- Zai Lab to Lead the Development and
Commercialization of Ripretinib in Greater China -
- Deciphera To Receive $20 Million Upfront Cash
Payment, up to $185 Million in Potential Future Milestones and
Royalties -
- Deciphera Intends to Expand Ripretinib
Development Program in Gastrointestinal Stromal Tumors (GIST) by
Potentially Adding China Sites to the Ongoing Global Phase 3
INTRIGUE Study -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage
biopharmaceutical company focused on addressing key mechanisms of
tumor drug resistance, and Zai Lab Ltd. (NASDAQ: ZLAB), a China and
U.S.-based innovative biopharmaceutical company, today announced an
exclusive license agreement to advance the development and
commercialization of ripretinib in Greater China (mainland China,
Hong Kong, Macau and Taiwan). Discovered and developed by
Deciphera, ripretinib is an investigational, oral, kinase switch
control inhibitor in clinical development for the treatment of GIST
and other solid tumors driven by KIT or PDGFRα.
Under the terms of the agreement, Deciphera will receive an
upfront cash payment of $20 million and will be eligible to receive
up to $185 million in potential development and commercial
milestone payments. In addition, Zai Lab would pay Deciphera
royalties from low to high teens on annual net sales of ripretinib
in Greater China. Zai Lab receives exclusive regional development
and commercialization rights for ripretinib in Greater China. Zai
Lab plans to leverage its regulatory and clinical expertise to lead
development of ripretinib in this territory. Deciphera intends to
expand the ongoing global Phase 3 INTRIGUE study, comparing
ripretinib to sunitinib in second-line GIST patients, and is
currently assessing the addition of clinical trial sites in
China.
“We believe Zai Lab is the ideal partner for the development and
potential commercialization of ripretinib in Greater China,” said
Steve Hoerter, President and Chief Executive Officer of Deciphera.
“Zai Lab’s strong track record of rapidly progressing the
development of innovative product candidates will be a major asset
in accelerating the development of ripretinib in this area of the
world. We are excited to be working with Zai Lab to potentially
offer patients in Greater China what we believe is a much needed
therapeutic option for the treatment of GIST.”
“We are very pleased to enter into this exclusive agreement for
ripretinib and look forward to partnering with Deciphera to
potentially bring ripretinib to GIST patients in Greater China,”
said Dr. Samantha Du, Chairman and Chief Executive Officer of Zai
Lab. “Based on encouraging clinical data reported to-date, we
believe ripretinib, if approved, could alter the treatment
landscape for GIST patients. Ripretinib has strong clinical and
commercial synergies with our existing pipeline of late stage
gastrointestinal cancer programs. We are committed to working with
Deciphera to expand the global effort to bring this important
potential therapy to patients.”
“Each year in China, approximately 30,000 patients are newly
diagnosed with GIST, and an estimated 100,000 GIST patients are
currently under treatment,” said Dr. Lin Shen, Head of the Chinese
Society of Clinical Oncology GIST Expert Committee and Vice
President of Clinical Oncology at Beijing Cancer Hospital. “There
are significant unmet medical needs in GIST treatment especially
for refractory patients after imatinib therapy. Based on
preliminary data, I believe that ripretinib has a promising
efficacy and safety profile that, if approved, could make it a good
potential option for GIST patients.”
About Ripretinib
Ripretinib is an investigational KIT and PDGFRα kinase switch
control inhibitor in clinical development for the treatment of KIT
and/or PDGFRα-driven cancers, including GIST, systemic
mastocytosis, or SM, and other cancers. Ripretinib was specifically
designed to improve the treatment of GIST patients by inhibiting a
broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT
and PDGFRα inhibitor that blocks initiating and secondary KIT
mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST as
well as the primary D816V exon 17 mutation involved in SM.
Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14
and 18, including the exon 18 D842V mutation, involved in a subset
of GIST.
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals (NASDAQ: DCPH) is a clinical-stage
biopharmaceutical company focused on improving the lives of cancer
patients by tackling key mechanisms of drug resistance that limit
the rate and/or durability of response to existing cancer
therapies. Our small molecule drug candidates are directed against
an important family of enzymes called kinases, known to be directly
involved in the growth and spread of many cancers. We use our deep
understanding of kinase biology together with a proprietary
chemistry library to purposefully design compounds that maintain
kinases in a “switched off” or inactivated conformation. These
investigational therapies comprise tumor-targeted agents designed
to address therapeutic resistance causing mutations and
immuno-targeted agents designed to control the activation of
immunokinases that suppress critical immune system regulators, such
as macrophages. We have used our platform to develop a diverse
pipeline of tumor-targeted and immuno-targeted drug candidates
designed to improve outcomes for patients with cancer by improving
the quality, rate and/or durability of their responses to
treatment.
About Zai Lab
Zai Lab (NASDAQ: ZLAB) is a China and U.S.-based innovative
commercial stage biopharmaceutical company focused on bringing
transformative medicines for cancer, autoimmune and infectious
diseases to patients in China and around the world. Zai Lab’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 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.
Availability of Other Information About Deciphera
Pharmaceuticals
Investors and others should note that Deciphera Pharmaceuticals
communicates with its investors and the public using its company
website (www.deciphera.com), including but not limited to investor
presentations and scientific presentations, Securities and Exchange
Commission filings, press releases, public conference calls and
webcasts. The information that Deciphera Pharmaceuticals posts on
these channels and websites could be deemed to be material
information. As a result, Deciphera Pharmaceuticals encourages
investors, the media and others interested in Deciphera
Pharmaceuticals to review the information that it posts on these
channels, including Deciphera Pharmaceuticals’ investor relations
website, on a regular basis. This list of channels may be updated
from time to time on Deciphera Pharmaceuticals' investor relations
website and may include other social media channels than the ones
described above. The contents of Deciphera Pharmaceuticals' website
or these channels, or any other website that may be accessed from
its website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding our expectations regarding our license with Zai Lab,
future development and potential commercialization of ripretinib in
the Greater China territory and the potential payments we may
receive therefrom, and the potential for ripretinib and our other
drug candidates based on our kinase switch control inhibitor
platform to provide clinical benefit and treat cancers such as GIST
and other possible indications, enrollment for our INTRIGUE pivotal
Phase 3 study, including, without limitation, the potential for and
expectations with respect to opening China sites and enrolling
China patients and estimates of China GIST patients. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks and uncertainties related to our ability to
derive the benefits and mitigate the risks of any licensing
transaction, the ability of our licensee to execute a successful
development and potential commercialization of ripretinib in
Greater China, our plans and ability to expand our INTRIGUE study,
successfully open sites and enroll patients in China, the inherent
uncertainty in estimating the number of target patient populations,
including without limitation GIST patients in China, the delay of
any current or planned clinical studies or the development of our
drug candidates, including ripretinib, rebastinib, and DCC-3014,
our advancement of multiple early-stage and later-stage efforts,
our ability to successfully demonstrate the efficacy and safety of
our drug candidates including in later-stage studies, the
preclinical and clinical results for our drug candidates, which may
not support further development of such drug candidates, our
efforts to scale up and manage drug product manufacturing, our
ability to implement commercial readiness, actions of regulatory
agencies, any or all of which may affect the initiation, timing and
progress of clinical studies and other risks identified in our SEC
filings, including our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, and subsequent filings with the SEC.
We caution you not to place undue reliance on any forward-looking
statements, which speak only as of the date they are made. We
disclaim any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent our views only as of the date hereof and should not be
relied upon as representing its views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements.
Zai Lab Forward-Looking Statements
This press release contains statements about future
expectations, plans and prospects for Zai Lab. All statements,
other than statements of historical fact, included in this press
release are forward-looking statements, and are identified by words
such as "anticipates", “believes”, "expects", “plan” and other
similar expressions. Such statements constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are not statements
of historical fact nor are they guarantees or assurances of future
performance. Forward-looking statements are based on Zai Lab’s
expectations and assumptions as of the date of this press release
and are subject to inherent uncertainties, risks and changes in
circumstances that may differ materially from those contemplated by
the forward-looking statements. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including but not limited
to (1) Zai Lab’s ability to obtain additional future funding, (2)
Zai Lab’s results of clinical and pre-clinical development of its
drug candidates, (3) the content and timing of decisions made by
the relevant regulatory authorities regarding regulatory approvals
of Zai Lab’s drug candidates, (4) Zai Lab’s ability to generate
revenue from its drug candidates, and (5) other factors discussed
in Zai Lab's Annual Report on Form 20-F for the fiscal year ended
December 31, 2018 and its other filings with the Securities and
Exchange Commission. Zai Lab anticipates that subsequent events and
developments will cause Zai Lab’s expectations and assumptions to
change and 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. These forward-looking statements should not be relied upon
as representing Zai Lab’s views as of any date subsequent to the
date of this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20190611005186/en/
Company:Christopher J. Morl, Chief Business OfficerDeciphera
Pharmaceuticals, LLCcmorl@deciphera.com781-209-6418
Investor Relations:Jen RobinsonDeciphera Pharmaceuticals,
Inc.jrobinson@deciphera.com781-906-1112
Media:Gina Nugent, The Yates Networkgina@theyatesnetwork.com617-460-3579
Zai Lab:Billy Cho, CFO+86 137 6151
2501billy.cho@zailaboratory.com
Media: Nancie Steinberg / Robert FlammBurns McClellan, on behalf
of Zai Lab212-213-0006, ext. 318 / 364, nsteinberg@burnsmc.com /
rflamm@burnsmc.com
Investors: Lee RothBurns McClellan, on behalf of Zai
Lab212-213-0006, ext. 331, lroth@burnsmc.com
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