07.09.2006 13:00:00
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Amgen Launches Aranesp(R) (Darbepoetin Alfa) Prefilled SureClick(TM) Autoinjector for Treatment of Anemia Associated with Chemotherapy and Chronic Kidney Disease
Amgen (NASDAQ:AMGN) today announced the launch of the Aranesp(R)(darbepoetin alfa) prefilled SureClick(TM) autoinjector for patientswith chemotherapy-induced anemia and anemia associated with chronickidney disease (CKD) in the United States.
"With the availability of the Aranesp prefilled SureClickautoinjector, healthcare providers and patients now have a new secureand simple option that automatically delivers a complete subcutaneousinjection in a single use," said Willard Dere, M.D., senior vicepresident for Global Development and chief medical officer at Amgen."The added safety features of the SureClick autoinjector minimizepotential needlestick injuries, offering dependable benefits fornurses, oncologists and nephrologists who administer Aranesp inclinics and hospitals."
The Aranesp prefilled SureClick autoinjector has three importantand unique safety features, including a safety cover that limitsneedle exposure before and after the subcutaneous injection, twoaudible clicks to announce the beginning and end of the injection, anda large inspection window that confirms it automatically delivered thecomplete injection. In a survey that included the use of the Aranespprefilled SureClick autoinjector, most oncology nurses agreed that thedevice was easy to use.
The Centers for Disease Control and Prevention (CDC) estimatesthat one out of every seven healthcare professionals is accidentallystuck by a contaminated sharp, most often a needle, each year.Approximately 62 to 88 percent of needlestick injuries can potentiallybe prevented by the use of safer devices. To reduce these occupationalhazards, the CDC has identified eight desirable characteristics forsafety devices, and the Aranesp prefilled SureClick autoinjector hasat least six of these characteristics.
The FDA approval of the Aranesp prefilled SureClick autoinjectorbroadens current administration options for healthcare providers andpatients with anemia associated with chemotherapy and CKD. There arenow three administration options for Aranesp: single-use SureClickautoinjector, SingleJect(R) prefilled syringes and prefilled vials.This wide range of delivery options allows healthcare professionals toselect the option that best meets their needs and their patients' andstaffs' needs. The Aranesp prefilled SureClick autoinjector will beavailable in clinics, hospitals and retail pharmacies, along with theother currently available administration options. Additionally, theAranesp prefilled SureClick autoinjector will be offered at the sameprice as the other administration methods.
The Aranesp prefilled SureClick autoinjector, which was approvedin the European Union in 2005 for patients with chemotherapy-inducedanemia and anemia associated with CKD, has been delivered toapproximately 500,000 patients to date.
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce redblood cells that transport oxygen from the lungs to all of the body'smuscles and organs. Anemia occurs when there are too few red bloodcells and the body's tissues are "starved" of oxygen, which can make apatient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergochemotherapy in the United States; approximately 800,000 (67 percent)will become anemic. More than half of chemotherapy patients reportthat fatigue, a common symptom of anemia, affects their daily livesmore than any other side effect of treatment, including nausea, painand depression.
Although anemia is one of the most common side effects ofchemotherapy, it is often not recognized and frequently under-treated,despite treatments that have been available for more than a decade. Infact, approximately half of patients with a hemoglobin level less thanthe recommended target level of 11 to 12 g/dL in the NationalComprehensive Cancer Network(R) (NCCN) guidelines for "Cancer andTreatment-Related Anemia" are never treated with erythropoietictherapy.
About Anemia and Chronic Kidney Disease (CKD)
According to the National Kidney Foundation, CKD affects 20million Americans (one in nine adults) and more than 20 million othersare at increased risk for developing kidney disease. CKD is anirreversible condition characterized by kidney damage and impairedfunction that often progresses over time. Patients with CKD oftensuffer from serious complications such as anemia, which occurs whenfailing kidneys no longer produce sufficient erythropoietin, a hormonethat stimulates the production of oxygen-carrying red blood cells. Redblood cells contain hemoglobin, a red, iron-rich protein that carriesoxygen from the lungs to all of the body's tissues. Oxygen providesthe energy the body needs for normal activities. Anemia occurs whenthe number of red blood cells (or the hemoglobin in them) falls belownormal (12 to 18 g/dL of blood). Therefore, the body gets less oxygenand does not have enough energy to function properly.
About Aranesp
Amgen revolutionized anemia treatment with the development ofEpoetin alfa, a recombinant erythropoietin (a protein that stimulatesthe production of oxygen-carrying red blood cells). Building on thisheritage, Amgen developed Aranesp, a unique erythropoiesis-stimulatingprotein that can be dosed less frequently.
Aranesp was approved by the U.S. Food and Drug Administration(FDA) in September 2001 for the treatment of anemia associated withchronic renal failure (CRF), also known as CKD, for patients ondialysis and patients not on dialysis. In 2002, Aranesp was approvedfor the treatment of chemotherapy-induced anemia in patients withnonmyeloid malignancies in the U.S. and European Union (EU). Today,Aranesp is the only erythropoiesis-stimulating protein approved in theU.S. and EU for weekly and every-three-week administration, whichallows physicians to synchronize anemia treatment with the majority ofchemotherapy schedules. Since its introduction in 2001, more than 1.7million CKD and chemotherapy patients with anemia have receivedtreatment with Aranesp.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolledhypertension. Erythropoietic therapies may increase the risk ofthrombotic events and other serious events. Seizures have occurred inpatients with Chronic Kidney Disease. The target hemoglobin (Hb)should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any2-week period, dose reductions are recommended. In a study of Epoetinalfa treated hemodialysis patients with clinically evident cardiacdisease, where the target hematocrit (Hct) was 42 percent (Hb = 14g/dL), an increased incidence of thrombotic events and mortality wasseen. The reason for increased mortality observed in this study isunknown. In a study with another erythropoietic product, in women withmetastatic breast cancer receiving chemotherapy, where the target Hbwas 12-14 g/dL, an increased incidence of thrombotic events, diseaseprogression, and mortality was seen.
Cases of pure red cell aplasia (PRCA) and of severe anemia, withor without other cytopenias associated with neutralizing antibodies toerythropoietin have been reported in patients treated with Aranesp.This has been reported predominately in patients with CRF receivingAranesp by subcutaneous administration. A sudden loss of response toAranesp, accompanied by severe anemia and low reticulocyte count,should be evaluated. If anti-erythropoietin antibody-associated anemiais suspected, withhold Aranesp and other erythropoietic proteins.Aranesp should be permanently discontinued in patients withantibody-mediated anemia. Patients should not be switched to othererythropoietic proteins.
The most commonly reported side effects in clinical trials inpatients with CRF were infection, hypertension, hypotension, myalgia,headache, and diarrhea. The most commonly reported side effects inclinical trials in patients with chemotherapy-induced anemia werefatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
About Amgen
Amgen discovers, develops and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of thefirst companies to realize the new science's promise by bringing safeand effective medicines from lab, to manufacturing plant, to patient.Amgen therapeutics have changed the practice of medicine, helpingmillions of people around the world in the fight against cancer,kidney disease, rheumatoid arthritis, and other serious illnesses.With a broad and deep pipeline of potential new medicines, Amgenremains committed to advancing science to dramatically improvepeople's lives. To learn more about our pioneering science and ourvital medicines, visit www.amgen.com.
Forward-Looking Statement
This news release contains forward-looking statements that involvesignificant risks and uncertainties, including those discussed belowand others that can be found in Amgen's Form 10-K for the year endedDecember 31, 2005, and in Amgen's periodic reports on Form 10-Q andForm 8-K. Amgen is providing this information as of the date of thisnews release and does not undertake any obligation to update anyforward-looking statements contained in this document as a result ofnew information, future events or otherwise.
No forward-looking statement can be guaranteed and actual resultsmay differ materially from those Amgen projects. Discovery oridentification of new product candidates or development of newindications for existing products cannot be guaranteed and movementfrom concept to product is uncertain; consequently, there can be noguarantee that any particular product candidate or development of anew indication for an existing product will be successful and become acommercial product. Further, preclinical results do not guarantee safeand 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 animalmodels. The length of time that it takes for Amgen to completeclinical trials and obtain regulatory approval for product marketinghas in the past varied and Amgen expects similar variability in thefuture. Amgen develops product candidates internally and throughlicensing collaborations, partnerships and joint ventures. Productcandidates that are derived from relationships may be subject todisputes between the parties or may prove to be not as effective or assafe as Amgen may have believed at the time of entering into suchrelationship. Also, Amgen or others could identify side effects ormanufacturing problems with Amgen's products after they are on themarket. In addition, sales of Amgen's products are affected by theavailability of reimbursement and the reimbursement policies imposedby third-party payors, including governments, private insurance plansand managed care providers, and may be affected by domestic andinternational trends toward managed care and healthcare costcontainment as well as possible U.S. legislation affectingpharmaceutical pricing and reimbursement. Government regulations andreimbursement policies may affect the development, usage and pricingof Amgen's products. In addition, Amgen competes with other companieswith respect to some of Amgen's marketed products as well as for thediscovery and development of new products. Amgen believes that some ofthe newer products, product candidates or new indications for existingproducts, may face competition when and as they are approved andmarketed. Amgen products may compete against products that have lowerprices, established reimbursement, superior performance, are easier toadminister, or that are otherwise competitive with our products. Inaddition, while Amgen routinely obtains patents for Amgen's productsand technology, the protection offered by Amgen's patents and patentapplications may be challenged, invalidated or circumvented by Amgen'scompetitors and there can be no guarantee of Amgen's ability to obtainor maintain patent protection for Amgen's products or productcandidates. Amgen cannot guarantee that it will be able to producecommercially successful products or maintain the commercial success ofAmgen's existing products. Amgen's stock price may be affected byactual or perceived market opportunity, competitive position, andsuccess or failure of Amgen's products or product candidates. Further,the discovery of significant problems with a product similar to one ofAmgen's products that implicate an entire class of products could havea 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 relatedto our product candidates is preliminary and investigative. Suchproduct candidates are not approved by the U.S. Food and DrugAdministration (FDA), and no conclusions can or should be drawnregarding the safety or effectiveness of the product candidates. Onlythe FDA can determine whether the product candidates are safe andeffective for the use(s) being investigated. Further, the scientificinformation discussed in this news release relating to new indicationsfor our products is preliminary and investigative and is not part ofthe labeling approved by the FDA for the products. The products arenot approved for the investigational use(s) discussed in this newsrelease, and no conclusions can or should be drawn regarding thesafety or effectiveness of the products for these uses. Only the FDAcan determine whether the products are safe and effective for theseuses. Healthcare professionals should refer to and rely upon theFDA-approved labeling for the products, and not the informationdiscussed in this news release.
Aranesp prescribing information can be accessed by calling800-772-6436 or by logging on to www.aranesp.com.
EDITOR'S NOTE: An electronic version of this news release may beaccessed via our Web site at www.amgen.com. Journalists and mediarepresentatives may sign up to receive all news releaseselectronically at time of announcement by filling out a short form inthe Media section of the Web site.
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