Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) to­day an­nounced that the U.S. District Court in Delaware issued a de­ci­sion upholding the validity of pat­ent claims from three pat­ents that pro­tect Amgen's multiple myeloma ther­apy KYPROLIS® (car­filz­o­mib). Today's de­ci­sion will prevent Cipla Limited, and Cipla USA, Inc. (collectively "Cipla") from making, using, selling, offering to sell, or importing its generic version of KYPROLIS until expiration of these three U.S. pat­ents. The latest pat­ent expiry is in De­cem­ber 2027.

Onyx Thera­peutics, Inc., an indirect, wholly-owned sub­sid­i­ary of Amgen Inc., brought a pat­ent in­fringe­ment suit against Cipla in 2016. The de­ci­sion comes after the Delaware court held a bench trial in May 2019. Prior to trial, Cipla acknowledged that its generic prod­uct would in­fringe all of the as­serted claims, leaving only the issue of validity of the as­serted pat­ents to be addressed by the court.

KYPROLIS is approved for the treat­ment of patients with re­lapsed or re­frac­tory multiple myeloma who pre­vi­ously re­ceived one to three lines of other ther­apy. KYPROLIS is also in­di­cated in com­bi­na­tion with dexa­meth­a­sone or with lena­lido­mide plus dexa­meth­a­sone. Three pat­ents that are the subject of the de­ci­sion are: U.S. Patent No. 7,417,042, U.S. Patent No. 7,737,112 and U.S. Patent No. 8,207,125.

About KYPROLIS

INDICATIONS

KYPROLIS® (car­filz­o­mib) is in­di­cated in com­bi­na­tion with dexa­meth­a­sone or with lena­lido­mide plus dexa­meth­a­sone for the treat­ment of patients with re­lapsed or re­frac­tory multiple myeloma who have re­ceived one to three lines of ther­apy.

KYPROLIS® is in­di­cated as a single agent for the treat­ment of patients with re­lapsed or re­frac­tory multiple myeloma who have re­ceived one or more lines of ther­apy.

IMPORTANT SAFETY INFORMATION FOR KYPROLIS

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. Some events oc­curred in patients with nor­mal base­line ventricular function. Death due to cardiac arrest has oc­curred within one day of admin­istra­tion.

Monitor patients for signs or symp­toms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is sus­pected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until re­cov­ery, and con­sider whether to restart at 1 dose level re­duc­tion based on a benefit / risk assess­ment.

While 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.

For 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, conduction ab­nor­mal­i­ties, angina, or arrhythmias may be at greater risk for cardiac com­pli­ca­tions and should have a com­pre­hen­sive med­i­cal assess­ment prior to starting treat­ment with KYPROLIS and remain under close follow-up with fluid man­agement.

Acute Renal Failure

Cases of acute renal failure, in­clud­ing some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have oc­curred. Acute renal failure was reported more fre­quently in patients with ad­vanced re­lapsed and re­frac­tory multiple myeloma who re­ceived KYPROLIS mono­therapy. 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. Patients with 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, and withhold until 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. Some events have been fatal. In the event of drug-induced pul­mo­nary toxicity, dis­con­tinue KYPROLIS.

Pulmonary Hypertension

Pulmonary arterial hyper­tension (PAH) was reported. 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 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 based on a benefit / risk assess­ment.

Hypertension

Hypertension, in­clud­ing hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hyper­tension prior to starting KYPROLIS. Monitor blood pres­sure reg­u­larly in all patients. If hyper­tension cannot be adequately con­trolled, withhold KYPROLIS and eval­u­ate. Consider whether to restart based on a benefit / risk assess­ment.

Venous Thrombosis

Venous thrombo­embolic events (including deep venous thrombosis and pul­mo­nary embolism) have been observed. Thrombo­pro­phy­laxis is rec­om­mended for patients being treated with the com­bi­na­tion of KYPROLIS with dexa­meth­a­sone or with lena­lido­mide plus dexa­meth­a­sone. The thrombo­pro­phy­laxis regi­men should be based on an assess­ment of the patient's under­lying risks.

Patients using hormonal con­tra­cep­tion asso­ci­ated with a risk of thrombosis should con­sider an alter­na­tive method of effective con­tra­cep­tion during treat­ment.

Infusion Reactions

Infusion reac­tions, in­clud­ing life-threatening reac­tions, have oc­curred. Signs and symp­toms in­clude fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal 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. Premedicate with dexa­meth­a­sone to reduce the in­ci­dence and severity of in­fusion reac­tions. Inform patients of the risk and of symp­toms and seek im­medi­ate med­i­cal attention if they oc­cur.

Hemorrhage

Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have in­cluded gastro­in­tes­ti­nal, pul­mo­nary, and intracranial hemorrhage and epistaxis. Promptly eval­u­ate signs and symp­toms of blood loss. Reduce or withhold dose as appro­pri­ate.

Thrombocytopenia

KYPROLIS causes thrombo­cyto­penia with re­cov­ery to base­line platelet count usually by the start of the next cycle. Monitor platelet counts fre­quently during treat­ment. Reduce or withhold dose as appro­pri­ate.

Hepatic Toxicity and Hepatic Failure

Cases of hepatic failure, in­clud­ing fatal cases, have oc­curred. KYPROLIS can cause in­creased serum transaminases. Monitor liver enzymes reg­u­larly re­gard­less of base­line values. Reduce or withhold dose as appro­pri­ate.

Thrombotic Microangiopathy

Cases of thrombotic microangiopathy, in­clud­ing thrombotic thrombocytopenic purpura / hemolytic uremic syn­drome (TTP/HUS), in­clud­ing fatal out­come, have oc­curred. Monitor for signs and symp­toms of TTP/HUS. Discontinue if diag­nosis is sus­pected. If the diag­nosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)

Cases of PRES have oc­curred in patients re­ceiv­ing KYPROLIS. If PRES is sus­pected, dis­con­tinue and eval­u­ate with appro­pri­ate imaging. The safety of reinitiating KYPROLIS is not known.

Increased Fatal and Serious Toxicities in Com­bi­na­tion with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

In a clin­i­cal trial of trans­plant-ineligible patients with newly diag­nosed multiple myeloma com­par­ing KYPROLIS, mel­phalan, and pred­ni­sone (KMP) vs bor­tez­o­mib, mel­phalan, and pred­ni­sone (VMP), a higher in­ci­dence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not in­di­cated for trans­plant-ineligible patients with newly diag­nosed multiple myeloma.

Embryo-fetal Toxicity

KYPROLIS can cause fetal harm when admin­istered to a pregnant woman.

Females of reproductive poten­tial should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months fol­low­ing the final dose. Males of reproductive poten­tial should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months fol­low­ing the final dose. If this drug is used during pregnancy, or if pregnancy oc­curs while taking this drug, the patient should be apprised of the poten­tial hazard to the fetus.

Adverse Reactions

The most common adverse reac­tions in the com­bi­na­tion ther­apy trials: anemia, neu­tro­penia, diarrhea, dyspnea, fatigue, thrombo­cyto­penia, pyrexia, insomnia, muscle spasm, cough, upper res­pira­tory tract in­fec­tion, hypokalemia.

The most common adverse reac­tions in mono­therapy trials: anemia, fatigue, thrombo­cyto­penia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema periph­eral.

Please see full Prescribing Information 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 the world's largest independent bio­tech­nology com­pany, 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. All state­ments, other than state­ments of historical fact, are state­ments that could be deemed for­ward-looking state­ments, in­clud­ing any state­ments on the out­come, benefits and synergies of col­lab­o­rations, or poten­tial col­lab­o­rations, with any other com­pany, in­clud­ing Adaptive Bio­tech­nologies (including state­ments re­gard­ing such col­lab­o­ration's ability to discover and de­vel­op fully-human neutralizing anti­bodies targeting SARS-CoV-2 to poten­tially prevent or treat COVID-19), BeiGene, Ltd., or the Otezla acquisition, in­clud­ing antic­i­pated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as 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, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, out­comes, progress, or effects relating to studies of Otezla as a poten­tial treat­ment for COVID-19, 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 reports filed by Amgen, in­clud­ing our most recent annual report on Form 10-K and any sub­se­quent periodic reports on Form 10-Q and current reports on Form 8-K. Unless other­wise noted, Amgen is providing this in­for­ma­tion as of the date of this news release and does not under­take any obli­ga­tion to update any for­ward-looking state­ments con­tained in this document as a result of new in­for­ma­tion, future events or other­wise.

No for­ward-looking state­ment can be guar­an­teed and actual results may differ ma­teri­ally from those we project. Our results may be affected by our ability to suc­cess­fully mar­ket both new and existing prod­ucts domestically and inter­na­tionally, clin­i­cal and regu­la­tory de­vel­op­ments involving current and future prod­ucts, sales growth of recently launched prod­ucts, com­pe­ti­tion from other prod­ucts in­clud­ing bio­sim­i­lars, dif­fi­culties or delays in manu­fac­tur­ing our prod­ucts and global economic con­di­tions. In addi­tion, sales of our prod­ucts are affected by pricing pres­sure, political and pub­lic scrutiny and 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. Further­more, our re­search, testing, pricing, mar­ket­ing and other op­er­a­tions are subject to extensive reg­u­la­tion by domestic and foreign gov­ern­ment regu­la­tory author­i­ties. We or others could identify safety, side effects or manu­fac­tur­ing problems with our prod­ucts, in­clud­ing our devices, after they are on the mar­ket. Our business may be impacted by gov­ern­ment in­ves­ti­ga­tions, lit­i­ga­tion and prod­uct liability claims. In addi­tion, our business may be impacted by the adoption of new tax legislation or exposure to addi­tional tax liabilities. 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. Further, while we routinely obtain pat­ents for our prod­ucts and tech­nology, the pro­tec­tion offered by our pat­ents and pat­ent appli­ca­tions may be chal­lenged, invalidated or circumvented by our com­pet­i­tors, or we may fail to prevail in present and future in­tel­lec­tual property lit­i­ga­tion. We per­form a sub­stan­tial amount of our commercial manu­fac­tur­ing ac­­tiv­i­ties at a few key facilities, in­clud­ing in Puerto Rico, and also depend on third parties for a portion of our manu­fac­tur­ing ac­­tiv­i­ties, and limits on supply may constrain sales of cer­tain of our current prod­ucts and prod­uct can­di­date de­vel­op­ment. An outbreak of dis­ease or similar pub­lic health threat, such as COVID-19, and the pub­lic and gov­ern­mental effort to mitigate against the spread of such dis­ease, could have a sig­nif­i­cant adverse effect on the supply of ma­teri­als for our manu­fac­tur­ing ac­­tiv­i­ties, the distribution of our prod­ucts, the com­mer­cial­iza­tion of our prod­uct can­di­dates, and our clin­i­cal trial op­er­a­tions, and any such events may have a ma­teri­al adverse effect on our prod­uct de­vel­op­ment, prod­uct sales, business and results of op­er­a­tions. We rely on col­lab­o­rations with third parties for the de­vel­op­ment of some of our prod­uct can­di­dates and for the com­mer­cial­iza­tion and sales of some of our commercial prod­ucts. In addi­tion, we compete with other com­pa­nies with respect to many of our mar­keted prod­ucts as well as for the discovery and de­vel­op­ment of new prod­ucts. 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, some raw ma­teri­als, med­i­cal devices and component parts for our prod­ucts are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have sub­stan­tial pur­chas­ing leverage in their dealings with us. 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 col­lab­o­rate with or acquire other com­pa­nies, prod­ucts or tech­nology, and to integrate the op­er­a­tions of com­pa­nies or to sup­port the prod­ucts or tech­nology we have acquired, may not be suc­cess­ful. A breakdown, cyberattack or in­for­ma­tion se­cu­ri­ty breach could compromise the con­fi­den­tiality, integrity and avail­a­bil­ity of our sys­tems and our data. Our stock price is volatile and may be affected by a number of events. 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 our common stock. We may not be able to access the capital and credit mar­kets on terms that are fa­vor­able to us, or at all.

Source: Amgen.