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"The long-term evaluation of medications for the treatment of RA isimportant because this is a chronic, progressive disease that requirescontinuous treatment to inhibit the progression of further joint damage," saidMark Genovese, M.D., Stanford University Medical Center, Palo Alto,California. "These 10-year data demonstrate that improvements in diseaseactivity measures were maintained and the safety profile was consistent overtime. Rheumatologists may find this long-term data helpful when prescribingENBREL for clinically appropriate patients."
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Data from two long-term, open-label extension studies presented at ACRshowed that ENBREL provided improvement in the signs and symptoms of RA thatwas maintained for up to 10 years in adult patients with early rheumatoidarthritis (ERA) or long-standing RA (LRA). Approximately one-third ofpatients who started either study continued on ENBREL throughout the decade ofuse.
Of the proportion of patients evaluated for efficacy and still on therapyfor up to 10 years, 56 percent achieved an ACR 50 response. Further 39percent and 31 percent (ERA and LRA, respectively) achieved an ACR 70response. These scores represent a 50 percent or 70 percent improvement in RAoutcome measures that include joint swelling and tenderness, pain, level ofdisability, overall patient and physician disease assessment, and an objectivemarker of inflammation.
"RA may pose serious challenges to remaining physically active andparticipating in the normal daily activities, such as grocery shopping orwalking up a flight of stairs, that many people take for granted," saidGenovese. "The study findings showed that in addition to managing thesymptoms of RA, treatment with ENBREL helped patients to remain active up to10 years."
Additional data demonstrated sustained improvement in physical function inthe subset of patients studied for efficacy. Yearly snapshots of the HealthAssessment Questionnaire (HAQ) score showed that 73-86 percent of patientswith ERA and 64-72 percent of patients with LRA achieved a clinicallysignificant improvement in HAQ Disability Index. HAQ scores measure apatient's self-reported ability to perform activities of daily living such asdressing, walking, and grooming. A clinically significant reduction in HAQwas defined as at least a 0.22 improvement from baseline.
The data being presented at ACR also showed that the rates and types ofserious adverse events and serious infections reported in patients treatedwith ENBREL for up to 10 years have remained consistent with what was reportedin the control populations during the double-blind phases of the studies.Important safety information for ENBREL is provided below.
STUDY DESIGN
The studies were designed to assess the long-term safety and efficacy ofENBREL in adult patients with ERA (defined as less than or equal to threeyears of disease duration), as well as adult patients with LRA (defined asfailure to respond to at least one disease-modifying antirheumatic-drug).Patients with RA who participated in controlled clinical trials of ENBREL wereeligible to enroll in open-label extension studies. Safety data were analyzedfor all patients who received at least one dose of ENBREL (ERA, N=558; LRA,N=714). Efficacy endpoints were analyzed in patients who received ENBREL 25mg twice weekly in ERA (baseline: N=207, 10-year: N=79) and LRA studies(baseline: N=644, 10-year: N=255).
ABOUT RHEUMATOID ARTHRITIS
According to the Arthritis Foundation, approximately 1.3 million Americanshave been diagnosed with RA, which can cause pain, stiffness, swelling, andlimitation in the motion and function of multiple joints. If RA is leftuntreated, joint damage caused by the disease can impair function, disablingsome patients.
ABOUT ENBREL
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF)receptor and has 16 years of collective clinical experience with anestablished safety profile. ENBREL was first approved in 1998 for moderate tosevere rheumatoid arthritis and was later approved to treat children andadolescents with juvenile rheumatoid arthritis (now called juvenile idiopathicarthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severeplaque psoriasis in adults.
What important safety information do I need to know about takingprescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blockerthat blocks the action of a substance your body's immune system makes calledTNF. People with an immune disease, such as rheumatoid arthritis, juvenileidiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, orpsoriasis, have too much TNF in their bodies. ENBREL can reduce the amount ofactive TNF in the body to normal levels, helping to treat your disease. But,in doing so, ENBREL can also lower the ability of your immune system to fightinfections.
Serious infections, including tuberculosis (TB), have happened in patientstaking ENBREL. Some of these serious infections have been fatal. Manyserious infections occurred in people prone to infection. Serious infectionshave also occurred in patients with advanced or poorly controlled diabetes.Do not start ENBREL if you have an infection or are allergic to ENBREL or itscomponents. Once on ENBREL, if you get an infection or have any sign of aninfection, including fever, cough, or flu-like symptoms, or have open sores,tell your doctor. Your doctor should test you for TB before starting ENBRELand should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, orinflammation of the nerves of the eyes have been reported. There have beenrare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen inpatients taking TNF blockers compared to similar patients who were not takingTNF blockers. The risk of lymphoma may be several-fold higher in people withrheumatoid arthritis and psoriasis; the role of TNF blockers in thedevelopment of malignancies is unknown.
Common side effects in adult clinical trials were injection site reaction,infection and headache.
In a medical study of patients with JIA, infection, headache, abdominalpain, vomiting, and nausea occurred more frequently than in adults. The kindsof infections reported were generally mild and similar to those usually seenin children. Other serious adverse reactions were reported, including seriousinfection and depression/personality disorder.
If you have any questions about this information, be sure to discuss themwith your doctor. You are encouraged to report negative side effects ofprescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call1-800-FDA-1088.
Please visit http://www.enbrel.com or call 1-888-4ENBREL to requestadditional information, including the U.S. Prescribing Information andMedication Guide.
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL inNorth America. Wyeth markets ENBREL outside of North America. ImmunexCorporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Amgen discovers, develops, manufactures and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of the firstcompanies to realize the new science's promise by bringing safe and effectivemedicines from lab, to manufacturing plant, to patient. Amgen therapeuticshave changed the practice of medicine, helping millions of people around theworld in the fight against cancer, kidney disease, rheumatoid arthritis, andother serious illnesses. With a deep and broad pipeline of potential newmedicines, Amgen remains committed to advancing science to dramaticallyimprove people's lives. To learn more about our pioneering science and ourvital medicines, visit http://www.amgen.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in theareas of women's health care, infectious disease, gastrointestinal health,central nervous system, inflammation, transplantation, hemophilia, oncology,vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical andhealth care products companies. It is a leader in the discovery, development,manufacturing and marketing of pharmaceuticals, vaccines, biotechnologyproducts and non-prescription medicines that improve the quality of life forpeople worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. Tolearn more, visit http://www.wyeth.com.
Amgen Forward-Looking Statement
This news release contains forward-looking statements that are based onAmgen's current expectations and beliefs and are subject to a number of risks,uncertainties and assumptions that could cause actual results to differmaterially from those described. All statements, other than statements ofhistorical fact, are statements that could be deemed forward-lookingstatements, including estimates of revenues, operating margins, capitalexpenditures, cash, other financial metrics, expected legal, arbitration,political, regulatory or clinical results or practices, customer andprescriber patterns or practices, reimbursement activities and outcomes andother such estimates and results. Forward-looking statements involvesignificant risks and uncertainties, including those discussed below and morefully described in the Securities and Exchange Commission (SEC) reports filedby Amgen, including Amgen's most recent annual report on Form 10-K and mostrecent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen'smost recent Forms 10-K, 10-Q and 8-K for additional information on theuncertainties and risk factors related to Amgen's business. Unless otherwisenoted, Amgen is providing this information as of Oct. 27, 2008, and expresslydisclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results maydiffer materially from those Amgen projects. Discovery or identification ofnew product candidates or development of new indications for existing productscannot be guaranteed and movement from concept to product is uncertain;consequently, there can be no guarantee that any particular product candidateor development of a new indication for an existing product will be successfuland become a commercial product. Further, preclinical results do notguarantee safe and effective performance of product candidates in humans. Thecomplexity of the human body cannot be perfectly, or sometimes, evenadequately modeled by computer or cell culture systems or animal models. Thelength of time that it takes for Amgen to complete clinical trials and obtainregulatory approval for product marketing has in the past varied and Amgenexpects similar variability in the future. Amgen develops product candidatesinternally and through licensing collaborations, partnerships and jointventures. Product candidates that are derived from relationships may besubject to disputes between the parties or may prove to be not as effective oras safe as Amgen may have believed at the time of entering into suchrelationship. Also, Amgen or others could identify safety, side effects ormanufacturing problems with Amgen's products after they are on the market.Amgen's business may be impacted by government investigations, litigation andproducts liability claims. Amgen depends on third parties for a significantportion of its manufacturing capacity for the supply of certain of its currentand future products and limits on supply may constrain sales of certain of itscurrent products and product candidate development.
In addition, sales of Amgen's products are affected by the reimbursementpolicies imposed by third-party payors, including governments, privateinsurance plans and managed care providers and may be affected by regulatory,clinical and guideline developments and domestic and international trendstoward managed care and health care cost containment as well as U.S.legislation affecting pharmaceutical pricing and reimbursement. Governmentand others' regulations and reimbursement policies may affect the development,usage and pricing of Amgen's products. In addition, Amgen competes with othercompanies with respect to some of its marketed products as well as for thediscovery and development of new products. Amgen believes that some of itsnewer products, product candidates or new indications for existing products,may face competition when and as they are approved and marketed. Amgen'sproducts may compete against products that have lower prices, establishedreimbursement, superior performance, are easier to administer, or that areotherwise competitive with its products. In addition, while Amgen routinelyobtain patents for its products and technology, the protection offered by itspatents and patent applications may be challenged, invalidated or circumventedby its competitors and there can be no guarantee of Amgen's ability to obtainor maintain patent protection for its products or product candidates. Amgencannot guarantee that it will be able to produce commercially successfulproducts or maintain the commercial success of its existing products. Amgen'sstock price may be affected by actual or perceived market opportunity,competitive position, and success or failure of its products or productcandidates. Further, the discovery of significant problems with a productsimilar to one of Amgen's products that implicate an entire class of productscould have a material adverse effect on sales of the affected products and onAmgen's business and results of operations.
The scientific information discussed in this news release related toAmgen's product candidates is preliminary and investigative. Such productcandidates are not approved by the U.S. Food and Drug Administration (FDA),and no conclusions can or should be drawn regarding the safety oreffectiveness of the product candidates. Only the FDA can determine whetherthe product candidates are safe and effective for the use(s) beinginvestigated. Further, the scientific information discussed in this newsrelease relating to new indications for Amgen's products is preliminary andinvestigative and is not part of the labeling approved by the FDA for theproducts. The products are not approved for the investigational use(s)discussed in this news release, and no conclusions can or should be drawnregarding the safety or effectiveness of the products for these uses. Onlythe FDA can determine whether the products are safe and effective for theseuses. Healthcare professionals should refer to and rely upon the FDA-approvedlabeling for the products, and not the information discussed in this newsrelease.
Wyeth Forward-Looking Statement
The statements in this press release that are not historical facts areforward-looking statements that are subject to risks and uncertainties thatcould cause actual results to differ materially from those expressed orimplied by such statements. These risks and uncertainties include, withoutlimitation, the inherent uncertainty of the timing and success of, and expenseassociated with, research, development, regulatory approval andcommercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for ourproducts; substantial competition in our industry, including from branded andgeneric products; emerging data on our products and pipeline products; theimportance of strong performance from our principal products and ouranticipated new product introductions; the highly regulated nature of ourbusiness; product liability, intellectual property and other litigation risksand environmental liabilities; uncertainty regarding our intellectual propertyrights and those of others; difficulties associated with, and regulatorycompliance with respect to, manufacturing of our products; risks associatedwith our strategic relationships; economic conditions including interest andcurrency exchange rate fluctuations; changes in generally accepted accountingprinciples; trade buying patterns; the impact of legislation and regulatorycompliance; risks and uncertainties associated with global operations andsales; and other risks and uncertainties, including those detailed from timeto time in our periodic reports filed with the Securities and ExchangeCommission, including our current reports on Form 8-K, quarterly reports onForm 10-Q and annual report on Form 10-K, particularly the discussion underthe caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for theyear ended December 31, 2007, which was filed with the Securities and ExchangeCommission on February 29, 2008. The forward-looking statements in this pressrelease are qualified by these risk factors. We assume no obligation topublicly update any forward-looking statements, whether as a result of newinformation, future developments or otherwise.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 the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children ages 2 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
SOURCE Amgen
