THOUSAND OAKS, Calif.,
Nov. 10, 2017 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion for
the Marketing Authorization of ABP 215, a biosimilar to
Avastin® (bevacizumab). ABP 215 has been recommended for
approval for the treatment of certain types of cancer, 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.
"ABP 215 has the potential to provide healthcare professionals
and appropriate patients across Europe access to high-quality, targeted cancer
therapy," said Sean E. Harper, M.D.,
executive vice president of Research and Development at Amgen. "The
positive CHMP opinion for ABP 215
marks the first time a bevacizumab biosimilar has been
recommended for approval in the European Union, which is an
exciting milestone for Amgen."
Amgen and Allergan are committed to developing high-quality
biosimilars with a robust analytic and clinical package. The
Marketing Authorization Application for ABP 215 was based on a
comprehensive data package that demonstrated ABP 215 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.
"This positive opinion underscores our commitment with Amgen to
bringing biosimilars to market to help patients with
difficult-to-treat cancers," said David
Nicholson, chief research and development officer at
Allergan. "We are encouraged by the progress Amgen and Allergan
have made in developing biosimilars in critical disease areas and
look forward to providing important medicines to patients in the
future."
The CHMP positive opinion will now be reviewed by
the European Commission (EC), which has the authority to
approve medicines for the European Union (EU). If
approved, a centralized marketing authorization will be granted
that will be valid in the 28 countries that are members of the
EU. Norway, Iceland and Liechtenstein, as
members of the European Economic Area (EEA), will take
corresponding decisions on the basis of the decision of the EC.
In September 2017, ABP 215 became
the first anti-cancer biosimilar, as well as the first bevacizumab
biosimilar, to be approved by the U.S. Food and Drug Administration
(FDA). It is approved in the U.S. with the brand name MVASI™
(bevacizumab-awwb). Amgen and Allergan are collaborating on the
development and commercialization of four oncology biosimilars.
Amgen has a total of 10 biosimilars in its portfolio, one of which
has been approved by the EC.
About ABP 215 in the European Union
ABP 215 is
being developed as a biosimilar to bevacizumab. Once approved in
the EU, ABP 215 will be indicated 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 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. Indications in the U.S., EU
and other regions vary due to regional differences.
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 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 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.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
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clinical results or practices, customer and prescriber patterns or
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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
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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
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and through licensing collaborations, partnerships and joint
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Also, Amgen or others could identify safety, side effects
or manufacturing problems with its products, including its devices,
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Amgen's results may be affected by its ability to
successfully market both new and existing products domestically and
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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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