- Ripretinib Marketing Applications Submitted
to Health Canada and Australia’s Therapeutic Goods Administration
for Patients with Advanced GIST via the U.S. FDA’s Project Orbis
Pilot Program -
- Commercial Preparations Underway to Support
Potential Approval and Launch of Ripretinib in the U.S. for
Patients with Advanced GIST -
- INTRIGUE Pivotal Phase 3 Study of Ripretinib
in 2nd line GIST Expected to Complete Enrollment in the Second Half
of 2020 -
- Additional Pipeline Development Milestones
Expected in Second Half of 2020 -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today provided a
corporate update and highlighted key 2020 milestones in conjunction
with its presentation at the 38th Annual J.P. Morgan Healthcare
Conference in San Francisco. The Company will webcast its
presentation today at 11:00 a.m. PT (2:00 p.m. ET) at
https://investors.deciphera.com/news-events/events-presentations.
"2019 was a year of many exciting accomplishments for Deciphera
as we submitted our first New Drug Application (NDA) to the FDA for
ripretinib in advanced gastrointestinal stromal tumors (GIST) based
on positive results from the INVICTUS pivotal Phase 3 study and
advanced our portfolio of wholly-owned product candidates,” said
Steve Hoerter, President and Chief Executive Officer of Deciphera.
“We are preparing for a potential commercial launch in the U.S. and
working to bring ripretinib to other parts of the world.”
The Company announced today that two additional marketing
applications have been submitted for ripretinib as part of the U.S.
Food and Drug Administration’s (FDA) Project Orbis pilot program.
The marketing applications of ripretinib for advanced GIST in
Canada and Australia have both received priority review
designations. The Project Orbis pilot program, an initiative of the
FDA Oncology Center of Excellence, is designed to provide a
framework for concurrent submission and review of oncology products
among international partners. Additional information about Project
Orbis can be found at:
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.
Mr. Hoerter continued, “In parallel with these efforts, we have
laid the groundwork for further expansion across our pipeline of
novel agents. We continued to activate sites and enroll patients in
the INTRIGUE Phase 3 study in the 2nd line GIST patient population,
advanced the DCC-3014 and rebastinib clinical development programs,
and added a new internally-discovered candidate, DCC-3116, to our
pipeline. We look forward to building on our momentum in 2020 as we
work with the FDA towards a potential approval of ripretinib in
advanced GIST and rapidly advance our additional programs.”
In 2020, the Company seeks to achieve the following
milestones:
Ripretinib - Potential FDA approval and commercial launch
of ripretinib in advanced GIST. - Submit marketing authorization
application to European Medicines Agency. - Complete enrollment of
INTRIGUE Phase 3 study in 2nd line GIST. - Present Phase 1 study
expansion data.
DCC- 3014 - Select Phase 2 dose for tenosynovial giant
cell tumor (TGCT) patients and open expansion cohort. - Provide
update on Phase 1 data in TGCT patients.
Rebastinib - Selected Phase 2 dose of 100 mg BID of
rebastinib and activated Part 2 of Phase 1b/2 study in combination
with carboplatin. (Completed January 2020) - Present Phase 1b/2
data in combination with carboplatin. - Present Phase 1b/2 data in
combination with paclitaxel.
DCC-3116 - Submit an Investigational New Drug (IND)
application to FDA.
Presentation at 38th Annual J.P. Morgan Healthcare
Conference
Deciphera will webcast its corporate presentation from the 38th
Annual J.P. Morgan Healthcare Conference in San Francisco on
Monday, January 13, 2020 at 11:00 a.m. PT (2:00 p.m. ET). A live
webcast of the presentation can be accessed under "Events &
Presentations" in the Investors section of the Company's website at
deciphera.com. A replay of the webcast will be archived on the
Deciphera website for at least two weeks following the
presentation. In conjunction with the conference, the Company has
also updated its corporate presentation which can be found here:
https://investors.deciphera.com/news-events/events-presentations.
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on improving the lives of cancer patients by
addressing key mechanisms of drug resistance that limit the rate
and/or durability of response to existing cancer therapies. Our
small molecule product 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, and
agents designed to inhibit reprogramming of cancer cell metabolism.
We have used our platform to develop a diverse pipeline of
tumor-targeted, immuno-targeted, and metabolism-targeted product
candidates designed to improve outcomes for patients with cancer by
improving the quality, rate and/or durability of their responses to
treatment.
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 goal of bringing
ripretinib to patients with advanced GIST, the potential for
ripretinib to serve as an important new treatment option for people
with advanced GIST, working with the FDA through its review of our
NDA application via the FDA’s Real-Time Oncology Review pilot
program, working with the FDA, Health Canada and the Therapeutic
Goods Administration on our Canadian and Australian regulatory
approval filings under the Project Orbis pilot program, and the
possible benefits of those pilot programs and breakthrough therapy
designation, receipt of priority review, preparing for the
potential launch of ripretinib in the United States, if approved,
and corporate guidance for 2020, including related to our
expectations and timing for an MAA submission to the EMA for
ripretinib in advanced GIST patients, presentation of additional
Phase 1 ripretinib expansion data, completion of enrollment in the
INTRIGUE Phase 3 study, selection of a recommended Phase 2 dose for
DCC-3014 and opening a TGCT expansion cohort in such trial, the
timing of and our expectations regarding our product candidates,
including data for DCC-3014 from TGCT patients, data updates for
rebastinib and submitting an IND for DCC-3116. 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 the delay of any current or planned
clinical studies or the development of our product candidates,
including ripretinib, our ability to successfully demonstrate the
efficacy and safety of our product candidates including in
later-stage studies, the preclinical and clinical results for our
product candidates, which may not support further development of
such product candidates, the possibility that results experienced
in early, preliminary, top-line or initial data may not be
indicative of the results experienced in final data, our ability to
work with the FDA under its RTOR pilot program and our ability to
work with the FDA, Health Canada and the TGA under the Project
Orbis pilot program and timely respond to information requests or
requirements in connection with our recently-filed NDAs and
marketing approval applications in Canada and Australia for
ripretinib in advanced GIST, that acceptance into the RTOR and
Project Orbis pilot programs does not guarantee or influence
approvability of our NDAs for ripretinib in advanced GIST, which
are subject to the standard benefit-risk evaluation by FDA, Health
Canada and the TGA, and that we may not derive any benefit from
inclusion in the RTOR or Orbis pilot programs, including, but not
limited to, a more efficient review process compared to
investigational drugs evaluated without these pilot programs or
under standard FDA, Health Canada or TGA procedures, the fact that
these pilot programs are being tested by FDA, are not formal
regulatory pathways with regulatory process, regulations or
procedures, and may be suspended or halted at any time, including,
without limitation, because FDA decides not to continue these
pilots, or because FDA determines that our application no longer
meets its criteria for inclusion in one or both of these pilot
programs, the fact that receipt of a breakthrough therapy
designation for a product candidate, such as ripretinib, may not
result in us receiving any of the benefits of such designation such
as a faster development process, review or approval compared to
drugs considered for approval under conventional FDA procedures,
the fact such designation does not assure ultimate approval by FDA
and is subject to the risk FDA may later decide that the products
no longer meet the conditions for qualification or decide that the
time period for FDA review or approval will not be shortened, the
fact that any priority review received may not result in any more
efficient review or other benefits, our ability to manage and our
reliance on sole-source third parties such as our third party drug
substance and drug product contract manufacturers, actions of
regulatory agencies, our ability to plan for potential
commercialization of our product candidates, such as ripretinib,
and if approved execute on our marketing plans, the inherent
uncertainty in estimates of patient populations and incidence and
prevalence estimates, competition from other products, our ability
to obtain and maintain reimbursement for any approved product and
the extent to which patient assistance programs are utilized, our
ability to comply with healthcare regulations and laws, our ability
to obtain, maintain and enforce our intellectual property rights,
any or all of which may affect the initiation, timing and progress
of clinical studies and the timing of and our ability to obtain
regulatory approval, if at all, and make our investigational drugs,
including ripretinib, available to patients, and, once commercial,
to derive revenue from product sales, and other risks identified in
our SEC filings, including our Quarterly Report on Form 10-Q for
the quarter ended September 30, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200113005354/en/
Investor Relations: Jen Robinson Deciphera Pharmaceuticals, Inc
jrobinson@deciphera.com 781-906-1112
Media: David Rosen Argot Partners David.Rosen@argotpartners.com
212-600-1902
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