Prometheus Biosciences Achieves Milestone Payment from Dr. Falk Pharma GmbH Further Validating the Prometheus360™ Platform
June 21 2021 - 9:00AM
Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage
biotechnology company pioneering a precision medicine approach for
the discovery, development, and commercialization of novel
therapeutic and companion diagnostic products for the treatment of
immune-mediated diseases, starting first with inflammatory bowel
disease (IBD), today announced it has received a $10 million
milestone payment from Dr. Falk Pharma GmbH under its collaboration
agreement to develop and commercialize Prometheus’ second program,
PR600. Prometheus has selected a clinical candidate for PR600,
targeting an undisclosed member of the tumor-necrosis factor
superfamily for the treatment of IBD and is initiating IND-enabling
studies.
“Partnering with Dr. Falk on PR600 has enabled us to accelerate
the PR600 program by sharing costs, resources, and drug development
know-how, which has resulted in the achievement of this important
milestone within the first year of our collaboration,” said Mark
McKenna, President and CEO of Prometheus. “We expect to file an
Investigational New Drug Application for PR600 in the third quarter
of 2022 and plan to explore its utility in other immune-mediated
indications beyond IBD.”
Under the collaboration agreement, which was executed in July
2020, Prometheus and Dr. Falk will share responsibility for the
global development of PR600, with Dr. Falk contributing a certain
portion of the external development costs associated with PR600 and
its companion diagnostic. Dr. Falk acquired exclusive rights to
commercialize PR600 in Europe, Australia and New Zealand, and
Prometheus retains exclusive rights to commercialize PR600 in the
United Stated and rest of world.
About Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH specializes in the development and
marketing of pharmaceuticals used in hepatology and
gastroenterology. Falk is one of the leading European companies in
the field marketing its products by means of subsidiaries in
selected countries and a network of sales partners. Further, the
Falk Foundation, an independent organization associated with Dr.
Falk Pharma, is well-known for its international symposia, forums
and educational literature supporting medical doctors, patients and
their families.
About Prometheus Biosciences
Prometheus Biosciences, Inc. is a clinical-stage biotechnology
company pioneering a precision medicine approach for the discovery,
development, and commercialization of novel therapeutic and
companion diagnostic products for the treatment and diagnosis of
immune-mediated diseases, starting first with IBD. The Company’s
precision medicine platform, Prometheus360TM, combines proprietary
bioinformatics discovery methods with one of the world’s largest
gastrointestinal bioinformatics databases to identify novel
therapeutic targets and develop therapeutic candidates to engage
those targets. Prometheus is headquartered in San Diego, CA.
Forward Looking Statements
Prometheus cautions readers that statements contained in this
press release regarding matters that are not historical facts are
forward-looking statements. These statements are based on our
current beliefs and expectations. Such forward-looking statements
include, but are not limited to statements regarding Prometheus’
expected timing to file an IND for PR600, the realization of future
cost savings under the collaboration with Dr. Falk, and Prometheus’
plans to explore PR600 in other indications beyond IBD. The
inclusion of forward-looking statements should not be regarded as a
representation by Prometheus that any of our plans will be
achieved. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in our
business, including, without limitation: Prometheus’ approach to
the discovery and development of precision medicines based on
Prometheus360 is unproven; potential delays in the commencement,
enrollment and completion of preclinical studies and future
clinical trials, including due to the COVID-19 pandemic;
Prometheus’ dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing, and
potential supply chain disruptions related to the COVID-19
pandemic; Prometheus’ ability to develop a companion diagnostic for
PR600; Prometheus may not realize any benefits from our
collaboration with Dr. Falk; and other risks described in our
prior press releases and filings with the Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in our most recent quarterly report on Form 10-Q and any
subsequent filings with the SEC. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and we undertake no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary
statement, which is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
Investors:Noel KurdiVP Investor Relations and
Communications(646) 241-4400nkurdi@prometheusbiosciences.com
Media:Juniper PointAmy Conrad(858)
914-1962media@prometheusbiosciences.com
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