AstraZeneca PLC (AZN)

[idpickering]

Imfinzi significantly improved event-free survival in AEGEAN Phase III trial for patients with resectable non-small cell lung cancer.

Positive high-level results from a planned interim analysis of the AEGEAN Phase III, placebo- controlled trial showed that treatment with AstraZeneca's Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC).

https://www.investegate.co.uk/astrazene ... 00063664S/

Ian.

[idpickering]

Notice of Annual General Meeting and Board Committee change.

https://www.investegate.co.uk/astrazene ... 00028684T/

Ian (I hold).

[Bouleversee]

I heard on the radio today that AZN was being sued following illness and death from blood clots of several people following being vaccinated with the AZN vaccine. Awful for the people affected but how significant for AZN remains to be seen. I haven't heard any comments from that p.o.v.

[idpickering]

License agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate, completed.

AstraZeneca has completed an exclusive global license agreement with KYM Biosciences Inc.i for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancers.

CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive solid tumours, including gastric cancer. Preliminary results from the trial have shown an encouraging profile for CMG901, with early signs of anti-tumour activity across the dose levels tested.

https://www.investegate.co.uk/astrazene ... 00036711U/

Ian.

[idpickering]

Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD).

Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). If authorised, Ultomiris would be the first and only approved long-acting C5 complement inhibitor for the treatment of AQP4 Ab+ NMOSD in the EU.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the CHAMPION-NMOSD Phase III trial.1 In the CHAMPION-NMOSD trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.

Ultomiris met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. Notably, data showed zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks (relapse risk reduction: 98.6%, hazard ratio (95% CI): 0.014 (0.000, 0.103), p<0.0001), and continuing through a median duration of 90 weeks.1

https://www.investegate.co.uk/astrazene ... 00110382V/

Ian.

[idpickering]

Lynparza and Imfinzi combination improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without tumour BRCA mutations in DUO-O Phase III trial.

Positive high -level results from a planned interim analysis of the DUO-O Phase III trial showed treatment with a combination of Lynparza (olaparib), Imfinzi (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. Patients were treated with Imfinzi in combination with chemotherapy and bevacizumab followed by Imfinzi, Lynparza and bevacizumab as maintenance therapy.

https://www.investegate.co.uk/astrazene ... 00044488V/

Ian (I hold).

[idpickering]

Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi.

AstraZeneca, Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi have updated and simplified their contractual arrangements relating to the development and commercialisation of nirsevimab in the US. Given the upcoming launch of nirsevimab in the US and other markets, simplification of the prior arrangements clarifies the roles and responsibilities of relevant parties.

Under the updated arrangements, Sobi has entered into a direct relationship with Sanofi, replacing the previous participation agreement with AstraZeneca entered into in November 2018. Under the previous agreement, from the day of the transaction with Sobi, AstraZeneca had to provision the risk adjusted value of the discounted cash flow of future payments to be made to Sobi as a liability. As a result of this simplification agreement, Sanofi will pay royalties to Sobi as US nirsevimab sales arise, and the liability related to future obligations is eliminated. AstraZeneca will record a gain of $0.7 billion, to be recognised in Core Other operating income in 2023. This does not impact AstraZeneca's financial guidance for 2023.

https://www.investegate.co.uk/astrazene ... 00087193V/

Ian (I hold).

[Dod101]

Closed today at £121.86. Somebody likes them.

Dod

[idpickering]

Closed today at £121.86. Somebody likes them.

Dod

For what it's worth, I'm one of them. I wish I bought more AZN when they were cheaper than of late.

I'm a very happy holder of AZN though.

Ian.

[monabri]

I just wish GSK would replicate AZN'S performance. 5year total return of 181% for AZN and 30% for GSK. That's a heck of a difference.

Source:
https://www.hl.co.uk/funds/fund-discoun ... ion/charts

[idpickering]

Q1 2023 Results.

Financial performance (Q1 2023 figures unless otherwise stated , growth numbers at CER)

‒ Total Revenue stable at $10,879m, despite a decline of $1,460m from COVID-19 medicines

‒ Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 16%

‒ Total Revenue from Oncology medicines increased 19%, CVRM[7] 22%, R&I[8] 8%, and Rare Disease 14%

‒ Core Gross margin of 83%, up four percentage points, reflecting the decline in sales of lower margin COVID‑19 medicines, the cost of production in prior periods, and a mix shift to more speciality medicines

‒ Core Operating margin of 36%, up one percentage point, reflecting a $220m increase in Core Other operating income, which included a gain from the divestment of PulmicortFlexhaler rights in the US

‒ Core EPS increased 6% to $1.92

‒ Reiterating guidance for FY 2023 Total Revenue and Core EPS

https://www.investegate.co.uk/astrazene ... 00056102X/

Ian (I hold).

[idpickering]

Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer.

The Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca and MSD's Lynparza (olaparib) plus abiraterone and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) based on the PROpel Phase III trial. The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation.

https://www.londonstockexchange.com/new ... r/15938202

Ian.

[idpickering]

Farxiga extended in the US to reduce risk of cardiovascular death and hospitalisation for heart failure to a broader range of patients.

AstraZeneca's Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. The approval by the Food and Drug Administration (FDA) was based on positive results from the DELIVER Phase III trial.1 Farxiga was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).

Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit, AstraZeneca, said: "Approximately half of heart failure patients die within five years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death. The approval of Farxiga in the US not only reinforces AstraZeneca's commitment to reducing the burden of this complex and life-threatening disease, but will help patients across the full spectrum of heart failure lead healthier lives."

https://www.investegate.co.uk/announcement/7516952

Ian (I hold).

[idpickering]

Tagrisso plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial.

Positive high-level results from the FLAURA2 Phase III trial showed AstraZeneca's Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to Tagrisso alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

Safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine. At the time of this analysis, the overall survival (OS) data were immature and will be formally assessed at a subsequent analysis.

Each year, there are an estimated 2.2 million people diagnosed with lung cancer globally with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.1-3 Approximately 70% of people are diagnosed with advanced NSCLC. Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4-6

https://www.investegate.co.uk/announcement/7530020

Ian (I hold).

[idpickering]

Imfinzi plus Lynparza and Imfinzi alone both significantly improved progression-free survival in advanced endometrial cancer when added to chemotherapy.

Positive high-level results from the DUO-E Phase III trial showed Imfinzi (durvalumab) in combination with platinum-based chemotherapy followed by either Imfinzi plus Lynparza (olaparib) or Imfinzi alone as maintenance therapy both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy alone in patients with newly diagnosed advanced or recurrent endometrial cancer. There was a greater clinical benefit observed with the combination of Imfinzi and Lynparza as maintenance treatment.

https://www.investegate.co.uk/announcement/7545938

Ian (I hold).

[idpickering]

Lynparza approved in US for BRCAm prostate cancer.

AstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

This approval was based on a subgroup analysis of the Phase III PROpel trial which showed that Lynparza plus abiraterone demonstrated highly clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR of 0.24, 95% CI, 0.12-0.45) and overall survival (OS) (HR of 0.30, 95% CI, 0.15-0.59) versus abiraterone alone in patients with BRCA mutations.1 Median rPFS and median OS were not reached for patients treated with Lynparza plus abiraterone versus a median of 8 months and 23 months, respectively, for those treated with abiraterone alone.

https://www.investegate.co.uk/announcement/7553874

Ian.

[idpickering]

AstraZeneca agreement with Quell Therapeutics.

AstraZeneca has entered into an exciting collaboration, exclusive option and license agreement with Quell Therapeutics to develop multiple engineered T-regulator (Treg) cell therapies that have the potential to be curative in Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD) indications.

Under the terms of the agreement, Quell's proprietary toolbox of Treg cell engineering modules, including its innovative Foxp3 Phenotype Lock will be leveraged to develop autologous multi-modular Treg cell therapy candidates for major autoimmune disease indications.

Iain McGill, Chief Executive Officer of Quell Therapeutics, said: "We are extremely pleased to have AstraZeneca on board as our first major partner. This collaboration builds on our pioneering work to develop exquisitely engineered, multi-modular Treg cell therapies for immune disorders and provides excellent validation for the technologies and capabilities we have established. We are proud and incredibly excited to partner our leading science with the deep experience of AstraZeneca to accelerate the application of our Treg cell therapy platform in major autoimmune disease, where we believe there is a broad opportunity to reset immune tolerance and drive durable responses for patients."

https://www.investegate.co.uk/announcement/7567248

Ian (I hold).

[idpickering]

nirsevimab recommended for infant RSV protection.

The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously 21 to 0 that AstraZeneca and Sanofi's nirsevimab has a favourable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The Committee also voted 19 to 2 in support of nirsevimab's favourable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab has the potential to protect the broad infant population through its first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. The single dose can be flexibly administered at the beginning of the RSV season or at birth for newborns born during the RSV season.

https://www.investegate.co.uk/announcement/7567468

Ian.

[idpickering]

AstraZeneca planning China business spin off.

Drugmaker AstraZeneca is drafting a plan to spin off its China business, and listing a separate unit in Hong Kong is being viewed as an option, the Financial Times reported on Sunday.

"A separation might not ultimately take place," the report said, citing people familiar with the matter, with one of them saying listing the entity in Shanghai was also possible.

https://www.marketscreener.com/quote/st ... -44137889/

Ian (I hold).

[idpickering]

Dato-DXd significantly improved PFS in lung cancer.

Positive high-level results from the TROPION-Lung01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.

https://www.investegate.co.uk/announcem ... er/7608349

Ian (I hold).