AstraZeneca expands 1st-line lung cancer immuno-oncology programme opportunities

AstraZeneca expands 1st-line lung cancer immuno-oncology programme opportunities

Refined endpoints and statistical analysis plan in the Phase III MYSTIC trial

China regulatory submission opportunity strengthened with the expansion of the Phase III NEPTUNE trial and the initiation of the new Asia-focused Phase III PEARL trial

AstraZeneca today provides an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial.

The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) chemotherapy, focused on progression-free survival (PFS).

The MYSTIC trial will now assess PFS and overall survival (OS) endpoints in patients with PDL1-expressing tumours for both durvalumab monotherapy and the combination of durva + treme, as well as in ‘all comers’ for the combination of durva + treme, versus SoC chemotherapy.

While the focus remains on exploring the benefit of durva + treme as combination therapy, the Company has updated the endpoints of the MYSTIC trial to include OS and PFS in durvalumab monotherapy. This is based on recent internal and external data, including durvalumab’s strong efficacy in monotherapy presented at recent medical meetings, as well as significant opportunities in the competitive landscape.

The estimated primary completion date hasbeen updated to reflect both an increase in patient recruitment (as reported in February 2016 with the inclusion of OS as a co-primary endpoint) and the event-based nature of the trial. As a result, the Company anticipates MYSTIC PFS data in mid-2017 and final OS data at the latest in 2018. MYSTIC also includes several undisclosed interim analyses for OS.

Additionally, the ongoing Phase III NEPTUNE trial will be expanded with local patients to support regulatory submission of durva + treme combination therapy in Chinafor 1st-line NSCLC patients without delaying the anticipated OS data readout in 2018 from the global cohort, which is approaching full recruitment. The Company has also initiated the new Phase III PEARL trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line NSCLC patients whose tumours express PD-L1. The PEARL trial focuses on Asian countries, primarily China, due to the high prevalence of NSCLC in the region.

All amendments will be reflected in updates to clinical trials websites, including clinicaltrials.gov.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The MYSTIC trial amendments, the NEPTUNE trial expansion and initiation of the new PEARL trial are all designed to enhance our options in 1st-line NSCLC for IO-IO combination as well as for IO monotherapy. We continue to follow the science through both internal and external sources for the benefit of patients and look forward to sharing our first pivotal data in mid-2017.”

About MYSTIC

The MYSTIC trial is a randomised, open-label, multi-centre, global, Phase III trial of durvalumab in combination with tremelimumab or durvalumab monotherapy versus SoC platinum-based chemotherapy in 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

About NEPTUNE

The NEPTUNE trial is randomised, open-label, multi-centre, global, Phase III trial of durvalumab in combination with tremelimumab versus SoC platinum-based chemotherapy in 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

About PEARL

The PEARL trial is a randomised, open-label, multi-centre Phase III trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic PDL1-expressing NSCLC. The trial was initiated to determine the efficacy and safety of durvalumab in Asian countries, some of which have the highest current NSCLC burden, with over 1.1 million new cases projected for China alone in 2030.

About Durvalumab

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 expression enables tumours to evade detection from the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks PD-L1 interaction with both PD-1 and CD80 on T cells, countering the tumour’s immune- evading tactics and activating the patient’s immune system to attack the cancer. Durvalumab received FDA Breakthrough Therapy Designation in patients with PD-L1 positive inoperable or metastatic UC in 2016 and Fast Track Designation in 2015 for the treatment of patients with PD-L1 positive metastatic head and neck squamous cell carcinoma. The durvalumab biological license application (BLA) in second-line urothelial carcinoma (UC) has been accepted by the FDA with a PDUFA date in the second quarter of 2017.

AstraZeneca’s Approach to Immuno-Oncology (IO)

IO is a therapeutic approach designed to stimulate the body’s immune system to destroy tumours. At AstraZeneca, and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial programme that includes durvalumab (PD-L1) monotherapy and durvalumab in combination with tremelimumab (CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our partners, may provide new treatment options across a broad range of tumours.

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 six 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, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. 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 and follow us on Twitter @AstraZeneca.

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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 terapiområden – andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. 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

Åtgärder för bättre arbetsmiljö och ökad patientsäkerhet vid Danderyds sjukhus

Åtgärder för bättre arbetsmiljö och ökad patientsäkerhet vid Danderyds sjukhus
Media vittnar om ett mycket ansträngt läge för medarbetarna på Danderyds sjukhus. Nu har dock läget lugnat ner sig och förhoppningsvis nåddes kulmen för några dagar sedan.

Media har idag rapporterat om att läget vid Danderyds sjukhus är mycket ansträngt. Särskilt jul- och nyårshelgen var mycket intensiv bland annat beroende på influensan som har startat flera veckor tidigare än normalt. Det har inneburit att fler patienter än vanligt måste läggas in och att medarbetare i vården har arbetat mycket hårt.

Så här ser Danderyds sjukhus åtgärdsplan ut:

  • Vi har öppnat upp 35-40 extra vårdplatser på sjukhuset.
  • Vi har tagit in extra läkare och annan vårdpersonal från olika specialiteter på sjukhuset, för att klara patientsäkerheten.
  • Alla kliniker samverkar på flera sätt. Medicinkliniken har varit hårt belastad men patienter har tagits om hand på närliggande kliniker där de vårdats. Utöver det har vi öppnat upp fler vårdplatser på medicinkliniken som till stor del bemannats med extrapersonal. 
  • Samtliga verksamhetsområden har undersökt möjligheten att minska planerade operationer och därmed kunnat styra om personal till sjukhusets akuta vård.
  • Vi har köpt vårdplatser inom vissa specialiteter hos andra närliggande vårdgivare, som kan ge oss lediga vårdplatser till de som behöver vår akutsjukvård bäst.
  • Vi har erbjudit ökad ersättning till alla personalkategorier.
  • Vi gör en översyn av belastningen på respektive vårdavdelning vid överbeläggningar för att förbättra samverkan mellan klinikerna på sjukhuset.
  • Vi har haft bakjoursmöten varje dag, där vi stämt av läget och beslutat om akuta åtgärder. Vi har satt in extra ledningsgruppmöten och haft kontinuerliga avstämningar med andra chefläkare i länet etc. Akutsjukhusen i Stockholm brukar kunna stötta varandra i den här typen av pressade lägen, men i år är läget lika pressat på alla sjukhus (precis som i övriga landet).

– Trots bristen på sjuksköterskor har vi kunnat öka antalet från 1 061 under 2014 till 1 123 under 2016. Det är en ökning med 5,8 procent, men bristen kvarstår och vi har en rad åtgärder som vi nu vidtar för att förbättra situationen, säger Lena Henning, stf sjukhusdirektör, och HR-direktör.

Sjukhusledningen följer kontinuerligt upp att åtgärderna genomförs på ett effektivt sätt och är beredda att vidta ytterligare åtgärder om det behövs. Patienterna ska få god vård och medarbetarna ska få rimliga förutsättningar för sitt arbete. Sjukhuset använder erfarenheter från den här situationen för att se över hur man kan organisera, styra och leda vården på sjukhuset vid extremt höga patientflöden i framtiden.

– Jag har stor förståelse för medarbetarna. Alla har gjort sitt yttersta i den här pressade situationen, som vi aldrig tidigare har upplevt, och vi från sjukhusledningen vill tacka alla medarbetare för sina fantastiska insatser och för en god samverkan mellan klinikerna, säger Lena Henning.

– Samtliga chefer kommer nu att vara extra uppmärksamma på sina medarbetares stressreaktioner efter en lång period av hög arbetsbelastning, och se till att stödåtgärder sätts in där det behövs.

Danderyds sjukhus är ett av landets största akutsjukhus. Det viktigaste för oss är att våra patienter känner sig trygga och säkra och får bästa möjliga vård och behandling. Det målet arbetar vi mot varje dag – tillsammans. Läs mer om oss på www.ds.se

Formellt beviljad särläkemedelsansökan i Europa för Idogen

Formellt beviljad särläkemedelsansökan i Europa för Idogen
Formellt beviljad särläkemedelsansökan i Europa för Idogen

Idogen AB (”Idogen”) meddelar idag att den Europeiska kommissionen formellt beviljat Idogen särläkemedelsstatus (orphan drug designation) för behandling av patienter med blödarsjuka (hemofili A) i Europa. Särläkemedelsstatus innebär flera viktiga fördelar för Idogen ‒ produkten erhåller ensamrätt på marknaden inom EU i tio år efter marknadsgodkännande och Idogen får möjlighet till kostnadsfri vetenskaplig rådgivning och lägre kostnader för regulatoriska ansökningar inför marknadsintroduktionen.

I december 2016 fattade den Europeiska läkemedelsmyndighetens kommitté för särläkemedel (Committee for Orphan medicinal products, COMP) ett positivt beslut avseende Idogens ansökan om särläkemedelsstatus i Europa. Därmed rekommenderade COMP den europeiska kommissionen att bevilja Idogen en särläkemedelsstatus. Europeiska kommissionen har nu formellt godkänt Idogens ansökan om särläkemedelsstatus i Europa för behandling av patienter med blödarsjuka.

”Att vi nu erhållit formell särläkemedelsstatus i Europa för vår första produkt är givetvis oerhört glädjande och betyder mycket för oss. Det innebär att vi nu får kostnadsfri rådgivning med Europeiska läkemedelsmyndigheten och marknadsexklusivitet för produkten i tio år efter godkännande, vilket är oerhört värdefullt för vår första produkt!”, kommenterar VD Lars Hedbys.

För ytterligare information om Idogen, vänligen kontakta:

Lars Hedbys, VD

Tel: 046-275 63 30

E-post: lars.hedbys@idogen.com

Denna information är sådan information som Idogen AB är skyldigt att offentliggöra enligt EU:s marknads­missbruks­förordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 16 januari 2017.

Idogen utvecklar tolerogena vacciner som programmerar om immunförsvaret. Benämningen ”tolerogen” kommer av att immunförsvaret efter behandling tolererar den valda molekylen. Det innebär en ny behandlingsmetod för autoimmuna sjukdomar, organavstötning efter transplantation och patienter som har utvecklat antikroppar mot behandling med biologiska läkemedel. Behandlingen bygger på att celler från patientens blod programmeras om till dendritiska celler med kapacitet att specifikt motverka en skadlig immunreaktion. Bolagets plattformsteknologi har potential att kunna utveckla långtidsverkande behandling av patienter som bildat antikroppar mot sitt ordinarie läkemedel och även för att behandla autoimmuna sjukdomar som idag inte går att bota. Härutöver har bolaget potential att förändra transplantationsmarknaden genom att minska behovet av immundämpande behandling efter transplantation. Idogen grundades år 2008 kring en immunologisk upptäckt vid Lunds Universitet. För mer information, besök www.idogen.com

Swedish/Danish Biotech Company 2A Pharma Raises SEK 27 Million and Signs Exclusive Worldwide License Agreement

New Swedish/Danish biotech company 2A Pharma AB has closed its first financing round and has been granted an exclusive, worldwide license from Medigene AG (FSE: MDG1) for its adeno-associated virus like particles (AAVLPs) technology.

Malmö, Sweden, 16 January 2016. 2A Pharma AB, based in Malmö, Sweden with research facilities in Aalborg, Denmark, aims to develop novel, cost effective vaccines and therapeutics based on Medigene AG’s AAVLP technology which was exclusively in-licensed by 2A Pharma AB in December 2016. The company’s first financing round of SEK 27 million, closed in December 2016, provides sufficient funding to complete phase I clinical trials of the lead drug candidate.

Prof.Dr. Søren Nielsen, CEO of 2A Pharma AB: “We are extremely pleased with the support we have received from our investors and the progress the team has achieved in a very short period. We believe we have tremendous opportunities to develop the company and its products, both internally and with partners. Our initial focus is to maintain an aggressive schedule for our first project to enable us to start clinical trials in 2018. This follows our strategy at Aalborg University to take science out where it makes a difference.”

Dr. John Nieland, COO of 2A Pharma AB and co-inventor of the AAVLP technology, adds: “The AAVLP platform is versatile and can be applied to a wide range of vaccines and therapeutics. While we currently focus on our lead drug candidate, a HPV vaccine which in laboratory tests has shown potential to be a very significant improvement over existing approved products, we have three other vaccines ready for clinical development and a significant pipeline of development opportunities.”

About AAVLP: AAVLPs offer the potential to develop vaccines and therapeutics against various indications, including cancer and infectious diseases. The adeno-associated virus is non-pathogenic, and the virus protein shell, the capsid, is well-suited to produce virus-like particles, as a basis for novel vaccines. AAVLPs have previously been developed as B-cell vaccines. Peptides inserted in the capsid can induce a humoral immune response (B-cell induction and antibody production). The first preclinical tests with AAVLPs were conducted by academic partners of Medigene AG.

2A Pharma AB was founded in December 2016 in Malmö, Sweden, with Prof.Dr. Søren Nielsen as CEO, Preben Bruun-Nyzell as CFO and Dr. John Nieland as COO, as a start-up biotech company with the aim to develop novel vaccine products. Strong private investors participated in the company’s first financing round. Jensen Corporate Finance, Malmö, www.jensencf.com, advised 2A Pharma.

For more information, please visit www.2apharma.com

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative, complementary treatment platforms to target various types and stages of cancer with candidates in clinical and pre-clinical development. Medigene concentrates on the development of personalized T cell-based immunotherapies.

For more information, please visit www.medigene.com

Contact 2A Pharma AB

Prof. Dr. Søren Nielsen, CEO

Tel: +45 2539 4137

Email: sn@2apharma.com

2A Pharma AB was founded in December 2016 in Malmö, Sweden, with Prof.Dr. Søren Nielsen as CEO, Preben Bruun-Nyzell as CFO and Dr. John Nieland as COO, as a start-up biotech company with the aim to develop novel vaccine products. Strong private investors participated in the company’s first financing round.

Europeiska patentverket avser att bevilja Idogens patentansökan

Europeiska patentverket avser att bevilja Idogens patentansökan
Europeiska patentverket avser att bevilja Idogens patentansökan

Idogen AB (”Idogen”) meddelar idag att det europeiska patentverket (”EPO”) har utfärdat ett ”Notice of intention to grant”, vilket innebär att patentverket avser att bevilja Idogens patentansökan, som täcker bolagets tolerogena vaccinteknologi. En relaterad patentansökan fick i december 2016 ”Notice of Allowance” i Japan. Patentet, och dess validering i viktiga Europeiska länder, kommer att ge Idogens vaccinteknologi ett brett skydd och stärker bolagets patentportfölj ytterligare.

EPO har meddelat att de avser bevilja Idogens patentansökan med ansökningsnummer 11850142.8. Detta patent tillhör Idogens andra patentfamilj och avser inducering av IDO för behandling av autoimmuna sjukdomar eller bortstötning av transplanterade organ. En relaterad ansökan fick i december 2016 ”Notice of Allowance” i Japan och andra ansökningar är under handläggning i Kanada, USA och internationellt. Det godkända patentet kommer att komplettera ett tidigare europeiskt patent i Idogens första patentfamilj som godkändes i december 2013. Formellt godkännande av detta andra patent beräknas att erhållas från EPO inom två till tre månader efter att Idogen slutfört rutinmässiga formaliteter under kommande veckor.

”Patentet ger ett mycket viktigt skydd för vår tolerogena vaccin-plattform på den europeiska marknaden – en betydande marknad för oss. Beslutet från det europeiska patentverket att de avser att bevilja patentet är mycket glädjande”, kommenterar VD Lars Hedbys.

För ytterligare information om Idogen, vänligen kontakta:

Lars Hedbys, VD

Tel: 046-275 63 30

E-post: lars.hedbys@idogen.com

Denna information är sådan information som Idogen AB är skyldigt att offentliggöra enligt EU:s marknads­missbruks­förordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 13 januari 2017.

Idogen utvecklar tolerogena vacciner som programmerar om immunförsvaret. Benämningen ”tolerogen” kommer av att immunförsvaret efter behandling tolererar den valda molekylen. Det innebär en ny behandlingsmetod för autoimmuna sjukdomar, organavstötning efter transplantation och patienter som har utvecklat antikroppar mot behandling med biologiska läkemedel. Behandlingen bygger på att celler från patientens blod programmeras om till dendritiska celler med kapacitet att specifikt motverka en skadlig immunreaktion. Bolagets plattformsteknologi har potential att kunna utveckla långtidsverkande behandling av patienter som bildat antikroppar mot sitt ordinarie läkemedel och även för att behandla autoimmuna sjukdomar som idag inte går att bota. Härutöver har bolaget potential att förändra transplantationsmarknaden genom att minska behovet av immundämpande behandling efter transplantation. Idogen grundades år 2008 kring en immunologisk upptäckt vid Lunds Universitet. För mer information, besök www.idogen.com

STUDY RESULTS PUBLISHED IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION SHOW AMGEN’S PARSABIV™ (ETELCALCETIDE) SIGNIFICANTLY REDUCED SERUM PARATHYROID HORMONE IN ADULTS WITH SECONDARY HYPERPARATHYROIDISM ON HEMODIALYSIS

THOUSAND OAKS, Calif. (Jan. 10, 2016) – Amgen (NASDAQ:AMGN) today announced the Journal of the American Medical Association (JAMA) publication of findings from three Phase 3 studies of Parsabiv™ (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Parsabiv in more than 1,700 adults with secondary hyperparathyroidism (sHPT) on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker of sHPT. sHPT is a chronic and serious condition that is often progressive among patients with chronic kidney disease (CKD) and is associated with significant clinical consequences.1

“sHPT is often a progressive condition in patients with advanced chronic kidney disease, including those with kidney failure. Despite the use of phosphate binders and calcitriol or active vitamin D analogs, management of sHPT has been relatively poor in a sizeable proportion of patients,” said Glenn M. Chertow, M.D., professor of Medicine and chief of the Division of Nephrology at Stanford University School of Medicine. “Intravenous treatment with etelcalcetide could give healthcare providers greater control over calcimimetic delivery, and provide patients with sHPT on hemodialysis an additional treatment option, lowering parathyroid hormone and improving other key laboratory parameters.”

In two parallel Phase 3 randomized placebo-controlled studies in CKD patients with sHPT on hemodialysis, Parsabiv met the primary endpoint and significantly reduced serum PTH by more than 30 percent in 74.7 percent of patients compared to 8.9 percent given placebo. In addition, a head-to-head study comparing Parsabiv to oral Sensipar® (cinacalcet) also met its primary endpoint. This head-to-head study showed Parsabiv was non-inferior to oral Sensipar in the proportion of patients achieving 30 percent or greater serum PTH reduction. Further, Parsabiv was superior to Sensipar for the secondary endpoints of proportion of patients achieving greater than 30 percent and greater than 50 percent reduction in mean PTH during the Efficacy Assessment Phase (EAP) compared with baseline.

A total of 1,706 patients were enrolled across the three trials to evaluate the safety and efficacy of Parsabiv in the treatment of adult sHPT patients on hemodialysis.

The two placebo-controlled trials were double-blind studies in a total of 1,023 adult patients with sHPT on hemodialysis. The patients were randomized to receive intravenous Parsabiv or placebo three times a week at the end of their dialysis sessions, and both arms also received standard of care as prescribed by the treating physician. Both of the trials showed that, by weeks 20-27, significantly more Parsabiv patients compared to placebo patients, achieved:

  • Greater than a 30 percent reduction from baseline in mean serum PTH during weeks 20-27:74.0 percent versus 8.3 percent (p<0.001) and 75.3 percent versus 9.6 percent (p<0.001)
  • Serum PTH levels of 300 pg/mL or less: 49.6 percent versus 5.1 percent (p<0.001) and 53.3 percent versus 4.6 percent (p<0.001)

The most common treatment-emergent adverse events (TEAEs) in the placebo-controlled studies that occurred at a rate greater than 10 percent in the Parsabiv group, and more frequently than in the placebo group in either of the studies, were blood calcium decreases (asymptomatic reductions in serum calcium), muscle spasms, diarrhea, nausea and vomiting. The overall rates of fatal adverse events, serious adverse events and adverse events leading to discontinuation of investigational product were similar in the Parsabiv and placebo groups.

The head-to-head study against Sensipar included 683 patients with sHPT on hemodialysis, and found Parsabiv resulted in a higher proportion of patients reaching at least a 30 percent reduction in mean serum PTH during weeks 20-27 compared to baseline: 68.2 percent versus 57.7 percent, respectively (p=0.004). Significantly more Parsabiv patients also achieved greater than a 50 percent reduction from baseline in mean serum PTH during weeks 20-27: 52.4 percent versus 40.2 percent, respectively (p=0.001). There was no statistically significant difference between the two groups in the mean number of days of vomiting or nausea per week in the first eight weeks, a secondary endpoint.TEAEs that were reported in greater than 10 percent of patients in either arm included blood calcium decreases, nausea, vomiting and diarrhea. TEAEs of hypocalcemia (symptomatic) were reported in 5.0 percent of patients who received Parsabiv versus 2.3 percent in the Sensipar group.

“As we work toward advancing the treatment of patients with sHPT on hemodialysis, the findings published in JAMA are particularly noteworthy given patients were typically receiving conventional therapy for sHPT, but showed a sustained reduction in PTH over 26 weeks in the placebo controlled trials,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are encouraged by these data as they demonstrate improvements in key biomarkers for sHPT and support its potential for a disease that has not seen any advances in more than a decade.”

In the U.S., the Parsabiv application has been resubmitted to the Food and Drug Administration (FDA) addressing the Complete Response Letter. The US user fee goal date is February 9, 2017. On Nov. 11, 2016, the European Commission (EC) granted marketing authorization for Parsabiv for the treatment of sHPT in adult patients with CKD on hemodialysis.Russian regulatory authorities approved Parsabiv on Dec. 5, 2016. Regulatory submissions for Parsabiv are currently pending in Colombia, Brazil, Switzerland and South Africa. On Dec. 19, 2016, Amgen’s collaborator, Ono Pharmaceuticals, received manufacturing and marketing approval in Japan for Parsabiv for the treatment of secondary hyperparathyroidism in patients on hemodialysis.

About the Phase 3 Placebo-Controlled Studies

In the two 26-week, multicenter, randomized, double-blind, placebo-controlled studies, an aggregate of 1,023 adult patients with sHPT (PTH greater than 400 pg/mL) on hemodialysis were randomized to receive intravenous Parsabiv or placebo three times a week at the end of their dialysis sessions. All patients, regardless of treatment assignment, received standard of care with phosphate binders and calcitriol or active vitamin D analogs, as prescribed.

The primary endpoint of the studies was the proportion of patients achieving greater than 30 percent reduction in PTH during the EAP. Secondary endpoints included the proportion of patients with PTH less than or equal to 300 pg/mL during the EAP, and percent change from baseline during the EAP for PTH, serum calcium, phosphate and calcium phosphate product (Ca x P).

About the Phase 3 Head-to-Head Study

The Phase 3 randomized, double-blind, double-dummy, active controlled trial was designed to compare the efficacy and safety of intravenous Parsabiv and oral Sensipar in 683 adult sHPT patients (340 randomized to Parsabiv and 343 to Sensipar) on hemodialysis. The patients were from 164 sites in the U.S., Canada, Europe, Russia and New Zealand. Patients receiving maintenance hemodialysis three times per week with sHPT (pre-dialysis serum PTH>500 pg/mL) on stable doses of calcium supplements or phosphate binders and calcitriol or active vitamin D analogs, if prescribed, with albumin-corrected serum calcium >8.3 mg/dL were eligible for participation.

Patients who were randomized to treatment with Parsabiv/oral placebo received intravenous doses three times a week at the end of their dialysis sessions and daily oral doses of placebo tablets. Patients in the comparison group received daily oral doses of Sensipar tablets and intravenous doses of placebo three times a week at the end of their dialysis sessions. The primary endpoint was the proportion of patients with greater than 30 percent reduction from baseline in mean serum PTH during the EAP (weeks 20-27). Key secondary endpoints included the proportion of patients with greater than 50 percent and greater than 30 percent reduction in PTH, and the mean weekly days of self-reported nausea and vomiting over the first eight weeks.

About Secondary Hyperparathyroidism

sHPT is a chronic and serious condition which affects many of the approximately two million people throughout the world who are receiving dialysis, including 468,000 people in the U.S.1-3 Approximately 88 percent of dialysis patients and 79 percent of patients on hemodialysis will develop sHPT.4 sHPT refers to the excessive secretion of PTH by the parathyroid glands in response to decreased renal function and impaired mineral metabolism.1,5 The elevated levels of PTH can lead to an increase in the release of calcium and phosphorus from the bones.6 sHPT is often initially silent and asymptomatic.1 As a result, sHPT is frequently underdiagnosed and undertreated.1,7

About Parsabiv™ (etelcalcetide) in the U.S.

Parsabiv is a novel calcimimetic agent in clinical development for the treatment of sHPT in adult CKD patients on hemodialysis that is administered intravenously at the end of the hemodialysis session. A calcimimetic is a drug that mimics the action of calcium by activating the calcium-sensing receptors on the parathyroid gland. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing PTH levels.

Parsabiv Indication and Important Safety Information in the EU

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Parsabiv should not be initiated if corrected serum calcium is less than the lower limit of the normal range.

Special Warnings and Precautions:

Hypocalcaemia: Since Parsabiv lowers serum calcium, patients should be advised to seek medical attention if they experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia. Serum calcium levels should be measured prior to initiating treatment, within 1 week of initiation or dose adjustment of Parsabiv and every 4 weeks during treatment. Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and seizures. Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. The threshold for seizures may be lowered by significant reductions in serum calcium levels.

Worsening heart failure: Decreased myocardial performance, hypotension, and congestive heart failure may be associated with significant reductions in serum calcium levels.

Co-administration with other medicinal products

Administer Parsabiv with caution in patients receiving any other medicinal products known to lower serum calcium. Patients receiving Parsabiv should not be given cinacalcet. Concurrent administration may result in severe hypocalcaemia.

Interactions: No interaction studies have been performed. There is no known risk of pharmacokinetic interaction with Parsabiv.

Fertility, Pregnancy and Lactation: There are no or limited amount of data from the use of Parsabiv in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Parsabiv therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. No data are available on the effect of Parsabiv on human fertility. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Undesirable Effects: The following common (≥10%) adverse reactions have been reported in pivotal, controlled clinical studies: decreases in serum calcium, diarrhea, nausea, vomiting, and muscle spasms.

Pharmaceutical Precautions: Store in a refrigerator (2 degrees C – 8 degrees C). Once removed from the refrigerator, Parsabiv must be used within 7 days if stored in the original carton.

To see the full Parsabiv Safety Information, visit http://www.ema.europa.eu

About Sensipar® (cinacalcet) in the U.S.

Sensipar® (cinacalcet) is the first oral calcimimetic agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of sHPT in adult patients with CKD on dialysis. Sensipar is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia. The therapy is also approved in the U.S. for treatment of hypercalcemia in adult patients with parathyroid carcinoma and hypercalcemia in adult patients with primary hyperparathyrodisim (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. Sensipar binds to the calcium-sensing receptor, resulting in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Sensipar Important Safety Information in the U.S.

Sensipar®(cinacalcet) treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Sensipar®lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar®, including pediatric patients. Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcemia have been reported in patients treated with Sensipar®.

Significant reductions in calcium may lower the threshold for seizures. Patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.

In Sensipar®postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar®therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL. Patients with moderate to severe hepatic impairment should be monitored throughout treatment with Sensipar®, as cinacalcet exposure assessed by area under the curve (AUC) was higher than in patients with normal hepatic function.

Patients with secondary HPT: Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months. Patients with primary HPT or parathyroid carcinoma: Serum calcium should be measured within 1 week after initiation or dose adjustment of Sensipar®. Once maintenance dose levels have been established, serum calcium should be measured every 2 months.

In clinical trials of patients with secondary HPT comparing Sensipar®to placebo, the most commonly reported side effects were nausea (31 percent vs. 19 percent), vomiting (27 percent vs. 15 percent), and diarrhea (21 percent vs. 20 percent). In clinical trials of patients with primary HPT and parathyroid carcinoma treated with Sensipar®, the most commonly reported side effects were nausea (63 percent), vomiting (46 percent), and paresthesia (20 percent).

Please seeFull Prescribing Information.

About Mimpara® (cinacalcet) in the EU

Mimpara® (cinacalcet) is the first oral calcimimetic agent approved by the European Medicines Agency for the treatment of sHPT in patients with CKD on dialysis. The therapy is also approved in the EU for the treatment of hypercalcemia in patients with parathyroid carcinoma and hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. Mimpara binds to the calcium-sensing receptor, resulting in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Mimpara Important Safety Information in the EU

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

Special Warnings and Precautions:

Serum Calcium:

Mimpara treatment should not be initiated in patients with a serum calcium below the lower limit of the normal range. Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult and paediatric patients treated with Mimpara. Manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions. Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia. The threshold for seizures is lowered by significant reductions in serum calcium levels. Patients should be monitored carefully for the occurrence of hypocalcaemia. Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara. Once the maintenance dose has been established, serum calcium should be measured approximately monthly.

Hypotension and/or worsening heart failure: In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.

Hepatic impairment:

Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment, Mimpara should be used with caution in these patients and treatment should be closely monitored.

In the treatment of secondary hyperparathyroidism the most commonly reported adverse reactions in clinical trials were nausea and vomiting.

To see the full Mimpara Safety Information, visit http://www.ema.europa.eu

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

###

CONTACT: Amgen, Thousand Oaks

Kristen Davis, 805-447-3008 (media)

Kristen Neese, 805-313-8267 (media)

Arvind Sood, 805-447-1060 (investors)

1Tomasello S. Secondary Hyperparathyroidism and Chronic Kidney Disease. Diabetes Spectrum. 2008 Jan;21(1)19-25.

2 Liyanage T, Ninomiya T, Jha V, et al. Worldwide access to treatment for end-stage kidney disease:

a systematic review. Lancet. 2015; 385: 1975–82..

3 National Kidney Foundation. Fast Facts. Available at: https://www.kidney.org/news/newsroom/factsheets/FastFacts. Accessed November 28, 2016.

4 Data on File, Amgen; 2016.

5 Joy MS, Karagiannis PC, Peyerl FW. Outcomes of secondary hyperparathyroidism in chronic kidney disease and the direct costs of treatment. J Manag Care Pharm. 2007 Jun;13(5)397-411.

6 National Institutes of Health. MedlinePlus: Hyperparathyroidism. Available at: www.nlm.nih.gov/medlineplus/ency/article/001215.htm. Accessed November 28, 2016.

7 National Kidney Foundation. Parathyroid Hormone and Secondary Hyperparathyroidism in Chronic Kidney Disease. Available at: https://www.kidney.org/sites/default/files/02-10-4899_GB_SHPT-PTH_v8.pdf. Accessed November 28, 2016.

Riddarens vårdcentral inleder samarbete med MIND Stockholm

Riddarens vårdcentral inleder samarbete med MIND Stockholm

För att kunna ge våra patienter bästa tänkbara vård inom alla områden nära hemmet inleder Riddarens vårdcentral ett samarbete med MIND Stockholm gällande psykosocialt stöd. 

Detta innebär att inom kort kommer Riddarens patienter kunna träffa legitimerade psykologer, psykoterapeuter, psykiatriker och kuratorer på kliniken. Tills dessa är på plats hänvisas våra remitterade patienter till MIND Stockholms egen klinik. 

Hammad Al-Saaid VD Riddarens Vårdcentral om samarbetet:
Vi vill kunna ge alla våra patienter en så bra vård som möjligt, oavsett åkomma, i deras geografiska närområde. Vi har remitterat patienter till MIND Stockholm under en period och vi ser det som ett naturlig steg att nu kunna dela lokaler med dem i Kista. Våra patienter behöver inte längre åka längre sträckor för att träffa kvalificerad personal. Dessutom delar MIND vår vision om en digitaliserad sjukvård och de har redan nu digitala lösningar som vi med spänning följer. 

Åsa Hedrén Videbæk VD MIND Stockholm om samarbetet: 
Vi är stolta över samarbetet med Riddarens vårdcentral. Det är en innovativ vårdcentral med patientens behov och önskemål i centrum, värderingar som vi på MIND Stockholm delar. Vi ser mycket fram emot att tillsammans förbättra vården för psykisk ohälsa så att den blir ännu mer på patienternas villkor.

Webuild Group är verksam inom hälso- och sjukvård, vård och omsorg, IT samt ekonomi. Inom hälso- och sjukvård är Webuild verksamma under namnet Riddarens vårdcentral – Sveriges modernaste vårdcentral.

Webuild syftar till digitaliseringen och automatisering av tjänster inom hälso- och sjukvård samt omsorgssektorn. Enligt SKL ska Sverige vara ledande inom e-hälsa 2025 och där ämnar Webuild att vara ledande. Redan i dag är Webuild med dess vårdenheter under Riddarens och vårdplattformen Omentia världsledande inom hälsa- och sjukvård. Inom Webuild finns även MinFam vars mål är att vara motsvarigheten till Omentia inom vård och omsorg.

Ny kommunikationschef på Läkemedelsverket

Ny kommunikationschef på Läkemedelsverket

Birgitta Brink har anställts som kommunikationschef på Läkemedelsverket och tillträdde den 9 januari 2017. Birgitta kommer närmast från en tjänst som verksamhetsutvecklare på Folkhälsomyndigheten.

Birgitta har under större delen av sitt yrkesliv arbetat i ledande roll inom kommunikationsområdet. Hon byggde upp Smittskyddsinstitutets kommunikationsverksamhet från grunden och ansvarade som kommunikationschef under 13 år, innan myndigheten gick samman med Folkhälsomyndigheten, där Birgitta förvärvade viktig GD-stabserfarenhet.

– Läkemedelsverkets uppdrag kräver omvärldskontakt och dialog med flera grupper i samhället; från allmänhet, media och opinionsbildare till industrin, akademin och olika vårdaktörer. Birgitta har mångårig kommunikationserfarenhet och det i kombination med en gedigen myndighetskompetens borgar för att myndighetens kommunikation ska utvecklas och gå i linje med vårt uppdrag, säger Läkemedelsverkets generaldirektör Catarina Andersson Forsman.

– Jag ser väldigt mycket fram emot att leda, förvalta och utveckla Läkemedelsverkets kommunikation samt att få vara en del av en av Europas ledande organisationer för folk- och djurhälsa, säger Birgitta Brink.

Läkemedelsverkets uppgift är att se till att den enskilde patienten, hälso- och sjukvården samt djursjukvården får tillgång till säkra och effektiva läkemedel av god kvalitet och att dessa används ändamålsenligt och kostnadseffektivt. Myndigheten ansvarar också för tillsyn av medicintekniska produkter, tatueringsfärger samt kosmetiska och hygieniska produkter. Läs mer om oss på www.lakemedelsverket.se.

Takeda to Acquire ARIAD Pharmaceuticals, Inc.

Strategic Highlights

  • Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology
  • Accretive to Takeda’s Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth
  • Attractive value drivers include two very innovative precision medicines, Iclusig®(ponatinib) and brigatinib, an exciting early stage pipeline and cost synergies
    • Iclusig is a globally commercialized product with continued strong sales growth potential
    • Brigatinib approval in the U.S. is expected in the first half of 2017, with peak sales potential over $1 billion and the potential to be the best-in-class ALK inhibitor
    • Takeda will leverage ARIAD’s research and development capabilities and platform
  • Takeda retains financial flexibility with no impact on dividend policy

Cambridge, Mass. and Osaka, Japan, January 9, 2017 – Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) (“ARIAD”) today announced that they have entered into a definitive agreement under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or an enterprise value of approximately $5.2 billion. The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions. Sarissa Capital, the holder of 6.6% of ARIAD’s common shares, as well as each of the members of ARIAD’s Board of Directors have agreed to tender their shares to Takeda pursuant to the offer.

“The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders,” said Christophe Weber, president and chief executive officer of Takeda. “This is a very exciting time for Takeda as we will broaden our hematology portfolio and transform our global solid tumor franchise through the addition of two innovative targeted therapies. Opportunities to acquire such high-quality, complementary targeted therapies do not come often, and we are very excited about the potential for this transaction to benefit patients, our shareholders and other stakeholders.”

Paris Panayiotopoulos, president and chief executive officer of ARIAD, said, “We are very pleased to combine with Takeda, which will allow us to not only accelerate our mission to discover, develop and deliver precision therapies to patients with rare cancers, but also deliver immediate and meaningful value to our shareholders through a substantial cash premium. This exciting transaction is a testament to the hard work and dedication of ARIAD’s talented team of employees. We have tremendous respect for Takeda, and I believe our shared commitment to innovation and research-driven cultures will provide for a smooth transition.”

“This transaction is a great outcome for shareholders of ARIAD and Takeda. Both ARIAD and Takeda are passionate about helping cancer patients, and I believe the talent and resources of Takeda coupled with ARIAD’s pipeline and people will accelerate the development of cancer treatments. I would like to extend my deepest gratitude to the management team and everyone at ARIAD for their unrelenting dedication,” said Alexander J. Denner, Ph.D., Chairman of the Board of ARIAD.

Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology

The acquisition of ARIAD brings two innovative targeted therapies that will expand and enhance Takeda’s existing oncology portfolio. Brigatinib, an investigational drug product, has the potential to add a differentiated, global therapy in a genetically-defined subpopulation of non-small cell lung cancer (NSCLC). The addition of Iclusig will broaden Takeda’s strong hematology franchise to include chronic myeloid leukemia (CML) and a subset of acute lymphoblastic leukemia (ALL). Together, these two innovative targeted therapies will position Takeda for sustainable long-term growth in oncology.

Takeda’s track record of successful oncology product launches [ADCETRIS® (Brentuximab Vedotin), NINLAROTM (ixazomib) and VELCADE® (bortezomib)] means it has the experience and expertise required to deliver the successful launch of brigatinib and to ensure that it achieves global reach and share of voice thereafter.

Accretive to Takeda’s Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth

The transaction is a compelling opportunity for Takeda shareholders. It will provide immediate revenue, bring considerable long-term revenue potential and deliver synergy savings.

ARIAD provided calendar year 2016 revenue guidance for Iclusig of $170-180 million, and Takeda expects significant long-term revenue potential from the two lead assets.

Takeda projects the acquisition of ARIAD to be accretive to Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch.

Attractive value drivers include two very innovative medicines, Iclusig and brigatinib, an exciting early stage pipeline and cost synergies

Iclusig, a commercialized therapy with continued strong sales growth potential, delivers immediate value. Brigatinib, an investigational drug product with peak annual sales potential of over $1 billion, will generate significant long-term value for Takeda. U.S. approval is expected in the first half of 2017 with global filing thereafter. Beyond Iclusig and brigatinib, ARIAD’s commitment and expertise in targeted kinase inhibition linked to strong translational science generated further pipeline opportunities which provide additional long-term upside potential.

Takeda will leverage ARIAD’s R&D capabilities and platform, and largely absorb its R&D costs within Takeda’s existing R&D budget. G&A cost synergies will be fully captured by FY2018.

Takeda retains financial flexibility with no impact on dividend policy

The transaction will be funded by up to $4.0 billion of new debt and the remainder from existing cash. FY2017 Net Debt/EBITDA is estimated at approximately 2.6x, which is expected to remain investment grade. The transaction has no impact on Takeda’s dividend policy.

Transaction terms

The acquisition is structured as an all cash tender offer by a subsidiary of Takeda for all of the outstanding shares of ARIAD common stock, followed by a merger in which remaining shares of ARIAD would be converted into the right to receive the same $24.00 cash per share price paid in the tender offer and ARIAD will become an indirect wholly owned subsidiary of Takeda.

The transaction is subject to the tender of a majority of the outstanding shares of ARIAD common stock as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close by the end of February 2017.

Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of Takeda, has established Kiku Merger Co., Inc. to effect the transaction.

Company name ARIAD Pharmaceuticals, Inc.
Headquarters 125 Binney Street, Cambridge, Massachusetts 02142, USA
Representative Paris Panayiotopoulos, President and Chief Executive Officer
Business description ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines.
Capital US$1,339 million (Additional paid-in capital as of December 31, 2015)
Date of establishment April, 1991
Major shareholders and percentage of shares held* Wellington Management Group LLP 8.8%
FMR LLC 7.8%
Vanguard Group Inc. 6.8%
Others
Relationships between Takeda Capital relationship Not applicable
Personnel relationship Not applicable
Transactional relationship Not applicable
Operating result and financial conditions for the last three years (consolidated)
Accounting period Fiscal year ended December 31, 2013 Fiscal year ended December 31, 2014 Fiscal year ended December 31, 2015
Net assets
(US$ in thousands)
185,517 80,801 (103,141)
Total assets
(US$ in thousands)
370,894 603,116 546,692
Net assets per share
(US$)
1.01 0.43 (0.55)
Revenue
(US$ in thousands)
45,561 105,412 118,804
Operating profit
(US$ in thousands)
(273,566) (160,195) (217,276)
Net loss
(US$ in thousands)
(274,158) (162,602) (231,156)
Net loss per share
(US$)
(1.49) (0.87) (1.23)

* As reported in the 13F filings. Percentage of shares is calculated by dividing the number of shareholdings (as of the end of September 2016) by the number of total shares outstanding of the target company.Change in ownership before and after acquisition

(1) Number of shares already acquired 0 shares
Percentage of voting rights: 0%
(2) Number of shares to be acquired 194,389,661 shares*
Percentage of voting rights: 100% (planned)
* Total shares outstanding

Schedule

(1) Board meeting resolution January 6, 2017
(2) Signing date January 8, 2017
(3) Commencement date and settlement date of the tender offer From January, 2017 to February, 2017
**The initial period of the tender offer will commence within 10 business days following execution of the merger agreement with ARIAD [January 8, 2017 (U.S.)], and will close 20 business days after commencement. If the conditions of the tender offer are not satisfied, the period of the tender offer will be extended, but the extension period will not exceed May 2017 (or August 2017 if antitrust clearance not received).
(4) Completion of acquisition By the end of February, 2017 (planned)*

* Fulfillment of the terms and conditions of the U.S. Antitrust Law and the satisfaction of certain other customary conditions are required to complete the acquisition.

Outlook

FY2016

At this stage we expect minimal impact on Underlying Revenue and Underlying Core Earnings. We do expect to incur transition and integration expenses, however, these expenses are not material to the current year result. We will incorporate the financial impact in our FY2016 consolidated earnings forecast and announce at the third quarter earnings conference in February 2017.

FY2017 and beyond

It is expected that the acquisition of ARIAD will be accretive to Takeda’s Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch. Takeda’s financial guidance, including EPS, for FY2017 will be announced when Takeda reports earnings for FY2016 in May 2017.

Conference Call Webcast Information

Takeda will host a media/investors conference call at 7:30 p.m. EST January 9, 2017 (9:30 a.m. JST January 10, 2017) to discuss the transaction.

You can listen to the conference call at the following link:
http://www.Takeda.com/investor-information/results/

A replay of the conference call will be available within 24 hours.

In light of this announcement, ARIAD will not be presenting today at the 35th Annual J.P. Morgan Healthcare Conference.

I Sverige är Takeda ett sälj- och marknadsbolag för både receptbelagda och receptfria läkemedel inom hjärta/kärl, gastroenterologi, inflammatoriska och immunologiska sjukdomar, onkologi, kirurgi och smärta. Takeda har en mycket spännande pipeline med ett antal nya produkter som kommer att lanseras under de kommande åren. Det svenska dotterbolaget har cirka 45 anställda och en omsättning som år 2015 nådde 438 miljoner kronor. Kontoret ligger i Bergshamra, i omedelbar närhet till tunnelbana och bussar.

Takeda globalt är en läkemedelskoncern med inriktning mot specialistvård. Koncernen har cirka 31 300 anställda och en omsättning om cirka 14,6 miljarder Euro. Idag är Takeda representerat i 70 länder och marknadsför och säljer produkter i mer än 100 länder.

Takeda – Japans största läkemedelsföretag har en lång historia, med mer än 230 års erfarenhet inom läkemedelsområdet. Takeda strävar mot en bättre hälsa för människor över hela världen genom ledande innovationer inom läkemedelsområdet.

För mer information vänligen besök: www.takeda.se och/eller www.takeda.com

MSD välkomnar bred vaccinportfölj tillbaka i verksamheten

MSD välkomnar bred vaccinportfölj tillbaka i verksamheten

Vid årsskiftet får MSD tillbaka tio vacciner från det tillsammans med Sanofi gemensamma bolaget Sanofi Pasteur MSD, ett bolag som nu avvecklas, vilket meddelats tidigare i år. Det är vacciner för barn, ungdomar och vuxna som kommer att vara en viktig del av produktportföljen för MSD.

Från årsskiftet ska MSD i Sverige och 18 systerbolag i Europa själva tillhandahålla företagets vacciner också i Europa, produkter som genom åren har bidragit till att förebygga och förbättra hälsan för miljontals människor.

– Jag är stolt över att få fortsätta bygga på Sanofi Pasteur MSDs tjugoåriga framgång och ser fram emot att stärka den ledande rollen för MSD inom vacciner och förebyggande av infektionssjukdomar, säger Marc Gailhardou, sedan årsskiftet ny Vd på MSD i Sverige.

– MSD har en lång historia av att framgångsrikt upptäcka, utveckla, producera och distribuera vaccin och har bidragit till att minska förekomsten av numera mycket ovanliga sjukdomar som mässling och påssjuka men även sjukdomar man historiskt inte trodde var möjliga att förebygga som livmoderhalscancer och bältros, säger Anders Kärnell, sedan årsskiftet medicinsk chef på MSD i Sverige.

I mer än 100 år har MSD spelat en viktig roll i den globala utvecklingen av vacciner. I dag tillhandahåller MSD årligen mer än 150 miljoner vaccindoser världen över. Dagens forskning inom MSD omfattar både förbättringar av befintliga vacciner och utveckling av vacciner mot nya sjukdomar, som Ebola och Zika.

I mars 2016 meddelade MSD och Sanofi att det gemensamma bolaget Sanofi Pasteur MSD skulle avvecklas efter tjugo framgångsrika år och att de två ägarna själva skulle ta ansvar för sina respektive produkter. Till grund för beslutet låg strategiska prioriteringar samt den ekonomiska och regulatoriska utvecklingen inom EU.

De produkter som vid årsskiftet förs över från Sanofi Pasteur MSD till MSD är Gardasil®, Hbvaxpro5mikrog®, Hbvaxpro10mikrog®, M-M-Rvaxpro®, Pneumovax®, RotaTeq®, Vaqta25E®, Vaqta50E®, Varivax® och Zostavax®. Av administrativa skäl kommer det formella marknadstillståndet att träda i kraft först i slutet av februari varför dessa produkter kommer att stå under Sanofi Pasteur MSD i Fass under ytterligare en tid.

MSD är ett forskningsintensivt företag som i samverkan med hälso- och sjukvården upptäcker, utvecklar och förser samhället med läkemedel och tjänster som förbättrar människors hälsa. Vi investerar årligen cirka 6,5 miljarder dollar i forskning och utveckling.

Som ett ledande globalt hälso- och sjukvårdsföretag arbetar vi på MSD för att göra skillnad för många människor världen över. I USA och Kanada är företagsnamnet Merck & Co. Inc., Kenilworth, NJ, USA. Vi har en bred produktportfölj av receptbelagda läkemedel, vacciner samt veterinärmedicinska läkemedel och företaget är representerat i mer än 140 länder.

MSD i Sverige har cirka 170 medarbetare med kontor i Hagastaden, ett internationellt kluster som växer fram kring Karolinska Institutet och universitetssjukhuset Nya Karolinska Solna. Hagastaden är ett kluster där akademi, sjukvård och företagande kan utvecklas tillsammans och bli ett nav för forskning och utveckling inom life science i Stockholm.

MSD marknadsför läkemedel och genomför kliniska prövningar inom bland annat följande behandlingsområden: kardiologi, immunologi, diabetes, infektionssjukdomar, astma/allergi, kvinnohälsa, cancer, dermatologi och centrala nervsystemets sjukdomar. Sedan flera år har MSD fler patienter i kliniska prövningar i Sverige än något annat företag.