AstraZeneca PLC (AZN)

[idpickering]

Tagrisso adjuvant lung cancer US Priority Review

AstraZeneca's Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.1-4

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2021.

https://www.investegate.co.uk/astrazene ... 00066215C/

[idpickering]

Forxiga CV outcomes benefit approved in China

China's National Medical Products Administration (NMPA) has updated the label for AstraZeneca's Forxiga (dapagliflozin) to include data from the DECLARE-TIMI 58 Phase III trial.

DECLARE-TIMI 58 demonstrated that Forxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or cardiovascular (CV) death, versus placebo, in adults with type-2 diabetes (T2D) and established CV disease or multiple CV risk factors. The trial confirmed the well-established safety profile of Forxiga.1

https://www.investegate.co.uk/astrazene ... 00044500D/

This sounds like a big win for AZN, being as it applies to China.
I hold AZN in my HYP.

Ian.

[idpickering]

Year-to-date and Q3 2020 results.

Here; https://www.investegate.co.uk/astrazene ... 00043134E/

[idpickering]

3 approvals in EU for AZN;

Lynparza approved in the EU for wider ovarian use

https://www.investegate.co.uk/astrazene ... 15013099E/

Lynparza approved in the EU for prostate cancer

https://www.investegate.co.uk/astrazene ... 10023098E/

Forxiga approved in the EU for heart failure

https://www.investegate.co.uk/astrazene ... 10023098E/

[idpickering]

Brilinta approved in the US to reduce the risk of stroke in patients

https://www.investegate.co.uk/astrazene ... 00024958E/

[idpickering]

Calquence approved in the EU for CLL

https://www.investegate.co.uk/astrazene ... 00126388E/

[idpickering]

AstraZeneca and Oxford University: Confirms immune response in elderly, phase 3 vaccine trial results in weeks

AstraZeneca and Oxford University jointly developed COVID-19 vaccine-induced immune response in older adults in their phase 2 trial, the British drug makers confirmed Thursday.

https://www.fxstreet.com/news/astrazene ... 2011190708

[idpickering]

Imfinzi new dosing approved in the US.

AstraZeneca's Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

https://www.investegate.co.uk/astrazene ... 00049930F/

[idpickering]

AZD1222 vaccine effective against COVID-19.

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.

https://www.investegate.co.uk/astrazene ... 00071391G/

[Bouleversee]

Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.

[monabri]

Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.

I think it is a case of not what you say, it's how you say it!. I read the papers this morning and it wasn't clear what the "success rate" was (60/70/90%?).
It struck me as naive the way in which the results were presented. I could well imagine some scientist presenting the data, warts and all, but can you imagine a US company NOT leading with a headline along the lines of "our latest dosage trials show a NINETY PERCENT SUCCESS RATE...we've improved our initial dosage regime which gave ~60% and we have achieved 90% and it can be stored in a normal fridge unlike our competitors and it's cheaper".

Looks like AZN management have not got a grip on their scientists! British management not controlling the news.

[idpickering]

Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.

I feel your pain Lorna. I'm as surprised as you. From what I've seen on Bloomberg TV today, it seems people have more faith in the other potential vaccine providers figures, and find those put out by AZN as confusing.

Either way, I'm not concerned, and shall continue as a long term AZN shareholder.

Ian.

[Bouleversee]

I thought they said that the initial dose was only a half dose and achieved 70% success (whatever that means) but with a full dose later it was 90% and I think they did emphasise in the interview that because they were using 25% less vaccine, the vaccine would be available to more people and that the viability with normal refrigeration would mean it could be used anywhere in the world. I do agree with Monabri, however, that they could do with better PR to blow their trumpet more effectively but I think the press has a lot to answer for.

I gather some people had flu-like symptoms. Is it known whether those who took the other vaccines also had those symptoms? I heard Prof. John Bell say that it might not be suitable for the highly vulnerable who might have to be given antibodies instead. I got the impression that he is not totally clued up about the product. however.

Anyway, although I am now losing on my last top up, I shall continue to hold and console myself with being a tiny part of an organisation which is doing good in the world and not just concerned with making money. Am glad they didn't sell out earlier as many of my best holdings have done.

[Bouleversee]

I see there are some interesting comments about this on Beerpig's Snug today under the Coronavirus thread.

viewtopic.php?p=359309#p359309

[idpickering]

This might be of interest;

AstraZeneca, Oxford coronavirus vaccine prevents COVID-19, though study results raise questions.

An experimental coronavirus vaccine developed by AstraZeneca and the University of Oxford protected against COVID-19 in two late-stage, placebo-controlled trials of roughly 23,000 participants in the U.K. and Brazil, the development partners said Monday.

An interim analysis after 131 volunteers developed COVID-19 found that, on average, vaccination was 70% effective in preventing the disease. A lower-dose regimen, with a half-dose given first followed by a full dose one month later, was 90% effective, while two full doses appeared 62%
effective.

The preliminary results are encouraging and suggest a third experimental coronavirus vaccine works, after positive data from the team of Pfizer and BioNTech, and Moderna earlier this month. AstraZeneca and Oxford's shot uses a different technology than the other two — a signal other vaccines approaches could be effective, too — and is viewed as easier to distribute around the world.

Yet the differing results between dosing regimens are likely to raise questions about how AstraZeneca and Oxford's vaccine triggers the immune system. And the data will be compared to the higher-than-expected efficacy shown by Pfizer and BioNTech and by Moderna, both of which said their vaccines were roughly 95% effective in preventing COVID-19.

https://www.biopharmadive.com/news/astr ... ts/589542/

[Bouleversee]

Thanks, Ian. Of interest but incomprehensible.

[idpickering]

Thanks, Ian. Of interest but incomprehensible.

I get that a lot!

Ian.

[monabri]

Give it a while and we will see if the Pfizer vaccine is actually viable ..... Can you imagine the logistical nightmare of keeping it at -70°C even in the developed World. Of course, the message will be it will not sell in the USA ..so what? The AZN vaccine will be sold around the World. It has the reputable names of AZN and Oxford University attached to it, it is practical regarding storage requirements and it is cheaper than Pfizer's offering.

What AZN don't want is for Oxford labs to come up with a method whereby the Pfizer vaccine can be stored at a warmer temperature (I think they are doing research along those lines - they should stop it at once!).

[Lootman]

Of course, the message will be it will not sell in the USA ..so what? The AZN vaccine will be sold around the World. It has the reputable names of AZN and Oxford University attached to it, it is practical regarding storage requirements and it is cheaper than Pfizer's offering.

Suppose the US does not approve it. Now suppose the US requires visitors to show documentation that they have been vaccinated and the AZN one is not on the approved list.

That makes the AZN vaccine less attractive versus Pfizer and the others.

[Arborbridge]

Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.

Monabri is correct, I reckon. For some reason, the news people keep emphasising that it is "only" 70% effective, which sounds like a failure. Why do the Brits always like to do themselves down?

I gather the original idea was that better than 50% would be useful, and the idea of 90% would have been considered improbable. 70% is amazing, but because of these silly new hounds reporting scientists (who are clearly not sales people) AZN is on the back foot trying to explain that actually "it's all rather good" - which in Brit speak means excellent.

Another problem for the share price might be because it is gradually sinking in that AZN have promised to supply the stuff at cost to developing countries, which is a heck of a lot of profit foregone, I assume - though I gather they will have some element of variable pricing for richer countries in mitigation.

Arb.