Förlängd progressionsfri överlevnad i myelom med Kyprolis en gång i veckan

Pressmeddelanden   •   Jun 15, 2018 08:37 CEST

På EHA presenteras nya data från fas III-studien ARROW som visar att Kyprolis administrerat en gång i veckan, hälften så ofta jämfört med dagens rekommendation, ger statistiskt signifikant förlängd progressionsfri överlevnad vid recidiverande och refraktär myelomsjukdom. Säkerhetsprofilen är jämförbar med den för nuvarande rekommenderade behandling, två gånger i veckan.

​Cancerkommissionen presenterar sin slutrapport

Pressmeddelanden   •   Jun 13, 2018 08:30 CEST

Idag presenterar Cancerkommissionen sin slutrapport Nationell Cancerplan 2020. Bättre tillgänglighet och lägre dödlighet – dags att trappa upp kampen mot cancer! I rapporten presenteras 18 förslag på hur den svenska cancervården kan förbättras.

Cancer är en global folksjukdom som fortsätter att öka. Det finns därmed ett stort behov av bättre behandlingar och effektivare vård inom den framtida cancervården. Därför tog Bristol-Myers Squibb (BMS), Amgen och Microsoft initiativ till ett projekt vid namn Cancerkommissionen. Syftet med kommissionen är att förbättra cancervården och skapa hållbara och lika förutsättningar för alla cancerpatienters vård i Sverige.

I sin rapport föreslår Cancerkommissionen att Sverige antar en Nationell Cancerplan 2020. En sådan plan blir ett nationellt åtagande. Den antas av riksdagen efter förankring hos vårdgivare och andra nyckelaktörer. Syftet är att effektivisera och samordna kampen mot cancer. Planen ska innehålla tydliga mål, exempelvis en ökning av andelen femårsöverlevande från dagens 65 procent till minst 75 procent, att antalet insjuknade ska ligga klart under den nuvarande prognosen och att antal personer som erbjuds rehabilitering efter den akuta sjukdomstiden inom planperioden ökar kraftigt för att inom några få år motsvara behovet. Även arbetet med att korta köer och minska väntetider bör målsättas, liksom andelen patienter som är nöjda med det psykosociala stödet under sjukdomstiden. I planen fastställs vilken eller vilka instanser som har huvudansvaret för att respektive mål nås och hur målsättningarna ska följas upp.

- Svensk cancersjukvård är i många stycken väldigt bra. Men det finns också stora framtidsutmaningar. Kampen mot cancer behöver ytterligare trappas upp för att möta utmaningarna och samtidigt ytterligare förbättra behandlingsresultaten, säger Cancerkommissionens ordförande Lars Leijonborg.

Cancerkommissionen har arbetat fristående från BMS, Amgen och Microsoft. Kommissionens åsikter, synpunkter och förslag är kommissionens egna. Hela Cancerkommissionens rapport finns att ta del av på Cancerkommissionens hemsida, www.cancerkommissionen.s

- Vi välkomnar Cancerkommissionens rapport om hur den svenska cancervården kan effektiviseras och förbättras. Vår förhoppning är att förslagen blir ett användbart inspel till beslutsfattare inom cancervården och kan göra en faktisk skillnad för såväl patienter som anhöriga, säger Annica Holmberg, kommunikationschef på BMS.

- Cancerkommissionens rapport är mycket välkommen och bidrar till en fortsatt konstruktiv dialog kring hur vi tillsammans kan genomföra det. Det är viktigt med en öppen dialog kring hur cancervården i Sverige kan utvecklas. Frågan är stor och kräver mångas engagemang, kunskap och insikter för att kunna komma vidare, säger Lauri Lindgren, Country Director Amgen AB.

- Microsoft välkomnar Cancerkommissionens rapport och ser mycket positivt på kommissionens föreslagna mål. Vi ser fram emot att följa det fortsatta arbetet för förbättrad cancervård där digitaliseringen spelar en central roll och skapar nya möjligheter att underlätta livet för vårdsökande, vårdtagare och rehabiliteringspatienter runt om i Sverige, säger Mathias Ekman, Director Industry Solutions på Microsoft Western Europe.

Cancerkommissionen är en del av ett internationellt projekt vid namn All.Can, som syftar till att skapa en mer effektiv, hållbar och jämlik cancervård. I All.Can deltar i dag tolv länder.

Mer information rörande Cancerkommissionen kan fås av dess sekretariat, på info@cancerkommissionen.se samt via hemsidan: www.cancerkommissionen.se

Mer information om All.Can finns på www.all-can.org

Idag presenterar Cancerkommissionen sin slutrapport Nationell Cancerplan 2020. Bättre tillgänglighet och lägre dödlighet – dags att trappa upp kampen mot cancer! I rapporten presenteras 18 förslag på hur den svenska cancervården kan förbättras.

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Prolia godkänt i EU som frakturförebyggande behandling hos patienter med kortisoninducerad osteoporos

Pressmeddelanden   •   Jun 11, 2018 14:10 CEST

EU-kommissionen har nu beviljat ett utökat godkännande av Amgens läkemedel Prolia (denosumab). Detta är den tredje indikation för Prolia som innebär att Prolia nu även kan ges som behandling av benförlust till patienter som riskerar frakturer på grund av långtidsbehandling med kortison.

Nyheter från Amgen på Europas största blodcancerkongress

Pressmeddelanden   •   Jun 11, 2018 08:37 CEST

På torsdag samlas blodcancerexperter från hela världen i Stockholm då EHA 2018, Europas största hematologikongress, börjar. – Som ett av världens ledande bioteknikföretag kommer vi att presentera nya data från ett flertal studier för några av de mest innovativa läkemedlen inom blodcancerområdet, säger Maria Eriksson Svensson, medicinsk chef på Amgen.

Kolesterolsänkaren Repatha godkänd i EU som förebyggande behandling mot återinsjuknande i hjärtinfarkt och stroke

Pressmeddelanden   •   Maj 17, 2018 11:20 CEST

EU-kommissionen har nu beviljat ett utökat godkännande av Amgens läkemedel Repatha (evolocumab). EU-godkännandet innebär att Repatha nu kan ges för att sänka LDL-kolesterol hos vuxna patienter med fastställd kardiovaskulär sjukdom som förebyggande behandling mot nya hjärt-kärlhändelser.

Till grund för beslutet ligger den globala studien Fourier vilken omfattade totalt 27 564 patienter som alla hade haft hjärtinfarkt, stroke eller symtomatisk perifer artärsjukdom. Samtliga patienter stod på optimerad statinbehandling. Resultaten av Fourier visade en riskreduktion för hjärtinfarkt med 27 procent, stroke med 21 procent samt behandling med koronär revaskularisering med 22 procent hos de patienter som behandlats med Repatha som tillägg till behandling med statin. I kontrollgruppen fanns patienter som fått placebo som tillägg till statinbehandling.

-Jag välkomnar EU-kommissionens beslut och hoppas att denna nya indikation kan vara ett steg mot att fler patienter med hög risk för nya hjärtkärlhändelser kan få tillgång till kraftfull blodfettsänkande behandling, säger Åke Olsson, kardiolog och huvudprövare för Fourier i Sverige.

PCSK9-hämning – helt ny verkningsmekanismRepatha (evolocumab) är en human monoklonal antikropp som hämmar PCSK9 (proproteinkonvertas subtilisin/kexin typ 9), ett enzym som binder till LDL-receptorn på leverns yta och bidrar till att LDL-receptorn bryts ner och därmed minskar leverns förmåga att avlägsna det skadliga LDL-kolesterolet från blodet. När PCSK9 hämmas ökar antalet LDL-receptorer varpå levern effektivare kan avlägsna LDL från blodet.

Om Repatha (evolocumab)

Det europeiska godkännandet av Repatha avser idag behandling av vuxna med primär hyperkolesterolemi (heterozygot familjär och icke-familjär [HeFH]) eller blandad dyslipidemi, som komplement till kolesterolsänkande kost, a) i kombination med en statin eller statin med andra lipidsänkande behandlingar hos patienter som inte kan nå målen för LDL-kolesterol med maximal tolererbar dos av en statin, eller b) ensamt eller i kombination med andra lipidsänkande behandlingar hos patienter som är statinintoleranta, eller för vilka statiner är kontraindicerade.

Godkännandet gäller även behandling av personer som är 12 år och äldre med homozygot familjär hyperkolesterolemi (HoFH) i kombination med andra lipidsänkande behandlingar.

För mer information, se även:
https://www.tlv.se/beslut/beslut-lakemedel/begransad- subvention/arkiv/2017-12-15-repatha-fortsatter-att-inga-i-hogkostnadsskyddet-med-begransning-till- och-med-31-december-2018.html

För mer information, vänligen kontakta:

Maria Eriksson Svensson, medicinsk chef, Amgen, tel: 076-1099440 

​EU-kommissionen har nu beviljat ett utökat godkännande av Amgens läkemedel Repatha (evolocumab). EU-godkännandet innebär att Repatha nu kan ges för att sänka LDL-kolesterol hos vuxna patienter med fastställd kardiovaskulär sjukdom som förebyggande behandling mot nya hjärt-kärlhändelser.

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CHMP rekommenderar ändring av produktinformationen för Kyprolis efter att ännu en studie visat förlängd överlevnad för patienter med myelom

Pressmeddelanden   •   Maj 03, 2018 08:39 CEST

Den europeiska läkemedelsmyndighetens vetenskapliga nämnd, Committee for Medicinal Products for Human Use (CHMP), har gett ett positivt utlåtande att produktinformationen ska utökas med resultaten för total överlevnad (OS = Overall Survival) från fas III-studien ASPIRE.

​Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia (denosumab) To Patients With Glucocorticoid-Induced Osteoporosis

Pressmeddelanden   •   Apr 30, 2018 11:21 CEST

Treats Bone Loss in Patients Using Glucocorticoid Medications who are at Increased Risk of Fracture

​Patienter med multipelt myelom kan nu behandlas med Xgeva för att förebygga skelettkomplikationer

Pressmeddelanden   •   Apr 04, 2018 15:42 CEST

EU-kommissionen har nu godkänt en utökad indikation för Xgeva som därmed kan ges till patienter med multipelt myelom för att förhindra skelettkomplikationer som till exempel benbrott eller kotkompressioner. Godkännandet baseras på den hittills största studie som gjorts inom detta område.

​AMGEN AND ALLERGAN RECEIVE POSITIVE CHMP OPINION FOR ABP 980 (BIOSIMILAR HERCEPTIN®) FOR THE TREATMENT OF THREE TYPES OF CANCER

Pressmeddelanden   •   Mar 26, 2018 09:22 CEST

THOUSAND OAKS, Calif. (March 23 2018) – Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 980, a biosimilar to Herceptin® (trastuzumab). ABP 980 has been recommended for approval for the treatment of the same three types of cancer as Herceptin is approved for in the European Union (EU), including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.

“The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar portfolio, as it’s our second oncology biosimilar to reach this important milestone, and further underscores our commitment to providing the oncology community access to high-quality cancer therapies,” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to continuing our work with Allergan and European regulatory authorities to bring additional options to patients with cancer.”

The Marketing Authorization Application for ABP 980 was supported by analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.

“We are committed to providing patients with important medicines to help them fight cancer,” said David Nicholson, chief research and development officer at Allergan. “The CHMP’s positive opinion for the marketing authorization of ABP 980 reinforces its potential to increase physician choice and patient access to an important biologic.”

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the EU. If approved, a centralized marketing authorization will be granted that will be valid 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 and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars will help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide. For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

About ABP 980
ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the treatment of HER2-overexpressing early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.

Allergan also submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) for ABP 980 in 2017.

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, continues to grow its portfolio of innovative and biosimilar oncology medicines. 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 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.

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company’s success is powered by our more than 16,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.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 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 reports filed by Amgen, including its 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 Amgen projects. 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 Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops 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 Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen's results may be affected by its 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 its products and global economic conditions. In addition, sales of Amgen's 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, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between it and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock.

Allergan plc Forward-Looking Statements
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan’s Quarterly Report on Form 10-Q for the period ended September 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

Herceptin® is registered trademark of Genentech. ###

CONTACT: Amgen, Thousand Oaks Kelley Davenport, 202-585-9637 (media) Kristen Davis, 805-447-3008 (media) Arvind Sood, 805-447-1060 (investors)

CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006 (investor relations) Mark Marmur, 862-261-7558 (media) 

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 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. 

Recommended for Approval for the Same Indications as Herceptin® (trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients with HER2-Postive Early Breast Cancer

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​AMGEN RECEIVES POSITIVE CHMP OPINION RECOGNIZING THAT REPATHA® (EVOLOCUMAB) PREVENTS HEART ATTACKS AND STROKES

Pressmeddelanden   •   Mar 26, 2018 08:56 CEST

THOUSAND OAKS, Calif. (Mar. 23, 2018) - Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to include a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. The recommended label recognizes the positive findings from the Repatha cardiovascular outcomes study (FOURIER) and includes data on the additional reduction and prevention of heart attacks, strokes and coronary revascularizations on top of maximally tolerated statin therapy.

The Repatha cardiovascular outcomes study showed reductions in the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization procedures by 22 percent in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.

“We welcome the CHMP’s positive opinion to incorporate a new indication for adults with cardiovascular disease into the European label, recognizing the impact of Repatha to prevent life- changing events such as heart attacks and strokes,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “With the FOURIER outcomes data now included in the U.S. label and an anticipated label update in Europe in the coming months, we will continue to work with payers globally to ensure access to medication for higher risk patients. Furthermore, we value and support the efforts by many stakeholders, including clinicians, advocates, and payers as we all work to reduce barriers to access and increase affordability for patients who need PCSK9 treatment.”

The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, the centralized European marketing authorization for Repatha will be updated to include the new indication. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the EC’s decision.

On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved a new indication for Repatha as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease following a priority review of Amgen’s supplemental Biologics License Application.

Repatha Cardiovascular Outcomes (FOURIER) Study: Key Outcomes

The 27,564-patient Repatha cardiovascular outcomes study (FOURIER) demonstrated that adding Repatha to optimized statin therapy resulted in a statistically significant 20 percent (p<0.001) reduction in major adverse cardiovascular events (MACE) represented in the key secondary composite endpoint of time to first heart attack, stroke or cardiovascular death. The study found a statistically significant 15 percent reduction (p<0.001) in the risk of the primary composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death.

The magnitude of risk reduction in both the primary and key secondary composite endpoints grew over time, with the robust benefit starting as early as six months and accruing through the median 2.2 years of the study.

Patients on Repatha experienced a reduction in the risk of heart attack (27 percent, nominalp<0.001), stroke (21 percent, nominalp=0.01) and coronary revascularization (22 percent, nominal p<0.001).1 Consistent with recent trials of more intensive LDL-C lowering, there was no observed effect on cardiovascular mortality. Similarly, there was no observed effect on hospitalization for unstable angina.2-6

The safety profile of Repatha in the outcomes trial was generally consistent with the safety profile for the 12- and 52-week controlled trials involving patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

Repatha Cardiovascular Outcomes (FOURIER) Study Design

FOURIER (Further CardiovascularOUTcomesResearch with PCSK9Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with high- or moderate- intensity statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The hard MACE composite endpoint is the time to cardiovascular death, myocardial infarction or stroke (key secondary endpoint). The extended MACE composite endpoint is the time to cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina or coronary revascularization (primary endpoint).

Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and established cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus high- or moderate-intensity effective statin dose; or placebo subcutaneous every two weeks or monthly plus high- to moderate-intensity statin dose. Statin therapy was defined in the protocol as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.

About Repatha® (evolocumab)

Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.7

Repatha is approved in more than 60 countries, including the U.S., Japan, Canada, and in all 28 countries that are members of the European Union. Applications in other countries are pending.

Important EU Product Information

In Europe Repatha is approved for use in:

Hypercholesterolemia and mixed dyslipidemia

Repatha is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin- intolerant, or for whom a statin is contraindicated.

    Homozygous familial hypercholesterolemia

    Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.

    Posology

    Primary hypercholesterolaemia and mixed dyslipidaemia in adults

    The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.

    Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and overThe initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.

Important 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.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Special Warnings and Precautions: Renal impairment: Patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) have not been studied. Repatha should be used with caution in patients with severe renal impairment. Hepatic impairment: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDLC reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Repatha- should be used with caution in patients with severe hepatic impairment. Dry natural rubber: The needle cover of the glass pre-filled syringe and of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.Sodium content: Repatha contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'sodium- free'.

Interactions: No formal drug-drug interaction studies have been conducted for Repatha. No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid- lowering drugs other than statins and ezetimibe have been conducted.

Fertility, Pregnancy and Lactation: There are no or limited amount of data from the use of Repatha in pregnant women. Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. No data on the effect of evolocumab on human fertility are available.

Undesirable Effects: The following common (> 1/100 to < 1/10) adverse reactions have been reported in pivotal, controlled clinical studies: influenza, nasopharyngitis, upper respiratory tract infection, rash, nausea, back pain, arthralgia, injection site reactions. Please consult the SmPC for a full description of undesirable effects.

Pharmaceutical Precautions: Store in a refrigerator (2 degrees C – 8 degrees C). Do not freeze. Keep the pre-filled syringe or the pre-filled pen in the original carton in order to protect from light. If removed from the refrigerator, Repatha may be stored at room temperature (up to 25 degrees C) in the original carton and must be used within 1 month.

About Amgen in the Cardiovascular Therapeutic Area
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.8 Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.

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 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. 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 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. 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 to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. 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, including our devices, after they are on the market.

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. 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. 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. 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 acquire other companies or products and to integrate the operations of companies 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.

CONTACT: Amgen, Thousand Oaks Kristen Davis, 805-447-3008 (Media) Kristen Neese, 805-313-8267 (Media) Arvind Sood, 805-447-1060 (Investors)

REFERENCES

  1. Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.
  2. Cannon CP, et al. N Engl J Med. 2004;350:1495-1504.
  3. LaRosa JC, et al. N Engl J Med. 2005;352:1425-1435.
  4. Pederson TR, et al. JAMA. 2005;294:2437-2445.
  5. Search Collaborative Group. Lancet 2010;376:1658–69.
  6. Cannon CP, et al. N Engl J Med. 2015;372:2387-2397.
  1. Repatha® U.S. Prescribing Information. Amgen.
  2. World Health Organization. Cardiovascular diseases (CVDs) fact sheet.

    http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed October 30, 2017. 

Recommended Label Includes New Indication Based on the Repatha Cardiovascular Outcomes Study (FOURIER) Amgen Continues to Work Closely With Payers on a Country-by- Country Basis to Ensure Access to Repatha for High-Risk Cardiovascular Patients

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Om Amgen AB

Om Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.se

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