• Kyprolis Plus Dexamethasone Doubled Progression-Free Survival to More Than 18 Months Versus Velcade Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
• First Head-to-Head Study Comparing two Proteasome Inhibitors

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that The Lancet Oncology published results from the pivotal Phase 3 head-to-head ENDEAVOR study com­par­ing Kyprolis^® (car­filz­o­mib) plus dex­a­meth­a­sone to Velcade^® (bor­tez­o­mib) plus dex­a­meth­a­sone in patients with re­lapsed multiple myeloma. The data showed that patients treated with Kyprolis plus dex­a­meth­a­sone achieved pro­gres­sion-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bor­tez­o­mib plus dex­a­meth­a­sone (HR=0.53; 95 per­cent CI: 0.44,0.65 p<0.0001), a current standard of care in re­lapsed multiple myeloma.

These findings dem­onstrate that patients with re­lapsed multiple myeloma treated with Kyprolis lived twice as long without disease worsening as those treated with bor­tez­o­mib. The most common adverse events (greater than 25 per­cent) in the Kyprolis arm were diarrhea, anemia, fatigue, dyspnea, pyrexia and insomnia. Treat­ment dis­con­tinu­a­tion due to adverse events and on-study deaths were com­parable be­tween the two arms.

“In this head-to-head comparison, car­filz­o­mib plus dex­a­meth­a­sone resulted in a twofold de­crease in the risk of pro­gres­sion or death, compared with bor­tez­o­mib plus dex­a­meth­a­sone, a result that was con­sis­tent re­gard­less of age or prior bor­tez­o­mib exposure,” said study co-author and investigator, Meletios A. Dimopoulos, M.D., pro­fessor of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine. “For patients with multiple myeloma, these results are clin­i­cally meaningful and translate to more than nine months without disease pro­gres­sion.”

“Coupled with results pre­vi­ously seen in the ASPIRE pivotal trial, data from the ENDEAVOR study sup­port the use of Kyprolis as a back­bone ther­apy for the man­agement of re­lapsed multiple myeloma, a dif­fi­cult-to-treat blood cancer,” said Sean E. Harper, M.D., exec­u­tive vice pres­i­dent of Research and Development at Amgen. “This is an im­por­tant publication because it provides clin­i­cal evi­dence of Kyprolis’ poten­tial to extend the time patients live without their disease progressing and im­prove the depth and duration of a response.”

Multiple myeloma is an incurable blood cancer, char­ac­ter­ized by a recurring pattern of remission and re­lapse, and while new ther­a­pies have become avail­able, a sig­nif­i­cant unmet need still remains for patients no longer responding to treat­ment.^1,2 Multiple myeloma is an orphan disease and accounts for approxi­mately one per­cent of all cancers.^3,4

Regulatory Status

Data from the ENDEAVOR study are the basis of the supple­mental New Drug Application (sNDA) of Kyprolis in com­bi­na­tion with dex­a­meth­a­sone for patients with re­lapsed multiple myeloma. The sNDA was accepted Sept.19, 2015, for priority review by the U.S. Food and Drug Admin­istra­tion (FDA) and the Prescription Drug User Fee Act (PDUFA) target action date is Jan. 22, 2016. Priority review is assigned to appli­ca­tions for drugs that treat serious con­di­tions and would, if approved, provide sig­nif­i­cant im­prove­ments in the safety or effectiveness of the treat­ment, diag­nosis or prevention of serious con­di­tions. Amgen also just announced sub­mission of the ENDEAVOR data to the European Com­mis­sion for poten­tial authori­za­tion of Kyprolis in com­bi­na­tion with dex­a­meth­a­sone in the European Union.

About ENDEAVOR

The ran­dom­ized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExa­methA­sone Vs Bortezomib Plus Dexa­metha­sOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients eval­u­ated Kyprolis in com­bi­na­tion with low-dose dex­a­meth­a­sone, versus bor­tez­o­mib with low-dose dex­a­meth­a­sone in patients whose multiple myeloma has re­lapsed after at least one, but not more than three prior thera­peutic regi­mens. The pri­mary end­point of the trial was PFS, defined as the time from treat­ment initiation to disease pro­gres­sion or death. In a clin­i­cal trial, measuring the PFS is one way to dem­onstrate how well a treat­ment works.5

The superiority of the Kyprolis com­bi­na­tion compared to the bor­tez­o­mib com­bi­na­tion with respect to PFS was seen across all pre-specified subgroups, in­­clud­ing Velcade-naïve patients, those with high- or standard-risk cyto­genetics and with or without prior trans­plan­ta­tion. The Kyprolis com­bi­na­tion also dem­onstrated supe­ri­or­ity over the bor­tez­o­mib com­bi­na­tion for sec­ond­ary end­points, achieving a higher over­all response rate (76.9 per­cent vs. 62.6 per­cent; p<0.0001) and lower rate of grade 2 or higher neu­rop­athy events (6 per­cent vs. 32 per­cent; p<0.0001). Treatment with the Kyprolis com­bi­na­tion resulted in a two-fold in­­crease in the median duration of response (21.3 months) compared to the bor­tez­o­mib com­bi­na­tion (10.4 months).

In the Kyprolis and bor­tez­o­mib groups, 54.3 per­cent and 28.6 per­cent of patients achieved a very good partial response or better (p<0.0001), and 12.5 per­cent and 6.2 per­cent of patients achieved a com­plete response or better (p<0.0001), re­spec­tive­ly. Overall survival data are not yet mature and con­tinue to be monitored.

Treatment dis­con­tinu­a­tion due to adverse events and on-study deaths were com­parable be­tween the two arms. A number of known adverse drug reac­tions were reported at a higher rate in the Kyprolis group com­pared with the bor­tez­o­mib group, in­­clud­ing any-grade dyspnea, hyper­tension, pyrexia, and cough (preferred terms) as were any-grade cardiac failure (grouped term; 8.2 per­cent vs. 2.9 per­cent) and acute renal failure (grouped term; 8.2 per­cent vs. 4.8 per­cent). However, the rates of cardiac and renal failure for Kyprolis were com­parable to those observed in the pre­vi­ous Phase 3 ASPIRE study.

Rates of grade 3 or higher adverse events were 73.2 per­cent in the Kyprolis group and 66.9 per­cent in the bor­tez­o­mib group. Grade 3 or higher adverse events of interest in the Kyprolis and bor­tez­o­mib groups in­cluded hyper­tension (preferred term; 8.9 per­cent vs. 2.6 per­cent), dyspnea (preferred term; 5.4 per­cent vs. 2.2 per­cent), cardiac failure (grouped term; 4.7 per­cent vs. 1.8 per­cent), acute renal failure (grouped term; 4.0 per­cent vs. 2.6 per­cent), ischemic heart disease (grouped term; 1.7 per­cent vs. 1.6 per­cent) and pul­mo­nary hyper­tension (grouped term; 0.6 per­cent vs. 0.2 per­cent).

Patients received treat­ment until pro­gres­sion with Kyprolis as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28 day treat­ment cycles, along with low-dose dex­a­meth­a­sone (20 mg). For Cycle 1 only, Kyprolis was admin­istered at 20 mg/m² on days 1 and 2, followed by escalation to 56 mg/m2 from day 8. Patients who tolerated 56 mg/m² in Cycle 1 were kept at this dose for sub­se­quent cycles. Patients who received bor­tez­o­mib (1.3 mg/m²) with low-dose dex­a­meth­a­sone (20 mg) were admin­istered bor­tez­o­mib sub­cu­taneously or intra­venously at the discretion of the investigator and in accordance with regu­la­tory approval of bor­tez­o­mib. More than 75 per­cent of the patients in the control arm received bor­tez­o­mib sub­cu­taneously. This study was conducted at 235 sites world­wide. For in­­for­ma­tion about this trial, please visit www.clinicaltrials.gov under trial identi­fi­ca­tion number NCT01568866.

Amgen Webcast Investor Meeting

Amgen will host a webcast in­­vestor meeting at the 57th Anuual American Society of Hematology (ASH) Meeting on Monday, Dec. 7, 2015, at 7 p.m. ET. Sean E. Harper, M.D., exec­u­tive vice pres­i­dent of Research and Development at Amgen, along with members of Amgen’s clin­i­cal devel­op­ment team and clin­i­cal in­vesti­gators will par­tic­i­pate to discuss data presented at ASH and Amgen’s broader on­col­ogy portfolio of prod­ucts.

Live audio of the conference call will be simultaneously broadcast over the Internet and will be avail­able to members of the news media, in­­vestors and the general public.

The webcast, as with other selected presentations re­gard­ing devel­op­ments in Amgen’s business given by man­agement at certain in­­vestor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information re­gard­ing presentation times, webcast avail­a­bil­ity and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and avail­able for replay for at least 90 days after the event.

About Kyprolis® (car­filz­o­mib) for Injection

Kyprolis is an irreversible pro­te­a­some inhibitor for use in the treat­ment of patients with re­lapsed multiple myeloma.² Proteasomes play an im­por­tant role in cell function and growth by breaking down proteins that are damaged or no longer needed.⁶ Kyprolis has been shown to block pro­te­a­somes, leading to an excessive build-up of proteins within cells.⁷ In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to con­tain a higher amount of ab­nor­mal proteins.⁷ The irreversibility of Kyprolis’ binding has also been shown to offer a more sustained inhibition of the targeted enzymes.⁸

Kyprolis is cur­rently approved in the U.S. in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of patients with multiple myeloma who have received one to three prior lines of ther­apy.

Kyprolis is also indicated under FDA accelerated approval as a single agent for the treat­ment of patients with multiple myeloma who have received at least two prior ther­a­pies in­­clud­ing bor­tez­o­mib and an immuno­modu­la­tory agent and have dem­onstrated disease pro­gres­sion on or within 60 days of completion of the last ther­apy. Approval is based on response rate. Clinical benefit, such as im­prove­ment in survival or symp­toms, has not been verified.

Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia and the European Union. Additional regu­la­tory appli­ca­tions for Kyprolis are underway and have been submitted to health author­i­ties world­wide.

Kyprolis is a prod­uct of Onyx Pharma­ceu­ticals, Inc. Onyx Pharma­ceu­ticals is a sub­sid­i­ary of Amgen and holds devel­op­ment and com­mer­cial­iza­tion rights to Kyprolis globally, excluding Japan.

For more in­­for­ma­tion about Kyprolis, visit www.kyprolis.com.

Important Safety Information Regarding Kyprolis (car­filz­o­mib) for Injection U.S. Indication

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pul­mo­nary edema, and de­creased ejection fraction), restrictive car­dio­my­op­athy, myo­cardial ischemia, and myo­cardial infarction in­clud­ing fatalities have occurred fol­low­ing admin­istra­tion of Kyprolis. Death due to cardiac arrest has occurred within a day of Kyprolis admin­istra­tion.

Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until re­cov­ery, and con­sider whether to restart Kyprolis based on a benefit / risk assess­ment.

Adequate hydration is required prior to each dose in Cycle 1. Monitor all patients for evi­dence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clin­i­cally appro­pri­ate in patients with base­line cardiac failure or who are at risk for cardiac failure. Patients ≥ 75 years, the risk of cardiac failure is in­­creased. Patients with New York Heart Association Class III and IV heart failure, recent myo­cardial infarction, and conduction ab­nor­mal­i­ties may be at greater risk for cardiac com­pli­ca­tions.

Acute Renal Failure

Cases of acute renal failure and renal insufficiency adverse events (renal im­pair­ment, acute renal failure, and renal failure) have occurred in patients receiving Kyprolis. Acute renal failure was reported more frequently in patients with ad­vanced re­lapsed and refractory multiple myeloma who received Kyprolis mono­therapy. This risk was greater in patients with a base­line reduced esti­mated creatinine clearance. Monitor renal function with regular mea­sure­ment of the serum creatinine and/or esti­mated creatinine clearance. Reduce or withhold dose as appro­pri­ate.

Tumor Lysis Syndrome

Cases of Tumor Lysis Syndrome (TLS), in­­clud­ing fatal out­comes, have occurred in patients receiving Kyprolis. Patients with multiple myeloma and a high tumor burden should be con­sidered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in sub­se­quent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evi­dence of TLS during treat­ment and man­age promptly. Withhold Kyprolis until TLS is resolved.

Pulmonary Toxicity

Acute Respiratory Distress Syndrome (ARDS), acute res­pira­tory failure, and acute diffuse in­fil­tra­tive pul­mo­nary disease such as pneu­mo­nitis and interstitial lung disease have occurred in patients receiving Kyprolis. Some events have been fatal. In the event of drug-induced pul­mo­nary toxicity, dis­con­tinue Kyprolis.

Pulmonary Hypertension

Pulmonary arterial hyper­tension (PAH) was reported in patients treated with Kyprolis. Evaluate with cardiac imaging and/or other tests as indicated. Withhold Kyprolis for PAH until resolved or returned to base­line and con­sider whether to restart Kyprolis based on a benefit / risk assess­ment.

Dyspnea

Dyspnea was reported in patients treated with Kyprolis. Evaluate dyspnea to exclude cardio­pulmonary con­di­tions in­­clud­ing cardiac failure and pul­monary syn­dromes. Stop Kyprolis for Grade 3 or 4 dyspnea until resolved or returned to base­line. Consider whether to restart Kyprolis based on a benefit / risk assess­ment.

Hypertension

Hypertension, in­­clud­ing hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal. Monitor blood pressure regularly in all patients. If hyper­tension cannot be adequately controlled, withhold Kyprolis and eval­u­ate. Consider whether to restart Kyprolis based on a benefit / risk assess­ment.

Venous Thrombosis

Venous thrombo­embolic events (including deep venous thrombosis and pul­mo­nary embolism) have been observed with Kyprolis. Thrombo­pro­phy­laxis is recommended and should be based on an assess­ment of the patient’s under­lying risks, treat­ment regi­men, and clin­i­cal status.

Infusion Reactions

Infusion reac­tions, in­­clud­ing life-threatening reac­tions, have occurred in patients receiving Kyprolis. Symp­toms in­clude fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypo­tension, syncope, chest tightness, or angina. These reac­tions can occur im­medi­ately fol­low­ing or up to 24 hours after admin­istra­tion of Kyprolis. Premedicate with dex­a­meth­a­sone to reduce the incidence and severity of infusion reac­tions. Inform patients of the risk and of symp­toms of an infusion reac­tion and to con­tact a physician im­medi­ately if they occur.

Thrombocytopenia

Kyprolis causes thrombo­cytopenia with re­cov­ery to base­line platelet count usually by the start of the next cycle. Thrombo­cyto­penia was reported in patients receiving Kyprolis. Monitor platelet counts frequently during treat­ment with Kyprolis. Reduce or withhold dose as appro­pri­ate.

Hepatic Toxicity and Hepatic Failure

Cases of hepatic failure, in­­clud­ing fatal cases, have been reported during treat­ment with Kyprolis. Kyprolis can cause in­­creased serum transaminases. Monitor liver enzymes regularly. Reduce or withhold dose as appro­pri­ate.

Thrombotic Thrombocytopenic Purpura /Hemolytic Uremic Syndrome (TTP/HUS)

Cases of TTP/HUS in­­clud­ing fatal out­come have occurred in patients receiving Kyprolis. Monitor for signs and symp­toms of TTP/HUS. Discontinue Kyprolis if diag­nosis is sus­pected. If the diag­nosis of TTP/HUS is excluded, Kyprolis may be restarted. The safety of reinitiating Kyprolis ther­apy in patients pre­vi­ously experiencing TTP/HUS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)

Cases of PRES have occurred in patients receiving Kyprolis. PRES was formerly known as Reversible Posterior Leuko­en­ceph­alopathy Syndrome. Consider a neuro-radiological imaging (MRI) for onset of visual or neurological symp­toms, such as seizure, headache, lethargy, confusion, blindness, altered conscious­ness, along with hyper­tension. Dis­continue Kyprolis if PRES is sus­pected and eval­u­ate. The safety of re­initiating Kyprolis ther­apy in patients pre­vi­ously experiencing PRES is not known.

Embryo-fetal Toxicity

Kyprolis can cause fetal harm when admin­istered to a pregnant woman based on its mech­a­nism of action and findings in animals.

Females of reproductive poten­tial should be advised to avoid becoming pregnant while being treated with Kyprolis and the poten­tial hazard to the fetus if Kyprolis is used during pregnancy.

ADVERSE REACTIONS

The most common adverse events of any grade occurring in at least 20 per­cent of patients treated with Kyprolis in mono­therapy trials: anemia, fatigue, thrombo­cyto­penia, nausea, pyrexia, de­creased platelets, dyspnea, diarrhea, de­creased lym­pho­cyte, headache, de­creased hemoglobin, cough, edema periph­eral.

The most common adverse events of any grade occurring in at least 20 per­cent of patients treated with Kyprolis in the com­bi­na­tion ther­apy trial: de­creased lym­pho­cytes, de­creased absolute neu­tro­phil count, de­creased phosphorus, anemia, neutro­penia, de­creased total white blood cell count, de­creased platelets, diarrhea, fatigue, thrombo­cyto­penia, pyrexia, muscle spasm, cough, upper res­pira­tory tract in­fec­tion, de­creased hemoglobin, hypo­kalemia.

Full U.S. pre­scrib­ing in­­for­ma­tion is avail­able at www.kyprolis.com.

Important EU Product Safety Information

This medicinal prod­uct is subject to addi­tional monitoring. This will allow quick identi­fi­ca­tion of new safety in­­for­ma­tion. Healthcare professionals are asked to report any sus­pected adverse reac­tions.

Kyprolis treat­ment should be supervised by a physician ex­peri­enced in the use of anti-cancer ther­apy. The most serious side effects that may occur during Kyprolis treat­ment in­clude: cardiac toxicity, pul­mo­nary toxicities, pul­mo­nary hyper­tension, dyspnoea, hyper­tension in­­clud­ing hypertensive crises, acute renal failure, tumour lysis syn­drome, infusion reac­tions, thrombo­cyto­penia, hepatic toxicity, posterior reversible en­ceph­alopathy syn­drome (PRES) and thrombotic thrombo­cyto­penic purpura/haemolytic uremic syn­drome (TTP/HUS). The most common side effects are anaemia, fatigue, diarrhoea, thrombo­cyto­penia, nausea, pyrexia, dyspnoea, res­pira­tory tract in­fec­tion, cough and periph­eral oedema.

Please refer to the Summary of Product Characteristics for full European pre­scrib­ing in­­for­ma­tion.

About Amgen’s Commitment to Oncology

Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treat­ment options exist. Amgen’s sup­port­ive care treat­ments help patients combat certain side effects of strong chemo­therapy, and our targeted medicines and immuno­therapies focus on more than a dozen dif­fer­en­t malig­nan­cies, ranging from blood cancers to solid tumors. With decades of ex­peri­ence providing ther­a­pies for cancer patients, Amgen con­tinues to grow its portfolio of inno­va­tive and bio­sim­i­lar on­col­ogy medicines.

About Amgen

Amgen is committed to unlocking the poten­tial of biology for patients suffering from serious illnesses by discovering, devel­op­ing, manu­fac­tur­ing and delivering inno­va­tive human thera­peutics. This ap­proach begins by using tools like ad­vanced human genetics to unravel the complexities of disease and under­stand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manu­fac­tur­ing expertise to strive for solu­tions that im­prove health out­comes and dramatically im­prove people’s lives. A bio­technology pioneer since 1980, Amgen has grown to be one of the world’s leading independent bio­technology com­panies, has reached millions of patients around the world and is devel­op­ing a pipe­line of medicines with break­away poten­tial.

For more in­­for­ma­tion, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release con­tains forward-looking state­ments that are based on the current ex­pec­ta­tions and beliefs of Amgen Inc. and its sub­sid­i­aries (Amgen or us) 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 Inc., in­­clud­ing Amgen Inc.’s most recent annual report on Form 10-K and any sub­se­quent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’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 Dec. 5, 2015, 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 we project. 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 us and our partners to com­plete clin­i­cal trials and obtain regu­la­tory approval for prod­uct market­ing has in the past varied and we ex­pec­t similar variability in the future. We develop 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 we may have believed at the time of entering into such rela­tion­ship. Also, we or others could identify safety, side effects or manu­fac­tur­ing problems with our prod­ucts after they are on the market. Our business may be impacted by gov­ern­ment in­ves­ti­ga­tions, litigation and prod­uct liability claims. If we fail to meet the compliance obli­ga­tions in the corporate integrity agree­ment be­tween us and the U.S. gov­ern­ment, we could become subject to sig­nif­i­cant sanctions. We depend on third parties for a sig­nif­i­cant portion of our manu­fac­tur­ing capacity for the supply of certain of our current and future prod­ucts and limits on supply may constrain sales of certain of our current prod­ucts and prod­uct can­di­date devel­op­ment.

In addi­tion, sales of our prod­ucts (including prod­ucts of our wholly-owned sub­sid­i­aries) are affected by the reim­burse­ment policies imposed by third-party payers, 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 our prod­ucts. In addi­tion, we compete with other com­pa­nies with respect to some of our marketed prod­ucts as well as for the discovery and devel­op­ment of new prod­ucts. We believe that some of our newer prod­ucts, prod­uct can­di­dates or new indi­ca­tions for existing prod­ucts, may face com­pe­ti­tion when and as they are approved and marketed. Our prod­ucts may compete against prod­ucts that have lower prices, estab­lish­ed reim­burse­ment, superior per­for­mance, are easier to admin­ister, or that are other­wise competitive with our prod­ucts. In addi­tion, while Amgen and its partners routinely obtain patents for their prod­ucts and tech­nology, the protection of our prod­ucts offered by patents and patent appli­ca­tions may be chal­lenged, invalidated or circumvented by our or our partners’ com­pet­i­tors and there can be no guar­an­tee of our or our partners’ ability to obtain or main­tain patent protection for our prod­ucts or prod­uct can­di­dates. We cannot guar­an­tee that we will be able to produce commercially suc­cess­ful prod­ucts or main­tain the commercial success of our existing prod­ucts. Our stock price may be affected by actual or perceived market oppor­tu­ni­ty, competitive position, and success or failure of our prod­ucts or prod­uct can­di­dates. Further, the discovery of sig­nif­i­cant problems with a prod­uct similar to one of our prod­ucts that implicate an entire class of prod­ucts could have a ma­teri­al adverse effect on sales of the affected prod­ucts and on our business and results of operations. Our efforts to integrate the operations of com­pa­nies we have acquired may not be suc­cess­ful. We may ex­peri­ence dif­fi­culties, delays or unexpected costs and not achieve antic­i­pated benefits and savings from our ongoing restructuring plan. Our business per­for­mance could affect or limit the ability of our Board of Directors to declare a dividend or their ability to pay a dividend or repurchase our common stock.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 or the European Medicines Agency for the prod­ucts. The prod­ucts are not approved for the inves­ti­ga­tional use(s) discussed in this news release and no conclusions can or should be drawn re­gard­ing the safety or effectiveness of the prod­ucts for these uses.

References:

1. Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives. Seminars in Hematology. 2012; 49(3)(1),S16-S32.
2. Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma. N Engl J Med. 2015; 372:142-152.
3. GLOBCAN 2012, Global Prevalence and Incidence, available at http://globocan.iarc.fr/old/summary_table_pop_prev.asp?selection=224900&title=World&sex=0&window=1&sort=0&submit=%C2%A0Execute%C2%A0. Accessed on October 22, 2015.
4. Palumbo A and Anderson K, Multiple myeloma, N Engl J Med, 2011;364:1046–60.
5. FDA.gov. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. http://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf. Accessed on November 20, 2015.
6. Moreau P, Richardson PG, Cavo M, et al. Proteasome Inhibitors in Multiple Myeloma: 10 Years Later. Blood. 2012; 120(5):947-959.
7. Kyprolis® [package insert]. Thousand Oaks, CA: Amgen; 2015.
8. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012; 121(6):893-897.

Source: Amgen.