Amgen and Pfizer highlight data to be presented at American College of Rheumatology Meeting

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.