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Enhertu demonstrated clinically meaningful and durable response in patients with HER2-positive advanced gastric cancer in DESTINY-Gastric02 Phase II trial

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First Enhertu trial in Western patients with gastric cancer

Efficacy and safety results consistent with registrational DESTINY-Gastric01 will support ongoing discussions with global health authorities

Detailed results from the positive Phase II DESTINY-Gastric02 trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), provided a clinically meaningful and durable tumour response in patients with HER2-positive metastatic and/or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with a trastuzumab-containing regimen. Results were presented during a late-breaking mini-oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

Gastric cancer is associated with a poor prognosis, particularly in the advanced stages of the disease, with only 5% to 10% of metastatic patients surviving five years globally.1,2 Approximately one in five gastric cancers are HER2-positive.3,4

In the primary analysis of DESTINY-Gastric02, the first trial of Enhertu specifically in Western patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma, Enhertu (6.4 mg/kg) demonstrated a confirmed overall response rate (ORR) of 38% as assessed by independent central review (ICR). Three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed in patients treated with Enhertu.

These results were consistent with those from the registrational DESTINY-Gastric01 Phase II trial previously published in The New England Journal of Medicine.

After a median follow-up of 5.7 months, the median duration of response (DoR) of Enhertu was 8.1 months (95% CI 4.1-NE). The median progression-free survival (PFS) was 5.5 months (95% CI 4.2-7.3). An exploratory endpoint of confirmed disease control rate (DCR) of 81% (95% CI; 70.6-89.0) was seen.

Eric Van Cutsem, MD, PhD, University Hospitals Leuven, said: “While the benefit of a HER2-targeted therapy in the first-line metastatic gastric cancer setting has been well-established, the disease will eventually progress. The positive results of DESTINY-Gastric02 show a strong response rate and reinforce the established efficacy and safety profile of Enhertu in patients who are in need of additional therapeutic options.”

Susan Galbraith, Executive Vice President, Oncology R&D, said: “The data from DESTINY-Gastric02 reaffirm the clinical significance of the potential benefit of Enhertu in patients with advanced gastric cancer. Patients often experience disease progression following initial therapies, and then face limited treatment options, so today’s news brings hope to both patients and treating physicians.”

Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Daiichi Sankyo, said: “The encouraging results from DESTINY-Gastric02 are consistent with those previously seen in the pivotal DESTINY-Gastric01 trial. This additional data will support our ongoing discussions with global health authorities as we work toward Enhertu becoming an option for patients with HER2-positive metastatic gastric cancer.

Summary of Results

Efficacy Measure Total Evaluable (n=79)i,ii                                          
Confirmed ORR (%) (95% CI)ii,iii 38.0% (27.3-49.6)
   Complete response (%) 3.8%
   Partial response (%) 34.2%
   Stable disease (%) 43.0%
DCR (95% CI)iv 81% (70.6-89.0)
Median DoR (months) (95% CI) 8.1 months (4.1-NE)
Median PFS (months) (95% CI) 5.5 months (4.2-7.3)

i Enhertu 6.4 mg/kg; median duration of follow-up was 5.7 months.

ii As assessed by independent central review

iii ORR is (CR + PR)

iv DCR is (CR + PR +SD)

The overall safety profile of Enhertu in DESTINY-Gastric02 was consistent with that seen in DESTINY-Gastric01. The most common Grade 3 or higher drug-related treatment-emergent adverse events seen in DESTINY-Gastric02 were anaemia (7.6%), neutropenia (7.6%), nausea (3.8%) and fatigue (3.8%).

There were six cases (7.6%) of treatment-related interstitial lung disease (ILD) or pneumonitis reported, as determined by an independent adjudication committee. The majority (83%) were low Grade (Grade 1 or Grade 2), with one Grade 5 (ILD or pneumonitis-related death).

Enhertu is approved in Israel, Japan and the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

Several presentations featured during the ESMO Congress 2021 will showcase the strength and depth of Enhertu data across multiple tumour types, including gastric, lung and breast cancers, reinforcing the transformational potential of this medicine in the treatment of HER2-targetable cancers.

Gastric cancer

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth highest leading cause of cancer mortality, with a five-year survival rate of 5% to 10% for advanced or metastatic disease.1,5 There were approximately one million new cases of gastric cancer and 768,000 deaths reported worldwide in 2020.6

Incidence rates for gastric cancer are markedly higher in eastern Asia, where approximately half of all cases occur.1,6,7 Gastric cancer is typically diagnosed in the advanced stage but even when diagnosed in earlier stages of the disease the survival rate remains modest.8-10

Approximately one in five gastric cancers are HER2-positive.3,4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers.4 HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification.4

Recommended first-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy.7 For patients with metastatic gastric cancer that progresses following initial treatment with a trastuzumab-based regimen, treatment options are limited, and in many regions of the world, there are no additional HER2-directed medicines available.1,8,11

DESTINY-Gastric02

DESTINY-Gastric02 is a global, open-label, single-arm, Phase II trial evaluating the safety and efficacy of Enhertu (6.4mg/kg) in patients with HER2-positive metastatic and/or unresectable gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.

The primary endpoint of DESTINY-Gastric02 is objective response rate (ORR), confirmed by Independent Central Review (ICR). Secondary endpoints include progression-free survival (PFS) confirmed by ICR, investigator assessed PFS, investigator assessed ORR, overall survival (OS) and duration of response (DoR).

DESTINY-Gastric02 enrolled 79 patients at multiple sites in North America and Europe. For more information about the trial, visit ClinicalTrials.gov.

Enhertu

Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in Canada, the EU, Israel, Japan, the UK and the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is also approved in Israel, Japan and the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme

A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Enhertu was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the “ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers,” based on data from both the DESTINY-CRC01 and DESTINY-Gastric01 trials, as well as one of the targeted therapy advances of the year in non-small cell lung cancer (NSCLC), based on the interim results of the HER2-mutated cohort of the DESTINY-Lung01 trial.

In May 2020, Enhertu also received Breakthrough Therapy Designation for the treatment of patients with metastatic NSCLC whose tumours have a HER2-mutation and with disease progression on or after platinum-based therapy.

Daiichi Sankyo collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in gastrointestinal cancers

AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines spanning a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented over five million new cancer cases leading to more than 3.5 million deaths.12 Within this programme, the Company is committed to improving outcomes in gastric, liver, oesophageal, pancreatic, and colorectal cancers.

The Company aims to understand the potential of Enhertu in the two most common GI cancers, colorectal and gastric cancers. Imfinzi (durvalumab) is being assessed as both monotherapy and in combinations including with tremelimumab across the two main types of liver cancer, hepatocellular carcinoma and biliary tract cancer, and in oesophageal and gastric cancers.

Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is development and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

References

1. Casamayor M, et al. Targeted literature review of the global burden of gastric cancer. E cancer medical science. 2018;12:883.

2. SEER Survival rates: Stomach 2004-2017. Available at: https://seer.cancer.gov/explorer/application.html?site=18&data_type=4&graph_type=6&compareBy=sex&chk_sex_1=1&chk_sex_3=3&chk_sex_2=2&race=1&age_range=1&stage=106&advopt_precision=1&advopt_show_ci=on&advopt_display=2. Accessed: September 2021.

3. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;852748.

4. Abrahao-Machado LF, et al. HER2 testing in gastric cancer: An Update. World J Gastroenterol. 2016;22(19):4619-4625.

5. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249.

6. WHO. International Agency of Cancer Research. Cancer Today. Available at: 

https://gco.iarc.fr/today/home. Accessed: September 2021.

7. Oditura M, et al. Treatment of gastric cancer. World J Gastroenterol. 2014 Feb 21;20(7):1635-49.

8. Thuss-Patience PC, et al. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017;18(5):640-653.

9. SEER Cancer Stat Facts: Stomach Cancer 2011-2017. Available at:

https://seer.cancer.gov/statfacts/html/stomach.html. Accessed: September 2021.

10. Cancer Research UK. Stomach Cancer Survival Statistics. Available at:

https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/stomach-cancer/survival. Accessed: September 2021.

11. Satoh T, et al. Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: TyTAN–a randomized, phase III study. J Clin Oncol. 2014;32(19):20392049.

12. Global Cancer Observatory. Cancer Today. Lyon, France: International Agency for Research on Cancer. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.

Accessed September 2021.

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Ämnesbetyg i gymnasieskolan – ny bok ger stöd inför reformen

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Gymnasieskolan står inför en stor förändring i och med gymnasiereformen GY25. Pernilla Lundgren och Anna Karlefjärd har båda lång erfarenhet och kunskap om bedömnings- och betygsfrågor genom sina uppdrag för bland annat Skolverket. I den nya boken Ämnesbetyg i gymnasieskolan – en handbok går de tydligt igenom vad reformen innebär och de frågor lärare har kring bedömning och betygssättning.

Vi synliggör regelverket, vilket handlingsutrymme som finns och ger lärarna ett tydligt stöd kring hur de kan tänka, säger Anna Karlefjärd, utbildningsledare vid rektorsutbildningen på Karlstads universitet, gymnasielärare och föreläsare.

Många hoppas att intentionen med gymnasiereformen och dess ämnesbetyg kommer att minska den stress och press lärare och elever upplever i dagens system. Idag ligger fokus på att samla in så mycket underlag som möjligt för att kunna sätta betyg och försvara sin betygssättning, med följden att betygssättningen ibland kommit att handla om en mekanisk avprickning.

Nu ska vi komma ifrån det och i stället fokusera på undervisningen, säger Pernilla Lundgren, gymnasielärare och tidigare forsknings- och utvecklingsansvarig på Stockholm stads utbildningsförvaltning och undervisningsråd vid Skolverket.

För att reformens syfte ska bli verklighet behöver även rektorer förstå hur reformen påverkar program och kursutbud och organisera därefter. Samtidigt som det finns många fördelar med att en elevs progression speglas i betyget innebär en betygssättning av 300 poäng en mer avgörande roll än idag för elevens möjlighet att söka in till högre studier. Här menar Pernilla Lundgren och Anna Karlefjärd att det gäller att vara vaksam så att lärarna inte hamnar i fällan att återigen fokusera för mycket på betygskriterier och insamlandet av betygsunderlag. Fo­kus måste alltid ligga på att elever rustas för sin framtid genom god undervisning.

– Lärarna behöver därför få möjlighet att prata om de ämnesdidaktiska frågorna tillsammans med kollegorna för att kunna skapa en fördjupande undervisning och helhet, säger Anna Karlefjärd.

– Vi vill att den här boken ska ge lärarna stöd i arbetet och att de fortsatta samtalen ska komma att handla om undervisning, säger Pernilla Lundgren och Anna Karlefjärd.

Om författarna
Pernilla Lundgren är föreläsare om bedömningsfrågor och gymnasielärare och tidigare forsknings- och utvecklingsansvarig på Stockholm stads utbildningsförvaltning. Som undervisningsråd på Skolverket ansvarade hon för att ta fram Allmänna råd om betyg och betygssättning. Hon har lång erfarenhet av bedömnings- och betygsfrågor och är en Sveriges främsta experter inom området. Pernilla skrev bilagan Om betyg och betygssättning – en forskningsöversikt i Betygsutredningen.

Anna Karlefjärd är gymnasielärare, föreläsare och utbildningsledare vid rektorsutbildningen på Karlstads universitet där hon också forskat om styrdokument och bedömning. Hon är expert på bedömning och betyg inkluderat skolans styrdokument och dokumentation. Anna har varit involverad i att ta fram Allmänna råd om betyg och betygssättning, grundskolans reviderade kursplaner samt Betygsutredningens betänkande.

Om boken
Titel: Ämnesbetyg i gymnasieskolan – en handbok
Utgivning: 7 maj 2024
ISBN: 978-91-7741-444-5
Sidor: 120
Pris: 220 kronor exkl. moms
Boken finns hos bokhandlare på nätet och i butik samt på www.gothiakompetens.se

Helén Kim Sörensdotter
Projektledare marknad: Skola
helen.kim.sorensdotter@gothiakompetens.se

För en bättre dag på jobbet
Gothia Kompetens – kompetensutveckling och kunskapsförmedling för och av oss som jobbar med förskola, skola, vård och omsorg. Tillsammans utvecklar vi både verksamheter och människorna i dem. Verksamhetsnära kompetensutveckling – för en bättre dag på jobbet.

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Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia

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ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue.

Voydeya (danicopan) has been approved in the European Union (EU) as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.1 Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor.2,3

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal ALPHA Phase III trial. Results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology.2

Professor Hubert Schrezenmeier, MD, Medical Director, Institute of Transfusion Medicine at The University of Ulm, said: “The EC approval of Voydeya as an add-on therapy represents an important innovation for the subset of patients with PNH who experience continued symptoms of anaemia due to EVH while treated with a C5 inhibitor. These patients now have an option to address the manifestations of EVH while remaining on treatment with standard-of-care C5 inhibitor therapy, Soliris or Ultomiris, to maintain disease control and help prevent the potentially life-threatening complications that can be associated with this devastating disease.”

Marc Dunoyer, Chief Executive Officer, Alexion, said: “For patients with PNH, Voydeya as an add-on therapy has been shown to address signs and symptoms of clinically significant EVH, including anaemia, while maintaining standard-of-care treatment with Soliris or Ultomiris. We look forward to making this first-in-class Factor D inhibitor available to patients in Europe and to advancing access around the globe.”

The ALPHA Phase III trial evaluated the efficacy and safety of Voydeya as add-on to Ultomiris or Soliris in patients with PNH who experienced clinically significant EVH. Results showed that Voydeya met the primary endpoint of change in haemoglobin from baseline to week 12 and all key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) score.2 

Results from the ALPHA Phase III trial showed Voydeya was generally well tolerated, and no new safety concerns were identified. In the trial, the most common treatment-emergent adverse events were headache, nausea, arthralgia and diarrhoea.2 

Voydeya has been granted Breakthrough Therapy designation by the United States (US) Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) status by the European Medicines Agency (EMA). Voydeya has also been granted Orphan Drug Designation in the US, EU and Japan for the treatment of PNH. Voydeya has been approved in the US and Japan, and regulatory reviews are ongoing in additional countries.

Notes

PNH

PNH is a rare, chronic, progressive and potentially life-threatening blood disorder. It is characterised by red blood cell destruction within blood vessels (also known as intravascular haemolysis) and white blood cell and platelet activation, which can result in thrombosis (blood clots).4-6

PNH is caused by an acquired genetic mutation that may happen any time after birth and results in the production of abnormal blood cells that are missing important protective blood cell surface proteins. These missing proteins enable the complement system, which is part of the immune system and is essential to the body’s defence against infection, to ‘attack’ and destroy or activate these abnormal blood cells.4 Living with PNH can be debilitating, and signs and symptoms may include blood clots, abdominal pain, difficulty swallowing, erectile dysfunction, shortness of breath, excessive fatigue, anaemia and dark-coloured urine.4,7,8

Clinically Significant EVH

EVH, the removal of red blood cells outside of the blood vessels, can sometimes occur in PNH patients who are treated with C5 inhibitors.9,10 Since C5 inhibition enables PNH red blood cells to survive and circulate, EVH may occur when these now surviving PNH red blood cells are marked by proteins in the complement system for removal by the spleen and liver.4,6,11 PNH patients with EVH may continue to experience anaemia, which can have various causes, and may require blood transfusions.9,10,12,13 A small subset of people living with PNH who are treated with a C5 inhibitor experience clinically significant EVH, which results in continued symptoms of anaemia and may require blood transfusions.4,7,14,15

ALPHA

ALPHA is a pivotal, global Phase III trial designed as a superiority study to evaluate the efficacy and safety of Voydeya as an add-on to C5 inhibitor therapy Soliris or Ultomiris in patients with PNH who experience clinically significant EVH. In the double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo (2:1) in addition to their ongoing Soliris or Ultomiris therapy for 12 weeks. A prespecified interim analysis was performed once 63 randomised patients had completed 12 weeks of the primary evaluation period or discontinued treatment as of 28 June 2022. At 12 weeks, patients on placebo plus Soliris or Ultomiris were switched to Voydeya plus Soliris or Ultomiris, and patients on Voydeya plus Soliris or Ultomiris remained on this treatment for an additional 12 weeks. Patients who completed both treatment periods (24 weeks) had the option to participate in a two-year long-term extension period and continue to receive Voydeya in addition to Soliris or Ultomiris. The open-label period of the study is ongoing.2,16

Voydeya (danicopan)

Voydeya (danicopan) is a first-in-class, oral, Factor D inhibitor. The medication works by selectively inhibiting Factor D, a complement system protein that plays a key role in the amplification of the complement system response. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. Voydeya has been granted Breakthrough Therapy designation by the US Food and Drug Administration and PRIority MEdicines (PRIME) status by the European Medicines Agency. Voydeya has also been granted Orphan Drug Designation in the US, EU and Japan for the treatment of PNH.

Voydeya is approved in the US, EU and Japan as add-on therapy to ravulizumab or eculizumab for the treatment of certain adults with PNH.

Alexion is also evaluating Voydeya as a potential monotherapy for geographic atrophy in a Phase II clinical trial.

Alexion

Alexion, AstraZeneca Rare Disease is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

References

  1. Voydeya (danicopan) European Product Information; April 2024.
  2. Lee JW, et al. Addition of danicopan to ravulizumab or eculizumab in patients with paroxysmal nocturnal haemoglobinuria and clinically significant extravascular haemolysis (ALPHA): a double-blind, randomised, phase 3 trial. The Lancet Haematology. 2023;10(12):E955-E965.
  3. Kulasekararaj AG, et al. Prevalence of clinically significant extravascular hemolysis in stable C5 inhibitor-treated patients with PNH and its association with disease control, quality of life and treatment satisfaction. Presented at: European Hematology Association (EHA) Hybrid Congress. 8-11 June 2023; Frankfurt, Germany. Abs PB2056.
  4. Brodsky RA. Paroxysmal nocturnal hemoglobinuria. Blood. 2014;124(18):2804-2811.
  5. Griffin M, et al. Significant hemolysis is not required for thrombosis in paroxysmal nocturnal hemoglobinuria. Haematologica. 2019;104(3):E94-E96.
  6. Hillmen P, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355(12):1233-1243.
  7. Kulasekararaj AG, et al. Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study. Blood. 2019;133(6):540–549.
  8. Hillmen P, et al. Effect of the complement inhibitor eculizumab on thromboembolism on patients with paroxysmal nocturnal hemoglobinuria. Blood. 2007;110(12):4123-4128.
  9. Brodsky RA. A complementary new drug for PNH. Blood. 2020;135(12):884–885.
  10. Risitano AM, et al. Anti-complement treatment for paroxysmal nocturnal hemoglobinuria: time for proximal complement inhibition? A position paper from the SAAWP of the EBMT. Front Immunol. 2019;10:1157.
  11. Kulasekararaj AG, et al. Long-term safety and efficacy of ravulizumab in patients with paroxysmal nocturnal hemoglobinuria: 2-year results from two pivotal phase 3 studies. Eur J Haematol. 2022;109(3):205-214.
  12. Berentsen S, et al. Novel insights into the treatment of complement-mediated hemolytic anemias. Ther Adv Hematol. 2019;10:2040620719873321.
  13. Kulasekararaj AG, et al. Monitoring of patients with paroxysmal nocturnal hemoglobinuria on a complement inhibitor. Am J Hematol. 2021;96(7):E232-E235. 
  14. Lee JW, et al. Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study. Blood. 2019;133(6):530-539.
  15. Röth A, et al. Transfusion requirements in adult patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibitors receiving ravulizumab and eculizumab: results from a phase 3 non-inferiority study [abstract]. ECTH 2019. Glasgow, UK ed. Glasgow, UK2019.
  16. ClinicalTrials.gov. Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA). NCT Identifier: NCT04469465. Available here. Accessed April 2024.
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Återköp av aktier under vecka 16, 2024

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Attendo AB (LEI-kod 549300KEJDL2FNITUW65) (“Attendo”) har mellan den 15 april 2024 och den 19 april 2024 återköpt sammanlagt 303 768 egna aktier (ISIN: SE00076666110) inom ramen för det återköpsprogram som styrelsen beslutat om.  

Återköpen är en del av det återköpsprogram om högst 16 138 659 egna aktier för ett sammanlagt maximalt belopp om 110 000 000 SEK som Attendo offentliggjorde den 8 februari 2024. Återköpsprogrammet, som löper under perioden 9 februari till 24 april 2024, genomförs i enlighet med Marknadsmissbruksförordningen (EU) nr 596/2014 och Kommissionens delegerade förordning (EU) nr 2016/1052.

Attendo-aktier har återköpts enligt följande:

Datum:

Aggregerad daglig volym (antal aktier):

Viktat genomsnittspris för aktier per dag (SEK):

Totalt dagligt transaktionsvärde (SEK):

15 april 2024

43 137

44,6902

1 927 801,16

16 april 2024

64 142

45,6833

2 930 218,23

17 april 2024

74 518

46,3357

3 452 843,69

18 april 2024

60 727

46,7207

2 837 207,95

19 april 2024

61 244

47,0521

2 881 658,81

Totalt ackumulerat under vecka 16/2024

303 768

46,1857

14 029 729,84

Totalt ackumulerat under återköpsprogrammet

1 876 648

40,7634

76 498 549,55

Samtliga förvärv har genomförts på Nasdaq Stockholm av Skandinaviska Enskilda Banken AB för Attendo:s räkning. Efter ovanstående förvärv uppgår Attendo:s innehav av egna aktier till 2 330 345 aktier per den 19 april 2024. Det totala antalet aktier i Attendo, inklusive de egna aktierna, är 161 386 592 och antalet utestående aktier, exklusive de egna aktierna, är 159 056 247.

Attendo AB (publ)

För ytterligare information, vänligen kontakta:

 

Andreas Koch, Kommunikations- och IR-direktör Attendo

Telefon: +46 705 09 77 61   I   epost: andreas.koch@attendo.com

 

attendo.com

Attendo – det ledande omsorgsföretaget i Norden   |   I mer än 35 år har Attendo haft som utgångspunkt att se, stödja och stärka människor med behov av omsorg i allt det vi gör. Förutom äldreomsorg erbjuder Attendo omsorg till personer med funktions­nedsättningar samt individ- och familjeomsorg. Attendo har över 30 000 medarbetare och finns lokalt förankrat med omkring 700 verksamheter i runt 300 kommuner i Sverige, Finland och Danmark. Varje dag möter våra medarbetare tiotusentals kunder i deras vardag. Alla våra omsorgsinsatser utgår från Attendos gemensamma värderingar om omtanke, engagemang och kompetens. 

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