GlaxoSmithKline PLC (GSK)

[idpickering]

GSK daprodustat gains positive EMA CHMP opinion.

GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis

https://www.investegate.co.uk/announcem ... on/7593593

Ian.

[idpickering]

Japan's Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over.

· Approval expands the number of people who can be protected against shingles, now including all adults considered at increased risk by their healthcare provider

· Shingrix (Recombinant Zoster Vaccine - RZV) is already approved in Japan for adults aged 50 and over

https://www.investegate.co.uk/announcem ... r-/7593918

Ian.

[idpickering]

FDA Fast Track for Gonorrhoea Vaccine Candidate.

GSK receives US FDA Fast Track designation for investigational vaccine against gonorrhoea

· Fast Track designation accelerates the vaccine candidate's path to US FDA submission for the prevention of Neisseria gonorrhoeae infection

· Gonorrhoea is the second most prevalent bacterial sexually transmitted infection worldwide with an estimated 82 million new cases globally each year[1],[2]

· Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing2

https://www.investegate.co.uk/announcem ... te/7596377

Ian (I hold and intend increasing my holdings soon).

[idpickering]

GSK completes acquisition of BELLUS Health.

GSK plc (LSE/NYSE: GSK) and BELLUS Health Inc. (TSX/NASDAQ: BLU) today announced GSK has completed the acquisition of BELLUS, a biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC), by way of a plan of arrangement in accordance with Section 192 of the Canada Business Corporations Act (the "Arrangement"). The Arrangement was approved by BELLUS' shareholders on 16 June 2023.

As previously announced, the acquisition of BELLUS includes camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC.

https://www.investegate.co.uk/announcem ... th/7601039

Ian.

[idpickering]

ViiV Healthcare's cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency.

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, welcomed a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention. Cabotegravir is recommended in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kg.

https://www.investegate.co.uk/announcem ... p-/7649501

Ian (I hold).

[idpickering]

2nd Quarter Results.

Strong performance and momentum drive upgraded guidance

Sales and earnings growth delivered by key growth drivers

Q2 2023 sales +4% and +11% ex COVID

Vaccines sales +18%, +15% ex COVID with Shingrix +20%

Specialty Medicines sales -7%, +12% ex COVID with HIV +12%

General Medicines sales +8% with Trelegy +30%

Strong sales growth of products launched since 2017 including in Vaccines and HIV contributing to step change in performance

Total operating profit and Total continuing EPS >100% driven by strong operating performance and favourable movements in contingent consideration liabilities

Adjusted operating profit +11% and Adjusted EPS +16% reflects strong sales ex COVID and higher royalty income offset by increased investment in R&D and new product launches

And later;

Quarterly dividends

The Board has declared a second interim dividend for 2023 of 14p per share (Q2 2022: 16.25p(1) per share).

Dividends remain an essential component of total shareholder return and GSK recognises the importance of dividends to shareholders. On 23 June 2021, at the GSK Investor Update, GSK set out that from 2022 a progressive dividend policy will be implemented guided by a 40 to 60 percent pay-out ratio through the investment cycle. The dividend policy, the total expected cash distribution, and the respective dividend pay-out ratios for GSK remain unchanged. GSK expects to declare a dividend of 56.5p per share for 2023. In setting its dividend policy, GSK considers the capital allocation priorities of the Group, its investment strategy for growth alongside the sustainability of the dividend.

https://www.investegate.co.uk/announcem ... ts/7654911

Ian.

[Dod101]

That sounds more optimistic than for some time. The trouble is that they are giving us guidance on Adjusted figures which are all very well but it is the underlying statutory figures that really matter. However I suppose that we should be grateful that our patience is sort of being rewarded.

Dod

[idpickering]

Shingrix data demonstrate 100% efficacy in China.

GSK plc (LSE/NYSE: GSK) today announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license phase IV trial (ZOSTER-076), which evaluated the efficacy and safety of RZV in preventing shingles in adults aged 50 and over. The trial included almost 6,000 participants randomised 1:1 to the RZV or placebo group and followed in an observer-blind design. No cases of shingles were reported among the participants who received RZV, compared to 31 cases in the placebo arm.1

The results are in line with findings from the pivotal phase III trials ZOE-50 and ZOE-70 investigating the efficacy and safety of RZV, showing vaccine efficacy was up to 97%[2] in adults aged 50 and over, over a follow-up period of approximately four years.2,[3] The safety profile observed in this trial was consistent with the established safety profile of the vaccine.1 The new data add to the growing body of evidence affirming the efficacy and safety profile of RZV in preventing shingles in adults aged 50 and over.1

Globally, the varicella zoster virus (VZV) is present in over 90% of adults.[4],[5] VZV remains dormant in the nervous system, waiting to reactivate as shingles with advancing age.8,9 The population of people aged 65 and over in China is rapidly increasing, with a predicted percentage increase from 6.8% in 2000 to 23.6% by 2050.[6] It is estimated that there are approximately 6 million cases of shingles in China each year6, and this number is expected to increase in line with local population ageing.

https://www.investegate.co.uk/announcem ... na/7711794

Ian (I hold, and intend adding to my GSK holdings soon).

[idpickering]

GSK’s Nucala CRSwNP submission accepted in Japan.

· If approved, Nucala would be the first anti-interleukin-5 biologic available in Japan for the treatment of adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)

· This would be the third indication for mepolizumab in Japan for an IL-5 mediated condition

https://www.investegate.co.uk/announcem ... n-/7729224

Ian.

[idpickering]

GSK regulatory submission for momelotinib for the treatment of myelofibrosis accepted for review by Japanese regulator.

GSK plc (LSE/NYSE: GSK) today announced that the Ministry of Health, Labour and Welfare (MHLW), Japan, has accepted for review a new drug application (NDA) for momelotinib, a potential new medicine with a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with anaemia. The NDA is based on data from the pivotal phase III trials SIMPLIFY-1 and MOMENTUM.

https://www.investegate.co.uk/announcem ... n-/7746413

Ian (I hold).

[idpickering]

FDA approves Ojjaara (momelotinib).

Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia

· Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy

· Nearly all myelofibrosis patients are estimated to develop anaemia over the course of the disease, and over 30% will discontinue treatment due to anaemia[1],[2],[3]

· Ojjaara addresses key manifestations of myelofibrosis, namely anaemia, constitutional symptoms and splenomegaly

https://www.investegate.co.uk/announcem ... b-/7760408

Ian ( I hold and intend adding to my GSK holdings soon).

[idpickering]

Apretude for PrEP receives EMA approval.

European Commission authorises ViiV Healthcare's Apretude (cabotegravir long-acting and tablets) for HIV prevention

· Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition in clinical trials.[1],[2],[3],[4]

· With approximately 100,000 people newly diagnosed with HIV each year in Europe,[5] expanding HIV prevention options is crucial in reducing HIV transmission.

https://www.investegate.co.uk/announcem ... l-/7763238

Ian.

[idpickering]

GSK RSV vaccine for older adults approved in Japan.

GSK) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV (respiratory syncytial virus) disease for adults 60 years of age and above. This is the first time an RSV vaccine for older adults has been approved in Japan.

https://www.investegate.co.uk/announcem ... an/7773694

Ian.

[idpickering]

GSK lifts growth ambitions for HIV business on long-acting drug.

GSK - on Thursday lifted its medium-term growth forecast for its HIV drugs business ViiV, encouraged by strong sales of long-acting injections that aim to replace daily pills for preventing and treating the infection.

The ViiV business, in which Pfizer and Shionogi (4507.T) hold small stakes, is a key element of a push by group CEO Emma Walmsley to improve investor confidence in the strength of GSK's drug development pipeline, which has lagged rivals.

https://www.reuters.com/business/health ... 023-09-28/

Ian.

[idpickering]

GSK announces intention to sell 270m shares in Haleon.

GSK plc (LSE/NYSE: GSK) today announced that it intends to sell 270m ordinary shares in Haleon, equivalent to approximately 2.9% of Haleon's issued share capital.

Following the successful demerger and premium listing of Haleon plc ("Haleon") as announced on 18 July 2022, GSK initially retained a 12.94%1 stake in Haleon. As subsequently announced on 12 May 2023, GSK completed the sale of 240m ordinary shares in Haleon, reducing its stake in Haleon to approximately 10.3%1.

The disposal announced today will be conducted through a placing of ordinary shares in Haleon to institutional investors (the "Offering"). The offer price will be determined by means of an accelerated bookbuild offering process which is to start immediately.

A further announcement will be made following completion of the bookbuild and pricing of the Offering.

https://www.investegate.co.uk/announcem ... on/7799629

Ian (I hold GSK).

[idpickering]

GSK completes sale of shares in Haleon plc.

GSK plc (LSE/NYSE: GSK) today announced that, further to its announcement on 5 October 2023, GSK has agreed to sell 270m ordinary shares in Haleon plc ("Haleon") at a price of 328 pence per share (the "Placing Shares"), raising gross proceeds of approximately £885.6m (the "Placing").

Following settlement of the Placing, GSK will hold 685m1 ordinary shares in Haleon, representing approximately 7.4% of the issued share capital of Haleon.

GSK and Pfizer Inc. (which holds a 32% stake in Haleon), have each undertaken not to dispose of any further shares in Haleon for a period of 60 days following settlement of the Placing, subject to certain customary exceptions and waiver by BofA Securities and Citigroup Global Markets Limited.

https://www.investegate.co.uk/announcem ... lc/7800145

Ian.

[idpickering]

GSK and Zhifei announce vaccine partnership.

GSK announced today that it has reached an exclusive agreement with Chongqing Zhifei Biological Products, Ltd. (Zhifei) to co-promote GSK's shingles vaccine, Shingrix, in China for an initial three-year period, with the potential to extend the partnership should all parties agree. Zhifei, the largest Chinese vaccine company by revenue, has a track record of driving access to innovative vaccines in China. By bringing together the scale and expertise of the two companies, the strategic partnership will significantly extend the availability of Shingrix, supporting the rapid expansion of patient access to the vaccine and future potential indications.

Set to start on 1 January 2024, Zhifei will have exclusive rights to import and distribute Shingrix in China - focusing on promoting the vaccine through its extensive service network, which covers more than 30,000 vaccination points across the country. In partnership, GSK - as the license holder for the product - will co-promote Shingrix by raising awareness of the importance of shingles vaccination amongst healthcare professionals within community health centres and hospital settings.

https://www.investegate.co.uk/announcem ... p-/7803642

Ian.

[idpickering]

Zantac (ranitidine) litigation.

GSK plc (LSE/NYSE: GSK) today confirmed it has reached a confidential settlement in the Cantlay/Harper case filed in California state court. The case, which was set to begin trial on 13 November 2023, will be dismissed. The company has also settled the three remaining breast cancer bellwether cases in California. GSK will be dismissed from these cases, removing all related pre-trial hearings for the company.

The settlements reflect the Company's desire to avoid the distraction related to protracted litigation. GSK does not admit any liability in the settlements and will continue to vigorously defend itself based on the facts and the science in all other Zantac cases.

https://www.investegate.co.uk/announcem ... on/7808657

Ian.

[idpickering]

GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer.

· If approved, dostarlimab would become the first new frontline treatment option in the European Union (EU) in decades and the only immuno-oncology combination regimen available for this patient population with high unmet need

· Decision on EU marketing authorisation expected by the end of the year

https://www.investegate.co.uk/announcem ... n-/7817498

Ian.

[idpickering]

New data for Arexvy, GSK’s RSV vaccine.

GSK plc today announced positive preliminary results from its phase III trial [https://clinicaltrials.gov/study/NCT05590403] evaluating the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59, including those at increased risk of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) due to certain underlying medical conditions. These results will be presented at the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on 25 October 2023. This vaccine is currently approved in the US for active immunisation for the prevention of RSV-LRTD in adults 60 years of age and older. It is also approved in Europe, Japan and several other countries.

https://www.investegate.co.uk/announcem ... e-/7837194

Ian.