THOUSAND OAKS, Calif. and
HOUSTON, Jan. 12, 2015 /PRNewswire/ -- Amgen (NASDAQ:
AMGN) and The University of Texas MD
Anderson Cancer Center today announced a research collaborative
agreement focusing on Amgen's bispecific T cell engager
(BiTE®) antibody constructs, an immunotherapy that
serves as a "bridge" between T cells and cancer cells.
The research agreement will identify targets for this therapy in
myelodysplastic syndrome (MDS), a bone marrow disorder in which the
body does not produce sufficient healthy blood cells. MDS
affects primarily older adults over age 60 and can cause severe
anemia, potentially leading to development of acute myelogenous
leukemia (AML), a blood cell cancer.
"This is a unique collaboration that explores BiTE®
therapy for its potential in treating a disorder that affects
thousands of people each year," said Guillermo Garcia-Manero, M.D., professor of
leukemia at MD Anderson. "At MD Anderson, we have unrivaled
proteomics capabilities to explore new targets for this disease,
and this novel approach may very well open up new potential
treatments for our patients."
The collaboration's innovative approach will draw on the
expertise of MD Anderson's Moon Shots Program, which aims to
accelerate the conversion of scientific discoveries into clinical
advances and significantly reduce cancer deaths. Garcia-Manero
leads the MDS/AML Moon Shots Program.
The collaborative agreement will allow Amgen and MD Anderson to
join forces in a research partnership that aims to take new drug
development from "A to Z." The agreement provides for joint
development of new agents under pre-determined terms. Amgen retains
all commercial rights, while MD Anderson is eligible to receive
milestones and royalties upon successful achievement of key
objectives.
"We are excited about the new research opportunities this
collaboration will open up in further exploring the potential of
BiTE® technology," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "BiTE® antibody constructs
represent an innovative immunotherapy approach that helps the
body's immune system target cancer cells. MD Anderson is a great
partner in our quest to find potential new treatments for patients
with serious illnesses."
BiTE® antibody constructs are recombinant proteins
consisting of two separate antibodies held together by a flexible
peptide linker or bands of amino acids. The antibodies are designed
to function as a link between T cells and cancer cells. One
antibody or protein domain binds to the cancer cell's surface,
while the other binds to the CD3 on the T cell, resulting in the
malignant cell's death. It is thought that BiTE®
antibody constructs may be engineered to target a range of
tumors.
"This long-term collaboration between leading scientists at MD
Anderson and Amgen takes advantage of significant advances in
technologies available for target discovery through the MD Anderson
Moon Shots Program," said Samir
Hanash, M.D., Ph.D., professor of clinical cancer prevention
and director, the Red and Charline McCombs Institute for the Early
Detection and Treatment of Cancer at MD Anderson. "The agreement
covers the full scope of clinical development from identifying
targets for this therapy in MDS to developing fully tested and
approved new therapies."
About MD Anderson
The University
of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most
respected centers focused on cancer patient care, research,
education and prevention. MD Anderson is one of only 41
comprehensive cancer centers designated by the National Cancer
Institute (NCI). For the past 25 years, MD Anderson has ranked as
one of the nation's top two cancer centers in U.S. News & World
Report's annual "Best Hospitals" survey. MD Anderson receives a
cancer center support grant from the NCI of the National Institutes
of Health (P30 CA016672).
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 biologics manufacturing 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 BiTE® Technology
Bispecific T cell
engager (BiTE®) antibody constructs are a type of
immunotherapy being investigated for fighting cancer by helping the
body's immune system to detect and target malignant cells. The
modified antibodies are designed to engage two different targets
simultaneously, thereby juxtaposing T cells (a type of white blood
cell capable of killing other cells perceived as threats) to cancer
cells. BiTE® antibody constructs help place the T cells
within reach of the targeted cell, with the intent of allowing T
cells to inject toxins and trigger the cancer cell to die
(apoptosis). BiTE® antibody constructs are currently
being investigated for their potential to treat a wide variety of
cancers. For more information, visit www.biteantibodies.com.
On Dec. 3, 2014 the U.S. Food and
Drug Administration (FDA) granted approval of BLINCYTO™
(blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-)
relapsed or refractory B-cell precursor acute lymphoblastic
leukemia (ALL). This indication was approved under accelerated
approval. Continued approval for this indication may be contingent
upon verification of clinical benefit in subsequent trials. With
this approval, BLINCYTO becomes the first FDA-approved bispecific
CD19-directed CD3 T cell engager (BiTE®) antibody
construct product, and the first single-agent immunotherapy to be
approved for the treatment of patients with Ph- relapsed or
refractory B-cell precursor ALL, a rare and rapidly progressing
cancer of the blood and bone marrow.1-3
BLINCYTO has a BOXED WARNING in its product label
regarding Cytokine Release Syndrome (CRS) and Neurological
Toxicities.
Cytokine Release Syndrome (CRS), which may be life-threatening
or fatal, occurred in patients receiving BLINCYTO. Interrupt or
discontinune BLINCYTO as recommended. Neurological toxicities,
which may be severe, life-threatening, or fatal, occurred in
patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as
recommended.
BLINCYTO is contraindicated to patients with known
hypersensitivity to blinatumomab or to any component of the product
formulation.
Monitor patients for signs and symptoms of infection and treat
appropriately.
Advise patients to refrain from driving and engaging in
hazardous occupations or activities such as driving, operating
heavy or potentially dangerous machinery while BLINCYTO is being
administered.
It is important to strictly follow instructions for preparation
(including admixing) and administration to prevent overdose and
underdose.
The most common adverse reactions (≥ 20 percent) were pyrexia
(62 percent), headache (36 percent), peripheral edema (25 percent),
febrile neutropenia (25 percent), nausea (25 percent), hypokalaemia
(23 percent), rash (21 percent), tremor (20 percent) and
constipation (20 percent). Serious adverse reactions were reported
in 65 percent of patients. The most common serious adverse
reactions (≥ 2 percent) included febrile neutropenia, pyrexia,
pneumonia, sepsis, neutropenia, device-related infection, tremor,
encephalopathy, infection, overdose, confusion, Staphylococcal
bacteremia and headache.
The FDA has also approved a risk evaluation and mitigation
strategy (REMS) for BLINCYTO. The purpose of the BLINCYTO
REMS is to inform healthcare providers of the serious risks of CRS,
neurological toxicities, and preparation and administration
errors. Additional information about the BLINCYTO REMS
program can be found at http://www.BLINCYTOREMS.com.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen)
and are subject to a number of risks, uncertainties and assumptions
that could cause actual results to differ materially from those
described. 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 (SEC) reports
filed by Amgen Inc., including Amgen Inc.'s most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms
10-K, 10-Q and 8-K for additional information on the uncertainties
and risk factors related to Amgen's business. Unless otherwise
noted, Amgen is providing this information as of Jan. 12, 2015, and expressly disclaims any duty
to update information contained in this news release.
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 and its partners to complete clinical trials and obtain
regulatory approval for product marketing has in the past varied
and Amgen expects similar variability in the future. 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 Amgen's products after they are on the
market. Amgen's business may be impacted by government
investigations, litigation and product liability claims. 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. Amgen depends on third parties
for a significant portion of its manufacturing capacity for the
supply of certain of its current and future products and limits on
supply may constrain sales of certain of its current products and
product candidate development.
In addition, sales of Amgen's products (including products of
Amgen's wholly-owned subsidiaries) are affected by the
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 as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of Amgen's products. In addition, Amgen competes
with other companies with respect to some of its marketed products
as well as for the discovery and development of new products. Amgen
believes that some of its newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Amgen's products may compete
against products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with its products. In addition, while Amgen
and its partners routinely obtain patents for their products and
technology, the protection of Amgen's products offered by patents
and patent applications may be challenged, invalidated or
circumvented by its competitors and there can be no guarantee of
Amgen's or its partners' ability to obtain or maintain patent
protection for Amgen's products or product candidates. Amgen cannot
guarantee that it will be able to produce commercially successful
products or maintain the commercial success of its existing
products. Amgen's stock price may be affected by actual or
perceived market opportunity, competitive position, and success or
failure of its products or product candidates. Further, 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 Amgen's business and results of operations. Amgen's efforts
to integrate the operations of companies it has acquired may not be
successful. Cost savings initiatives may result in Amgen incurring
impairment or other related charges on Amgen's assets. Amgen may
experience difficulties, delays or unexpected costs and not achieve
anticipated benefits and savings from its recently announced
restructuring plans. Amgen's business performance could affect or
limit the ability of Amgen's Board of Directors to declare a
dividend or Amgen's ability to pay a dividend or repurchase common
stock.
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.
CONTACT: Amgen, Thousand
Oaks
Cuyler Mayer, 805-447-6332 (Amgen
media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: MD Anderson
Ron Gilmore, 713-745-1898
rlgilmore@mdanderson.org
References
- Mayo Clinic. "Acute lymphocytic leukemia." Available at:
http://www.mayoclinic.com/health/acute-lymphocytic-leukemia/DS00558.
Accessed on October 30, 2014.
- BLINCYTO™ Draft US Prescribing Information.
- NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®): Acute Lymphoblastic Leukemia. Version 1.2014.
Available at:
https://www.nccn.org/store/login/login.aspx?ReturnURL=http://www.nccn.org/professionals/physician_gls/pdf/all.pdf.
Accessed on November 24, 2014.
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