Zai Lab granted license to commercialize oncology platform
technology Tumor Treating Fields, including the brand name Optune®,
in China, Hong Kong, Macau and Taiwan
Zai Lab will support enrollment of Chinese patients to certain
clinical trials investigating Tumor Treating Fields, intended to
accelerate clinical trial enrollment
Tumor Treating Fields currently marketed in the U.S., the EU and
Japan for the treatment of glioblastoma and in advanced clinical
development for multiple solid tumor indications
Novocure (NASDAQ:NVCR), a global oncology company developing a
proprietary platform technology called Tumor Treating Fields, and
Zai Lab (NASDAQ:ZLAB), a Shanghai-based innovative
biopharmaceutical company, announced today an exclusive license
agreement for Tumor Treating Fields, including the brand name
Optune, in Greater China and a global strategic development
collaboration. This agreement will enable Novocure to access the
Chinese market and is intended to accelerate clinical trial
enrollment. For Zai Lab, this agreement will add a complementary
commercial stage oncology asset to its innovative pipeline.
“The Zai Lab team is passionate about bringing innovative
treatments to patients in need, a passion we share at Novocure,”
said Novocure’s Executive Chairman Bill Doyle. “We believe this
collaboration supports our mission of making Tumor Treating Fields
available to patients throughout the world and will accelerate the
development of Tumor Treating Fields in indications beyond
glioblastoma (GBM).”
Tumor Treating Fields is a cancer therapy that uses electric
fields tuned to specific frequencies to disrupt cell division,
inhibiting tumor growth and causing affected cancer cells to die.
Tumor Treating Fields is currently marketed under the brand name
Optune in the U.S., the EU, Switzerland, Japan and certain other
countries for the treatment of GBM and is in advanced clinical
development for multiple solid tumor indications. Novocure reported
trailing 12-month revenues from Optune of $217 million as of June
30, 2018, representing 60 percent year-over-year revenue growth Q2
2018 versus Q2 2017. While Optune is not yet approved for
commercialization in China, the technology was included and
recommended with Level 1 evidence as a treatment for GBM in China’s
Glioma Treatment Guideline published in 2016.
“There are approximately 45,000 newly diagnosed GBM patients
annually in China,” said Lvhua Wang, Associate Director of China
National Cancer Center and Vice President of China Society of
Clinical Oncology. “Temozolomide is currently the only approved
therapy for GBM in China so there are limited choices for one of
the most deadly cancers. I am eagerly anticipating Tumor Treating
Fields approval in China.”
Novocure granted Zai Lab an exclusive license to commercialize
Tumor Treating Fields in China, Hong Kong, Macau and Taiwan. Zai
Lab will be responsible for regulatory submissions in Greater China
and will work to establish Tumor Treating Fields as an oncology
treatment in this territory.
Preclinical and clinical research demonstrated that Tumor
Treating Fields’ mechanism of action affected fundamental aspects
of cell division and may have broad applicability across a variety
of solid tumors. In addition to GBM, Novocure and Zai Lab will
collaborate on development activities for Tumor Treating Fields in
multiple solid tumor indications, including Novocure’s ongoing
phase 3 pivotal trials in non-small cell lung cancer (NSCLC) and
pancreatic cancer, and a phase 3 pivotal trial in ovarian cancer
planned to open later this year. In addition, Zai Lab will conduct
a phase 2 pilot trial to investigate Tumor Treating Fields in
gastric cancer in China. China has one of the highest incidence
rates of gastric cancer in the world, with approximately 680,000
new cases annually. Gastric cancer is the second leading cause of
cancer death in men and women in China.
“Optune has demonstrated strong efficacy in a very challenging
and difficult to treat cancer, GBM,” said Dr. Samantha Du, CEO of
Zai Lab. “Optune was approved in Japan without the need for a local
bridging trial and we hope for similar rapid development in China.
In addition, Tumor Treating Fields has the potential to treat a
variety of solid tumors, which we believe are complementary to Zai
Lab’s existing late-stage oncology assets and represent strong
commercial synergy for us.”
Novocure will receive a $15 million upfront payment and is
eligible to receive additional payments upon achievement of certain
development, regulatory and commercial milestones. Novocure is also
eligible to receive a royalty on net sales of the licensed products
in Greater China ranging from 10 percent to the mid-teens.
China Renaissance served as sole financial advisor to Novocure
for the transaction.
About NovocureNovocure is a global oncology company
developing a proprietary platform technology called Tumor Treating
Fields, the use of electric fields tuned to specific frequencies to
disrupt solid tumor cancer cell division. Novocure’s commercialized
product is approved in the United States and Europe for the
treatment of adult patients with glioblastoma. Novocure has ongoing
or completed clinical trials investigating Tumor Treating Fields in
brain metastases, non-small cell lung cancer, pancreatic cancer,
ovarian cancer, mesothelioma and liver cancer.
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,
Japan and Israel. For additional information about the company,
please visit www.novocure.com or follow us at
www.twitter.com/novocure.
About Zai LabZai Lab (NASDAQ:ZLAB) is a Shanghai-based
innovative biotech company focused on bringing transformative
therapies for cancer, autoimmune and infectious diseases to
patients in China and around the world. The Company’s experienced
team has secured partnerships with leading global biopharma
companies, generating a broad pipeline of innovative drug
candidates targeting the fast-growing segments of China's
pharmaceutical market and addressing global unmet medical needs.
Zai Lab's vision is to become a fully integrated biopharmaceutical
company, discovering, developing, manufacturing and commercializing
its partners' and its own products in order to impact human health
worldwide.
Novocure Forward-Looking StatementsIn 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, clinical trial
progress, development of potential products, interpretation of
clinical results, prospects for regulatory submission and approval,
manufacturing development and capabilities, market prospects for
its products, coverage, collections from third-party payers 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 22, 2018, 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.
Zai Lab Forward-Looking StatementsThis press release
includes certain disclosures which contain "forward-looking
statements.” You can identify forward-looking statements because
they contain words such as "anticipate" and "expected."
Forward-looking statements are based on Zai Lab's current
expectations and assumptions. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that may differ materially from
those contemplated by the forward-looking statements, which are
neither statements of historical fact nor guarantees or assurances
of future performance. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements are set forth in Zai Lab's Annual Report on Form 20-F
for the fiscal year ended December 31, 2017, and its other filings
with the Securities and Exchange Commission. Zai Lab undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20180912005524/en/
Media and Investors:NovocureAshley Cordova,
212-767-7558acordova@novocure.comorZai LabBilly Cho, +86 21
6163 7322billy.cho@zailaboratory.comorBurns McClellan, on behalf
of Zai LabInvestors:Jill Steier, 212-213-0006, ext.
367jsteier@burnsmc.comorMedia:Nancie Steinberg, 212-213-0006, ext.
318nsteinberg@burnsmc.comorRobert Flamm, Ph.D., 212-213-0006, ext.
364rflamm@burnsmc.com
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