Amgen and Pfizer Highlight Data to be Presented at American College
of Rheumatology Meeting
THOUSAND OAKS, Calif. and
NEW YORK, Nov. 12, 2012 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Pfizer (NYSE:PFE) today announced that results
from several Enbrel® (etanercept) studies will be
presented at the American College of Rheumatology/Association of
Rheumatology Health Professionals (ACR/ARHP) 2012 Annual Meeting in
Washington, D.C. from Nov. 10-14, 2012.
"Moderate to severe rheumatoid arthritis (RA) places a
significant burden on patients, and we are pleased that ENBREL
remains the number one most prescribed biologic among
rheumatologists to help reduce pain and help stop the progression
of joint damage in these patients," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "Physicians have been
prescribing ENBREL for 14 years, and the data being presented at
ACR demonstrate our ongoing commitment to the study of RA and the
meaningful impact ENBREL has on patients."
Abstracts are available on the ACR website at
www.rheumatology.org.
SELECTED ABSTRACTS OF INTEREST INCLUDE:
Oral Presentations
- Induction of Remission in Patients with up to 12 Months of
Moderate-to-Severe Rheumatoid Arthritis Symptoms Treated with
Etanercept Plus Methotrexate Over 52 Weeks
Lead Author:
Paul Emery, Department of
Rheumatology, Leeds General Infirmary, Leeds, United Kingdom
Abstract No. 2549
Tuesday, Nov. 13, 5:30 p.m. – 5:45 p.m.
EST
Poster Presentations
- Impact of Etanercept-Methotrexate Therapy on
Patient-Reported Outcomes in Rheumatoid Arthritis Patients with up
to 12 Months of Symptoms
Lead Author: Paul Emery, Department of Rheumatology, Leeds
General Infirmary, Leeds, United
Kingdom
Abstract No. 368
Sunday, Nov. 11, 9:00 a.m. – 6:00 p.m.
EST
- Structural Damage is Reduced by Early Achievement of
Clinical Remission
Lead Author: Paul
Emery, Department of Rheumatology, Leeds General Infirmary,
Leeds, United Kingdom
Abstract No. 1011
Monday, Nov. 12, 9:00 a.m. – 6:00 p.m.
EST
- Relationship Between Clinical Response and Radiographic
Outcomes in Patients with Moderate Rheumatoid Arthritis
Lead
Author: Josef S. Smolen, Division of
Rheumatology, Department of Internal Medicine III, Medical
University of Vienna, Vienna, Austria
Abstract No. 2133
Tuesday, Nov. 13, 9:00 a.m. – 6:00 p.m.
EST
- Factors that Impact Work Productivity in the PRESERVE Trial:
A Randomized Controlled Trial of Combination
Etanercept-Methotrexate Therapy in Patients with Moderately Active
Rheumatoid Arthritis
Lead Author: Vibeke Strand, Division of
Immunology/Rheumatology, Stanford
University School of Medicine, Palo Alto, California, United States
Abstract No. 1827
Tuesday, Nov. 13, 9:00 a.m. – 6:00 p.m.
EST
About Rheumatoid Arthritis
RA is a chronic inflammatory disease that affects approximately
one percent of the adult population worldwide and can start at any
age, but usually occurs between 40 and 70 years of age. RA can
cause pain, stiffness, swelling and limited motion and function of
multiple joints. In RA, joint damage can significantly worsen over
time, especially if left untreated. Joint damage may impair
function, and potentially disable some patients.
About ENBREL
ENBREL is a soluble form of a fully human tumor necrosis factor
(TNF) receptor with efficacy and safety evaluated in clinical
studies over the past 19 years. ENBREL was first approved in the
U.S. in 1998 for moderate to severe rheumatoid arthritis and was
later approved to treat children and adolescents with moderate to
severe juvenile rheumatoid arthritis (now called polyarticular
juvenile idiopathic arthritis) in 1999. In 2004, ENBREL was
approved in the U.S. to treat adult patients with chronic moderate
to severe plaque psoriasis who are candidates for systemic therapy
or phototherapy. Prescription ENBREL is taken by injection.
ENBREL indications in the U.S.:
- ENBREL is indicated for reducing signs and symptoms, keeping
joint damage from getting worse and improving physical function in
patients with moderate to severe rheumatoid arthritis. ENBREL can
be taken with methotrexate or used alone.
- ENBREL is indicated for reducing signs and symptoms of
moderately to severely active polyarticular juvenile idiopathic
arthritis (JIA) in children ages 2 years and older.
- ENBREL is indicated for reducing signs and symptoms, keeping
joint damage from getting worse and improving physical function in
patients with psoriatic arthritis. ENBREL can be used in
combination with methotrexate in patients who do not respond
adequately to methotrexate alone.
- ENBREL is indicated for reducing signs and symptoms in patients
with active ankylosing spondylitis.
- ENBREL is indicated for the treatment of adult patients (18
years or older) with chronic moderate to severe plaque psoriasis
who are candidates for systemic therapy or phototherapy.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ENBREL?
ENBREL is a medicine that affects your immune system. ENBREL can
lower the ability of your immune system to fight infections.
Serious infections have happened in patients taking ENBREL. These
infections include tuberculosis (TB) and infections caused by
viruses, fungi, or bacteria that have spread throughout the body.
Some patients have died from these infections. Your doctor should
test you for TB before you take ENBREL and monitor you closely for
TB before, during, and after ENBREL treatment, even if you have
tested negative for TB.
There have been some cases of unusual cancers reported in
children and teenage patients who started using tumor necrosis
factor (TNF) blockers before 18 years of age. Also, for children,
teenagers, and adults taking TNF blockers, including ENBREL, the
chances of getting lymphoma or other cancers may increase. Patients
with RA or psoriasis may be more likely to get lymphoma.
Before starting ENBREL, tell your doctor if you:
- Have any existing medical conditions
- Are taking any medicines, including herbals
- Think you have, are being treated for, have signs of, or are
prone to infection. You should not start taking ENBREL if you have
any kind of infection, unless your doctor says it is okay
- Have any open cuts or sores
- Have diabetes, HIV, or a weak immune system
- Have TB or have been in close contact with someone who has had
TB
- Were born in, lived in, or traveled to countries where there is
more risk for getting TB. Ask your doctor if you are not sure
- Live, have lived in, or traveled to certain parts of the
country (such as, the Ohio and
Mississippi River valleys, or the Southwest) where there is a
greater risk for certain kinds of fungal infections, such as
histoplasmosis. These infections may develop or become more severe
if you take ENBREL. If you don't know if these infections are
common in the areas you've been to, ask your doctor
- Have or have had hepatitis B
- Have or have had heart failure
- Develop symptoms such as persistent fever, bruising, bleeding,
or paleness while taking ENBREL
- Use the medicine Kineret® (anakinra),
Orencia® (abatacept), or Cytoxan®
(cyclophosphamide)
- Are taking anti-diabetic medicines
- Have, have had, or develop a serious nervous disorder,
seizures, any numbness or tingling, or a disease that affects your
nervous system such as multiple sclerosis or Guillain-Barre
syndrome
- Are scheduled to have surgery
- Have recently received or are scheduled for any vaccines. All
vaccines should be brought up-to-date before starting ENBREL.
Patients taking ENBREL should not receive live vaccines.
- Are allergic to rubber or latex
- Are pregnant, planning to become pregnant, or
breastfeeding
- Have been around someone with chicken pox
What are the possible side effects of ENBREL?
ENBREL can cause serious side effects including: New infections
or worsening of infections you already have; hepatitis B can become
active if you already have had it; nervous system problems, such as
multiple sclerosis, seizures, or inflammation of the nerves of the
eyes; blood problems (some fatal); new or worsening heart failure;
new or worsening psoriasis; allergic reactions; autoimmune
reactions, including a lupus-like syndrome and autoimmune
hepatitis.
Common side effects include: Injection site reactions, upper
respiratory infections (sinus infections), and headache.
These are not all the side effects with ENBREL. Tell your doctor
about any side effect that bothers you or does not go away.
If you have any questions about this information, be sure to
discuss them with your doctor. You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Prescribing Information and Medication Guide at
www.ENBREL.com.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was
one of the first companies to realize the new science's promise by
bringing safe, effective medicines from lab to manufacturing plant
to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, bone disease
and other serious illnesses. With a deep and broad pipeline of
potential new medicines, Amgen remains committed to advancing
science to dramatically improve people's lives. To learn more about
our pioneering science and vital medicines, visit
www.amgen.com. Follow us on www.twitter.com/amgen.
About Pfizer Inc.
At Pfizer, we apply science and our global resources to improve
health and well-being at every stage of life. We strive to set the
standard for quality, safety and value in the discovery,
development and manufacturing of medicines for people and animals.
Our diversified global healthcare portfolio includes human and
animal biologic and small molecule medicines and vaccines, as well
as nutritional products and many of the world's best-known consumer
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as the world's leading
biopharmaceutical company, we also collaborate with healthcare
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all
who rely on us. To learn more about our commitments, please visit
us at www.pfizer.com.
Amgen Forward Looking Statements
This news release contains forward-looking statements that are
based on Amgen's current expectations and beliefs 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, including Amgen's most
recent annual report on Form 10-K and most recent periodic reports
on Form 10-Q and Form 8-K. Please refer to Amgen'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
Nov. 12, 2012, 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 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 products liability claims.
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 are affected by the
reimbursement policies imposed by third-party payors, 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 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 and there can be no guarantee of
Amgen's ability to obtain or maintain patent protection for its
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.
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 (FDA) 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. Only the FDA can determine whether the
products are safe and effective for these uses.
Healthcare professionals should refer to and rely upon
the FDA-approved labeling for the products, and not the information
discussed in this news release.
Pfizer Disclosure Notice
The information contained in this release is as of November 12, 2012. Pfizer assumes no obligation
to update forward-looking statements contained in this release as
the result of new information or future events or developments.
This release contains forward-looking information that involves
substantial risks and uncertainties about Enbrel, including data
relating to Enbrel and the potential implications of such data.
Such risks and uncertainties include, among other things, the
uncertainties inherent in research and development; competitive
developments; and the other risks and uncertainties set forth in
Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2011 and in its reports
on Form 10-Q and Form 8-K.
CONTACT:
Amgen
Christine Regan, 805-447-5476
(media)
Ashleigh Koss, 805-313-6151 (media)
Arvind
Sood, 805-447-1060 (investors)
|
Pfizer
Victoria Davis, 484-865-5194
(media)
Jennifer Davis, 212-733-0717
(investors)
|
(Logo:
http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)
SOURCE Amgen