NEWARK, Calif., July 28, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq:PTGX) ("Protagonist" or "the Company")
today announced its entry into an amended collaboration agreement
(the "Restated Agreement") with Janssen Biotech, Inc., one of the
Janssen Pharmaceutical Companies of Johnson & Johnson, relating
to research, development, manufacture and commercialization of
multiple oral Interleukin (IL)-23 receptor antagonist drug
candidates. The compounds currently in development are PTG-200, an
oral IL-23 receptor antagonist in Phase 2 development for the
treatment of Crohn's disease (CD), and PN-232 and PN-235, two
second-generation oral IL-23 receptor antagonist candidates. PN-232
and PN-235 are currently in Phase 1 clinical development.
The amended agreement provides for the concurrent development of
multiple oral IL-23 receptor antagonists against a broad range of
indications. As such, certain development milestones have been
reconfigured based on multiple drug candidates advancing in
parallel. Protagonist remains eligible to potentially receive
approximately $900 million in future
development and sales milestones, in addition to the $80 million in payments already received under
the original agreement. Royalty rates remain unchanged. Janssen
will have the right to continue research on IL-23 receptor
antagonists developed during the collaboration for three years from
the closing of the Restated Agreement.
Under the terms of the Restated Agreement, Janssen will conduct
all future studies beyond those that are currently ongoing with
PTG-200, PN-232 and PN-235 and will be solely financially
responsible for any such studies. Accordingly, Protagonist's
development and expense obligations will be limited to its relative
share of the currently ongoing studies with these candidates. With
this revised agreement, Janssen will continue to deploy the breadth
of its established global capabilities and proven experience toward
further clinical development of these assets.
"We are very pleased with this amendment to our agreement, which
reflects the successful trajectory of the collaboration to date,
giving rise to the parallel development of multiple oral IL-23
receptor antagonists," said Dinesh
Patel, PhD, President and Chief Executive Officer of
Protagonist. "The progress from de novo discovery to development
validates our innovative technology platform and its potential to
develop oral peptide drugs for diverse clinical indications. We
look forward to supporting our Janssen counterparts in their
parallel development efforts for PTG-200, PN-232, and PN-235 in
multiple indications, which may ultimately provide significant
benefit to patients."
Janssen retains exclusive, worldwide rights to develop and
commercialize PTG-200, PN-232, PN-235 and any other
second-generation compounds derived from the research collaboration
conducted under the Original Agreement, or Janssen's further
research under the Restated Agreement. Protagonist will have the
right to co-detail up to two licensed products in ulcerative
colitis (UC) and CD in the U.S. market.
Further details related to the Restated Agreement are available
on the Company's Form 8-K as submitted to the U.S. Securities and
Exchange Commission.
Conference Call and Webcast Information
Protagonist management will host a conference call and webcast
today at 5:00 p.m. ET to provide a brief overview of the
amended collaboration agreement. To access the live call, dial
(877) 870-4263 (U.S./Canada) or
(412) 317-0790 (international) five minutes prior to the call and
ask to be joined to the Protagonist Therapeutics call. A live and
archived webcast will also be accessible in the Investors section
of the Company's website at www.protagonist-inc.com.
About Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company
with multiple peptide-based investigational new chemical entities
in different stages of development, all derived from the Company's
proprietary technology platform.
Protagonist's pipeline includes rusfertide (PTG-300), an
investigational, injectable hepcidin mimetic currently in a Phase 2
proof-of-concept clinical trial for polycythemia vera (PV), a Phase
2 study in PV subjects with high hematocrit levels, and a Phase 2
study for hereditary hemochromatosis. Based on the feedback
provided by the FDA and EU regulatory authorities, the Company
plans to initiate a single, global Phase 3 randomized,
placebo-controlled trial evaluating the efficacy and safety of a
once weekly, subcutaneously self-administered dose of
rusfertide.
The Company is also evaluating an orally delivered,
gut-restricted alpha-4-beta-7 integrin specific antagonist peptide
(PN-943) currently in a Phase 2 study in adults with moderate to
severe active ulcerative colitis (UC). The Company is targeting
ulcerative colitis as the initial indication.
The Company has a worldwide license and collaboration agreement
with Janssen Biotech, Inc., for the development of oral peptide
IL-23 receptor antagonists. Compounds included in this agreement
are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered
interleukin-23 receptor specific antagonist peptide in a Phase 2
clinical trial for Crohn's disease. PN-235 and PN-232, both
second-generation oral interleukin-23 receptor antagonist
candidates, are currently in Phase 1 studies.
Protagonist is headquartered in Newark, California.
For further information, please
visit www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include
statements regarding our intentions or current expectations
concerning, among other things, the Restated Agreement, the
development of PTG-200, PN-232 and PN-235, and our plans conduct a
Phase 3 trial evaluating rusfertide for PV. In some cases, you can
identify these statements by forward-looking words such as
"anticipate," "believe," "may," "will," "expect," or the negative
or plural of these words or similar expressions. Forward-looking
statements are not guarantees of future performance and are subject
to risks and uncertainties that could cause actual results and
events to differ materially from those anticipated, including, but
not limited to, our ability to develop and commercialize our
product candidates, our ability to earn milestone payments under
our collaboration agreements, the impact of the current COVID-19
pandemic on our discovery and development efforts, our ability to
use and expand our programs to build a pipeline of product
candidates, our ability to obtain and maintain regulatory approval
of our product candidates, our ability to operate in a competitive
industry and compete successfully against competitors that have
greater resources than we do, and our ability to obtain and
adequately protect intellectual property rights for our product
candidates. Additional information concerning these and other
risk factors affecting our business can be found in our periodic
filings with the Securities and Exchange Commission, including
under the heading "Risk Factors" contained in our most recently
filed periodic reports on Form 10-K and Form 10-Q filed with
the Securities and Exchange Commission. Forward-looking
statements are not guarantees of future performance, and our actual
results of operations, financial condition and liquidity, and the
development of the industry in which we operate, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements that we make in
this press release speak only as of the date of this press release.
We assume no obligation to update our forward-looking statements,
whether as a result of new information, future events or otherwise,
after the date of this press release.
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SOURCE Protagonist Therapeutics, Inc.