THOUSAND OAKS, Calif. and
OLDWICK, N.J., Nov. 5, 2018 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Provention Bio, Inc. (NASDAQ:PRVB), a
clinical-stage biopharmaceutical company focused on immune-mediated
diseases, today announced a licensing and co-development agreement
for AMG 714, identified by Provention as PRV-015. AMG 714 is a
novel anti-IL-15 monoclonal antibody being developed for the
treatment of gluten-free diet non-responsive celiac disease (NRCD).
Development efforts at Provention will be led by researchers with
previous experience developing AMG 714.
Under the terms of the agreement, Provention will conduct and
fund a Phase 2b trial in NRCD and
lead the next phase of development and regulatory activities for
the program. Amgen will make a $20
million investment coincident with Provention's next
financing event, subject to certain terms and conditions. Amgen is
also responsible for the manufacturing of AMG 714. Upon completion
of the Phase 2b trial, Provention
will be eligible to receive a $150
million milestone payment, as well as additional regulatory
milestone payments and royalties if Amgen continues AMG 714
development.
"Celiac disease impacts millions of people around the world and
remains the only common autoimmune disease with no approved
therapeutic treatment," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "We are pleased to collaborate with
Provention, given their expertise and familiarity with AMG 714, in
advancing a potential new treatment option for patients living with
this life-interrupting illness."
"Our AMG 714 co-development collaboration with Amgen is a
significant milestone in the growth and advancement of Provention.
AMG 714 has the potential to be the first FDA-approved treatment
for celiac disease and aligns with Provention's mission to prevent
and intercept immune-mediated disease," said Ashleigh Palmer, co-founder and chief executive
officer of Provention.
"Data presented at Digestive Disease Week 2018 from two Phase 2a
clinical trials of AMG 714 demonstrated the drug's potential in
celiac disease and refractory celiac disease type II (RCD-II), an
in situ gastrointestinal T cell lymphoma, and confirmed that IL-15
plays a central role in non-responsive celiac disease and RCD-II,"
said Francisco Leon, M.D., Ph.D.,
co-founder and chief scientific officer of Provention. "We are
delighted to be collaborating with Amgen to advance AMG 714 by way
of the planned Phase 2b NRCD
study."
About AMG 714
AMG 714 (PRV-015) is a human
immunoglobulin monoclonal antibody that binds to IL-15. AMG 714 was
initially developed by Amgen in rheumatoid arthritis and later
investigated for possible use in celiac disease. In 2015, Amgen
outlicensed AMG 714 to Celimmune LLC, a clinical development-stage
immunotherapy company founded by Ashleigh
Palmer and Francisco Leon,
M.D., Ph.D. Celimmune conducted two separate AMG 714 Phase 2a
clinical trials in celiac disease and refractory celiac disease
type II, after which Amgen acquired Celimmune in 2017. Data from
both clinical trials were presented at Digestive Disease Week
2018.
About Celiac Disease
Celiac disease is a chronic
hereditary systemic autoimmune and inflammatory disease triggered
by gluten consumption that results in damage to the lining of the
small intestine, causing gastrointestinal dysfunction and
debilitating symptoms. Nutritional malabsorption can lead to a
failure to thrive in children, and anemia and osteopenia in
children and adults. Over the course of a lifetime, untreated or
poorly managed celiac disease is often associated with
deteriorating general health, multiple serious intestinal and
extra-intestinal medical complications, and increased morbidity and
mortality. It is estimated that currently one percent of
Western and .5 percent of Asian populations suffer from celiac
disease and diagnosed prevalence is expected to increase with
improved diagnostic tools and clinical awareness. There are no
approved medications for celiac disease.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About Provention Bio, Inc.
Provention Bio, Inc. is a
clinical-stage biopharmaceutical company leveraging a
transformational drug development strategy that is focused on the
prevention or interception of immune-mediated disease. Provention's
diverse portfolio was assembled with product candidates that have
undergone clinical testing but may have been underdeveloped or
deprioritized assets at other companies. Provention's mission is to
in-license, transform and develop clinical-stage, or nearly
clinical-stage, therapeutic candidates targeting the high
morbidity, mortality and escalating costs of autoimmune and
inflammatory diseases including: type 1 diabetes (T1D), Crohn's
disease, ulcerative colitis, lupus, and certain life-threating
viral diseases.
For more information on Provention Bio, please visit
www.proventionbio.com.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including its most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen
is providing this information as of the date of this news release
and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or otherwise.
No forward-looking statement can be guaranteed, and actual
results may differ materially from those Amgen project. Amgen's
results may be affected by its ability to successfully market both
new and existing products domestically and internationally,
clinical and regulatory developments involving current and future
products, sales growth of recently launched products, competition
from other products including biosimilars, difficulties or delays
in manufacturing its products and global economic conditions. In
addition, sales of Amgen's products are affected by pricing
pressure, political and public scrutiny and reimbursement policies
imposed by third-party payers, including governments, private
insurance plans and managed care providers and may be affected by
regulatory, clinical and guideline developments and domestic and
international trends toward managed care and healthcare cost
containment. Furthermore, Amgen's research, testing, pricing,
marketing and other operations are subject to extensive regulation
by domestic and foreign government regulatory authorities. Amgen or
others could identify safety, side effects or manufacturing
problems with its products, including its devices, after they are
on the market. Amgen's business may be impacted by government
investigations, litigation and product liability claims. In
addition, Amgen's business may be impacted by the adoption of new
tax legislation or exposure to additional tax liabilities. While
Amgen routinely obtains patents for its products and technology,
the protection offered by its patents and patent applications may
be challenged, invalidated or circumvented by its competitors, or
Amgen may fail to prevail in present and future intellectual
property litigation. Amgen performs a substantial amount of its
commercial manufacturing activities at a few key facilities,
including in Puerto Rico, and also
depends on third parties for a portion of its manufacturing
activities, and limits on supply may constrain sales of certain of
its current products and product candidate development. In
addition, Amgen competes with other companies with respect to many
of its marketed products as well as for the discovery and
development of new products. Discovery or identification of new
product candidates or development of new indications for existing
products cannot be guaranteed and movement from concept to product
is uncertain; consequently, there can be no guarantee that any
particular product candidate or development of a new indication for
an existing product will be successful and become a commercial
product. Further, some raw materials, medical devices and component
parts for Amgen's products are supplied by sole third-party
suppliers. Certain of Amgen's distributors, customers and payers
have substantial purchasing leverage in their dealings with Amgen.
The discovery of significant problems with a product similar to one
of Amgen's products that implicate an entire class of products
could have a material adverse effect on sales of the affected
products and on its business and results of operations. Amgen's
efforts to acquire other companies or products and to integrate the
operations of companies Amgen has acquired may not be successful. A
breakdown, cyberattack or information security breach could
compromise the confidentiality, integrity and availability of
Amgen's systems and Amgen's data. Amgen's stock price may be
volatile and may be affected by a number of events. Amgen's
business performance could affect or limit the ability of the Amgen
Board of Directors to declare a dividend or its ability to pay a
dividend or repurchase its common stock. Amgen may not be able to
access the capital and credit markets on terms that are favorable
to it, or at all.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S.
Food and Drug Administration, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates. Further, the scientific information discussed in this
news release relating to new indications for Amgen's products is
preliminary and investigative and is not part of the labeling
approved by the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for
these uses.
Provention Forward Looking Statements
Certain
statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by the use of forward-looking
words such as "anticipate," "believe," "forecast," "estimate,"
"expect," and "intend," among others. These forward-looking
statements are based on Provention's current expectations and
actual results could differ materially. There are a number of
factors that could cause actual events to differ materially from
those indicated by such
forward-looking statements. These factors include, but are not
limited to, risks related to failure to obtain FDA approvals or
clearances and noncompliance with FDA regulations; uncertainties of
patent protection and litigation; limited research and development
efforts and dependence upon third parties; substantial competition;
our need for additional financing and the factors listed under
"Risk Factors" in our quarterly report on Form 10-Q for the quarter
ended June 30, 2018 and any
subsequent filings with the Securities and Exchange Commission
(SEC). As with any pharmaceutical under development, there are significant risks in
the development, regulatory approval and commercialization of new
products. Provention does not undertake an obligation to up-date or
revise any forward-looking statement. The information set forth
herein speaks only as of the date hereof.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Provention Bio, Inc.
Tiberend Strategic Advisors, Inc.
Jason Rando, 212-375-2665,
jrando@tiberend.com
Joshua Drumm, Ph.D., 212-375-2664,
jdrumm@tiberend.com
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SOURCE Amgen