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Positive CHMP opinion for CAZ AVI in the EU for serious bacterial infections

Pressmeddelanden   •   2016-04-29 13:52 CEST

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

CAZ AVI is being developed to treat a broad range of Gram-negative bacterial infections that are increasingly resistant to antibiotics, including multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae. Increasing antibiotic resistance in Gram-negative bacteria is a growing public health concern because of the limited new treatment options for these serious infections. In Europe, Gram-negative bacteria are responsible for two thirds of the annually reported 25,000 deaths resulting from antimicrobial resistance.1

The recommendation is for intravenous use in the treatment of adult patients with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) including pyelonephritis, and hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). The CHMP also recommended that CAZ AVI be indicated for the treatment of infections caused by aerobic Gram-negative organisms in adult patients who have limited treatment options.

The CHMP’s positive opinion is based on a review of data from an extensive clinical trial programme demonstrating the safety and efficacy of CAZ AVI. The submission included data from three Phase III studies in cIAI; Phase II and III studies in cUTI; and data from a Phase I study for HAP/VAP. An additional Phase III study, which evaluated the efficacy of CAZ AVI in ceftazidime-resistant cUTI and cIAI compared to the best available therapy, was also included for consideration.

The CHMP’s positive opinion on CAZ AVI will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The final decision by the EC is expected in the coming months and will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.

CAZ AVI is being jointly developed by AstraZeneca and Allergan. AstraZeneca holds the global rights to commercialise ceftazidime-avibactam, with the exception of North America, where the rights are held by Allergan.

– ENDS –

NOTES TO EDITORS

About CAZ AVICAZ AVI is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of a combination of avibactam and ceftazidime - a third generation antipseudomonal cephalosporin with a well-established efficacy and safety profile. Avibactam is a first-in-class broad-spectrum β-lactamase inhibitor, which protects ceftazidime against degradation by Class A, C and some D, β-lactamases.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by β-lactamases. CAZ AVI offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its coverage of a broad range of species of Enterobacteriaceae including those that produce ESBL and KPC together with activity against difficult to treat P. aeruginosa.

About Complicated Intra-abdominal Infection (cIAI)

Most intra-abdominal infections (IAI) are a result of processes involving inflammation and perforations of the gastrointestinal tract, such as appendicitis, peptic ulcer disease, and diverticulitis (a common digestive disease which involves the formation of
pouches within the bowel wall). IAI is an important cause of morbidity and mortality. In fact, it is the second most commonly identified cause of severe sepsis in the intensive care unit (ICU).

About Complicated Urinary Tract Infection (cUTI)

Complicated urinary tract infections (cUTI) are defined as a clinical syndrome characterized by pyuria and a documented microbial pathogen on culture of urine or blood. Patients usually present with symptoms including fever, chills, malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness, that occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization.

About Hospital Acquired Pneumonia (HAP) including Ventilator Associated Pneumonia (VAP)

Hospital-acquired pneumonia (HAP) refers to the development of lung infections after a patient has been hospitalised for a minimum of 48 hours. If, after 48 hours the infection develops despite the use of intubation and mechanical ventilation, the condition is then called Ventilator associated Pneumonia (VAP).

VAP is generally a severe illness, with patients requiring treatment in the intensive care unit (ICU). Some non-intubated patients with HAP can have either mild or more severe pneumonia.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

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Vanessa Rhodes UK/Global +44 20 7604 8037
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Investor Enquiries
UK
Thomas Kudsk Larsen UK +44 7818 524185
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Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
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Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

References

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

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AstraZeneca PLC’s resultatrapport för första kvartalet 2016

Pressmeddelanden   •   2016-04-29 08:07 CEST

Ekonomisk sammanfattning

MUSD Ändring i %
i fasta valutakurser1 Utfall
Totala intäkter2 6 115 5 1
Rörelseresultat för kärnverksamheten 3 1 593 (8) (12)
Vinst per aktie för kärnverksamheten (Core EPS) $0,95 (7) (12)
Redovisat rörelseresultat 1 038 17 11
Redovisad vinst per aktie $0,51 26 17

De totala intäkterna ökade med 5%, drivet av en väsentlig ökning av intäkter från externa samarbeten FoU-kostnader för kärnverksamheten ökade med 15% jämfört med Q1 2015, bland annat på grund av nyligen gjorda förvärv; FoU-kostnaderna för kärnverksamheten minskade dock jämfört med Q4 2015

Försäljnings- och administrationskostnaderna för kärnverksamheten sjönk med 6% och motsvarade 35% av de totala intäkterna (Q1 2015: 39%)

Vinsten per aktie för kärnverksamheten minskade med 7%, vilket avspeglar en betydande minskning i övriga rörelseintäkter

Det redovisade rörelseresultatet ökade med 17% till 1 038 MUSD. Rapporterad vinst per aktie (EPS) ökade med 26% till 0,51USD.

Oförändrad prognos för helåret 2016 i fasta valutakurser

Affärsverksamheten i sammandrag

Tillväxtplattformarna ökade med 6%, motsvarar nu 56% av de totala intäkterna:

1.Andningsvägarna: +2%. Tillväxt för Pulmicort och nyligen förvärvade läkemedel uppvägdes av en minskad försäljning av Symbicort

2.Brilinta/Brilique: +46%. Fortsatta lovande framsteg; godkännande i EU för långsiktig behandling ett år efter tidigare hjärtinfarkt (MI)

3.Diabetes: +23%. Stark säljtillväxt inkluderar en ökning på +65% på tillväxtmarknaderna.

Global tillväxt för Farxiga/Forxiga på 128%

4.Tillväxtmarknader: +6%. God säljtillväxt i Kina på +11%; avmattning i övriga regioner

5.Japan: -7%, vilket speglar lageruttag inför de obligatoriska prissänkningarna vartannat år som träder i kraft från april 2016

6.Ny onkologi: Bidrog med 99 MUSD. Fin utveckling för lanseringen av Tagrisso på nyckelmarknader

Uppnå ledarskap inom forskningen: Framsteg sedan föregående resultatrapport

Myndighetsgodkännanden

BevespiAerosphere (tidigare PT003) – KOL (USA)

Zurampic – gikt (EU)

Brilique – tidigare hjärtinfarkt (EU)

Tagrisso – lungcancer (JAPAN)

Övriga viktiga utvecklingar

Genombrottsstatus:

odurvalumab – urinvägscancer (USA)

Särläkemedelsstatus:

oacalabrutinib – blodcancer (EU)

oMEDI551 – neuromyelitis optica (USA)

Snabbfilsstatus:

oMEDI8852 – influensa som kräver sjukhusvård (USA)

Vidareutveckling av vår strategi

  • Ett tydligare fokus på huvudterapiområdena, ytterligare investeringar inom onkologi
  • Samarbeten inom de möjlighetdrivna terapiområden ska accelereras
  • Effektivisering av verksamheten för att stötta skarpare fokusering och minska försäljnings- och administrationskostnaderna för kärnverksamheten
  • Stärka vår förmåga att leverera våra strategiska ambitioner

Pascal Soriot, koncernchef, kommenterade resultatet:

”Vi levererade ett resultat för första kvartalet i nivå med våra förväntningar, där tillväxten för totala intäkter underbyggs av resultaten för tillväxtplattformarna. Jag är särskilt nöjd över resultaten i Kina, där vi fortsatte att leverera en tvåsiffrig försäljningstillväxt, samt över framstegen för våra lanseringar inom ny onkologi.

”Vi gjorde starka framsteg när det gäller vår utvecklingsportfölj i sen fas med myndighetsgodkännanden för Bevespi Aerosphere i USA mot KOL, Brilique i EU för långsiktig behandling ett år efter tidigare hjärtinfarkt (MI) samt Tagrisso i Japan mot lungcancer. När vi blickar framåt förväntar vi oss ett ökat nyhetsflöde för hela portföljen, inklusive ett antal myndighetsbeslut och övergripande resultat, i synnerhet inom onkologi.

”Samtidigt som vi fortsätter att göra goda framsteg med våra prioriteringar och vår portfölj växer snabbare än förväntat, skärper vi vårt strategiska fokus på våra huvudterapiområden, intensifierar våra satsningar inom onkologi och accelererar möjligheten för samarbete inom våra möjlighetsdrivna terapiområden. Vi vidareutvecklar också vår strategi genom att öka effektiviteten i hela organisationen.”

Vidareutveckling av vår strategi genom tydligare fokus

AstraZeneca fortsätter att göra betydande framsteg för att uppnå målet 45 miljarder USD i totala intäkter år 2023. Företaget har ökat produktiviteten i forskningsportföljen, byggt upp ledarskap inom terapiområdena, utvecklat tillväxtplattformarna och förändrat AstraZenecas kultur. Företaget utvecklas snabbt med ett växande antal specialistvårdsläkemedel särskilt inom onkologi.

I linje med strategin att leverera nytta för patienter och värde för aktieägarna tillkännager företaget idag ett skärpt fokus på huvudterapiområdena för att öka produktiviteten inom hela organisationen. Det kommer bli tuffare prioriteringar, för att frigöra ytterligare investeringar inom onkologi. I tillägg till detta kommer företaget att fortsätta att jobba med partners inom möjlighetsdrivna delar av portföljen som infektion, neurovetenskap och inflammatoriska sjukdomar som ligger utanför området andningsvägar.

Detta fokus kommer ytterligare att effektivisera AstraZenecas verksamhet, i synnerhet på den kommersiella sidan och inom tillverkning. Detta kommer, tillsammans med en allmän press på ökad effektivitet, att leda till en avsevärd minskning i försäljnings- och administrationskostnaderna för kärnverksamheten under räkenskapsåren 2016 och 2017.

Förändringarna kommer att förbättra den operativa effektiviteten och förväntas, när detta har implementerats vid utgången av räkenskapsåret 2017, att generera årliga resultatförbättringar på cirka 1,1 miljarder USD1i, vilket primärt kommer att återspeglas inom försäljnings- och administrationskostnaderna för kärnverksamheten. Företaget förväntar sig att dessa förändringar kommer att medföra upp till 1,5 miljarder USD1 i omstruktureringskostnader av engångskaraktär, varav merparten kommer att utgöras av kontanta kostnader. De slutliga kostnadsuppskattningarna för omstruktureringsprogram, besparingar och påverkan på medarbetare kommer att bli föremål för överläggningar.

Prognos för 2016

Alla prognoser för 2016 är oförändrade och redovisas i fasta valutakurser (CER).

Totala intäkter En låg till medelhög ensiffrig procentuell nedgång
Vinst per aktie för kärnverksamheten En låg till medelhög ensiffrig procentuell nedgång

Ovanstående prognos innefattar effekterna från transaktionerna med Acerta Pharma B.V. (Acerta Pharma) och ZS Pharma, Inc. (ZS Pharma) som tillkännagavs i rapporten för helåret 2015. Prognosen bygger också på antagandet om förlorad exklusivitet för Crestor i USA från maj 2016. Intäkterna från externa samarbeten förväntas öka jämfört med helåret 2015, inklusive ett allt större inslag av återkommande intäkter från tidigare avtal. Detta går i linje med företagets långsiktiga affärsmodell som innefattar externa samarbeten som en del i portföljstyrningsstrategin.

Aktiviteter från externa samarbeten, ett resultat av en ökad FoU-produktivitet samt fokus på tre huvudsakliga terapiområden, avser specifika strategiska risk- och vinstdelningssamarbeten. De breddar, accelererar och maximerar utvecklings- och marknadsföringspotentialen för ett antal av företagets läkemedel. Initiala intäkter och intäkter baserade på vissa på förhand bestämda milstolpar inkluderas tillsammans med säljrelaterade intäkter från externa samarbeten i företagets resultatrapport i form av intäkter från externa samarbeten

FoU-kostnader för kärnverksamheten förväntas ligga på en liknande nivå som för helåret 2015. Företaget är inriktat på att avsevärt minska försäljnings- och administrationskostnaderna för kärnverksamheten under helåret 2016 jämfört med föregående år. Dessa åtgärder baseras på fasta valutakurser.

Valutakurseffekter helåret 2016

Baserat på genomsnittliga valutakurser under kvartalet och företagets publicerade valutakurskänslighet förväntas en negativ påverkan på helåret på cirka 2% från valutarörlighet på de totala intäkterna. En liknande påverkan förväntas avseende vinsten per aktie för kärnverksamheten sett till helåret. Ytterligare detaljer om valutakänsligheter framgår av Operating and Financial Review i det fullständiga pressmeddelandet på engelska.

Forskningsportföljen: kommande större nyheter

Innovation är avgörande för att kunna tillgodose stora medicinska behov och är och de är centrala för företagets tillväxtstrategi. Vårt fokus på forskning och utveckling är utformat att ge starka resultat för forskningsportföljen:

Andra kvartalet 2016

benralizumab – allvarlig astma: Övergripande resultat

saxagliptin/dapagliflozin – diabetes typ 2: Ansökan om registrering (USA)

ZS-9 – hyperkalemi: Myndighetsbeslut (USA)

Lynparza – magsäckscancer: Övergripande resultat

Andra halvåret 2016

Bevespi Aerosphere – KOL : registreringsansökan (EU)

benralizumab – allvarlig astma: Ansökan om registrering (USA, EU)

Brilinta/Brilique – perifer artärsjukdom (PAD): Övergripande resultat

saxagliptin/dapagliflozin: Myndighetsbeslut (EU)

roxadustat – anemi: Rullande inlämning av ansökan om registrering (Kina)

Lynparza – bröstcancer: Övergripande resultat

Lynparza – äggstockscancer (andra linjens behandling): Övergripande resultat

cediranib – äggstockscancer: Myndighetsbeslut (EU)
selumetinib – lungcancer: Övergripande resultat

durvalumab – cancer i huvud och hals (HAWK): Övergripande resultat

acalabrutinib – blodcancer: Övergripande resultat, Ansökan om registrering (USA)

CAZ AVI – allvarliga infektioner: Myndighetsbeslut (EU)

Första halvåret 2017

brodalumab – psoriasis: Myndighetsbeslut

Brilinta/Brilique – perifer artärsjukdom (PAD): Ansökan om registrering

ZS-9: Myndighetsbeslut (EU)

Lynparza – magsäckscancer: Ansökan om registrering

Lynparza – bröstcancer: Ansökan om registrering

Lynparza – äggstockscancer (andra linjens behandling): Ansökan om registrering

Lynparza – äggstockscancer (första linjens behandling): Övergripande resultat

selumetinib – lungcancer: Ansökan om registrering

durvalumab – cancer i huvud och hals (HAWK): Ansökan om registrering

durvalumab – lungcancer (PACIFIC) Övergripande resultat

durva + treme – lungcancer (MYSTIC, ARCTIC): Övergripande resultat

durva + treme – cancer i huvud och hals (CONDOR): Övergripande resultat

Den fullständiga rapporten på engelska finns som en bifogad PDF.

Noter

1.Samtliga tillväxttal och prognoser anges i fasta valutakurser (CER) om inte annat anges.

2.Totala intäkter definieras som produktförsäljning och intäkter från externa samarbeten.

3.Se ”Operating and Financial Review” i det fullständiga pressmeddelandet på engelska för en definition av ekonomisk information för kärnverksamheten och en avstämning mellan kärnverksamheten och redovisad ekonomisk information.

Resultatet som anges i denna rapport omfattar tremånadersperioden till 31 mars 2016 (kvartalet) jämfört med tremånadersperioden till 31 mars 2015 (jämförande kvartal).

Presentation av resultaten

En telefonkonferens för investerare och analytiker, anordnat av ledningen, börjar kl 13.00 idag. Detaljer fås via www.astrazeneca.com/investors.

Rapporteringskalender

Företaget kommer att publicera resultaten för det första halvåret den 28 juli 2016.

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden: andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. För mer information, se www.astrazeneca.com

Kontakter

Förfrågningar media

Neil Burrows

UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Abigail Bozarth US +1 302 885 2677
Förfrågningar Investor Relations
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Förkortningar: RIA – Andningsvägar, inflammation och autoimmunitet, CVMD – Hjärt-/kärlsjukdomar och metabola sjukdomar, ING – Infektion, n

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

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AstraZeneca enters into US licensing agreement with Ironwood Pharmaceuticals for lesinurad

Pressmeddelanden   •   2016-04-26 10:41 CEST

AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

Under the terms of the agreement, Ironwood will acquire exclusive US rights to Zurampic. In addition, Ironwood will gain the exclusive US rights to the fixed-dose combination oflesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016. Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on Product Sales. AstraZeneca will manufacture and supply Zurampic, provide certain support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.

Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “We’re pleased to be entering into this agreement with Ironwood, a company with whom we already have a number of successful commercial partnerships. Our new agreement with Ironwood will ensure the successful launch of Zurampic in the US, while allowing us to concentrate our resources on the innovative medicines in our main therapy areas.”

Tom McCourt, Chief Commercial Officer of Ironwood, said: “This transaction enables Ironwood to leverage our strong commercial capabilities to advance a durable franchise of innovative medicines addressing a significant unmet need in which patients are highly motivated and seeking relief. With focused investment into the gout franchise over time, we believe we can maximize cash flows and accelerate our efforts to build a top-performing commercial biotechnology company.”

Gout is a serious, progressive and debilitating form of inflammatory arthritis. Approximately two million patients in the US on urate lowering therapy remain inadequately controlled, asXOI treatment alone is not sufficient to achieve their treatment goals.

The development of AstraZeneca’s gout portfolio is led by Ardea Biosciences, a wholly owned subsidiary. The transaction does not include the transfer of any AstraZeneca or Ardea employees or facilities.AstraZeneca also retains the rights to the rest of the Ardea portfolio, including RDEA3170, a Phase IIb ready, potent selective uric acid reabsorption inhibitor. Under the terms of the agreement, Ironwood will have certain rights to potentially access RDEA3170 in gout indications in the US. The licensing agreement is expected to close in the second quarter of 2016, subject to antitrust approval in the US.

Financial considerations

Revenue from the licensing agreement will provide AstraZeneca with recurring Externalisation Revenue from any expected milestone payments and tiered single-digit royalty payments on Product Sales. The agreement does not impact AstraZeneca’s financial guidance for 2016.

– ENDS –

NOTES TO EDITORS

About Zurampic

ZURAMPIC® (lesinurad) is the first in a new class of medicines called Selective Uric Acid Reabsorption Inhibitors (SURI) that work selectively to complement xanthine oxidase inhibitors (XOIs) in the treatment of hyperuricemia associated with uncontrolled gout. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy. XOIs reduce the production of uric acid; ZURAMPIC increases the excretion of uric acid. Together, the combination of ZURAMPIC and an XOI provides a dual mechanism of action that both decreases production and increases excretion of uric acid, thereby lowering serum uric acid (sUA) levels in patients who have not achieved target serum acid levels with XOI treatment alone. ZURAMPIC selectively inhibits the function of transporter proteins urate transporter (URAT1) and organic anion transporter 4 (OAT4), involved in uric acid reabsorption in the kidney. In people, it does not inhibit OAT1 and OAT3, which are drug transporters in the kidney associated with drug-drug interactions. The efficacy of ZURAMPIC was established in three Phase III clinical trials that evaluated a once daily dose of ZURAMPIC in combination with the XOI allopurinol or febuxostat compared to XOI alone.

About Ironwood

Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are advancing an innovative pipeline of medicines in multiple areas of significant unmet need, including irritable bowel syndrome with constipation (IBS-C)/chronic idiopathic constipation (CIC), vascular and fibrotic diseases, and refractory gastroesophageal reflux disease, among others. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader in the IBS-C/CIC category, and we are applying our proven R&D and commercial capabilities to advance multiple internally-developed and externally-accessed product opportunities. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.

About Ardea Biosciences

Ardea Biosciences is a member of the AstraZeneca Group, located in San Diego, California. Ardea is leading the development of AstraZeneca’s gout portfolio, including Zurampic and RDEA3170.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

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Bevespi Aerosphere har godkänts av FDA för patienter med KOL

Pressmeddelanden   •   2016-04-25 23:13 CEST

Visar på tydlig förbättring i lungfunktion jämfört med monokomponenter och placebo

Den enda långtidsverkande dubbla luftrörsvidgaren som kommer i en dosaerosol (pMDI) och den första produkten med AstraZenecas patenterade Co-Suspension Technology

AstraZeneca meddelar idag att amerikanska Food and Drug Administration har godkänt Bevespi Aerosphere (glykopyrrolat och formoterolfumarat),en inhalationsaerosol avsedd för långverkande underhållsbehandling av luftvägsobstruktion hos patienter med kroniskt obstruktiv lungsjukdom (KOL) samt kronisk bronkit och/eller emfysem.

Sean Bohen, Executive Vice President, Global Medicines Development och Chief Medical Officer, säger: ”Tack vare godkännandet av Bevespi Aerospherekan vi nu ge patienter den första LAMA/LABA-kombinationen i en dosaerosol med vår nya unika beredningsteknik. LAMA/LABA-kombinationer blir allt vanligare som ett prioriterat behandlingsalternativ för många KOL-patienter. Denna läkemedelsklass syftar till att ge maximal luftrörsvidgning, vilket gör det möjligt för patienter att andas lättare och kan hjälpa dem att vara mer fysiskt aktiva.”

Bevespi Aerosphereär en dubbel luftrörsvidgare i fast kombination som tas två gånger dagligen och kombinerar glykopyrrolat, en långtidsverkande muskarinantagonist (LAMA), och formoterolfumarat, en långtidsverkande beta-2-agonist (LABA). FDA:s godkännande bygger på det kliniska prövningsprogrammet PINNACLE, som visade att Bevespi Aerosphere ledde till statistiskt signifikant förbättring av forcerad expiratorisk volym under första sekunden (FEV1) på morgonen före medicinering vid 24 veckor (p<0,001) jämfört med dess monokomponenter och placebo.

Bevespi Aerosphere är den första produkten som har godkänts med AstraZenecas Co-Suspension Technology. Denna teknik gör det möjligt att leverera en jämn dos av ett eller flera läkemedel från en och samma dosaerosol (pMDI). Tekniken tillämpas på en rad av AstraZenecas inhalerade kombinationsbehandlingar för andningsvägar som för närvarande är under klinisk utveckling, som till exempel den fasta trippelkombinationen av LAMA/LABA/Inhalerad kortikosteroid (PT010).

– ENDS –

NOTES TO EDITORS

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

About AstraZeneca’s Co-Suspension Technology

The Co-Suspension Technology uses porous, low-density phospholipid particles, which are designed to form a uniform suspension inside a pressurised metered-dose inhaler (pMDI) and distribution of drug crystals throughout the lungs for release at their sites of deposition.

In addition, Co-Suspension Technology addresses issues often seen when multiple drugs are combined in a pMDI. This technology provides a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time and to prevent drug crystals from interacting with one another, thus allowing for consistent dosing of one or more different drugs from a single pMDI.

About the PINNACLE studies

The FDA approval of Bevespi Aerosphereis based on data from the PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3. Overall the Phase III pivotal programme enrolled over 3,700 patients with moderate to very severe COPD.

Bevespi Aerospheredemonstrated statistically significant improvements in lung function as measured by change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo, all dosed twice daily.

Bevespi Aerospheredemonstrated a significant improvement versus placebo on secondary endpoints of peak FEV1within 2 hours post-dose, and rescue medication usage.

There were no unexpected safety findings with adverse events consistent with previous results from the development program. The most common adverse reactions with Bevespi Aerosphere, (with a ≥ 2% incidence and more common than with placebo) were urinary tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7% with placebo).

About Respiratory, Inflammation and Autoimmunity Diseases

Respiratory, Inflammation and Autoimmunity (RIA), one of AstraZeneca’s main therapy areas, has five potential medicines in pivotal trials or under registration. In respiratory disease, our aim is to transform asthma and COPD treatment through: Inhaled combinations at the core of care, precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-Suspension Technology.

In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead programme in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key treatable traits: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology,and autoimmunity.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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AstraZeneca lanserar integrerat forskningsinitiativ inom genomik som kommer ändra vårt sätt att jobba med upptäckt och utveckling av läkemedel

Pressmeddelanden   •   2016-04-22 07:24 CEST

AstraZeneca och MedImmune, koncernens globala forsknings- och utvecklingsbolag för biologiska läkemedel, meddelar idag ett integrerat forskningsinititativ inom genomik som kommer att ändra vårt sätt att arbeta för att upptäcka och utveckla läkemedel tvärsöver hela forsknings- och utvecklingsportföljen.

Initiativet omfattar nya samarbeten med Human Longevity Inc. i USA; Wellcome Trust Sanger Institute i Storbritannien och The Institute for Molecular Medicine Finland. AstraZeneca kommer också etablera ett internt center för genomikforskning, där man kommer att utveckla en skräddarsydd databas med genomsekvenser från prover donerade av patienter vid kliniska prövningar tillsammans med tillhörande kliniska data och data avseende behandlingseffekt.

AstraZeneca tror att man genom att införliva genomik i arbetet tvärsöver alla plattformar för forskning och utveckling kommer att:

  • få nya insikter om sjukdomars biologi
  • kunna identifiera nya målmolekyler för läkemedel
  • understödja processen kring urval av patienter för kliniska prövningar
  • bättre matcha patienter till de behandlingar som mer sannolikt kommer att gynna dem.

Mene Pangalos, Executive Vice-President, Innovative Medicines and Early Development (IMED) på AstraZeneca säger: ”Genom att uttnyttja den kraft genomiken utgör har vi ett fundament för vår ambition att utveckla de mest innovativa och effektfulla behandlingarna för patienter. Intåget av nästa generations sekvensering och ökad förfining av dataanalys innebär att tiden nu är inne för att fullt ut integrera oss i det internationella genomikarbetet genom dessa banbrytande samarbeten och genom att skapa vårt eget genomikcenter. Vi kommer att bygga vidare på information från upp till 2 miljoner genomsekvenser, inklusive över 500 000 från våra egna kliniska prövningar för att driva på läkemedelsupptäckter och utveckling inom alla våra terapiområden. Genomik kommer att vara grundläggande för forskningen i våra laboratorier, våra kliniska prövningsprogram och för lansering av nya produkter”.

  • Human Longevity, Inc i USA
    AstraZeneca kommer att dela med sig av upp till 500 000 DNA-prover till Human Longevity Inc, som kommer att sekvensera genom och driftsätta sin banbrytande maskininlärning, mönsterigenkänning och andra tekniker för analys. Proverna har donerats av patienter som givit sitt samtycke vid AstraZenencas kliniska prövningar. För sina analyser kommer AstraZeneca också att få tillgång till Human Longevitys unika databas med upp till 1 miljon patientjournaler integrerade med genom- och kliniska data.
  • AstraZenecas centrum för genomikforskning
    AstraZeneca skapar ett internt Center för genomikforskning inriktat på att skapa och använda en skräddarsydd databas över genomsekvenser. Proverna har donerats av patienter från kliniska prövningar under de senaste 15 åren och ska kompletteras med motsvarande prover under de närmaste 10 årens kliniska prövningar, samt integreras med tillhörande kliniska data avseende behandlingseffekt. Dessutom kommer centret ha tillgång till upp till 500 000 genomsekvenser via AstraZenecas samarbeten och publika data som är allmänt tillgängliga. Centret placeras i AstraZenecas huvudkontor i Cambridge där man kommer att arbeta i nära samverkan med det internationella forskningssamhället inom genomik för att dra vetenskaplig och klinisk nytta av denna nya genomresurs.
  • Wellcome Trust Sanger Institute i Cambridge i Storbritannien
    AstraZeneca kommer att etablera ett forskningsteam lett av en internationellt väl ansedd expert inom genomik. Teamet kommer integreras med Wellcome Trust Sanger Institutes världskända Genome Centre i Cambridge i Storbritannien. AstraZeneca kommer att dela med sig av genomsekvenser och tillhörande kliniska data samt sin läkemedelsutvecklingskompetens inom sina huvudterapiområden. Båda parter kommer att identifiera nya målmolekyler och biomarkörer som potentiellt kan användas vid diagnostiska provtagningar.
  • The Institute for Molecular Medince Finland (FIMM), Helsingfors universitet i Finland, AstraZeneca kommer att samarbeta med The Institute for Molecular Medicine i Finland och dess partners i Finland och USA för att studera gener av intresse i finska befolkningen, som har en högre frekvens av sällsynta varianter. Dessutom har Finland ett integrerat patientjournalsystem liksom en nationell biobankslag som underlättar att återkalla frivilliga för noggrann klinisk utvärdering.

Bahija Jallal, Executive Vice President, MedImmune, säger: ”Områdena genetik och genomik utvecklas så snabbt att inget enskilt företag kan hantera denna typ av forskning internt och göra allt själva. Vi är mycket medvetna om detta och vi har därför valt att samarbeta med andra genomikforskare för att utnyttja extern expertis inom genomik och utformning av storskaliga genetiska studier. Tillsammans med omfattande kliniska data från vår biobank kommer vi att använda resultaten till en ökad förståelse om sjukdomar och – i slutänden – till effektivare behandlingar för patienter.”

I linje med AstraZenecas strategi om ”öppen innovation” avseende forskning och utveckling, kommer forskningsresultaten från alla samarbeten inom ramen för genomplattformen att publiceras i vetenskapligt granskade tidskrifter. På så sätt kan vi bidra till en bredare förståelse av genetisk kopplingar till sjukdom och ge AstraZeneca en position som en ledande aktör global genomikforskningr.

– ENDS –

NOTES TO EDITORS

Watch a short video explaining the genomics platform at AstraZeneca.

About genomics

Genomics is the study of the genome, a double string of DNA which carries all the genes necessary to make and operate an organism. Although most of the information contained in the genome is the same between all individuals, there are many small differences which scientists believe can combine with environmental influences to cause common diseases such as diabetes, asthma or cancer. Studying genomes across large populations allows us to more accurately pinpoint these differences and to develop new treatments that combat unwanted abnormalities in gene function which give rise to disease.

About Human Longevity, Inc.

Human Longevity, Inc. (HLI) is the genomics-based, technology-driven company creating the world’s largest and most comprehensive database of whole genome, phenotype and clinical data. HLI is developing and applying large scale computing and machine learning to make novel discoveries to revolutionize the practice of medicine. HLI’s business also includes the HLI Health Nucleus™, a genomic powered clinical research center which uses whole genome sequence analysis, advanced clinical imaging and innovative machine learning, along with curated personal health information, to deliver the most complete picture of individual health. For more information please visit http://www.humanlongevity.com or http://www.healthnucleus.com.

About The Wellcome Trust Sanger Institute

The Wellcome Trust Sanger Institute is one of the world's leading genome centres. Through its ability to conduct research at scale, it is able to engage in bold and long-term exploratory projects that are designed to influence and empower medical science globally. Institute research findings, generated through its own research programmes and through its leading role in international consortia, are being used to develop new diagnostics and treatments for human disease. http://www.sanger.ac.uk/

About The Institute for Molecular Medicine Finland (FIMM), University of Helsinki

Institute for Molecular Medicine Finland (FIMM) is an international research institute in Helsinki focusing on human genomics and personalized medicine. FIMM integrates molecular medicine research, technology center and biobanking infrastructures “under one roof” and thereby promotes translational research and adoption of personalized medicine in health care. FIMM is hosted by the University of Helsinki and is part of the Nordic EMBL Partnership in Molecular Medicine as well as the EU-Life network. In 2015, FIMM had a staff of 200 and a budget of 17 million €, with competitive external funding accounting for a significant part of the budget. www.fimm.fi/en/

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers, with additional sites in Cambridge, UK and Mountain View, CA. For more information, please visit www.medimmune.com

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 7824 350541
Karen Birmingham UK/Global +44 7818 524012
Vanessa Rhodes UK/Global +44 7880 400690
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen Oncology +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca och MedImmune, koncernens globala forsknings- och utvecklingsbolag för biologiska läkemedel, meddelar idag ett integrerat forskningsinititativ inom genomik som kommer att ändra vårt sätt att arbeta för att upptäcka och utveckla läkemedel tvärsöver hela forsknings- och utvecklingsportföljen

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ASTRAZENECA PRESENTS POSITIVE TAGRISSO (OSIMERTINIB) FOLLOW-UP DATA IN LUNG CANCER AT ELCC 2016

Pressmeddelanden   •   2016-04-14 14:45 CEST

Phase I first-line Tagrisso (osimertinib) data show an objective response rate of 77%, and progression-free survival of 19.3 months in patients with EGFRm NSCLC1

Updated results in pre-treated patients with EGFR T790M mutation-positive NSCLC further support recent approvals in the US, EU and Japan

AstraZeneca today reported new Phase I extended follow-up data on osimertinib in both first- and second-line treatment of patients with non-small cell lung cancer (NSCLC), at the European Lung Cancer Conference (ELCC) 2016. Late-breaker presentations reinforced the efficacy and safety profile for osimertinibpreviously seen in the AURA clinical trials programme.

Phase I data from the AURA trial on osimertinib investigated as first-line treatment in 60 patients (pooled 80mg and 160mg dose cohorts) with epidermal growth factor receptor (EGFR) mutation-positive advanced NSCLC showed an objective response rate (ORR, a measurement of tumour shrinkage) of 77% (95% confidence interval (CI): 64%-87%) and a progression-free survival (PFS) of 19.3 months, with 55% of patients remaining progression-free at 18 months (95% CI: 41%-67%).1 Median duration of response (DoR) was non-calculable (NC) (95% CI: 12.5 months to NC) at the time of data cut off, with 53% of patients continuing to respond at 18 months (95% CI: 36%-67%).1

Of the 60 first-line patients, five had tumours also harbouring the T790M mutation at diagnosis (known as de novo patients) and all five of these patients showed durable responses.1 The most common adverse events were rash (78% overall; 2% ≥Grade 3), diarrhoea (73% overall; 3% ≥Grade 3), dry skin (58% overall; 0 ≥Grade 3) and paronychia (50% overall; 3% ≥Grade 3). All of the Grade 3 or above events in these categories occurred at the 160mg dose.1

Osimertinib is currently only approved in lung cancer patients harbouring a T790M mutation.

Martin Sandelin vid Akademiska sjukhuset i Uppsala kommenterar resultaten:

”Osimertinib har redan ingett nytt hopp till EGFR-mutations positiva patienter som progredierar på 1:a och 2:a generationens EGFR-TKI på grund av T790M resistensmekanism. Dessa nya fas 1 data från AURA studien är lovande och kan leda till en förändring av nuvarande behandlingssätt om varaktig respons i första linjen kan bekräftas i kommande fas 2- eller 3-studier. För patienter som behöver behandling med EGFR-TKI, är Osimertinib i allmänhet mer tolererbar och medför färre biverkningar än tidigare generationer EGFR-TKIs på grund av dess specificitet för den muterade receptorn.

Klaus Edvardsen, Vice President, Clinical Oncology and Interim Head of Oncology, Global Medicines Development at AstraZeneca said: “In a Phase I study with osimertinibas first-line therapy in EGFR-mutation positive NSCLC, we are seeing consistently durable responses.

In many cases, responses continue for at least 18 months including in a small group of patients with the T790M mutation detectable at diagnosis. The ongoing Phase III FLAURA trial will further characterise the potential of osimertinib80mg in the first-line EGFRm setting.”

Updated pooled results from AURA Phase II studies in 411 pre-treated patients with EGFR T790M mutation-positive NSCLC treated with osimertinib80mg showed a median PFS of 11 months (95% CI: 9.6-12.4 months), an ORR of 66% (95% CI: 61%-71%) and a median DoR of 12.5 months (95% CI:11.1 months to NC).2 Pooled treatment-related adverse events data from the AURA Phase II studies included rash (41% overall; <1% ≥Grade 3), diarrhoea (38% overall; <1% ≥Grade 3), dry skin (30% overall; 0% ≥Grade 3) and paronychia (29% overall; 0% ≥Grade 3). Interstitial lung disease was seen in 12 patients (3% overall; 2% ≥Grade 3), hyperglycaemia in 1 patient (<1% overall; 0 ≥Grade 3) and QT prolongation in 14 patients (3% overall; 1% ≥Grade 3).2

Osimertinibrecently received accelerated approval as the first indicated treatment for patients with EGFR T790M mutation-positive metastatic NSCLC in the US,3 EU4 and Japan.5The ongoing confirmatory Phase III trial, AURA3, is assessing the efficacy and safety of osimertinib versus platinum-based doublet chemotherapy in patients with EGFR T790M mutation-positive, locally advanced, or metastatic NSCLC who have progressed following prior therapy with an EGFR-TKI.6

– ENDS –

NOTES TO EDITORS

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, and more than breast, prostate and colorectal cancers combined.12Patients who have the EGFRm form of NSCLC, which occurs in 10-15% of NSCLC patients in Europe13 and 30-40% of NSCLC patients in Asia,14 are particularly sensitive to treatment with currently available EGFR-TKIs, which block the cell signaling pathways that drive the growth of tumour cells.15 However, tumours almost always develop resistance to treatment, leading to disease progression.16 In approximately two-thirds of patients treated with approved EGFR-TKIs such as gefitinib and erlotinib, this resistance is caused by the secondary mutation, T790M.16

About osimertinib

Osimertinib 80mg once-daily tablet is the first medicine indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC.3,4,5 Non-clinical in vitro studies have demonstrated that osimertinibhas high potency and inhibitory activity against mutant EGFR phosphorylation across the range of clinically relevant EGFR and T790M mutant NSCLC cell lines with significantly less activity against EGFR in wild-type cell lines.17

Osimertinib is being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who have progressed after EGFR-TKI therapy.6

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s

future. With at least 6 new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative

partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl/metabolism, andningsvägar/inflammation/autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com eller följ oss på twitter. Https:/twitter.com/AstraZenecaSE.

Kontaktperson:

Petra Eurenius, Kommunikationschef AstraZeneca Nordic-Baltic, mob: 0709 186562

Ref.:

1 Ramalingam SS, et al. Osimertinib (AZD9291) as first-line treatment for EGFR mutation-positive advanced NSCLC: updated efficacy and safety results from two Phase I expansion cohorts. Abstract LBA1_PR [Oral Presentation]. Presented at the European Lung Cancer Conference, 13-16 April 2016, Geneva, Switzerland.

2 Yang JCH, et al.Osimertinib (AZD9291) in pre-treated patients with T790M-positive advanced NSCLC: updated Phase I and pooled Phase II results. Abstract LBA2_PR [Oral Presentation].Presented at the European Lung Cancer Conference, 13-16 April 2016, Geneva, Switzerland.

3 AstraZeneca PLC. TAGRISSO™ (AZD9291) approved by the US FDA for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer. Issued on November 13th 2015. Available at: https://www.astrazeneca.com/our-company/media-centre/press-releases/2015/TAGRISSO-AZD9291-approved-by-the-US-FDA-for-patients-with-EGFR-T790M-mutation-positive-metastatic-non-small-cell-lung-cancer-13112015.html. Accessed April 2016.

4 AstraZeneca PLC. TAGRISSO™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer. Issued on February 3rd 2016. Available at: https://www.astrazeneca.com/media-centre/press-releases/2016/tagrisso-osimertinib-approved-in-eu-as-first-in-class-treatment-for-lung-cancer-03022016.html. Accessed April 2016.

5 AstraZeneca PLC. Tagrisso™ (osimertinib) approved in Japan for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer. Issued on March 29th 2016. Available at: https://www.astrazeneca.com/media-centre/press-releases/2016/tagrisso-approved-in-japan-for-patients-with-egfr-t790m-mutation-positive-metastatic-non-small-cell-lung-cancer-29032016.html. Accessed April 2016.

6 National Institutes of Health.AZD9291 Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (AURA3). Available at: https://clinicaltrials.gov/ct2/show/NCT02151981?term=AURA3&rank=1. Accessed April 2016.

7 National Institutes of Health. AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA). Available at: https://www.clinicaltrials.gov/ct2/show/NCT02511106?term=AZD9291+Versus+Placebo+in+Patients&rank=1. Accessed April 2016.

8 National Institutes of Health. AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA). Available at https://clinicaltrials.gov/ct2/show/NCT02296125?term=FLAURA&rank=1. Accessed April 2016.

9 National Institutes of Health. Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer (BLOOM). Available at: https://clinicaltrials.gov/ct2/show/NCT02228369?term=AZD9291+brain+met&rank=1.Accessed April 2016.

12 GLOBOCAN (2012). Estimated cancer incidence, mortality and prevalence worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed April 2016.

13 Szumera-Ciećkiewicz A, et al. EGFR mutation testing on cytological and histological samples in non-small cell lung cancer: a Polish, single institution study and systematic review of European incidence. Int J Clin Exp Pathol. 2013;6:2800-12.

14 Ellison G, et al. EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. J Clin Pathol. 2013;66:79-89.

15 Langer CJ, et al. Epidermal Growth Factor Receptor Inhibition in Mutation-Positive Non-Small-Cell Lung Cancer: Is Afatinib Better or Simply Newer? Journal of Clinical Oncology. 2013;31(27);3303-3305

16 Yu HA, et al. Analysis of Tumour Specimens at the Time of Acquired Resistance to EGFR-TKI Therapy in 155 Patients with EGFR-Mutant Lung Cancer. Clin Cancer Research:2013:19(8):2240-2246

17 Cross DAE, et al. AZD9291, an Irreversible EGFR TKI, Overcomes T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer Discov. 2014;4:1046-61.

968364.011 04,2016 SE

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

Phase I first-line Tagrisso (osimertinib) data show an objective response rate of 77%, and progression-free survival of 19.3 months in patients with EGFRm NSCLC1 Updated results in pre-treated patients with EGFR T790M mutation-positive NSCLC further support recent approvals in the US, EU and Japan

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AstraZeneca showcases breadth of oncology portfolio at AACR 2016 Annual Meeting

Pressmeddelanden   •   2016-04-14 08:04 CEST

More than 60 presentations featuring 26 potential medicines across four key scientific platforms, including DNA Damage Response (DDR) and Immuno-Oncology (IO)

14 April 2016

AstraZeneca and its global biologics research and development arm, MedImmune, will present 57 abstracts, deliver five oral presentations and two lectures as well as participating in a round-table session on PD-L1 diagnostic harmonisation at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans this week.

DNA Damage Response: an industry-leading portfolio

Three oral presentations will provide insight into AstraZeneca’s industry-leading DNA Damage Response (DDR) pipeline of potential medicines as both monotherapy and in combination:

Phase I data evaluating the combination of first-in-class PARP inhibitor Lynparza (olaparib) and AKT inhibitor AZD5363 in germline BRCA and non-BRCA mutant advanced cancer patients (Abstract #CT1010)

Early safety and efficacy data from a Phase Ib study of novel potential medicine AZD1775, a small molecule designed to inhibit the Wee1 kinase, which plays a critical role in the DNA damage repair that enables cell division (Abstract #CT013)

Pre-clinical pharmacology of AZD0156, an ATM kinase inhibitor that detects DNA double strand breaks to enable downstream DNA repair and cell survival (Sunday 17 Apr - 14:15-16:15)

Andrew Mortlock, Vice President, Global Projects and Alliances, Oncology iMed at AstraZeneca said: “The data we will present at AACR underscore the scientific promise shown by our industry-leading DDR portfolio as well as the clinical potential of this pioneering approach to targeting tumour cells. With three new molecules now in the clinic and one on the market, we are following the science and exploring their potential in both monotherapy and in combination with other therapies.”

Immuno-Oncology: biomarkers, next-generation Immunotherapies, and combinations

AstraZeneca’s Immuno-Oncology research will feature prominently at AACR, including with new data from a comparative study of commonly used PD-L1 diagnostic tests in approximately 500 tumour biopsies (Abstract #LB-094; also included in the AACR media programme). AstraZeneca will also take part in a roundtable discussing the value of PD-L1 diagnostic testing - “The Blueprint Project: Harmonizing Companion Diagnostics across a Class of Targeted Therapies”, scheduled for Tuesday 19 April, 13.00 – 15.00 EST (Room 283, Morial Convention Center).

AstraZeneca will also provide updates on its exploration of biological targets beyond PD-L1 and CTLA-4, including MEDI1873, an agonist of the GITR receptor (Abstract #561) and MEDI9197, a TLR7/8 agonist (Abstract #1475), as well as the combination strategy of PD-L1/PD1 axis inhibition with several complementary mechanisms of action targeting NKG2A, OX40 and immTACs.

In addition, researchers at the congress will present the latest results from a Phase I/II trial of tremelimumab plus tumour ablation in patients with advanced hepatocellular carcinoma (HCC) (Abstract #2653).

David Berman, Senior Vice President, Head of Oncology Innovative Medicines, at MedImmune, said: “At AACR, we will present pre-clinical data and mechanistic characterisation that support our ongoing clinical trials exploring next-generation immuno-oncology targets and their combination with durvalumab. We will present a comparison of the different PD-L1 diagnostic assays to help advance the science for the field of PD1/L1 blockade. In addition, the activity of tremelimumab, a CTLA4 inhibitor, will be further evidenced.”

Tumour drivers and resistance: A key area of expertise

AstraZeneca will also present data on Tagrisso (osimertinib), exploring the utilisation of non-small cell lung cancer (NSCLC) xenograft models from patients on Tagrisso to refine therapeutic strategies (Abstract #5192). Tagrisso recently received accelerated approval as the first indicated treatment for patients with EGFR T790M mutation-positive metastatic NSCLC in the US, EU and Japan.

The company will also showcase its continued progress in therapies targeting the genetic drivers of cancer with breaking data on an early-stage mTOR inhibitor that has shown pre-clinical activity in prostate cancer. Specific posters include:

Anti-tumour activity of mTOR inhibitor AZD2014 in a prostate cancer mouse model (Abstract #2147)

Overcoming mTOR resistance mutations with a next-generation mTOR inhibitor (Abstract #389)

– ENDS –

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at AACR

Lead author Abstract title Presentation details
DNA Damage Response
Thomason AG Discovery and pre-clinical pharmacology of AZD0156: A
first-in-class potent and selective inhibitor of Ataxia telangiectasia mutated (ATM) kinase
Oral New Drugs on the Horizon Sunday 17 Apr 14:15-16:15

New Orleans Theater C, Morial Convention Center

Webcast Available

Bauer TM A Phase Ib, open-label, multi-center study to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD1775 monotherapy in patients with advanced solid tumors: Initial findings OralClinical Trials Plenary Session 2 Early Clinical Trials of Agents Targeting DNA or the Epigenome Sunday 17 Apr 16:15-18:15
Room 291, Morial Convention Center

Abstract #CT013

Michalarea V Phase I trial combining the PARP inhibitor Olaparib (Ola) and AKT inhibitor AZD5363 (AZD) in germline (g)BRCA and non-BRCA mutant (m) advanced cancer patients (pts) incorporating non-invasive monitoring of cancer mutations Oral
Clinical Trials Plenary Session 2
Early Clinical Trials of Agents Targeting DNA or the Epigenome Sunday 17 Apr 16:15-18:15
Room 291, Morial Convention Center
Abstract #CT010
Laing N Genetic analysis of tumors from a Phase II trial evaluating AZD1775, carboplatin and paclitaxel in patients with TP53-mutant ovarian cancer Poster Experimental and Molecular Therapeutics Novel Antitumor Agents

Sunday 17 Apr 13:00–17:00 Convention Center, Halls G-J, Poster Section 14

Poster Board #18, Abstract #337

Durant S Blood-brain barrier penetrating ATM inhibitor (AZ32) radiosensitises intracranial gliomas in mice Poster Experimental and Molecular Therapeutics Preclinical Radiotherapeutics

Tuesday 19 Apr 08:00–12:00 Convention Center, Halls G-J, Poster Section 18

Poster Board #1, Abstract #3041

Oplustil O’Connor L A camptothecin-containing nanoparticle-drug conjugate combination with DDR agents provides a novel approach to increasing therapeutic index Poster Experimental and Molecular Therapeutics Cell Death Pathways and DNA Repair

Tuesday 19 Apr 13:00–17:00 Convention Center, Halls G-J, Poster Section 14

Poster Board #19, Abstract #3721

Perez-Lopez R Diffusion-weighted imaging of bone metastases as treatment response biomarker in prostate cancer Poster Clinical Research Novel Molecular Diagnostics and Imaging

Tuesday 19 Apr 13:00–17:00 Convention Center, Halls G-J, Poster Section 24

Poster Board #3, Abstract #3973

Williams L Continuous, low intensity systemic dosing maximizes the therapeutic margin of Eg5/KSP inhibition in a model of urothelial cell carcinoma Poster
Experimental and Molecular Therapeutics
Novel Antitumour DNA-Reactive Agents Tuesday 19 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 15
Poster Board #16, Abstract #3769
Cidado J AZ5576, a novel potent and selective CDK9 inhibitor, induces rapid cell death and achieves efficacy in multiple preclinical hematological models Poster
Molecular and Cellular Biology/Genetics
Cell Death 3Tuesday 19 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 4
Poster Board #22, Abstract #3572
Pike K Identifying high quality, potent and selective inhibitors of ATM kinase: Discovery of AZD0156 Poster Cancer Chemistry Drug Design

Wednesday 20 Apr 08:00–12:00 Convention Center, Halls G-J, Poster Section 21

Poster Board #24, Abstract #4859

Cuneo KC A dose escalation trial of the Wee1 inhibitor AZD1775, gemcitabine and concurrent radiation in locally advanced pancreatic cancer Poster Phase I Clinical Trials in Progress Monday 18 Apr 08:00–12:00

Convention Center, Halls G-J, Poster Section 13

Poster Board #16, Abstract #CT035

Min A Androgen receptor inhibitor enhances the anti-tumor effect of PARP inhibitor in breast cancer cells via modulation of DNA damage response Poster Late-Breaking Research: Experimental and Molecular Therapeutics 1 Monday 18 Apr 8:00 AM - 12:00

Convention Center, Halls G-J, Poster Section 11

Abstract #LB-107

Immuno-Oncology

Uppala A Tremelimumab plus tumor ablation for patients with hepatocellular carcinoma: Clinical results, Immunomonitoring analysis of peripheral T cells and tumor biopsies Oral
Immunology
Session Title TBD Monday 18 Apr 15:00-17:00
New Orleans Theater B, Morial Convention Center
Abstract #2653

Press Programme

Messenheimer DJ Timing of PD-1 blockade is critical to successful synergy with OX40 costimulation in preclinical mammary tumor models. Oral
Immunology
Potentiating Immunotherapy Responses with Generation Agents and Combinatorial Partners Tuesday 19 Apr 15:00-17:00
New Orleans Theater B, Morial Convention Center

Abstract #4361

Stewart R Generation and Characterisation of MEDI1873 A Novel Hexameric GITRL Fusion Protein and Potent Agonist of the GITR Receptor Poster
Immunology
Immune Modulating Agents 1 Sunday 17 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 26

Poster Board #22, Abstract #561

Mullins S Local immune activation resulting in tumor growth inhibition with MEDI9197 - an intratumorally administered TLR7/8 agonist Poster
Immunology
Immune Modulation Agents and Therapeutic Antibodies Monday 18 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 25

Poster Board #6, Abstract #1475

Ghadially H Analysis of expression MHC class I chain-related gene A and B (MICA/B) in normal and tumour tissue Poster
Immunology
Immune Microenvironment and Antitumor Immunity Monday 18 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 24

Poster Board #12, Abstract #1451

Ratcliffe M A comparative study of PD-L1 diagnostic assays and the classification of patients as PD-L1 positive and PD-L1 negative Poster Late-Breaking Research: Immunology Monday 18 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 10

Poster Board #18, Abstract #LB-094

Sola C NKG2A immune checkpoint blockade enhances the antitumor efficacy of PD1/PD-L1 inhibitors in a preclinical model Poster
Immunology
Immune Checkpoints 1 Monday 18 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 26

Poster Board #26, Abstract #2342

Odate S Inhibition of STAT3 with oligonucleotide antisense molecule, AZD9150 increases the chemosensitivity and decreases tumorigenicity of neuroblastoma Poster
Tumor Biology
Pediatric Cancer Molecular Pathways Monday 18 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 31

Poster Board #2, Abstract #2439

Harper J Exploring the oncolytic potential of Newcastle Disease virus Poster
Clinical Research
Adoptive Cell Therapy, Immune Checkpoints, and Vaccines Monday 18 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 21

Poster Board #26, Abstract #2234

Jiang L PD-L1 expression and its relationship with other driver genes in non-small cell lung cancer (NSCLC Poster
Tumor Biology
Immunomodulation and Immunotherapy Wednesday 20 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 31

Poster Board #26, Abstract #5140

Leyland R A Mouse GITRL Fusion Protein Drives T-Cell Activation and Antitumor Activity in Preclinical Mouse Models of Cancer Poster
Immunology
Immune Response Monitoring: Preclinical Wednesday 20 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 23

Poster Board #13, Abstract #4902

Bossi, G ImmTACs in combination with anti-CTLA-4 and anti-PD-L1 antibodies can re-direct the immune system more efficiently to eradicate cancer Poster
Immunology
Immune Modulation Agents 2 Wednesday 20 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 22

Poster Board #14, Abstract #4873

Huff CA Clinical cancer stem cell targeting in multiple myeloma: An early phase trial of the anti-CD19 monoclonal antibody, MEDI-551, in combination with lenalidomide and dexamethasone Poster Phase II, III, and Special Population Clinical Trials

Tuesday 19 Apr 13:00-17:00

Convention Center, Halls G-J, Poster Section 13

Poster Board #2, Abstract #CT102

Tumour Drivers & Resistance

Noble R Evaluating the consequences of MCT1 inhibition in Burkitt lymphoma following treatment with AZD3965 Poster
Experimental and Molecular Therapeutics
Novel Antitumor AgentsSunday 17 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 17
Poster Board #6, Abstract #325
Avivar-Valderas A Functional significance of co-occurring mutations in PIK3CA and MAP3K1 in breast cancer Poster
Experimental and Molecular Therapeutics
Cellular Processes and Responses to TherapySunday 17 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 14
Poster Board #6, Abstract #240
Sandi C Dual mTOR inhibitor, AZD2014, and castration induce immunogenic effects and anti-tumour activity in prostate cancer mouse model Poster
Experimental and Molecular Therapeutics
PI3K/AKT Inhibitors Sunday 17 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 19
Poster Board #20, Abstract #389
Feng S AZD4547 and AZD5363 synergistically inhibit prostate cancer progression by modulating MAPK and AKT activation Poster
Molecular and Cellular Biology/Genetics
Oncogenes and Tumor Suppressor Genes and PathwaysMonday 18 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 9
Poster Board #24, Abstract #1174
Barry E Targeting MET Exon 14 mutations with the selective small molecule inhibitor Savolitinib Poster
Molecular and Cellular Biology/Genetics
Oncogene Function, Regulation and TargetingMonday 18 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 8
Poster Board #30, Abstract #1150
Diallo B The MEK1/2 inhibitor selumetinib appears as an efficient targeted therapy when used in an adjuvant setting in Patient-Derived Xenografts of Uveal Melanoma Poster
Experimental and Molecular Therapeutics
Experimental TherapeuticsMonday 18 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 16
Poster Board #8, Abstract #2087
Rodrik-Outmezguine VS Overcoming mTOR Resistance Mutations with a new generation mTOR inhibitor Poster
Experimental and Molecular Therapeutics
New Drugs, Therapeutic Targets, and Treatment Approaches Monday 18 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 18
Poster Board #17, Abstract #2147
Yang Z Anti-tumor activities of AZD3759, a novel EGFR inhibitor with excellent penetration cross central nervous system (CNS), in pre-clinical animal models Poster
Session Category TBD
Late-Breaking Research: Experimental and Molecular Therapeutics 2Monday 18 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 12
Poster Board #24, Abstract #LB-217
Searle EJ Treatment with the novel Akt inhibitor AZD5363 following radiotherapy improves tumor control in mouse models of head and neck cancer Poster
Experimental and Molecular Therapeutics
Preclinical Radiotherapeutics Tuesday 19 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 18
Poster Board #2, Abstract #3042
Greenawalt D Your targeted population might not be what you predict: Changes in tumor genetic landscapes post standard of care Poster
Clinical Research
Molecular Classification and Genomic ApplicationsTuesday 19 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 23
Poster Board #5, Abstract #3168
Greer Y MEDI3039, a novel highly potent tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL) receptor agonist, induces apoptotic cell death in breast cancer cells Poster
Molecular and Cellular Biology/Genetics
Cell Death 1 Tuesday 19 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 2

Poster Board #4, Abstract #3494

De Velasco MA The Jak1/2 inhibitor AZD1480 suppresses tumor growth and metastasis in genetically engineered mouse models of PTEN-deficient prostate cancer Poster
Experimental and Molecular Therapeutics
Targeting Protein Kinases, Death Pathways, and the Tumor Microenvironment Tuesday 19 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 19

Poster Board #26, Abstract #3864

Deng J Pre-clinical study using KRAS mutant mouse models for lung cancer immunotherapy Poster
Tumor Biology
Mechanisms of Tumorigenesis in Animal Models of Cancer 2Tuesday 19 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 32
Poster Board #22, Abstract #4184
McEachern K Predicting response to Mcl-1 targeting agents in NSCLC and Multiple Myeloma Poster
Molecular and Cellular Biology/Genetics
Cell Death 3Tuesday 19 Apr 13:00-17:00
Convention Center, Halls G-J, Poster Section 4
Poster Board #8, Abstract #3558
Palakurthi S Utilizing NSCLC PDXs derived from patients on osimertinib (AZD9291) clinical trials to further refine therapeutic strategies Poster
Tumor Biology
Therapeutic Studies in Patient-derived XenograftsWednesday 20 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 33
Poster Board #18, Abstract #5192
Nilsson M Beta blockers abrogate EGFR TKI resistance induced by adrenergic receptor-mediated upregulation of IL-6 and modulation of the LKB1/AMPK/mTOR axis Poster
Experimental and Molecular Therapeutics
Combination Therapies and Approaches to Sensitizing Cancer Cells to Drugs Wednesday 20 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 15
Poster Board #3, Abstract #4662
Chen H Therapeutic activity of bivalent BRD4 inhibitor AZD5153 in haematological cancers Poster
Experimental and Molecular Therapeutics
Epigenetic AgentsWednesday 20 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 16
Poster Board #16, Abstract #4705
Capasso A A phase IB study of the combination of AZD6244 hydrogen sulfate (selumetinib) and cyclosporin A (CsA) in patients with advanced solid tumors with an expansion cohort in metastatic colorectal cancer Poster Phase I Clinical trials 2 Wednesday 20 Apr 08:00-12:00

Convention Center, Halls G-J, Poster Section 13

Abstract #CT146

Cortes J Phase I studies of AZD1208, a PIM kinase inhibitor, in patients with recurrent or refractory acute myelogenous leukemia or advanced solid tumors Poster Phase I Clinical Trials 2 Wednesday 20 Apr 08:00-12:00

Convention Center, Halls G-J, Poster Section 13

Poster Board #8, Abstract #CT147

Antibody Drug Conjugates

Li J MEDI4276, a HER2-targeting antibody tubulysin conjugate, displays potent in vitro and in vivo activity in preclinical studies Poster
Experimental and Molecular Therapeutics
Monoclonal Antibodies and Antibody-Drug Conjugates Tuesday 19 Apr 08:00-12:00
Convention Center, Halls G-J, Poster Section 15
Poster Board #16, Abstract #2970

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

More than 60 presentations featuring 26 potential medicines across four key scientific ​platforms, including DNA Damage Response (DDR) and Immuno-Oncolog

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AstraZeneca and Eli Lilly and Company announce continuation of pivotal clinical trial for people with early Alzheimer’s disease

Pressmeddelanden   •   2016-04-08 08:02 CEST

Phase II/III trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase III after positive interim safety data

AstraZeneca and Eli Lilly and Company today announced that AMARANTH, a Phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue into Phase III of the Phase II/III seamless trial.

The AMARANTH independent data monitoring committee recommended the study continue without modification after a scheduled interim safety analysis was conducted. The analysis was not designed to review efficacy.

Menelas Pangalos, Executive Vice President, IMED Biotech Unit, AstraZeneca, said: “Alzheimer’s disease remains one of the biggest challenges facing medical science today. BACE inhibitors have the potential to target one of the key drivers of disease progression and we are delighted that our combined efforts have resulted in the development of AZD3293 moving into the next phase of study. Disease modifying approaches, such as this, have the potential to transform the treatment of Alzheimer’s disease and help patients in this area of large unmet medical need.”

AZD3293 has been shown in Phase I studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s disease and healthy volunteers. The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.

Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly said: “This is an important and meaningful step forward on the path to better understand the Alzheimer’s puzzle. We’d like to thank the AMARANTH participants and the trial investigators for taking part in this important study and thank our colleagues at AstraZeneca for their partnership.”

AstraZeneca and Lilly have also announced the planned initiation of a new Phase III trial for AZD3293. The trial, named DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia. DAYBREAK will begin enrolling participants in the third quarter of 2016.

AstraZeneca and Lilly announced an alliance in 2014 for the development and commercialisation of AZD3293/LY3314814. Under the agreement, Lilly leads clinical development, working with researchers from AstraZeneca’s Neuroscience Research and Development Team, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch.

Financial Considerations

Under the terms of the agreement, AstraZeneca will receive a further milestone payment from Lilly now that AZD3293 will move into Phase III testing. The payment of $100 million will be reported as Externalisation Revenue in AstraZeneca’s financial statements and does not change the financial guidance for 2016.

– ENDS –

NOTES TO EDITORS

About the AMARANTH study

AMARANTH is a Phase II/III study that is investigating the safety and efficacy of AZD3293 and testing the hypothesis that it is a disease-modifying treatment for patients with early Alzheimer’s disease. Early Alzheimer’s disease is defined as the continuum of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and patients diagnosed with mild Alzheimer’s dementia. The study, which has a two-year treatment period, aims to enroll more than 2200 patients in 14 countries.

About Alzheimer’s disease

Alzheimer’s disease, a fatal illness, is the most common form of dementia, accounting for 60 to 80 percent of dementia cases. There are currently an estimated 46 million people living with dementia worldwide, and this number is expected to grow to more than 74 million in 2030 and 131 million in 2050. Only 50 percent of people with dementia ever receive a formal diagnosis, and Alzheimer’s disease continues to be one of the most significant health challenges facing the world. The total estimated worldwide cost of dementia in 2015 was $818 billion. By 2018, dementia will become a trillion dollar disease, rising to $2 trillion by 2030.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

Phase II/III trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase III after positive interim safety data

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AstraZeneca to showcase clinical and scientific leadership in lung cancer at ELCC 2016

Pressmeddelanden   •   2016-04-06 13:05 CEST

Tagrisso™ late-breaker presentations provide updated data in first-line EGFRm and second-line EGFRm T790M lung cancer

Studies demonstrate use of blood based testing to identify patients for treatment with Iressa and Tagrisso

Data from exploratory immuno-oncology and small molecule combination studies to be presented during the conference

AstraZeneca and its global biologics research and development arm, MedImmune, will report new clinical trial and scientific data from their industry-leading lung cancer franchise of marketed and pipeline medicines at the European Lung Cancer Conference (ELCC) in Geneva, Switzerland, 13 -16 April, 2016.

Fifteen abstracts will be presented at the meeting including eight oral presentations, two “best abstracts” and two “late-breakers”. Five abstracts have been selected for the official press programme. Highlights will reinforce the potential of Tagrisso (osimertinib) for the treatment of specific types of advanced non-small cell lung cancer (NSCLC), compare plasma testing and tumour tissue biopsy for treatment decisions in advanced NSCLC, and demonstrate the progress of combination therapy in immuno-oncology.

Tagrisso in first- and second-line lung cancer treatment

Two oral, late-breaker presentations share data from the Tagrisso AURA studies. They build on evidence that supported the accelerated approval of Tagrisso as the first indicated treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic NSCLCin the US, EU and Japan.

On Thursday 14 April, updated efficacy and safety data will be presented from two Phase I expansion cohorts exploring Tagrisso as first-line treatment for patients with EGFRm advanced NSCLC (Abstract #LBA1_PR). Phase I/II data in pre-treated patients with EGFR T790M advanced NSCLC (Abstract #LBA2_PR) will also be presented. Both presentations will feature in the ELCC press programme on Thursday 14 April.

Mondher Mahjoubi, Senior Vice President, Head of Oncology, Global Product and Portfolio Strategy at AstraZeneca, said: “ELCC’s recognition of the importance of our data for the lung cancer community is very encouraging and we are excited to present more mature data from the AURA programme for our new, first-in-class lung cancer medicine, Tagrisso. We are also reaffirming our commitment to deliver the right treatment to the right patient based on scientific research, with updates from our pioneering plasma circulating tumour DNA trials.”

Plasma ctDNA testing: Delivering the right treatment to the right patient

Accurate identification of patients with tumours carrying key molecular mutations is essential for delivering next-generation targeted therapies to those most likely to benefit. Detection of plasma circulating tumour-derived DNA (ctDNA) in a simple blood test offers a minimally invasive alternative to tumour tissue biopsy, and is already available for identifying patients suitable for treatment with AstraZeneca’s Iressa.

Building on this work, the latest results from innovative research in minimally invasive plasma ctDNA analysis to identify patients with EGFRm T790M NSCLC and predict response to Tagrisso will be reported (Abstract #134O_PR and #135O_PR). Further data from the ASSESS study for EGFR mutation detection in plasma from this patient group will also be presented (Abstract #58O_PR). ASSESS is the first largescale “real-world” study comparing tumour biopsy with ctDNA testing for EGFRm in advanced NSCLC. These studies are highlighted in the ELCC press programme on Friday 15 April.

Marc Denis, Professor of Biochemistry and Molecular Biology at Nantes University Hospital, Nantes, France, said: “Plasma ctDNA testing has the potential to rapidly identify patients suitable for targeted therapy not just for lung cancer but across a wide range of tumour types. Availability of these simple blood tests may streamline diagnosis, including for patients where tumour samples are unavailable.”

Immuno-oncology (IO): Combination focus

AstraZeneca has a broad programme of combination clinical trials underway in oncology and continues to explore novel combination therapies addressing the needs of difficult-to-treat patients with lung cancer. Safety and efficacy data from two exploratory trials combining immunotherapies and small-molecules will be reported at ELCC. These presentations have been designated “best abstracts” (Abstracts #57O and #136O) by the conference.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca, said: “Durvalumab is the cornerstone of our IO portfolio and we have a rapidly-advancing development programme focused primarily on novel combinations. At ELCC, we are presenting the exceptional science behind our combination approach with abstracts describing the ongoing MYSTIC and NEPTUNE studies combining durvalumab with tremelimumab. These build on recent data showing the anti-tumour activity of this combination in patients with metastatic NSCLC irrespective of PD-L1 status, as published in The Lancet Oncology.”

– ENDS –

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at ELCC

Lead authorAbstract title Presentation details
Osimertinib
AURARamalingam SOsimertinib as first-line treatment for EGFR mutation-positive advanced NSCLC: updated efficacy and safety results from two Phase I expansion cohortsOralProffered papers – New strategies for EGFR addicted NSCLC

Thursday 14 Apr 14:45-16:15 Room B

Abstract # LBA1_PR

Late Breaker

Press Programme

AURA & AURA 2Yang JOsimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) andpooled Phase 2 (P2) resultsOral
Proffered papers – New strategies for EGFR
addicted NSCLCThursday 14 Apr 14:45-16:15 Room B

Abstract # LBA2_PR

Late Breaker

Press Programme

TATTONAhn M-JOsimertinib combined with durvalumab in EGFR-mutant non-small cell lung cancer: results from the TATTON Phase Ib trialOral Proffered papers – Best abstracts: the evolving landscape of immunotherapy
Friday 15 Apr 16:45-18:30
Room B
Abstract # 136O
AURAJenkins S Yang J to presentPlasma ctDNA analysis for detection of EGFR T790M mutation in patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (aNSCLC)OralProffered papers – NSCLC targeted therapy and circulating biomarkers Friday 15 Apr 09:00-10:40
Room C

Abstract # 134O

Press Programme

AURAOxnard G Plasma genotyping for predicting benefit from osimertinib in patients (pts) with advanced NSCLCOralProffered papers – NSCLC targeted therapy and circulating biomarkers Fri 15 Apr 09:00-10:40
Room C

Abstract # 135O

Press Programme

Gefitinib

Gibbons DEfficacy, safety and tolerability of MEDl4736 (durvalumab [DJ), a human lgG1 anti-programmed cell death ­ligand-1 (PD-L 1) antibody, combined with gefitinib (G): a Phase I expansion in TKl-naïve patients (pts) with EGFR mutant NSCLCOral Proffered papers – Best abstracts: the evolving landscape of immunotherapy
Friday 15 Apr 16:45-18:30 Room BAbstract # 57O
Yeh T Inhibition of pEGFR in paired tumour biopsies from TKI treatment-naïve EGFR mutant NSCLC patientstreated with gefitinib (EGFR inhibitor) or gefitinib in combination with durvalumab (anti-PD-L1)Poster discussion Targeting EGFR and ALK driven tumoursThursday 14 Apr 14:45-16:00 Room WAbstract # 60PD
Normanno NClinical and demographic features that influence EGFR mutation detection in plasma from patients (pts) with aNSCLC: the ASSESS experienceOral Proffered papers – NSCLC targeted therapy and circulating biomarkers Friday 15 Apr 09:00-10:40 Room CAbstract # 58O_PR

Press programme

Han BEfficacy, safety and tolerability of MEDl4736 (durvalumab [DJ), a human lgG1 anti-programmed cell death ­ligand-1 (PD-L 1) antibody, combined with gefitinib (G): a Phase I expansion in TKl-naïve patients (pts) with EGFR mutant NSCLCPoster discussion Targeting EGFR and ALK driven tumoursThursday 14 Apr 14:45-16:00 Room WAbstract #59PD
Aperribay E Level of concordance between EGFR mutation status obtained from tissue/cytology and blood (plasma) for advanced non‐small‐cell lung cancer in Spain: ASSESS studyPosterTumour biology and pathology Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 147TiP

Cadranel JReal life practice of gefitinib in patients (pts) with non-small-cell lung cancer (NSCLC) depending on epidermal growth factor receptor (EGFR) mutation status: results from the prospective EPIDAURE study PosterTumour biology and pathology Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 168P

Jin BCombination of chemotherapy and gefitinib as first-line treatment of patients with advanced lung adenocarcinoma and sensitive EGFR mutations: a randomised controlled trialOralProffered papers – New strategies for EGFR addicted NSCLCThu 14 Apr 14:45-16:15 Room B

Abstract # 131O

Durvalumab

NEPTUNEMok TPhase 3, randomised, open-label study of durvalumab (MEDI4736) in combination with tremelimumab versus platinum-based chemotherapy in first-line treatment of patients with advanced or metastatic NSCLC: NEPTUNEPosterTumour biology and pathology Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 192TiP

MYSTIC Peters SPhase 3, randomised, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTICPosterTumour biology and pathology Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 191 TiP

Rothschild SSAKK 16/14 – Anti-PD-L1 antibody durvalumab (MEDI4736) in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC). A multicenter single-arm phase II trialPosterTumour biology and pathology Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 129TiP

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates -- and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Media Enquiries
Neil BurrowsUK/Global+44 20 7604 8032
Vanessa RhodesUK/Global+44 20 7604 8037
Karen BirminghamUK/Global+44 20 7604 8120
Jacob LundSweden+46 8 553 260 20
Michele MeixellUS+1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen+44 7818 524185
Eugenia LitzRIA+44 7884 735627
Nick StoneCVMD+44 7717 618834
Craig MarksFinance+44 7881 615764
Christer GruvrisConsensus Forecasts+44 7827 836825
US
Lindsey TrickettOncology, ING+1 240 543 7970
Mitchell ChanOncology+1 240 477 3771
Dial / Toll-Free+1 866 381 7277
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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Pandemic influenza vaccine receives positive CHMP opinion

Pressmeddelanden   •   2016-04-01 17:00 CEST

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.

This positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared. Once the World Health Organisation has declared an actual pandemic, a variation dossier specific for the pandemic strain can be submitted to the EMA for an accelerated assessment and approval. This provides an additional public health tool to protect European children when the next pandemic emerges.

P/LAIV is an intranasally administered vaccine that contains a live attenuated H5N1 strain of influenza virus. The vaccine is based on the same biologically-active components currently used to make AstraZeneca/MedImmune’s approved seasonal influenza vaccine, Fluenz Tetra. P/LAIV differs from Fluenz Tetra, because it protects against a single influenza A pandemic strain as opposed to four seasonal strains in Fluenz Tetra.

The positive CHMP opinion was based on a review of safety and immunogenicity studies of the H5N1 vaccine conducted in collaboration with the US National Institutes of Health as well as by the comprehensive clinical data that demonstrate the safety and efficacy for Fluenz Tetra in children.

The CHMP’s opinion will now be advanced to the European Commission for adoption of a decision on EU-wide marketing authorisation of the vaccine as a pandemic preparedness vaccine. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.

– ENDS –

NOTES TO EDITORS

About Influenza Pandemics

Influenza pandemics are defined as world-wide flu epidemics with high levels of morbidity and mortality. An influenza pandemic can occur when a non-human (novel) influenza virus for which individuals have limited or no immunity gains the ability to be transmitted easily between humans and then spreads globally. The last pandemic occurred in 2009 and the global mortality rate has been estimated between 18,000 and 186,300 deaths.

About FluMist®/Fluenz

FluMist®Quadrivalent (US brand name) / Fluenz Tetra (EU brand name) is the only widely available quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray and contains four protective strains for the prevention of influenza.

FluMist was originally approved in the US in 2003 and since the original approval, more than 100 million doses have been distributed around the world. Since 2013 it has become the vaccine of choice in the UK’s largest pediatric vaccine programme and preferential recommendations have also been adopted by vaccine advisory groups in Canada, Finland, Sweden (high-risk individuals) and Germany (high-risk individuals). A general recommendation for quadrivalent LAIV in people aged two to 49 has been adopted in the US.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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Kontaktpersoner 3 kontaktpersoner

  • Presskontakt
  • Extern kommunikationsdirektör
  • jacob.lund@astrazeneca.com
  • 08 553 260 20 Mobil: 072 560 21 57

Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden - andningsvägar/inflammation/autoimmunitet (RIA), hjärta/kärl/metabolism (CVMD) och cancer men också områdena infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se