THOUSAND OAKS, Calif.,
Aug. 22, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today
announced positive top-line results from a comparative clinical
study evaluating the efficacy and safety of ABP 798, a biosimilar
candidate to Rituxan® (rituximab), compared to
Rituxan in patients with CD20-positive B-cell non-Hodgkin's
lymphoma. The primary endpoint, an assessment of overall response
rate (ORR) by week 28, was within the prespecified margin for ABP
798 compared to Rituxan, showing clinical equivalence. Safety and
immunogenicity of ABP 798 were comparable to Rituxan.
This is the second of two studies intended to support regulatory
submissions for ABP 798. The first study was conducted in patients
with moderate-to-severe rheumatoid arthritis (RA) and met the
primary endpoint of pharmacokinetic similarity. This RA study
demonstrated clinical equivalence within the prespecified efficacy
margin, and a similar safety and immunogenicity profile.
"Today's results with ABP 798 demonstrate another positive
development from Amgen's robust pipeline of biosimilar medicines
and we look forward to working with regulatory agencies to bring
this treatment to patients," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "We continue to leverage our deep expertise
and heritage in biologics across innovative and biosimilar
medicines as part of our commitment to providing a range of
treatment options for patients with the most serious diseases,
including cancer."
ABP 798 is being developed as a biosimilar candidate to Rituxan,
an anti-CD20 monoclonal antibody that is approved in many regions
for the treatment of adult patients with non-Hodgkin's lymphoma,
chronic lymphocytic leukemia, moderate-to-severe rheumatoid
arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and
microscopic polyangiitis.
Amgen has a total of 10 biosimilars in its portfolio, including
three that are approved in the United
States (US).
About the JASMINE Study
The JASMINE study was a
randomized, double-blind comparative clinical study (study number
NCT02747043) that evaluated the efficacy, safety and immunogenicity
of ABP 798 compared to rituximab in patients with non-Hodgkin's
lymphoma. There were 256 adult patients enrolled and randomized to
receive either ABP 798 or rituximab at a dose of 375
mg/m2 administered as an intravenous (IV) infusion once
weekly for four weeks followed by dosing at weeks 12 and 20. The
primary endpoint of the study was risk difference of overall
response rate.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma is
a type of cancer that originates in the lymph system, part of the
body's immune system, and occurs when the body produces too many
abnormal lymphocytes, a type of white blood cell.1,2
Non-Hodgkin's lymphoma is one of the most common cancers in the
U.S., and about 85 percent of cases originate in B
cells.3,4 There are several subtypes, and follicular
lymphoma is one of the most common.2
About ABP 798
ABP 798 is being developed as a
biosimilar candidate to Rituxan® (rituximab), an
anti-CD20- monoclonal antibody that is approved in many regions for
the treatment of adult patients with non-Hodgkin's lymphoma,
chronic lymphocytic leukemia, moderate-to-severe rheumatoid
arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and
microscopic polyangiitis. The active ingredient of ABP 798 is a
monoclonal antibody that has the same amino acid sequence as
Rituxan.
About the Amgen and Allergan
Collaboration
In December
2011, Amgen and Allergan plc. (then Watson
Pharmaceuticals, Inc.) formed a collaboration to develop and
commercialize, on a worldwide basis, four oncology antibody
biosimilar medicines. This collaboration reflects the shared belief
that the development and commercialization of biosimilar products
will not follow a pure brand or generic model and will require
significant expertise, infrastructure, and investment to ensure
safe, reliably supplied therapies for patients. Under the terms of
the agreement, Amgen assumes primary responsibility for
developing, manufacturing and initially commercializing the
oncology antibody products.
About Amgen Biosimilars
Amgen is committed to building
upon Amgen's experience in the development and
manufacturing of innovative human therapeutics to
expand Amgen's reach to patients with serious illnesses.
Biosimilars will help to maintain Amgen's commitment to
connect patients with vital medicines, and Amgen is well
positioned to leverage its nearly four decades of experience in
biotechnology to create high-quality biosimilars and reliably
supply them to patients worldwide.
For more information,
visit www.amgenbiosimilars.com and follow us
on www.twitter.com/amgenbiosim.
About Amgen Oncology
Amgen is searching for and
finding answers to incredibly complex questions that will advance
care and improve lives for cancer patients and their families. Our
research drives us to understand the disease in the context of the
patient's life – not just their cancer journey – so they can take
control of their lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in the Company's history, moving with
great speed to advance those innovations for the patients who need
them.
At Amgen, we are driven by our commitment to transform the lives
of cancer patients and keep them at the center of everything we
do.
For more information, follow us on
www.twitter.com/amgenoncology.
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 Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a global pharmaceutical leader focused on developing,
manufacturing and commercializing branded pharmaceutical, device,
biologic, surgical and regenerative medicine products for patients
around the world. Allergan markets a portfolio of leading brands
and best-in-class products primarily focused on four key
therapeutic areas including medical aesthetics, eye care, central
nervous system and gastroenterology. As part of its approach to
delivering innovation for better patient care, Allergan has built
one of the broadest pharmaceutical and device research and
development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.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 projects.
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, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for Amgen to complete
clinical trials and obtain regulatory approval for product
marketing has in the past varied and Amgen expects
similar variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints Amgen has
selected. Amgen develops product candidates internally
and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be
not as effective or as safe as Amgen may have believed at
the time of entering into such relationship.
Also, 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 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'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. If Amgen fails to meet the compliance
obligations in the corporate integrity agreement
between Amgen and the U.S.
government, Amgen could become subject to significant
sanctions. Further, 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. Amgen relies on collaborations
with third parties for the development of some of its product
candidates and for the commercialization and sales of some of its
commercial products. 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. 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.
Allergan plc Forward-Looking
Statement
Statements contained in this press release
that refer to future events or other non-historical facts are
forward-looking statements that reflect Allergan's current
perspective on existing trends and information as of the date of
this release. Actual results may differ materially from Allergan's
current expectations depending upon a number of factors affecting
Allergan's business. These factors include, among others, the
difficulty of predicting the timing or outcome of FDA approvals or
actions, if any; the impact of competitive products and pricing;
market acceptance of and continued demand for Allergan's products;
the impact of uncertainty around timing of generic entry related to
key products, including RESTASIS®, on our financial
results; risks associated with divestitures, acquisitions, mergers
and joint ventures; risks related to impairments; uncertainty
associated with financial projections, projected cost reductions,
projected debt reduction, projected synergies, restructurings,
increased costs, and adverse tax consequences; difficulties or
delays in manufacturing; and other risks and uncertainties detailed
in Allergan's periodic public filings with the Securities and
Exchange Commission, including but not limited to Allergan's Annual
Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report
on Form 10-Q for the period ended June 30,
2019. Except as expressly required by law, Allergan
disclaims any intent or obligation to update these forward-looking
statements.
Rituxan® is a registered trademark of Biogen,
Inc.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Allergan plc.
Manisha Narasimhan, 862-261-7162
(investor relations)
Fran DeSena, 862-261-8820 (media
relations)
References:
- National Cancer Institute. Adult Non-Hodgkin Lymphoma
Treatment.
http://www.cancer.gov/types/lymphoma/patient/adult-nhl-treatment-pdq.
Accessed July 17, 2019
- Mayo Clinic. Non-Hodgkin's Lymphoma.
https://www.mayoclinic.org/diseases-conditions/non-hodgkins-lymphoma/symptoms-causes/syc-20375680.
Accessed July 17, 2019.
- American Cancer Society. Key Statistics for Non-Hodgkin's
Lymphoma.
https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/key-statistics.html.
Accessed July 17, 2019.
- Leukemia & Lymphoma Society. Non-Hodgkin Lymphoma.
https://www.lls.org/lymphoma/non-hodgkin-lymphoma. Accessed
July 17, 2019.
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