THOUSAND OAKS, Calif.,
Sept. 14, 2017 /PRNewswire/
-- Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today
announced that the U.S. Food and Drug
Administration (FDA) has approved MVASI™ (bevacizumab-awwb)
for all eligible indications of the reference product,
Avastin® (bevacizumab). MVASI is the first anti-cancer
biosimilar, as well as the first bevacizumab biosimilar, approved
by the FDA. MVASI is approved for the treatment of five types of
cancer, including in combination with chemotherapy for non-squamous
non-small cell lung cancer (NSCLC), in combination with
chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma,
metastatic renal cell carcinoma in combination with interferon alfa
and in combination with chemotherapy for persistent,
recurrent, or metastatic carcinoma of the cervix.
"The approval of MVASI marks a significant milestone for
healthcare practitioners and patients as the first anti-cancer
biosimilar approved in the United
States," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "With decades of experience in oncology and biologics, Amgen
continues to expand its biosimilar and oncology portfolios, and
MVASI has the potential to advance access to high-quality, targeted
cancer therapy."
Amgen is committed to developing high-quality biosimilars with a
robust analytic and clinical package. Approval is based on the
totality of evidence which includes structure, function, toxicity,
pharmacokinetics, pharmacodynamics, immunogenicity, clinical safety
and efficacy.1 The approval of MVASI was based on a
comprehensive data package that demonstrated MVASI and bevacizumab
are highly similar, with no clinically meaningful differences in
terms of the efficacy, safety and immunogenicity between the
products. Clinical studies included results from a Phase 3 trial in
patients with NSCLC.
"MVASI is the first product from our collaboration with Amgen to
be approved by the FDA and underscores our joint commitment to
bring cancer biosimilars to market to help patients," said
David Nicholson, chief research and
development officer at Allergan. "We are committed to developing
safe and effective therapies in critical disease areas, and MVASI
is leading the way for additional oncology biosimilars from Amgen
and Allergan."
Amgen and Allergan's bevacizumab biosimilar is also undergoing
review by the European Medicines Agency, following a Marketing
Authorization Application submitted in December 2016. The companies are collaborating on
the development and commercialization of four oncology biosimilars.
Amgen has a total of 10 biosimilars in its portfolio, two of which
have been approved by the FDA including MVASI.
About MVASI (bevacizumab-awwb) in the U.S.
MVASI is a biosimilar to bevacizumab, a recombinant
immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to
vascular endothelial growth factor (VEGF) and inhibits the
interaction of VEGF with its receptors, VEGF receptor-1 and VEGF
receptor-2, thus inhibiting establishment of new blood vessels
necessary for the maintenance and growth of solid tumors.
MVASI is indicated for the treatment of mCRC, with intravenous
5-fluorouracil–based chemotherapy for first- or second-line
treatment.
MVASI is indicated for the treatment of mCRC, with
fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based
chemotherapy for second-line treatment in patients who have
progressed on a first-line bevacizumab-containing regimen.
MVASI is not indicated for adjuvant treatment of colon cancer.
MVASI is indicated for the treatment of NSCLC, with carboplatin
and paclitaxel for first line treatment of unresectable, locally
advanced, recurrent or metastatic disease.
MVASI is indicated for the treatment of glioblastoma, as a
single agent for adult patients with progressive disease following
prior therapy.
The effectiveness of bevacizumab products in glioblastoma is based
on an improvement in objective response rate. There are no data
demonstrating an improvement in disease-related symptoms or
increased survival with bevacizumab products.
MVASI is indicated for the treatment of metastatic renal cell
carcinoma with interferon alfa.
MVASI is indicated for the treatment of cervical cancer, in
combination with paclitaxel and cisplatin or paclitaxel and
topotecan in persistent, recurrent, or metastatic disease.
MVASI U.S. Important Safety Information
Boxed WARNINGS
Gastrointestinal (GI) Perforations
The incidence of gastrointestinal perforation, some fatal, in
bevacizumab product-treated patients ranges from 0.3-3.2%. Fatal
outcome was reported in <1% of bevacizumab-treated patients.
Discontinue MVASI in patients with gastrointestinal
perforation.
Surgery and Wound Healing Complications
The incidence of wound healing and surgical complications,
including serious and fatal complications, is increased in
bevacizumab product-treated patients. Discontinue MVASI in patients
with wound dehiscence. The appropriate interval between termination
of bevacizumab products and subsequent elective surgery required to
reduce the risks of impaired wound healing/wound dehiscence has not
been determined. Discontinue at least 28 days prior to elective
surgery. Do not initiate MVASI for at least 28 days prior to
elective surgery. Do not initiate MVASI for at least 28 days after
surgery and until the surgical wound is fully healed.
Hemorrhage
Severe or fatal hemorrhage, including hemoptysis,
gastrointestinal bleeding, central nervous system hemorrhage,
epistaxis, and vaginal bleeding occur up to 5-fold more frequently
in patients receiving bevacizumab products. Across indications, the
incidence of grade ≥3 hemorrhagic events among patients receiving
bevacizumab ranged from 0.4% to 6.9%. Do not administer MVASI to
patients with serious hemorrhage or recent hemoptysis (≥1/2 tsp of
red blood). Discontinue MVASI in patients with serious hemorrhage
(ie, requiring medical intervention).
Additional serious adverse events
- Additional serious and sometimes fatal adverse events with
increased incidence in the bevacizumab product-treated arm vs
control included
-
- GI fistulae (up to 2% in metastatic colorectal cancer)
- Non-GI fistulae (<1% in trials across various indications;
1.8% in a cervical cancer trial)
- Arterial thromboembolic events (grade ≥3, 2.6%)
- Proteinuria (nephrotic syndrome, <1%)
- Additional serious adverse events with increased incidence in
the bevacizumab product-treated arm vs control included
-
- GI-vaginal fistulae occurred in 8.3% of patients in a cervical
cancer trial
- Venous thromboembolism (grade 3-4, up to 10.6%) in patients
with persistent, recurrent, or metastatic cervical cancer treated
with chemotherapy and bevacizumab product
- Hypertension (grade 3-4, 5%-18%)
- Posterior reversible encephalopathy syndrome (PRES)
(<0.5%)
- Infusion reactions with the first dose of bevacizumab
product-treated patients were uncommon (<3%), and severe
reactions occurred in 0.2% of patients
- Inform females of reproductive potential of the risk of ovarian
failure prior to starting treatment with MVASI
Pregnancy warning
- Based on the mechanism of action and animal studies,
bevacizumab products may cause fetal harm
- Advise female patients that MVASI may cause fetal harm, and to
inform their healthcare provider of a known or suspected
pregnancy
- Advise females of reproductive potential to use effective
contraception during treatment with MVASI and for 6 months after
the last dose of MVASI
- Advise nursing women that breastfeeding is not recommended
during treatment with MVASI
- MVASI may impair fertility
Most Common Adverse Events
- Across indications, the most common adverse reactions observed
in bevacizumab product-treated patients at a rate of >10% and at
least twice the control arm rate were: epistaxis, headache,
hypertension, rhinitis, proteinuria, taste alteration, dry skin,
rectal hemorrhage, lacrimation disorder, back pain, exfoliative
dermatitis
- Across all studies, bevacizumab product was discontinued in
8.4% to 21% of patients because of adverse reactions.
Please see full Prescribing Information, including Boxed
WARNINGS, at www.Amgen.com.
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
will assume primary responsibility for developing, manufacturing
and initially commercializing the oncology antibody products.
About Amgen Biosimilars
Amgen Biosimilars 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 more than 35 years 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's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of
the toughest cancers, such as those that have been resistant to
drugs, those that progress rapidly through the body and those where
limited treatment options exist. Amgen's supportive care
treatments help patients combat certain side effects of strong
chemotherapy, and our targeted medicines and immunotherapies focus
on more than a dozen different malignancies, ranging from blood
cancers to solid tumors. With decades of experience providing
therapies for cancer patients, Amgen continues to grow
its portfolio of innovative and biosimilar oncology medicines.
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 bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and
best-in-class products for the central nervous system, eye care,
medical aesthetics and dermatology, gastroenterology, women's
health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the
Company's R&D model, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. This approach has led to Allergan building
one of the broadest development pipelines in the pharmaceutical
industry with 70+ mid-to-late stage pipeline programs in
development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right.
With commercial operations 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.
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 it 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 manufacturing facilities 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. 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. Amgen may not be able to access the capital
and credit markets on terms that are favorable to it, or at
all. Amgen is increasingly dependent on information
technology systems, infrastructure and data
security. 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.
Avastin® is registered trademark of
Genentech.
References
1. US Department of Health and Human Services.
Scientific considerations in demonstrating biosimilarity to a
reference product. Available at:
https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf.
Accessed August 21, 2017
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006
(investor relations)
Mark Marmur, 862-261-7558
(media)
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