Data Confirm Efficacy and Safety of Kyprolis Combination Across Range of Patient Populations

Thousand Oaks, CA (Press Release) - Amgen (NASDAQ: AMGN) today announced the presentation of new key data eval­u­ating Kyprolis^® (car­filz­o­mib) -based regi­mens in patients with re­lapsed multiple myeloma. The data showed Kyprolis in com­bi­na­tion with dex­a­meth­a­sone sig­nif­i­cantly extended disease pro­gres­sion com­pared to bor­tez­o­mib plus dex­a­meth­a­sone across a range of dif­fi­cult-to-treat pop­u­la­tions, specifically those with high risk and pre­vi­ously treated disease. The analyses were presented during the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Fla.

Data analyzed in three presentations across patient subgroups from the Phase 3 ENDEAVOR trial showed that patients with re­lapsed or refractory multiple myeloma, who were treated with Kyprolis plus dex­a­meth­a­sone, achieved superior pro­gres­sion-free survival (PFS) compared to those receiving bor­tez­o­mib plus dex­a­meth­a­sone. The subgroup analyses eval­u­ated the Kyprolis com­bi­na­tion based on prior treat­ment, cyto­ge­netic risk status and age, re­spec­tive­ly (ASH abstracts #729, #30 and #1844). Pivotal data from the Phase 3 ENDEAVOR trial were pre­vi­ously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) and published online in The Lancet Oncology today.

A separate presentation analyzed the efficacy and safety of Kyprolis according to base­line cytogenetic risk status, based on data from the Phase 3 ASPIRE trial in which Kyprolis in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone dem­onstrated a sig­nif­i­cant im­prove­ment in PFS compared to lena­lido­mide and dex­a­meth­a­sone (ASH abstract #731).

"Our clin­i­cal research with Kyprolis aims to im­prove out­comes for patients in the re­lapsed setting, which are cur­rently poor due to more aggressive disease biology as multiple myeloma progresses," said Sean E. Harper, M.D., exec­u­tive vice pres­i­dent of Research and Development at Amgen. "This week's presentations show that even in dif­fi­cult-to-treat pop­u­la­tions, Kyprolis sig­nif­i­cantly extends the time patients can live without their disease progressing and im­proves the depth and duration of a response, compared to current standard of care ther­a­pies."

Multiple myeloma is char­ac­ter­ized by very complex cytogenetic and molecular genetic aberrations.¹ Cyto­genetic analysis may provide more in­­for­ma­tion about myeloma prognosis and help physicians with treat­ment plans.2 Myeloma cytogenetic analysis is an examination of the bone marrow cells to look for chro­mo­some ab­nor­malities.²

Abstracts are cur­rently avail­able on the ASH website.

ASH Abstract #729: Impact of Prior Treatment on Patients with Relapsed Multiple Myeloma Treated with Carfilzomib and Dex­a­meth­a­sone Versus Bortezomib and Dex­a­meth­a­sone in a Subgroup Analysis of the Phase 3 ENDEAVOR Study (NCT01568866)

This preplanned, exploratory sub-analysis assessed treat­ment with Kyprolis and dex­a­meth­a­sone or bor­tezo­mib and dex­a­meth­a­sone in 929 total patients. The proportion of patients with one prior ther­apy compared to those with two or more prior lines of ther­apy was bal­anced be­tween the treat­ment arms. The proportion of patients with prior bor­tez­o­mib or lena­lido­mide exposure was also bal­anced across treat­ment arms within the subgroups of patients with one or two or more prior lines of ther­apy. The analysis dem­onstrated a favorable benefit-risk profile of Kyprolis re­gard­less of prior treat­ment, in­­clud­ing number and types of prior ther­apy.

• Median PFS for patients after one prior line of therapy was 22.2 months (95 percent CI, 17.7–not estimable [NE]) for the Kyprolis-containing regimen versus 10.1 months (95 percent CI, 8.8–12.7) for the bortezomib-containing regimen (HR: 0.45). Median PFS for patients who had two or more previous lines of therapy was 14.9 months (10.2–NE) for Kyprolis patients compared with 8.4 months (6.5–10.2) for bortezomib patients (HR: 0.60).
• Grade 3 or higher adverse events were reported in 69.8 percent of Kyprolis patients and 63.9 percent of bortezomib patients previously treated with one prior line, and 76.6 percent of Kyprolis patients and 69.9 percent of bortezomib patients with two or more prior lines.

ASH Abstract #30: Efficacy and Safety of Carfilzomib and Dex­a­meth­a­sone Versus Bortezomib and Dex­a­meth­a­sone in Patients with Relapsed Multiple Myeloma Based on Cytogenetic Risk Status: Subgroup Analysis from the Phase 3 Study ENDEAVOR (NCT01568866)

In this preplanned, exploratory sub-analysis of the efficacy and safety of Kyprolis and dex­a­meth­a­sone versus bor­tez­o­mib and dex­a­meth­a­sone based on base­line cytogenetic risk status, Kyprolis dem­onstrated superiority to bor­tez­o­mib and a favorable benefit–risk profile, re­gard­less of base­line cytogenetic risk status, in patients with high-risk re­lapsed multiple myeloma.

• Median PFS in the high-risk group (n=210) was 8.8 months (95 percent CI, 6.9–11.3) for Kyprolis patients versus 6.0 months (4.9–8.1) for bortezomib patients (HR: 0.646). Median PFS in the standard-risk group (n=575) was not estimable for Kyprolis (18.7–NE) versus 10.2 months (9.3–12.2) for bor­tez­o­mib (HR: 0.439).
• Grade 3 or higher adverse events for Kyprolis compared with bortezomib, in the high- and standard-risk groups, were 70.1 percent versus 63.1 percent, and 73.9 percent versus 68.3 percent, respectively.

ASH Abstract #1844: Carfilzomib and Dex­a­meth­a­sone versus Bortezomib and Dex­a­meth­a­sone in Patients With Relapsed Multiple Myeloma: Results of the Phase 3 Study ENDEAVOR (NCT01568866) According to Age Subgroup

In this exploratory subgroup analysis from the ENDEAVOR study according to age, treat­ment with Kyprolis and dex­a­meth­a­sone dem­onstrated clin­i­cally meaningful im­prove­ment in PFS compared with bor­tez­o­mib and dex­a­meth­a­sone in all age subgroups examined, with a trend to­ward a greater im­prove­ment in the eldest-age subgroup (75 or older) than in the two younger-age subgroups (under 65 and 65–74 years).

• Median PFS was improved with the Kyprolis regimen compared with the bortezomib regimen, within each age subgroup (under 65: NE versus 9.5 months [HR: 0.58]; 65–74 years: 15.6 months versus 9.5 months [HR: 0.53]; 75 and older: 18.7 months versus 8.9 months [HR: 0.38]).
• Selected grade 3 or higher adverse events of interest that were higher in the Kyprolis arm within each age subgroup, compared with the bortezomib arm, were hypertension, dyspnea, cardiac failure and renal failure.

ASH Abstract #731: Efficacy and Safety of Carfilzomib, Lena­lido­mide, and Dex­a­meth­a­sone Versus Lena­lido­mide and Dex­a­meth­a­sone in Patients With Relapsed Multiple Myeloma Based on Cyto­genetic Risk Status: Subgroup Analysis From the Phase 3 Study ASPIRE (NCT01080391)

This preplanned, exploratory sub-analysis assessed the efficacy and safety of Kyprolis, lena­lido­mide and dex­a­meth­a­sone (KRd) compared with lena­lido­mide and dex­a­meth­a­sone (Rd) alone, in 417 patients with re­lapsed multiple myeloma with high- and standard-risk cytogenetic status, and found Kyprolis had a favorable benefit–risk profile, re­gard­less of base­line cytogenetic risk status, and im­proved out­comes in patients with high-risk disease.

• Median PFS in the high-risk group (n=100) was 23.1 months (95 percent CI, 12.5–24.2) for the Kyprolis-containing regimen versus 13.9 months (9.5–16.7) for lenalidomide and dex­a­meth­a­sone alone (HR: 0.639). Median PFS in the standard-risk group (n=317) was 29.6 months (24.1–NE) for the Kyprolis-containing regimen versus 19.5 months (14.8–26.0) for the Rd regimen (HR: 0.657).
• Selected grade 3 or higher adverse events in patients treated with Kyprolis, in both cytogenetic risk groups, included dyspnea, hypertension, acute renal failure, cardiac failure, ischemic heart disease and peripheral neuropathy.

Amgen Webcast Investor Meeting

Amgen will host a webcast in­­vestor meeting at ASH 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 Multiple Myeloma

Multiple myeloma is an incurable blood cancer, char­ac­ter­ized by a recurring pattern of remission and relapse.³ It is a rare and very aggressive orphan disease that accounts for approx­i­mately one per­cent of all cancers.^4-6 Worldwide, approx­i­mately 114,000 people are diag­nosed with multiple myeloma each year and 80,000 patient deaths are reported on an annual basis.⁴

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 Kyprolis^® (car­filz­o­mib) for Injection

Kyprolis^® (car­filz­o­mib) for Injection received approval from the U.S. Food and Drug Admin­istra­tion (FDA) in July 2015 for 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 in July 2012 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.

In Nov. 2015, the European Com­mis­sion granted market­ing authori­za­tion for Kyprolis 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 a prod­uct of Onyx Pharma­ceu­ticals, Inc. Onyx Pharma­ceu­ticals is a sub­sid­i­ary of Amgen and holds devel­op­ment and com­mer­cial­iza­tion rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel, Kuwait, Mexico, Thailand and Colombia. Additional regu­la­tory appli­ca­tions for Kyprolis are underway and have been submitted to health author­i­ties world­wide.

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

Important Safety Information Regarding Kyprolis® (car­filz­o­mib) for Injection

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. 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 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 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 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 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 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 plans. 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.

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 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. Sawyer JR. The prognostic significance of cytogenetics and molecular profiling in multiple myeloma. Cancer Genetics. 2011; 204(1):3-12.
2. The MMRF. Cytogenetic analysis & fluorescence in situ hybridization. Available at: http://www.themmrf.org/multiple-myeloma-knowledge-center/multiple-myeloma-tests/bone-marrow-tests/cytogenetic-analysis-fish/. Accessed on: November 11, 2015.
3. Jakubowiak A. Management Strategies for Relapsed/Refractory Multiple Myeloma: Current Clinical Perspectives. Seminars in Hematology. 2012; 49(3)(1),S16-S32.
4. 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 November 10, 2015.
5. American Cancer Society. Multiple myeloma. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf. Accessed on: November 10, 2015.
6. Palumbo A and Anderson K, Multiple myeloma, N Engl J Med, 2011;364:1046-60.

Source: Amgen.