ST. HELIER, Jersey, 20 March 2017 – Novocure (NASDAQ:NVCR) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved second generation Optune. Second generation Optune features a Tumor Treating Fields (TTFields) generator that is less than half the weight and half the size of the first generation generator, weighing less than 1.3 kilograms (2.7 pounds). The smaller, lighter TTFields delivery system is now available to glioblastoma (GBM) patients in all of Novocure’s active markets.

“The MHLW’s approval of second generation Optune represents another important milestone for Novocure in Japan as we prepare for a broad commercial launch pending reimbursement approval,” said Shungo Matori, Novocure’s General Manager, Japan and Representative Director of Novocure K.K. “We are dedicated to making Optune available to GBM patients who can benefit from our therapy. This approval enables us to provide Japanese patients with the latest TTFields technology, designed to be make it even easier for patients to incorporate treatment with Optune into their lives.”

Novocure established commercial operations in Japan in March 2015 after the MLHW approved Optune for the treatment of recurrent GBM. In December 2016, the MLHW approved Optune for the treatment of newly diagnosed GBM and Novocure is currently preparing to submit an application for public reimbursement of Optune. Approximately 1,500 people are diagnosed with GBM or tumors that typically progress to GBM in Japan each year.

The MHLW’s approval of Optune for the treatment of newly diagnosed GBM was supported by Novocure’s phase 3 pivotal EF-14 trial results, which showed significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone. Optune is the first MHLW-approved therapy in more than a decade to demonstrate statistically and clinically significant extension of survival in newly diagnosed GBM.


About Novocure
Novocure is an oncology company developing a profoundly different cancer treatment centered on a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has built a commercial organization and launched Optune for the treatment of GBM in the United States, Germany, Switzerland and Japan, referred to as Novocure’s currently active markets. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Approved Indications
In Japan, Optune (NovoTTF-100A) is approved in the treatment of adult patients with supra-tentorial glioblastoma (GBM) and is used following maximal safe surgical resection and radiation therapy.

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.