First Irreversible Proteasome Inhibitor for Relapsed Multiple Myeloma Approved in the European UnionApproval Based on Data From Pivotal Phase 3 ASPIRE Trial Which Demonstrated Patients Treated With Kyprolis in Combination Lived Nearly Nine Months Longer Without Disease Progression Compared to Common Treatment Course

{{image}}Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the European Com­mis­sion (EC) granted market­ing authori­za­tion for Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. Kyprolis is the first irreversible pro­te­a­some inhibitor approved in the European Union (EU) for use in com­bi­na­tion treat­ment of patients with re­lapsed multiple myeloma.¹

"The approval of Kyprolis in com­bi­na­tion provides physicians and patients across Europe with an im­por­tant new treat­ment option for re­lapsed multiple myeloma, helping to address a real unmet need for this rare blood cancer," said Sean E. Harper, M.D., exec­u­tive vice pres­i­dent of Research and Development at Amgen. "Multiple myeloma is a complex blood cancer that often becomes resistant to treat­ment, which is why there is a need for new thera­peutic options that provide deep and durable responses to extend the time patients live without their disease progressing."

Multiple myeloma is an incurable blood cancer, char­ac­ter­ized by a recurring pattern of remission and relapse.² It is a rare and very aggressive orphan disease that accounts for approx­i­mately one per­cent of all cancers.^3-5 In Europe, approx­i­mately 39,000 patients are diag­nosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.³

"In clin­i­cal studies, approx­i­mately one out of three patients achieved a com­plete response or better on the Kyprolis in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone arm, which is three times more frequent than in the lena­lido­mide and dex­a­meth­a­sone arm," said Prof. Meletios A. Dimopoulos, M.D., Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine. "In addi­tion, the regi­men provided patients with more than two years without disease pro­gres­sion. These results are sig­nif­i­cant for patients with re­lapsed multiple myeloma, who are faced with worse out­comes each time they ex­peri­ence a relapse."

The EC approved Kyprolis based on data from the pivotal Phase 3 ASPIRE (CArfilzomib, Lena­lido­mide, and DexamethSone versus Lena­lido­mide and Dexamethasone for the treat­ment of PatIents with Relapsed Multiple MyEloma) trial. The study showed that patients treated with Kyprolis in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone (regimen referred to as KRd) had in­­creased median time to progressive disease (PD) or death by 8.7 months compared to patients treated with lena­lido­mide and dex­a­meth­a­sone (regimen referred to as Rd). The median pro­gres­sion-free survival (PFS) was 26.3 months in the KRd arm compared to 17.6 months in the Rd arm (HR: 0.69;  95 per­cent CI: 0.57 to 0.83; p=0.0001). The most common adverse events (AEs) in the Kyprolis arm in­cluded pneu­monia (1 per­cent), myo­cardial infarction (0.8 per­cent) and upper res­pira­tory tract in­fec­tion (0.8 per­cent). Discontinuation of treat­ment due to AEs occurred in 15 per­cent of patients in the KRd arm versus 18 per­cent of patients in the Rd arm.

Kyprolis received an accelerated assess­ment from the European Medicines Agency (EMA), and  orphan drug desig­na­tion in 2008, given to medicines intended for the treat­ment, prevention or diag­nosis of a disease that is life threatening and has a prev­a­lence in the EU of no more than five in 10,000 people.

Approval from the EC grants a centralized market­ing authori­za­tion with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding de­ci­sions on the basis of the de­ci­sion of the EC.

Amgen plans to submit data from the Phase 3 ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial for poten­tial authori­za­tion of Kyprolis in com­bi­na­tion with dex­a­meth­a­sone in the EU. This data also serves as the basis of the supple­mental New Drug Application of Kyprolis in com­bi­na­tion with dex­a­meth­a­sone for patients with re­lapsed multiple myeloma, which has been accepted for priority review by the U.S. Food and Drug Admin­istra­tion (FDA).

About ASPIRE

The inter­na­tional, ran­dom­ized Phase 3 ASPIRE trial eval­u­ated Kyprolis in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone, versus lena­lido­mide and dex­a­meth­a­sone, in patients with re­lapsed multiple myeloma fol­low­ing treat­ment with one to three prior regi­mens. The pri­mary end­point of the trial was PFS, defined as the time from ran­domization to disease pro­gres­sion or death due to any cause, whichever is earlier. Secondary end­points in­cluded over­all survival (OS), over­all response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety. Patients were ran­dom­ized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle one, escalating, if tolerated, to 27 mg/m2 subsequently), in addi­tion to a standard dosing schedule of lena­lido­mide (25 mg per day for 21 days on, 7 days off) and dex­a­meth­a­sone (40 mg per week in 4 week cycles), versus lena­lido­mide and dex­a­meth­a­sone. In the Kyprolis arm, patients were given a 10 minute infusion on days 1, 2, 8, 9, 15 and 16. Kyprolis was omitted on days 8 and 9 during cycles 13-18 and not admin­istered beyond 18 cycles. The study ran­dom­ized 792 patients at sites in North America, Europe and Israel.

While the data for median OS were not yet mature at the time of pri­mary analysis, the analysis showed a trend in favor of KRd compared with Rd (HR=0.79; 95 per­cent CI: 0.63-0.99; p=0.02 [1-sided]). Patients con­tinue to be monitored for OS. The ORR was 87.1 per­cent with KRd and 66.7 per­cent with Rd. Median DOR was 28.6 months for patients receiving KRd (95 per­cent CI, 24.9 to 31.3 months) and 21.2 months for patients receiving Rd (95 per­cent CI, 16.7 to 25.8 months). In the KRd and Rd groups, 32 per­cent versus 9 per­cent of patients achieved a com­plete response or higher (stringent com­plete response [sCR] or com­plete response [CR]), a mea­sure­ment indicating depth of response.

The rate of death due to AEs within 30 days of the last dose was bal­anced be­tween the KRd arm and the Rd arm. The most common causes of death not due to PD occurring in patients in the KRd arm compared to the Rd arm in­cluded cardiac disorders (3 per­cent versus 2 per­cent), in­fec­tion (2 per­cent versus 3 per­cent), renal (0 per­cent versus less than 1 per­cent) and other AEs (2 per­cent versus 3 per­cent). Serious AEs (SAEs) were reported in 60 per­cent of the patients in the KRd arm and 54 per­cent of the patients in the Rd arm. The most common SAEs reported in the KRd arm compared to the Rd arm were pneu­monia (14 per­cent versus 11 per­cent), res­pira­tory tract in­fec­tion (4 per­cent versus 2 per­cent), pyrexia (4 per­cent versus 2 per­cent) and pul­mo­nary embolism (3 per­cent versus 2 per­cent). Discontinuation of treat­ment due to AEs occurred in 15 per­cent of patients in the KRd arm versus 18 per­cent of patients in the Rd arm. AEs leading to dis­con­tinu­a­tion of Kyprolis occurred in 12 per­cent of patients and the most common events in­cluded pneu­monia (1 per­cent), myo­cardial infarction (1 per­cent) and upper res­pira­tory tract in­fec­tion (1 per­cent).

The ASPIRE data were presented at the 56th Annual Meeting of the American Society of Hematology (ASH) and published in The New England Journal of Medicine in December 2014.¹

About Kyprolis^® (car­filz­o­mib)

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 and Colombia. 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.

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.

Important U.S. Product Safety Information

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pul­mo­nary edema, 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, 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, and 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 all grades 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 all grades  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 pre­scrib­ing in­­for­ma­tion for the U.S. is avail­able at www.kyprolis.com.

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, we 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 Amgen's business. Unless other­wise noted, Amgen is providing this in­­for­ma­tion as of Nov. 19, 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 we and our partners routinely obtain patents for our and 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 our ability to pay a dividend or repurchase common stock.

References:

1. Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib, Lena­lido­mide, and Dexamethasone for Relapsed Multiple Myeloma. N Engl J Med. 2015; 372:142-152.
2. Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives.Seminars in Hematology. 2012; 49(3)(1),S16-S32.
3. GLOBCAN 2012, Global Prevalence and Incidence, avail­able athttp://globocan.iarc.fr/old/summary_table_pop_prev.asp?selection=224900&title=World&sex=0&window=1&sort=0&submit=%C2%A0Execute%C2%A0 ^[1], accessed on March 9, 2015.
4. American Cancer Society. Multiple myeloma. http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf ^[2]. Accessed on: October 30, 2015.
5. Palumbo A and Anderson K, Multiple myeloma, N Engl J Med, 2011;364:1046–60
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.