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
ST. HELIER, Jersey & SHANGHAI--(BUSINESS WIRE)--
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 Novocure
Novocure 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 Lab
Zai 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 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, 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 Statements
This 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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Media and Investors:
Novocure
Ashley Cordova,
212-767-7558
acordova@novocure.com
or
Zai
Lab
Billy Cho, +86 21 6163 7322
billy.cho@zailaboratory.com
or
Burns
McClellan, on behalf of Zai Lab
Investors:
Jill Steier,
212-213-0006, ext. 367
jsteier@burnsmc.com
or
Media:
Nancie
Steinberg, 212-213-0006, ext. 318
nsteinberg@burnsmc.com
or
Robert
Flamm, Ph.D., 212-213-0006, ext. 364
rflamm@burnsmc.com
Source: Novocure