Amgen and Pfizer Highlight Data to be Presented at American College of Rheumatology Meeting

    Amgen and Pfizer Highlight Data to be Presented at American College of
                             Rheumatology Meeting

PR Newswire

THOUSAND OAKS, Calif. and NEW YORK, Nov. 12, 2012

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

  oInduction 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

  oImpact 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



  oStructural 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



  oRelationship 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



  oFactors 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.:

  oENBREL 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.
  oENBREL is indicated for reducing signs and symptoms of moderately to
    severely active polyarticular juvenile idiopathic arthritis (JIA) in
    children ages 2 years and older.
  oENBREL 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.
  oENBREL is indicated for reducing signs and symptoms in patients with
    active ankylosing spondylitis.
  oENBREL 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:

  oHave any existing medical conditions
  oAre taking any medicines, including herbals
  oThink 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
  oHave any open cuts or sores
  oHave diabetes, HIV, or a weak immune system
  oHave TB or have been in close contact with someone who has had TB
  oWere born in, lived in, or traveled to countries where there is more risk
    for getting TB. Ask your doctor if you are not sure
  oLive, 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
  oHave or have had hepatitis B
  oHave or have had heart failure
  oDevelop symptoms such as persistent fever, bruising, bleeding, or paleness
    while taking ENBREL
  oUse the medicine Kineret^® (anakinra), Orencia^® (abatacept), or Cytoxan^®
    (cyclophosphamide)
  oAre taking anti-diabetic medicines
  oHave, 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
  oAre scheduled to have surgery
  oHave 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.
  oAre allergic to rubber or latex
  oAre pregnant, planning to become pregnant, or breastfeeding
  oHave 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 theinvestigational
use(s) discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for theseuses.
Only the FDA can determine whether the products are safe and effective for
these uses. Healthcareprofessionals shouldrefer 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
                                      Pfizer
Christine Regan, 805-447-5476 (media)
                                      Victoria Davis, 484-865-5194 (media)
Ashleigh Koss, 805-313-6151 (media)
                                      Jennifer Davis, 212-733-0717 (investors)
Arvind Sood, 805-447-1060 (investors)



(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen

Website: http://www.amgen.com
 
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