GlaxoSmithKline PLC (GSK)

[Newroad]

Morning All.

Well, I've bought in at £14.51.

Given I would have bought in next month anyway, I've at least had some of the downside (but perhaps not all) taken away.

Regards, Newroad

[idpickering]

Statement: Zantac (ranitidine) litigation.

· FDA and EMA have concluded there is no evidence of a causal association between ranitidine therapy and the development of cancer.

· Substantial scientific evidence supports FDA/EMA conclusion.

· Plaintiff litigation inconsistent with the scientific consensus, GSK will vigorously defend all claims.

In response to recent speculative commentary regarding U.S. Zantac litigation , GSK plc (LSE/NYSE: GSK) today issued the following statement regarding Zantac (ranitidine) and N-nitrosodimethylamine (NDMA).

There have been no material developments to what has been previously disclosed.

GSK, independent cancer researchers, the U.S. Food & Drug Administration, and the European Medicines Agency, have all undertaken extensive reviews of available data and conducted numerous investigations into this issue since 2019.

Based on these investigations and experiments, GSK, the FDA, and the EMA have all independently concluded that there is no evidence of a causal association between ranitidine therapy and the development of cancer in patients.

· In November 2019, the FDA determined that levels of NDMA in ranitidine products are similar to levels in common foods like grilled and smoked meats, and that it would conduct tests to fully understand if ranitidine forms NDMA in the human body.

· In September 2020, the EMA's comprehensive review of epidemiological and post marketing data concluded there is "no evidence of a causal association between ranitidine therapy and the development of cancer in patients."

· In June 2021, the FDA reported that its testing did not support that ranitidine is converted to NDMA in a general, healthy population, and after reviewing the epidemiological studies found that "…no consistent signals emerged across studies, and studies with comparison to active controls found no association between ranitidine and overall or specific cancer risk."

These conclusions pertain to all forms of cancer, including but not limited to bladder, breast, colorectal, esophageal, kidney, liver, lung, pancreatic, prostate, and stomach. Even epidemiologic experts hired by the Multi-District Litigation (MDL) Plaintiffs' Steering Committee concluded in their expert reports that the "evidence was not sufficient to support an opinion that use of ranitidine can cause breast, prostate, kidney, lung, or colorectal cancer."

Full item here;

https://www.investegate.co.uk/gsk-plc-- ... 00047855V/

Ian.

I'm sure that the over 4% rise in the GSK sp thus far today is a welcome relief to holders hereabouts, after yesterday's wobble. I'm guessing that today's rise is in relation to the above item released by GSK today?

Ian.

[monabri]

Morning All.

Well, I've bought in at £14.51.

Given I would have bought in next month anyway, I've at least had some of the downside (but perhaps not all) taken away.

Regards, Newroad

Decision made...GSK goes xd 18th August just in case you've not pencilled it in your diary.

[Newroad]

Interestingly, Monabri.

I found my trade on the LSE record and is has a trade flag of "P ALGO". It was executed at £14.512 but I paid only £14.51, my limit order price, plus costs (£3 fee plus stamp duty).

So, it seems IBKR merged orders, as they do, to make everyone happy - someone presumably paid slightly over £14.512 for their part of the order. Or, I suppose, the other option is that it cost me the £14.512 but I can't see it or its a "rounding error".

In any case, the more I get used to it, the more I like IBKR.

Regards, Newroad

[monabri]

Interestingly, Monabri.

I found my trade on the LSE record and is has a trade flag of "P ALGO". It was executed at £14.512 but I paid only £14.51, my limit order price, plus costs (£3 fee plus stamp duty).

So, it seems IBKR merged orders, as they do, to make everyone happy - someone presumably paid slightly over £14.512 for their part of the order. Or, I suppose, the other option is that it cost me the £14.512 but I can't see it or its a "rounding error".

In any case, the more I get used to it, the more I like IBKR.

Regards, Newroad

I wouldn't be too concerned about the 3rd decimal place. I've used Interactive Broker, found it quite powerful but not easy on the trading side. When I was "forced " to join ITI Crapital it transpired that "their" trading platform was really IBKR's. As an aside, ITI offered their own systems ( plural)..now that was complicated..no wonder they needed a better platform.

(ITI have now exited the retail business..well done the FCA!)

[idpickering]

GSK completes acquisition of Affinivax, Inc.

GSK plc (LSE/NYSE: GSK) today announced it has completed the acquisition of Affinivax, Inc (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge (Boston, Massachusetts). Affinivax has pioneered the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines.

As previously announced, the acquisition of Affinivax aligns with GSK's strategy of building a strong portfolio of specialty medicines and vaccines. It includes a next-generation 24-valent pneumococcal vaccine candidate (AFX3772), currently in phase II development, which is based on the highly innovative Multiple Antigen Presenting System (MAPSTM) platform technology . A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development.

The MAPSTM technology supports higher valency than conventional conjugation technologies, potentially enabling broader coverage against prevalent pneumococcal serotypes and generating higher antibody responses against many individual serotypes than current pneumococcal vaccines.

Tony Wood, Chief Scientific Officer, GSK , said: "Affinivax's exciting pneumococcal vaccine candidates, the potentially disruptive MAPs technology and their fantastic scientific talent, further strengthen our pipeline of novel vaccines and presence in the Boston area".

In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. In July 2021, the US Food and Drug Administration granted Breakthrough Therapy designation for AFX3772 to prevent S. pneumoniae invasive disease and pneumonia in adults 50 years and above. Preparations for the start of the phase III program are underway. Phase II clinical trials started in June 2022 to assess the use of the vaccine in the paediatric population.

Financial considerations

Under the terms of the agreement, GSK has acquired 100% of the outstanding shares of Affinivax. The acquisition comprised an upfront payment of $2.1 billion paid upon closing and two potential milestone payments of $0.6 billion to be paid upon the achievement of certain paediatric clinical development milestones. The transaction was subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott- Rodino Anti-Trust Improvements Act of 1976. GSK will account for the transaction as a business combination.

https://www.investegate.co.uk/gsk-plc-- ... 06311480W/

Iam.

[idpickering]

Statement: Zantac (ranitidine) litigation update.

GSK plc (LSE/NYSE: GSK) today issued the following statement regarding U.S. Zantac (ranitidine) litigation.

The Plaintiff's counsel for Joseph Bayer, whose case was scheduled to be the first Zantac trial, informed the court and the parties yesterday that he will file a Notice of Voluntary Dismissal. GSK did not settle Mr. Bayer's claim and has not paid anything in exchange for the voluntary dismissal. GSK welcomes this outcome and believes the dismissal of Mr. Bayer's case is the correct result. The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine. GSK will continue to vigorously defend itself against all claims alleging otherwise.

Litigation update

GSK has been named as a defendant in approximately 3,000 filed personal injury cases in federal and state court. Class actions alleging economic injury and a third-party payer class action also has been filed in federal court.

On 6 February 2020, the US product liability litigation was assigned Multidistrict Litigation (MDL) status in the Southern District of Florida. In the MDL, plaintiffs were required to identify the types of cancer they wished to pursue and identified 10 different types. In November 2021, plaintiffs withdrew from consideration breast cancer and kidney cancer, reducing the number of types of cancer from 10 to eight. In January 2022, the MDL plaintiffs withdrew from consideration colorectal, prostate, and lung and will proceed only as to the following five types of cancer: bladder, esophageal, gastric, liver, and pancreatic, although plaintiffs in state courts continue to pursue claims based on types of cancers withdrawn from the MDL.

Unfiled claims have also been registered in a census established by the Court presiding over the MDL and the parties. The information in this registry is preliminary, unverified, subject to change, and it is unknown at this time if many of these unfiled claimants will proceed with filing suit. In the most recent review of unfiled claimants, conducted on behalf of GSK, it is estimated that the number of unfiled registry claims in the federal MDL Court have reduced to approximately 55,000 total claims. Not all the unfiled claims relate to GSK and there will be many claims involving multiple parties given that Zantac OTC has been owned and marketed by multiple companies.

These filed and unfiled counts are subject to change.

The MDL Court is scheduled to hold a hearing on defendants' motion to exclude plaintiffs' causation experts under Daubert on 20-21 September 2022.

Among the state court cases naming GSK, a trial in California is currently scheduled to begin 13 February 2023 and a trial is currently scheduled to begin in Madison County, Illinois in February 2023.

https://www.investegate.co.uk/gsk-plc-- ... 00042384W/

Ian.

[idpickering]

US FDA accepts New Drug Application for GSK's momelotinib for the treatment of myelofibrosis.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia. The US FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.

The NDA is based on the results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, including Total Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate (SRR). The primary analysis data from the MOMENTUM trial were recently presented at the 2022 American Society of Clinical Oncology Annual Meeting and the European Hematology Association 2022 Hybrid Congress.

https://www.investegate.co.uk/gsk-plc-- ... 00062395W/

Ian.

[Bouleversee]

Statement: Zantac (ranitidine) litigation update.

GSK plc (LSE/NYSE: GSK) today issued the following statement regarding U.S. Zantac (ranitidine) litigation.

The Plaintiff's counsel for Joseph Bayer, whose case was scheduled to be the first Zantac trial, informed the court and the parties yesterday that he will file a Notice of Voluntary Dismissal. GSK did not settle Mr. Bayer's claim and has not paid anything in exchange for the voluntary dismissal. GSK welcomes this outcome and believes the dismissal of Mr. Bayer's case is the correct result. The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use of ranitidine. GSK will continue to vigorously defend itself against all claims alleging otherwise.

Litigation update

GSK has been named as a defendant in approximately 3,000 filed personal injury cases in federal and state court. Class actions alleging economic injury and a third-party payer class action also has been filed in federal court.

On 6 February 2020, the US product liability litigation was assigned Multidistrict Litigation (MDL) status in the Southern District of Florida. In the MDL, plaintiffs were required to identify the types of cancer they wished to pursue and identified 10 different types. In November 2021, plaintiffs withdrew from consideration breast cancer and kidney cancer, reducing the number of types of cancer from 10 to eight. In January 2022, the MDL plaintiffs withdrew from consideration colorectal, prostate, and lung and will proceed only as to the following five types of cancer: bladder, esophageal, gastric, liver, and pancreatic, although plaintiffs in state courts continue to pursue claims based on types of cancers withdrawn from the MDL.

Unfiled claims have also been registered in a census established by the Court presiding over the MDL and the parties. The information in this registry is preliminary, unverified, subject to change, and it is unknown at this time if many of these unfiled claimants will proceed with filing suit. In the most recent review of unfiled claimants, conducted on behalf of GSK, it is estimated that the number of unfiled registry claims in the federal MDL Court have reduced to approximately 55,000 total claims. Not all the unfiled claims relate to GSK and there will be many claims involving multiple parties given that Zantac OTC has been owned and marketed by multiple companies.

These filed and unfiled counts are subject to change.

The MDL Court is scheduled to hold a hearing on defendants' motion to exclude plaintiffs' causation experts under Daubert on 20-21 September 2022.

Among the state court cases naming GSK, a trial in California is currently scheduled to begin 13 February 2023 and a trial is currently scheduled to begin in Madison County, Illinois in February 2023.

https://www.investegate.co.uk/gsk-plc-- ... 00042384W/

Ian.

Always worth going to the horse's mouth. A quick glance at the article headed "GSK boosted by dismissal of Zantac drug case in US" gave me the impression that GSK were out of the woods on this one, which it would appear is far from the case, though hopefully will be at some point. I had expected a rise in the s.p. which is not the case either.

[idpickering]

GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract infections.

· The exclusive licence allows GSK to commercialise tebipenem HBr in all regions except for Japan and certain other Asian countries

· Spero Therapeutics receives $66 million upfront, with potential for future milestone payments and tiered royalties

· GSK to purchase $9 million in shares of Spero common stock

GSK plc (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced they have entered into an exclusive licence agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a late-stage antibiotic being developed by Spero, as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

https://www.investegate.co.uk/gsk-plc-- ... 00052349A/

Ian.

[idpickering]

Oncologic Drugs Advisory Committee to review Zejula overall survival data from the NOVA phase III trial in recurrent ovarian cancer.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival (OS) data from the ENGOT-OV16/NOVA phase III clinical trial . NOVA is a randomised, double-blind, placebo-controlled phase III trial of Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer.

The phase III NOVA trial met the primary endpoint of progression-free survival (PFS) in both the gBRCAm and non-gBRCAm cohorts, demonstrating a statistically significant and clinically meaningful treatment effect of Zejula in this patient population, regardless of biomarker status. These PFS results served as the primary basis for the US FDA approval for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Overall survival was a secondary endpoint. Updated final overall survival data was recently shared with the FDA.

https://www.investegate.co.uk/gsk-plc-- ... 00033466A/

Ian.

[idpickering]

Iain Mackay, Chief Financial Officer, to retire from GSK, Julie Brown appointed as successor.

GSK plc (LSE/NYSE: GSK) today announced that Iain Mackay, Chief Financial Officer (CFO), has decided to retire from GSK. The Board has agreed that he will step down as CFO and as an Executive Director of the Board in May 2023.

The Board has selected Ms Julie Brown, currently Chief Operating and Financial Officer, Burberry Group plc, as successor to Iain. Julie is a highly respected CFO with extensive experience in the biopharma and medtech sectors, having previously worked at AstraZeneca plc and Smith & Nephew plc; and as a non-executive director and Audit Chair of Roche Holding AG.

Julie will join GSK in April 2023 and will work with Iain to transition responsibilities, taking responsibility as CFO and as an Executive Director of GSK on 1 May 2023.

https://www.investegate.co.uk/gsk-plc-- ... 00135410A/

Ian.

[Dod101]

Iain Mackay, Chief Financial Officer, to retire from GSK, Julie Brown appointed as successor.

GSK plc (LSE/NYSE: GSK) today announced that Iain Mackay, Chief Financial Officer (CFO), has decided to retire from GSK. The Board has agreed that he will step down as CFO and as an Executive Director of the Board in May 2023.

The Board has selected Ms Julie Brown, currently Chief Operating and Financial Officer, Burberry Group plc, as successor to Iain. Julie is a highly respected CFO with extensive experience in the biopharma and medtech sectors, having previously worked at AstraZeneca plc and Smith & Nephew plc; and as a non-executive director and Audit Chair of Roche Holding AG.

Julie will join GSK in April 2023 and will work with Iain to transition responsibilities, taking responsibility as CFO and as an Executive Director of GSK on 1 May 2023.

https://www.investegate.co.uk/gsk-plc-- ... 00135410A/

Ian.

Another change. Iain Mackay joined GSK from HSBC not that long ago, 2019 I think. Interesting these merry go rounds.

Dod

[idpickering]

Iain Mackay, Chief Financial Officer, to retire from GSK, Julie Brown appointed as successor.

GSK plc (LSE/NYSE: GSK) today announced that Iain Mackay, Chief Financial Officer (CFO), has decided to retire from GSK. The Board has agreed that he will step down as CFO and as an Executive Director of the Board in May 2023.

The Board has selected Ms Julie Brown, currently Chief Operating and Financial Officer, Burberry Group plc, as successor to Iain. Julie is a highly respected CFO with extensive experience in the biopharma and medtech sectors, having previously worked at AstraZeneca plc and Smith & Nephew plc; and as a non-executive director and Audit Chair of Roche Holding AG.

Julie will join GSK in April 2023 and will work with Iain to transition responsibilities, taking responsibility as CFO and as an Executive Director of GSK on 1 May 2023.

https://www.investegate.co.uk/gsk-plc-- ... 00135410A/

Ian.

Another change. Iain Mackay joined GSK from HSBC not that long ago, 2019 I think. Interesting these merry go rounds.

Dod

I had to smile at your comment Dod. It reminded me of all my moving around in The Army. We used to get disturbance allowance, and I'm sure a CFO or CEO's allowances/hand outs are a lot more generous.

Ian.

[monabri]

Iain Mackay, Chief Financial Officer, to retire from GSK, Julie Brown appointed as successor.

GSK plc (LSE/NYSE: GSK) today announced that Iain Mackay, Chief Financial Officer (CFO), has decided to retire from GSK. The Board has agreed that he will step down as CFO and as an Executive Director of the Board in May 2023.

The Board has selected Ms Julie Brown, currently Chief Operating and Financial Officer, Burberry Group plc, as successor to Iain. Julie is a highly respected CFO with extensive experience in the biopharma and medtech sectors, having previously worked at AstraZeneca plc and Smith & Nephew plc; and as a non-executive director and Audit Chair of Roche Holding AG.

Julie will join GSK in April 2023 and will work with Iain to transition responsibilities, taking responsibility as CFO and as an Executive Director of GSK on 1 May 2023.

https://www.investegate.co.uk/gsk-plc-- ... 00135410A/

Ian.

Another change. Iain Mackay joined GSK from HSBC not that long ago, 2019 I think. Interesting these merry go rounds.

Dod

I had to smile at your comment Dod. It reminded me of all my moving around in The Army. We used to get disturbance allowance, and I'm sure a CFO or CEO's allowances/hand outs are a lot more generous.

Ian.

I bet she's moved more times than you!

https://www.roche.com/about/leadership/julie-brown

I'm not really impressed by folk who stay in a job for a year or two then move on.

[idpickering]

I'm not really impressed by folk who stay in a job for a year or two then move on.

I agree, but imho, we don't know what's going on behind the scenes.

Ian.

[Dod101]

I bet she's moved more times than you!

https://www.roche.com/about/leadership/julie-brown

I'm not really impressed by folk who stay in a job for a year or two then move on.

Well Ian Mackay was wealthy I am sure before he joined Glaxo as it then was, having been with HSBC for some years. I guess the interesting work has been done at GSK, spinning off Haleon so he wants to move on.

Dod

[idpickering]

US FDA approves Boostrix for immunisation during pregnancy for the prevention of whooping cough in new born infants.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for immunisation during the third trimester of pregnancy to help prevent pertussis (whooping cough) in infants less than two months of age.

Since 2010, the Centers for Disease Control and Prevention (CDC) has reported 15,000 to 48,000 pertussis cases among people of all ages in the United States each year.1 Infants are at high risk of complications from whooping cough because their immune systems are still developing.1

According to the CDC, the Tdap vaccination given during pregnancy provides the best protection to infants against whooping cough. Vaccination passes protective antibodies to babies before birth to protect them in their first months of life.

https://www.investegate.co.uk/gsk-plc-- ... 00042601C/

Ian.

[idpickering]

Efficacy results for GSK's older adult RSV vaccine.

GSK's older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial

· Data to be presented at IDWeek 2022 showed overall vaccine efficacy against RSV-lower respiratory tract disease (LRTD) in adults aged 60 years and above, with a favourable safety profile

· Consistent high vaccine efficacy observed against LRTD in severe disease (94.1%), adults aged 70-79 years (93.8%) and in adults with underlying comorbidities (94.6%)

· High vaccine efficacy is consistent across RSV A and B strains

https://www.investegate.co.uk/gsk-plc-- ... 00017296C/

Ian.

[idpickering]

US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W . The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option . The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.

https://www.investegate.co.uk/gsk-plc-- ... 00080177D/

Ian.