THOUSAND OAKS, Calif.,
Jan. 18, 2018 /PRNewswire/
-- Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today
announced that the European Commission (EC) has granted marketing
authorization for MVASI® (biosimilar bevacizumab). MVASI
is the first biosimilar bevacizumab approved by the EC and is
approved for the treatment of certain types of cancers, including
in combination with fluoropyrimidine-based chemotherapy for
metastatic carcinoma of the colon or rectum; in combination with
paclitaxel for metastatic breast cancer; in combination with
platinum-based chemotherapy for unresectable advanced, metastatic
or recurrent non-squamous non-small cell lung cancer (NSCLC); in
combination with erlotinib for unresectable advanced, metastatic or
recurrent non-squamous NSCLC; in combination with interferon
alfa-2a for advanced and/or metastatic renal cell cancer; in
combination with carboplatin and paclitaxel, carboplatin and
gemcitabine, and paclitaxel, topotecan, or pegylated liposomal
doxorubicin for advanced, platinum-sensitive, or platinum-resistant
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer; and in combination with paclitaxel and cisplatin, or
alternatively, paclitaxel and topotecan for persistent, recurrent,
or metastatic carcinoma of the cervix.
"The European Commission's approval of MVASI marks a significant
milestone for both Amgen and the oncology community, providing a
biosimilar for a medicine which is used across multiple types of
cancer," said Sean E. Harper, M.D.,
executive vice president of Research and Development at Amgen.
"MVASI is the first targeted cancer biosimilar from Amgen's
portfolio approved in Europe,
underscoring our commitment to delivering high-quality medicines
that address some of the most serious illnesses."
Amgen and Allergan are committed to developing high-quality
biosimilars with a robust analytic and clinical package. The EC
approved MVASI 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 non-squamous
NSCLC.
"MVASI is the first product from our collaboration with Amgen to
receive marketing authorization from the European Commission,
highlighting the success of our joint commitment to developing
cancer biosimilars," said David
Nicholson, chief research and development officer at
Allergan. "We look forward to our continued work with Amgen and to
providing important medicines to patients in the future."
Approval from the EC grants a centralized marketing
authorization with unified labeling in the 28 countries that are
members of the European Union (EU). Norway, Iceland and Liechtenstein, as members of the European
Economic Area, will take corresponding decisions on the basis of
the decision of the EC.
In September 2017, MVASI became
the first anti-cancer biosimilar, as well as the first biosimilar
bevacizumab, to be approved by the U.S. Food and Drug
Administration (FDA). Amgen and Allergan 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 EC.
About MVASI® (biosimilar bevacizumab) in the
EU
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, in combination with fluoropyrimidine-based chemotherapy,
is indicated for treatment of adult patients with metastatic
carcinoma of the colon or rectum.
MVASI, in combination with paclitaxel, is indicated for
first-line treatment of adult patients with metastatic breast
cancer.
MVASI, in addition to platinum-based chemotherapy, is indicated
for first-line treatment of adult patients with unresectable
advanced, metastatic or recurrent NSCLC other than predominantly
squamous cell histology.
MVASI, in combination with erlotinib, is indicated for
first-line treatment of adult patients with unresectable advanced,
metastatic or recurrent non-squamous NSCLC with Epidermal Growth
Factor Receptor (EGFR) activating mutations.
MVASI, in combination with interferon alfa-2a, is indicated for
first-line treatment of adult patients with advanced and/or
metastatic renal cell cancer.
MVASI, in combination with carboplatin and paclitaxel, is
indicated for the front-line treatment of adult patients with
advanced (International Federation of Gynecology and Obstetrics
(FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian
tube, or primary peritoneal cancer.
MVASI, in combination with carboplatin and gemcitabine or in
combination with carboplatin and paclitaxel, is indicated for
treatment of adult patients with first recurrence of
platinum-sensitive epithelial ovarian, fallopian tube or primary
peritoneal cancer who have not received prior therapy with
bevacizumab or other VEGF inhibitors or VEGF receptor-targeted
agents.
MVASI, in combination with paclitaxel, topotecan, or pegylated
liposomal doxorubicin, is indicated for the treatment of adult
patients with platinum-resistant recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who received no more
than two prior chemotherapy regimens and who have not received
prior therapy with bevacizumab or other VEGF inhibitors or VEGF
receptor-targeted agents.
MVASI, in combination with paclitaxel and cisplatin or,
alternatively, paclitaxel and topotecan in patients who cannot
receive platinum therapy, is indicated for the treatment of adult
patients with persistent, recurrent, or metastatic carcinoma of the
cervix.
MVASI EU Important Safety Information
The EU Summary of Product Characteristics for MVASI lists the
following Special Warnings and Precautions: gastrointestinal (GI)
perforations and fistulae, GI-vaginal fistulae in study GOG-0240,
non-GI fistulae, wound healing complications, hypertension,
posterior reversible encephalopathy syndrome (PRES), proteinuria,
arterial thromboembolism, venous thromboembolism, haemorrhage,
pulmonary haemorrhage/haemoptysis, congestive heart failure (CHF),
neutropenia and infections, hypersensitivity reactions/infusion
reactions, osteonecrosis of the jaw (ONJ), intravitreal use, eye
disorders, systemic effects following intravitreal use, and ovarian
failure/fertility.
About MVASI™ (bevacizumab-awwb) in the U.S.
MVASI is a biosimilar to bevacizumab, a recombinant IgG1 mAb
that binds to 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 metastatic colorectal
cancer (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 non-squamous 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 is currently not available commercially. This is not
an offer for sale. The following information is derived from the
approved label in the U.S.
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 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 http://www.amgenbiosimilars.com and
follow us on http://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 http://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.
Amgen Forward-Looking Statements
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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
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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
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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
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guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
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sometimes, even adequately modeled by computer or cell culture
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Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
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Amgen or others could identify safety, side effects or
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after they are on the market.
Amgen's results may be affected by its ability to successfully
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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, including in
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limits on supply may constrain sales of certain of its current
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competes with other companies with respect to many of its marketed
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Allergan plc Forward-Looking Statements
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; uncertainty
associated with financial projections, projected cost reductions,
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, 2016
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2017. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
Avastin® is registered trademark of Genentech.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
Amgen, Europe
Emma Gilbert, +41 41 369 2542
CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006
(investor relations)
Mark Marmur, 862-261-7558
(media)
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