival from the start of treatment," said Elizabeth Wilson, president and CEO of the American Brain Tumor Association.
Investors weren't quite sure how to react in this rocky market to the news, driving Novocure shares up about 10% in after hours and premarket trading but then backtracking over all that ground and more once the market opened. Novocure shares were at about $18 in early trading on Oct. 6, down steeply from its $22 IPO price.
- here are the company FDA and CE mark announcements
- and here is the FDA statement