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Enbrel® (etanercept) Patent Issued
THOUSAND OAKS, Calif., Nov. 22, 2011 /PRNewswire via COMTEX/ --
Amgen (NASDAQ:AMGN) today issued the following statement:
Amgen today announced the issuance of U.S. Patent No. 8,063,182 related to Enbrel® (etanercept). This patent is owned by Hoffman-La Roche Inc. ("Roche") and exclusively licensed to Amgen. Immunex Corporation (acquired by Amgen in 2002) originally licensed this patent application from Roche in 1999, and in 2004, Amgen paid Roche a one-time payment and obtained an exclusive, fully paid-up license to the application which issued today as the '182 patent. The patent describes and claims the fusion protein that is etanercept, and by statute, the '182 patent has a term of 17 years from today.
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 18 years of collective clinical experience. 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 juvenile idiopathic arthritis) in 1999. In 2004, ENBREL was approved in the U.S. to treat adult chronic moderate to severe plaque psoriasis. Prescription ENBREL is given 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), Orenciaâ (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
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.
This news release contains forward-looking statements that are based on management'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 our business. Unless otherwise noted, Amgen is providing this information as of Nov. 22, 2011 and expressly disclaims any duty to update information contained in this news release.
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CONTACT: Amgen, Thousand Oaks
Christine Regan, 805-447-5476 (Media)
Arvind Sood, 805-447-1060 (Investors)