ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) approved its premarket approval (PMA) supplement application for Novocure’s second generation Optune system. The new smaller, lighter Tumor Treating Fields (TTFields) delivery system is now available to glioblastoma (GBM) patients in the United States.
Novocure designed the second generation Optune system to make treatment with TTFields more convenient and manageable for GBM patients. The new model features a TTFields generator that is less than half the weight and half the size of the generator in the first generation Optune system. Including its battery, the second generation Optune system weighs 2.7 pounds, compared to the first generation system that weighs 6 pounds. Novocure reduced the size and weight of Optune by utilizing novel digital signal generation technology. Additional improvements include: easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a “No-Stop Swap” feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.
Novocure started offering the second generation Optune system to patients in Germany in October 2015 and has since made it available to all new patients in Europe.
“From the start, Novocure’s mission has been to improve the lives of cancer patients,” said Mike Ambrogi, Novocure’s Chief Operating Officer. “The second generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives. We have received positive feedback from our second generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States.”
Novocure will offer existing Optune patients in the United States the opportunity to convert to the second generation Optune system over the next several weeks. All new patients will receive the second generation Optune system.
“We are happy to receive FDA approval of our second generation Optune system,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We believe the improvements incorporated into the second generation Optune system will make a big difference to the patients and families who face this devastating disease every day. We will continue to work to improve our technology and patient experience.”
About Novocure
Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. 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 Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
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.
Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on March 1, 2016, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
