|[March 20, 2017]
Novocure Receives MHLW Approval for Second Generation Optune® in Japan
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.
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
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
or follow us at www.twitter.com/novocure.
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
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.
Important Safety Information
Contraindications: Do not use Optune if you have an active
implanted medical device, a skull defect (such as, missing bone with no
replacement), or bullet fragments. Use of Optune together with implanted
electronic devices has not been tested and may theoretically lead to
malfunctioning of the implanted device. Use of Optune together with
skull defects or bullet fragments has not been tested and may possibly
lead to tissue damage or render Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive
hydrogels. In this case, skin contact with the gel used with Optune may
commonly cause increased redness and itching, and rarely may even lead
to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions: Use Optune only after receiving
training from qualified personnel, such as your doctor, a nurse, or
other medical personnel who have completed a training course given by
Novocure (the device manufacturer).
Do not use Optune if you are pregnant, you think you might be pregnant
or are trying to get pregnant. It is not known if Optune is safe or
effective in these populations.
The most common (=10%) adverse events involving Optune in combination
with temozolomide were low blood platelet count, nausea, constipation,
vomiting, fatigue, scalp irritation from device use, headache,
convulsions, and depression.
The most common (=10%) adverse events seen when using Optune alone were
scalp irritation from device use and headache.
The following adverse reactions were considered related to Optune when
using the device alone: scalp irritation from device use, headache,
malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and trained
Do not use any parts that do not come with the Optune Treatment Kit, or
that were not sent to you by the device manufacturer or given to you by
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp, discuss
with your doctor whether this may prevent or temporarily interfere with
Please see http://www.optune.com/safety
to see the Optune Instructions For Use (IFU) for complete information
regarding the device's indications, contraindications, warnings, and
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 February 23, 2017, 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.
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