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(GSK) GlaxoSmithKline General Share Chat

Discussion in 'General Share Chat' started by Microem1, Nov 10, 2015.

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    Evening Standard 27/05/2021
     
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    14 June 2021, London UK & Gosselies Belgium

    GSK and iTeos Therapeutics announce development and commercialisation collaboration for EOS-448, an anti-TIGIT monoclonal antibody, enabling novel next-generation immuno-oncology combinations


    · EOS-448 is currently in phase I for advanced solid tumours with a randomised PD-1 combination study planned for 2022

    · iTeos to receive a $625 million upfront payment in addition to potential milestones, and royalty payments on ex-US sales

    · GSK and iTeos will co-commercialise and share profits in the US

    · GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies

    GlaxoSmithKline plc (LSE/NYSE: GSK) and iTeos Therapeutics (NASD: ITOS) today announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer. TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as a promising target for the next generation of immuno-oncology therapies based on compelling preclinical data and a phase II randomised clinical trial. With this collaboration GSK is uniquely positioned with access to antibodies that synergistically target all three known CD226 checkpoints - TIGIT, CD96 and PVRIG.

    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Immuno-oncology has transformed cancer care but unfortunately less than 30 percent of patients respond to treatment with the current leading immune checkpoint inhibitors. Based on the underlying science, we believe that combinations of a PD-1, TIGIT, CD96 and PVRIG inhibitor could become transformative medicines for many patients with cancer. We are excited to collaborate with the team at iTeos and together we can play a leading role in the next generation of immuno-oncology therapies."

    Since GSK validated the role of CD226 axis targets as important in oncology, it has been strategically building a carefully constructed set of assets to target this network of checkpoint inhibitors. The addition of EOS-448 results in GSK being the only company with antibodies targeting all three known checkpoints - TIGIT (via EOS-448), CD96 (via GSK'608), and PVRIG (via GSK'562). Together with GSK's recently approved anti-PD-1, Jemperli (dostarlimab), this comprehensive portfolio of potential next generation immuno-oncology agents will be explored through various novel combinations, including doublets and triplets, to evaluate their potential to transform treatment options for patients with multiple different cancers.


    Michel Detheux, President and CEO, iTeos, said: "Through this transformative collaboration, iTeos now has access to GSK's best-in-class resources which will provide us with a significant advantage in a highly competitive, global market. We have chosen GSK because of their commercial capabilities, experience in immuno-oncology and their commitment to invest in the rapid advancement of our TIGIT programme and create a clear path forward for EOS-448. Inspired by the multifaceted mechanism of action of EOS-448 and promising early results in clinical trials, this collaboration allows us to accelerate and expand the clinical development of EOS-448. We are more confident than ever in our ability to succeed. This collaboration validates our science and provides a catalyst for the future of iTeos. The collaboration with GSK will allow our team to continue to develop next generation immunotherapies starting with inupadenant, our highly differentiated clinical-stage A2A adenosine receptor antagonist, and to drive scientific innovation with our expertise in tumour immunology to build our pipeline."

    EOS-448 is currently in an open-label phase I study in patients with advanced solid tumours. GSK and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022. GSK'608 (anti-CD96 being developed in collaboration with 23andMe) is in phase I as monotherapy and in combination with dostarlimab. GSK expects to submit an Investigational New Drug application for GSK'562 (anti-PVRIG in-licensed as SRF-813 from Surface Oncology) by mid-2022.

    Under the terms of the collaboration agreement, iTeos will receive an upfront payment of $625 million. iTeos will be eligible to receive up to an additional $1.45 billion in milestone payments, should the EOS-448 programme achieve certain development and commercial milestones.

    Within the collaboration, GSK and iTeos will share responsibility and costs for the global development of EOS-448 and will jointly commercialise and equally split profits in the US. Outside of the US, GSK will receive an exclusive license for commercialisation and iTeos will receive tiered royalty payments.

    The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    ###

    Conference Call Details

    iTeos will host a conference call to discuss the agreement today, Monday, June 14 at 8:30 a.m. ET. Details are as follows:
    Participant Dial-In: (833) 607-1661
    International Dial-In: (914) 987-7874
    Conference ID: 4598012
    Webcast: https://edge.media-server.com/mmc/p/xz7hasbz

    The live audio webcast will also be accessible from the Events page of the Company's IR website at https://investors.iteostherapeutics.com/news-and-events/events. A replay will be available on the Company's website approximately two hours after completion of the event and for 30 days following the call.
     
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    Evening Standard 14/06/2021
     
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    Mail on Sunday 20/06/2021
     
  8. Groucho

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    Issued: 23 June 2021, London UK - LSE announcement


    New GSK to deliver step-change in growth and performance over next ten years driven by high-quality Vaccines and Specialty Medicines portfolio and late-stage pipeline

    · Sales growth more than 5% and adjusted operating profit growth more than 10% CAGR 2021-26[1]

    · Sales ambition of more than £33 billion (CER) by 2031

    · Strategic focus to prevent and treat disease, with R&D leveraging science of the immune system, human genetics and advanced technologies

    · Strengthened balance sheet post separation supports investment in growth

    · Cash generated from operations expected to exceed £10 billion by 2026

    · 2022 aggregate dividend from GSK and New Consumer Healthcare expected to amount to 55p

    · New GSK progressive dividend policy starting at 45p in 2023

    · Leading ESG performance to be maintained and key target for New GSK

    · New GSK to positively impact health of >2.5 billion people next 10 years

    · Demerger to create new world leader in consumer healthcare confirmed mid-2022

    Notes on basis of preparation, assumptions and cautionary statements and on reporting definitions on pages 5-7.


    At an update to investors today, GlaxoSmithKline plc (GSK LSE & NYSE) will provide details of its strategy, outlook for growth and plans to create shareholder value, following the planned demerger in mid-2022 of its Consumer Healthcare business. The resulting New GSK will be a growth company with new ambitions for patients and shareholders and an overarching purpose to unite science, talent and technology to get ahead of disease together.


    Emma Walmsley, Chief Executive Officer, said:"The benefits of the huge transformation we have driven since 2017 are now clear. We have strengthened our R&D and commercial execution, and transformed our group structure and capital allocation, while driving a profound cultural change with new leadership.

    "Together, we are now ready to deliver a step-change in growth for New GSK and unlock the value of Consumer Healthcare. With world class capabilities across prevention and treatment of disease, New GSK is exceptionally well positioned to positively impact people's health and to deliver strong performance and value to shareholders through the decade."

    Key elements of the investor update are summarised below:


    Strategic transformation

    In 2017, GSK commenced a significant corporate transformation to address historic long-standing issues that have affected performance. Major progress has been achieved across the business to improve performance, strengthen capabilities and prepare GSK for a new future.

    The company has substantially strengthened its R&D performance and productivity. Since 2017, GSK has delivered 11 major product approvals* and doubled the number of assets in Phase III and registration to 22. Commercial execution has been transformed with new and specialty products now reaching £10 billion in annual sales. Meanwhile changes to the Group's portfolio and network within Vaccines and Pharma have led to annual cost savings delivery of £0.5 billionand proceeds from divestment of non-core brands of £1.4 billion.

    Following two successful global mergers, a new world-leading consumer healthcare business, with a radically transformed portfolio and sector-leading profitability has also been created.

    All of this has been achieved with acknowledged sector leadership in ESG performance.


    In addition, there has been significant cultural and leadership change across the company, to improve accountability and raise levels of ambition. 85% of the top 125 leaders are new in role since 2017 and new incentives and governance have been implemented in all key areas of the company.

    These changes now provide the platform for GSK to separate and create two new global companies which will have major impacts on human health and can deliver compelling performance and attractive returns and value to shareholders.


    New GSK financial outlooks


    2021-2026 outlook

    Over the next five-year period, New GSK expects to deliver sales growth and adjusted operating profit growth of more than 5% and more than 10%, respectively, CAGR at constant exchange rates (with 2021 as the base year). Profit growth is expected to be underpinned by a combination of strong revenue growth from new vaccines and specialty medicines, improving operational performance and benefits from the transformation of recent years. These financial outlooks exclude any contribution from COVID-19 related revenues.

    The company expects to improve adjusted operating margin from the mid-20s% in 2021 to over 30% by 2026. Improved sales growth, sales mix benefits and realisation of cost savings from previously announced programmes are all expected to contribute to margin improvements. GSK has identified a further £200 million of annual savings from the Separation Preparation (Future Ready) programme and has revised its cost savings target from £800 million to £1 billion with no extra costs for delivery. All restructuring programmes will complete in 2022 and no further major restructuring programmes are planned.


    2026-2031 ambition

    By 2031, New GSK aims to deliver sales of more than £33 billion (at constant exchange rates). Achievement of this ambition is driven by commercial execution of New GSK's current late-stage pipeline. The company estimates that certain assets in late-stage development have the potential in aggregate to deliver peak year sales of more than £20 billion on a non-risk adjusted basis+.

    The £33 billion sales ambition is before any significant revenue contribution from early-stage pipeline assets or any contribution from business development. Importantly, New GSK aims to grow sales through to 2031 despite the anticipated loss of exclusivity for dolutegravir in 2028/29.

    The new outlooks and ambition will be incorporated into existing incentive plans by the remuneration committee in due course.


    Maximising Vaccines and Specialty Medicines

    New GSK will prioritise R&D and commercial investment in Vaccines and Specialty Medicines, which are expected to grow to around three-quarters of company sales by 2026. As part of its 2021-26 outlook, Vaccines is expected to grow sales at a high single-digit % CAGR and Specialty Medicines at a double-digit % CAGR.

    The company is focused across four core therapeutic areas (TAs): Infectious Diseases, HIV, Oncology and Immunology/Respiratory. In addition, New GSK will remain open to opportunities outside these core TAs where there are scale opportunities rooted in immune science and genetic validation.

    Capturing the increasing opportunities now seen across the prevention and treatment of disease offers significant scientific and commercial opportunities for New GSK. At the heart of this is the company's R&D focus on the science of the immune system, human genetics and advanced technologies; and its world-leading capabilities in vaccine and pharmaceutical development.

    The company currently has a pipeline of 20 vaccines and 42 medicines - many of which are potential best or first in class opportunities.


    Optimising General Medicines

    A newly defined General Medicines product group will contain all of New GSK's primary care brands, including older established products as well as the inhaled respiratory portfolio. General Medicines will have differing performance profiles by region and brand, with growth expected most in emerging markets. Overall General Medicines is expected to show broadly stable sales over the period 2021-26 (CER).

    General Medicines will be optimised for profitability and cash generation to support investment in Vaccines and Specialty Medicines. As part of this approach, further streamlining of the portfolio is expected through divestment or partnering of non-priority brands.


    Strengthened balance sheet to support growth and returns to shareholders

    Following separation of the Consumer Healthcare business, New GSK is expected to have a net debt/adjusted EBITDA leverage ratio of less than 2 times. This, together with expected stronger cash flow generation, will provide additional flexibility to support future investments in growth. By 2026, cash generated from operations for New GSK is expected to exceed £10 billion.

    New GSK's capital allocation priorities will be: to strengthen the pipeline, including through targeted bolt-on and in-licensing business development transactions; to invest behind successful product launches; to enhance sustainability of its operations; and to underpin its progressive dividend policy.

    In 2022, GSK shareholders will receive dividends from GSK and New Consumer Healthcare due to the expected mid-year timing of the demerger. Together, these are expected to amount to approximately 55p per share for the year, assuming a New Consumer Healthcare dividend at the lower end of the previously announced 30-50% pay-out ratio range and subject to approval from the Board of New Consumer Healthcare. This pro-forma full year 2022 dividend would be a 31% reduction compared to the expected 2021 dividend of 80p per share.

    New GSK will adopt a progressive dividend policy targeting a dividend pay-out ratio equivalent to 40-60%, starting at 45p per share in 2023, the company's first full year of operation.

    Strong focus on ESG performance and to impact the health of more than 2.5 billion people

    Maintaining a sector leading ESG performance will be an integral part of New GSK's strategy and a key goal for the new company.

    The company intends to take a focused approach to ESG, driven by its strengths and to address the key challenges faced by the industry over the long-term. New GSK will prioritise resources across six areas it sees as material to its business: pricing/access, global health, inclusion and diversity, the environment, product governance and operating standards.

    Accountabilities for these six areas will be at executive level and New GSK expects to further strengthen the alignment of incentives and remuneration to delivery of ESG performance, with increased visibility in corporate reporting.

    This approach to ESG will support delivery of sustainable performance and long-term growth; build trust with stakeholders; reduce risk to operations; and enable delivery of very positive social impact.

    A critical measure of success for New GSK will be health impact at scale. This is at the core of the company's purpose and it expects to positively impact the health of more than 2.5 billion people around the world over the next 10 years.


    Consumer Healthcare separation

    The separation of Consumer Healthcare is expected in mid-2022 and the GSK Board's clear priorities are to unlock the potential of New GSK and Consumer Healthcare, strengthen New GSK's balance sheet and maximise value for shareholders.

    The new Consumer Healthcare company will have a portfolio which generated annual sales of more than £10 billion in 2020 and is well-positioned for further growth. Driven by brands, innovation, leading-edge science and human understanding to deliver better everyday health, the company will have nine global power brands holding category leadership positions and major sales presences in the US and China. Altogether the business offers strong prospects for sustainable sales and profit growth, high cash generation and delivery of attractive returns for shareholders.

    Subject to approval from shareholders, the separation will be by way of a demerger of at least 80% of GSK's 68% holding in the Consumer Healthcare business to GSK shareholders, with the new Consumer Healthcare company shares expected to attain a premium listing on the London Stock Exchange, with ADRs to be listed in the US. The company intends to structure the demerger in a manner that is tax efficient for UK and US shareholders, as compared to alternative separation options, and is seeking confirmation of such treatment from the relevant tax authorities. Details of the expected tax treatment will be provided in the circular sent to shareholders in connection with the approval of the demerger.

    New GSK will retain up to 20% of GSK's holding in the new Consumer Healthcare company as a short-term financial investment, which it intends to monetise in a timely manner to further strengthen New GSK's balance sheet and help fund certain pension benefit obligations. Prior to the demerger, New GSK is also expected to receive a dividend of up to £8 billion from Consumer Healthcare. As previously stated, the new Consumer Healthcare company is expected to have a net debt/adjusted EBITDA leverage ratio of up to 4.0 times. GSK plans to target an investment grade credit rating for the new Consumer Healthcare company.


    A comprehensive update on the prospects for New Consumer Healthcare is planned for investors in early 2022.

    The Board of GSK is preparing for two new independent boards following separation. A process has started to form a board of directors for the new Consumer Healthcare company, which will include the appropriate mix of skills and experience to represent and maximise the value of this business for shareholders.

    In addition, and building on recent non-executive appointments, further appointments are also expected to the Board of GSK prior to the separation to increase biopharmaceuticals and scientific experience for New GSK.

    4F35BE78-A499-4F2B-8C83-D8CC0480EA44.jpeg
    GlaxoSmithKline PLC - GSK to deliver step-change in growth & performance #GSK @GSK https://www.voxmarkets.co.uk/rns/announcement/ba50284b-c8e2-42a2-82d3-1b35c6722657 #voxmarkets undefined
     
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    Dividend cut lower than feared - AV 6m Target 1661p +17.7%
    During its Q4 20 earnings call, GSK announced its plan to cut dividends from 2022 onwards (vs. fixed dividend at 80p/share since 2014) to help fund its growth initiatives as it is about to lose the cash-generative CH unit next year. However, the quantum of cut was not shared at the time, and markets feared that the cut could be as high as 40-50%, given the need to reinvigorate its beleaguered pipeline – according to our estimates, every 10p/share cut in dividend could save c.£500m for the group. To everyone’s surprise, GSK announced a c.31% dividend cut. Moreover, from 2023 onwards, the group plans to follow a progressive dividend policy – at 40-60% of EPS, which, given the group’s history of variability in earnings, will help better manage its stretched balance sheet (2020 gearing: 159% vs. c.40% for AV peers) vs. fixed dividends.
    B116A54D-D9AE-430E-8BE0-5F15973FF741.jpeg D0FC6F5F-8925-44BB-9F78-993027DBA7E1.jpeg
     
    Last edited: Jun 25, 2021
  11. Groucho

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    02 July 2021

    GlaxoSmithKline plc

    (the ‘Company’ or 'GSK')


    Issued: 2 July 2021, London UK


    Elliott Advisors (UK) letter to GSK


    The Board of GSK notes the letter issued by Elliott Advisors (UK) Limited ("Elliott") on 1 July. The Board welcomes constructive input from all shareholders that is supportive of the creation and delivery of long-term sustainable shareholder value and benefits for patients. The Board is issuing this announcement to all shareholders and all parties with an interest in GSK to address the matters raised by Elliott in the letter.


    Clear priority is to deliver step-change in growth and performance, create shareholder value and deliver positive scale human health impact

    At its Investor Update on 23 June, GSK set out new ambitions for patients and a step-change in growth and performance for shareholders. Subsequent engagement with GSK's largest shareholders has evidenced widespread and strong support for these strategic ambitions and confidence in GSK's leadership team to deliver them.

    The ambitions and plans communicated at the Investor Update follow a significant four-year corporate transformation to address historic long-standing issues that have affected GSK's performance. These issues have been well recognised by the Board and the Executive team and include all of those identified in Elliott's letter.

    Major progress has been achieved to improve performance, strengthen R&D productivity, enhance commercial execution, and to streamline GSK's portfolio and cost base. In addition, there have been significant changes in culture and capabilities across the company, to improve accountability, increase agility and raise levels of ambition.

    This transformation provides the platform for GSK to separate into two, new global companies, both of which will have major impacts on human health and can deliver compelling performance and attractive returns and value to shareholders. The Board and the Executive team believe that focus and stability are now critical to deliver a successful separation and the key innovation, commercial and financial targets expected for New GSK as a growth-focused company.


    Robust governance in place to deliver separation and enhance board expertise

    In preparation for separation of Consumer Healthcare, the Board of GSK has been preparing for two new, appropriately qualified, independent boards. In the last 18 months, governance and oversight has been further strengthened with the appointment of two new non-executive directors; changes have been made to the remit of the Science Committee to deepen understanding of scientific strategy and execution; and Board focus and oversight have been increased on the detailed mechanics and preparations for separation with the formation of a new Transformation & Separation Committee.

    A formal process to appoint a Chair and to form a Board of Directors for the new Consumer Health company is already well underway. The appointment of a Chair is expected in the second half of 2021 who will then, in accordance with best practice, lead the process of appointments to establish the new Board. This new Board will include the appropriate mix of skills, experience and continuity, relevant to Consumer Health, to represent and maximise the value of this new business for shareholders.

    As previously stated, and building on recent non-executive appointments, further appointments to the Board of GSK are expected, prior to the separation, to increase biopharmaceuticals and scientific experience for New GSK.

    The Board of GSK believes that the appointment of executive leadership to the new Consumer Health company well in advance of the separation will benefit and support delivery of financial performance and execution of the separation. The Board has therefore conducted an extensive search and selection process to appoint a CEO Designate for Consumer Healthcare. This process, conducted over 6 months and supported by a leading global search firm, was overseen by the Nominations & Corporate Governance Committee and resulted in direct evaluation and interview of several external and internal candidates for the position. This process is now nearing completion and an announcement is expected to be made in due course.

    The separation of Consumer Healthcare is a clear part of GSK's strategic agenda, led by CEO Emma Walmsley, to transform GSK and to deliver a step-change in growth and performance. As evidenced at the Investor Update last week, and with New GSK representing the majority of GSK's existing business, the Board is not conducting a selection process post-separation.

    The Board strongly believes Emma Walmsley is the right leader of New GSK and fully supports the actions being taken by her and the management team, all of whom are subject to rigorous assessments of performance. Under Emma's leadership, the Board fully expects this team to deliver a step-change in performance and long-term shareholder value creation through the separation and in the years beyond.


    Separation of Consumer Healthcare to maximise value for shareholders

    The Board's clear priorities are to unlock the potential of New GSK and Consumer Healthcare, to strengthen New GSK's balance sheet and to maximise value for all shareholders.

    Subject to approval from shareholders, the separation will be by way of a demerger in mid-2022 of at least 80% of GSK's holding in Consumer Healthcare to GSK shareholders, with New GSK retaining up to 20% of that holding as a short-term financial investment to be monetised in a timely manner to further strengthen New GSK's balance sheet and help fund certain pension benefit obligations.

    The demerger structure reflects feedback from a significant proportion of GSK's shareholders that they wish to own Consumer Healthcare as a new listed entity, given its strong prospects for sustainable sales and profit growth, high cash generation and the expectation that it will deliver attractive returns for shareholders.

    The Board has a strong focus on maximising shareholder value and will fulfil its fiduciary duties to evaluate any alternative options for Consumer Healthcare that may arise. If any alternative opportunity should arise, the Board would consider, amongst other things, the realised value against the opportunity cost for shareholders of no longer being able to benefit from the future growth and value accretion of Consumer Healthcare as an independent global category-leading consumer company, which the Board believes will be significant over the coming years. In making this assessment, the Board will also take into account any additional tax or other frictional costs compared to the announced demerger structure.


    Outlooks for New GSK represent a step-change in growth and performance

    At its Investor Update, GSK announced a package of new financial outlooks and ambitions.

    · Over the period 2021-26, New GSK expects to deliver sales growth and adjusted operating profit growth of more than 5% and 10% respectively CAGR at constant exchange rates (with 2021 as the base year). Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026.

    · Profit growth is expected to be underpinned by a combination of strong revenue growth from new vaccines and specialty medicines, improving operational performance and benefits from the transformation.

    · These financial outlooks exclude any contribution from COVID-19 related revenues.

    · By 2031, New GSK aims to deliver sales of more than £33 billion (at constant exchange rates). The £33 billion sales ambition is before any significant revenue contribution from early-stage pipeline assets or any contribution from business development.

    · Cash generated from operations is expected to exceed £10 billion by 2026. New GSK is expected to have a stronger balance sheet (net debt / adjusted EBITDA of <2x following separation) and a progressive dividend policy starting at 45p per share in 2023.

    These financial outlooks and ambitions represent a step-change. They are based on rigorous challenge and follow assessment of 10-year forecasts, conducted over many months, by the Executive Team and the Board. These outlooks and ambitions are set as the minimum level of growth that New GSK is expected to achieve or is targeting, with clear ambitions to exceed as stated at the Investor Update.

    As stated at the Investor Update, the new outlooks and ambitions will be incorporated into existing incentive plans. Incentive measures for these plans include delivery of innovation sales, pipeline progress, operational performance and relative total shareholder returns, and so are strongly aligned to shareholder interests and shareholder value creation.


    New GSK positioned to maximise opportunities across prevention and treatment

    Innovations in science and technology are driving increasing convergence across prevention and treatment, offering significant scientific and commercial opportunities for New GSK. With R&D focussed on science of the immune system, and world-leading capabilities in vaccine and pharmaceutical development, GSK is well-placed to capture these opportunities and it underpins GSK's approach to further integration in R&D and prioritisation of capital to Vaccines and Specialty Medicines.

    GSK has built an industry-leading and high-performing Vaccines business, which has increased revenues from £4.6billion in 2016 to £7.0billion in 2020, and is expected to deliver high single digit % sales CAGR in 2021-26. This business has benefited from operational integration with pharmaceuticals in key areas for many years, notably commercial operations and clinical development; but is also operationally independent where it is optimal, for example in manufacturing.

    As announced at the Investor Update, New GSK will disclose revenues of Vaccines and Specialty Medicines. Reflecting their integration, and as is common to the sector, the Board does not believe it would be appropriate to have separate divisional reporting.


    Strong commitment to delivering sustainable shareholder value

    The Board and the Executive team fully recognise the need to deliver improved and sustained value for all shareholders. Both strongly believe that the separation of GSK and the launch of the two, new independent companies with thriving people will deliver significant and sustainable value for shareholders, together with positive, scale human health impact for patients and other stakeholders.

    ************

    Notes for Information


    Investor Update

    GSK hosted an Investor Update on 23 June that provided details of its strategy, outlook for growth and plans to create shareholder value, following the planned demerger in mid-2022 of its Consumer Healthcare business. Copies of the materials from the Investor Update are available in the investor relations section of GSK's website (https://www.gsk.com/en-gb/investors/new-gsk/).

    GlaxoSmithKline PLC - Elliott Advisors (UK) letter to GSK #GSK @GSK https://www.voxmarkets.co.uk/rns/announcement/b04bbd2f-55f2-4542-9b51-cce5ddf502de #voxmarkets
     
  12. Groucho

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    Issued: 2 July 2021, London UK


    GSK and Alector announce global collaboration in immuno-neurology for two clinical stage first-in-class monoclonal antibodies for neurodegenerative diseases


    · GSK and Alector to co-develop progranulin-elevating monoclonal antibodies, AL001 and AL101, for a range of neurodegenerative diseases, including frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's disease

    · Companies will co-commercialise and share profits in the US; GSK will retain exclusive commercialisation rights outside the US

    · Alector will receive $700 million in upfront payments, up to $1.5 billion in potential milestone payments, profit sharing and royalties

    GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments.

    The collaboration brings together Alector's leading immuno-neurology expertise with GSK's R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. Enrolment is currently underway for a pivotal Phase 3 trial for AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis and has no approved treatments. AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson's disease and Alzheimer's disease.


    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector's world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson's and Alzheimer's."

    Arnon Rosenthal, Ph.D., Chief Executive Officer, Alector, said: "This transformative collaboration brings together Alector's leading immuno-neurology expertise with GSK's commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build out of our own late-stage development and commercial capabilities. Importantly, this collaboration is designed to fully support AL001 and AL101's development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases. We are confident that GSK's extensive experience launching ground-breaking medicines at the intersection of immunology and human genetics, will ensure that AL001 and AL101 are developed to their full potential."

    As part of the recent Investor Update day on 23 June 2021, GSK committed to an R&D approach focused on maximising opportunities by leveraging an increased understanding of the science of the immune system and human genetics. The collaboration with Alector on AL001 and AL101, two antibodies designed to elevate PGRN levels and potentially slow the progression of FTD and other neurological disorders, provides GSK access to a promising clinical programme in immuno-neurology.


    Terms of the Collaboration

    Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.

    Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and all costs for global development will be divided between the two companies.

    The companies will be jointly responsible for commercialisation in the U.S. and will share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications and GSK will lead the commercialisation of AL101 in Alzheimer's and Parkinson's disease. Outside the U.S., GSK will be responsible for commercialisation of AL001 and AL101 and Alector will be eligible for tiered royalties.

    The collaboration agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    About the Progranulin-Elevating Monoclonal Antibodies - AL001 and AL101

    Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. AL001 and AL101 are novel human monoclonal antibodies that elevate levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation. AL001 is currently in a pivotal Phase 3 clinical study in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is also currently in a Phase 2 study in symptomatic FTD patients with a C9orf72 mutation, with another Phase 2 study in patients with ALS planned to begin in the second half of 2021. AL101, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers. AL101 is intended to be developed for treatment of Parkinson's disease and Alzheimer's disease.


    About Frontotemporal Dementia (FTD)

    Frontotemporal dementia is a rapidly progressing and severe form of dementia. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America. There are currently no FDA-approved treatment options for FTD.

    There are multiple heritable forms of FTD. In one form, FTD-GRN, people have a mutation in the progranulin gene. This population represents 5% to 10% of all people with FTD. Mutations in a single copy of a progranulin gene leads to a 50% or greater decrease in the level of progranulin protein and invariably leads to development of FTD. In another form, people with mutations in the chromosome 9 open reading frame 72 (C9orf72) gene can develop FTD. FTD-C9orf72 is associated with abnormal accumulation of the protein TDP-43, which is also a hallmark in FTD-GRN. To date researchers have identified more than 120 inherited loss of function mutations in the progranulin gene that lead to FTD.


    Alector Conference Call Information

    Alector management will host a conference call to discuss the collaboration today at 8:30 a.m. ET. Analysts and investors are invited to participate in the conference call by dialling (888) 705-0365 from the U.S. and Canada or (415) 817-9241 internationally and using the conference ID 9476664. The live webcast can be accessed on the investor page of Alector's website at investors.alector.com. A replay of the webcast will be available on Alector's website approximately two hours after the completion of the event and will be archived for up to 30 days.


    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/en-gb/about-us.


    About Alector

    Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain's immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company's immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease. This scientific approach is also the basis for the Company's immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.
     
  13. Groucho

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    16 July 2021


    GSK announces positive headline results from five Phase 3 studies of daprodustat for patients with anaemia due to chronic kidney disease


    Full results to be presented at a medical meeting later this year


    GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive headline results from five studies of the Phase 3 ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for patients with anaemia due to chronic kidney disease (CKD).


    The ASCEND programme showed that daprodustat met its primary efficacy endpoint in each study, demonstrating an improvement in haemoglobin (Hgb) levels in untreated patients and maintaining Hgb levels in patients treated with an erythropoietin stimulating agent (ESA), a standard treatment option, in patients with anaemia of CKD. In addition, the key cardiovascular outcomes studies for non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D) demonstrated that daprodustat was non-inferior when compared to an ESA in the risk of Major Adverse Cardiovascular Events (MACE), the co-primary endpoint of both studies.


    Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "I am particularly pleased with the results from the ASCEND-ND and ASCEND-D studies given the importance of managing cardiovascular outcomes for patients who are currently suffering from anaemia due to chronic kidney disease, as well as the need to provide a convenient, oral treatment option. We will continue to analyse the data from the robust phase 3 ASCEND programme and look forward to working closely with regulators as we plan for our submissions."

    In addition to the ASCEND-D and ASCEND-ND studies, the programme also included studies focused on incident dialysis, for patients just starting dialysis (ASCEND-ID); quality of life measures (ASCEND-NHQ); as well as three-times weekly dosing regimens (ASCEND-TD). Each of the studies from the programme met its respective primary or co-primary endpoint(s). The programme enrolled over 8,000 patients who were treated for up to 3.75 years. The full results of the studies will be presented at a forthcoming medical meeting later this year and will be used to inform regulatory pathways with health authorities worldwide.

    Across the ASCEND programme, daprodustat was generally well tolerated in both non-dialysis and dialysis patients. The incidence of treatment-emergent adverse events was similar between treatment groups and the nature of reported events was consistent with the underlying patient population. The most commonly reported adverse events in patients receiving daprodustat across the ASCEND programme included hypertension, diarrhoea, dialysis hypotension, peripheral edema, and urinary tract infection.

    Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia. It is not approved anywhere else in the world.


    About Anaemia of CKD

    Chronic kidney disease, characterised by progressive loss of kidney function, is an increasing global public health burden.1 Risk factors for CKD include hypertension, diabetes, obesity and primary renal disorders.1 Furthermore, CKD is an independent risk factor for cardiovascular disease.1 Anaemia is an important and frequent complication of CKD.2 However, it is often poorly diagnosed and undertreated in patients with early stage CKD, such as those not on dialysis.2 When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.2


    About daprodustat

    Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), belongs to a novel class of oral medicines indicated for the treatment of anaemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia, similar to the physiological effects that occur in the body at high altitude. Daprodustat has been developed to provide a convenient oral treatment option for patients with anaemia associated with CKD.
     
  14. Groucho

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    Issued: 22 July 2021, London UK - LSE announcement



    Brian McNamara appointed CEO Designate of new independent Consumer Healthcare company


    The Board of GSK (GSK) today announces that Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK in 2022.


    As set out at GSK's Investor Update on 23 June 2021, subject to approval from shareholders, the separation of Consumer Healthcare will be by way of a demerger in mid-2022 of at least 80% of GSK's holding to shareholders. The new resulting Consumer Healthcare company is expected to attain a premium listing on the London Stock Exchange.

    The company will be a new world-leader in Consumer Health with a portfolio which generated annual sales of more than £10 billion in 2020. The company will have a strong portfolio of brands including Sensodyne, Voltaren, Panadol and Centrum and will hold category leadership positions and major sales presences in the US and China.


    Sir Jonathan Symonds, GSK Chairman, said: "We are delighted to announce Brian's appointment to lead the proposed new Consumer Healthcare company, following a thorough process conducted by the Board. Brian is an exceptional leader, and through two global integrations, has successfully transformed GSK Consumer Healthcare into a category-leading business. His strong track record of success and deep experience of fast moving consumer goods and consumer health, proven at P&G, Novartis and GSK, means he is the right choice to unlock the potential of Consumer Healthcare as an independent company and deliver its strong prospects for sustainable sales and profit growth, high cash generation and attractive returns for shareholders."


    Brian joined GSK from Novartis in 2015, where he was head of the Over the Counter (OTC) division. He has been a driving force behind two successful Joint Ventures, first between GSK and Novartis and more recently with Pfizer to create a new world-leading Consumer Healthcare business.


    Brian McNamara, CEO Designate, Consumer Healthcare, said: "I am honoured to have this opportunity. Together with the many talented people we have in our business, I am looking forward to our exciting future as an independent company. I am confident we are well positioned for growth, building on our brands and innovation, with leading-edge science and human understanding, to deliver better everyday health."


    Appointment and selection process

    As previously communicated, the Board of GSK conducted an extensive search and selection process to appoint a CEO Designate for the new Consumer Healthcare company. The process, conducted over six months and supported by two leading global search firms, was overseen by the Nominations & Corporate Governance Committee and resulted in direct evaluation and interview of several external and internal candidates for the position.


    Consumer Healthcare Board

    With the separation of Consumer Healthcare, the Board of GSK has been preparing for two separate, appropriately qualified, independent boards at the point of separation. A formal process to appoint a Chair and to form a Board of Directors for the new Consumer Health company is well underway. The appointment of a Chair is expected in the second half of 2021 who will then, in accordance with best practice, lead the process of appointments to establish the new Board. This new Board will include the appropriate mix of skills, experience, diversity and continuity, relevant to Consumer Health, to represent and maximise the value of this new business for shareholders.
     
  15. Groucho

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  16. Groucho

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    Issued: 31 August 2021, London, UK and Seoul, Republic of Korea


    SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate

    · Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data

    · Global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine

    · Aim is for global supply through the COVAX facility in the first half of 2022, subject to data and regulatory review


    SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510,in combination with GSK's pandemic adjuvant following positive interim Phase 1/2 results.

    The randomised, active-controlled global trial will enrol around 4,000 participants from a range of countries and will aim to evaluate GBP510's safety and immunogenicity compared to an active comparator - the AstraZeneca/Oxford University COVID-19 vaccine. The study will be one of the first global Phase 3 trials to compare two different COVID-19 vaccine candidates.


    Jaeyong Ahn, CEO, SK bioscience said, "We are grateful that we were able to advance to the Phase 3 study with the unprecedented support of global initiatives, including GSK,Coalition for Epidemic Preparedness Initiative (CEPI), and the Bill & Melinda Gates Foundation (BMGF). Taking this important step towards overcoming the global pandemic situation, SK and GSK will bring our technical expertise together for the development of an adjuvanted protein-based vaccine candidate, GBP510."


    Thomas Breuer, Chief Global Health Officer, GSK said, "While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world.We are pleased to contribute with GSK's pandemic adjuvant and to be working with SK to deliver the vaccine at scale via COVAX if it is approved."


    The advance to Phase 3 study follows positive interim Phase 1/2 data which showed that all participants who received the adjuvanted vaccine candidate developed strong neutralizing antibody responses, demonstrating a 100% seroconversion rate. Neutralizing antibody titres were between five and a maximum of eight times higher compared to sera from people recovered from COVID-19. No safety concerns have been identified to date in this ongoing study.

    GBP510 is a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 Spike protein, combined with GSK's pandemic adjuvant. The antigen is being developed by SK in collaboration with the Institute for Protein Design (IPD) at the University of Washington with support from BMGF and CEPI as part of the 'Wave 2' vaccine investment project to develop more accessible and affordable COVID-19 vaccines.

    Results from the Phase 3 study are expected in the first half of 2022 after which, subject to positive results and regulatory approval, the vaccine is expected to be supplied at scale worldwide through the COVAX facility.


    GSK commitment to tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development.

    GSK is collaborating with several organisations on COVID-19 vaccines by providing access to our pandemic adjuvant. As well as working with SK, we are collaborating with Sanofi and Medicago to develop adjuvanted, protein-based vaccine candidates, and all are now in Phase 3 clinical trials. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protect more people in need.

    GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, optimised mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. Sotrovimab, a monoclonal antibody for the early treatment of COVID-19 in adults at high risk of hospitalisation, received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in May 2021. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.


    About SK bioscience

    SK bioscience is an innovative biopharmaceutical company specialized in the vaccine area. By leveraging strengths in cutting-edge vaccine development technologies, we have been dedicated to human health from prevention to cure across the globe. With the collaboration of domestic and international governments, regulatory agencies, healthcare providers and medical experts, our colleagues are passionately committed to provide affordable and high-quality vaccines to those who need them and improve the health care environment.

    For more information, please visit https://www.skbioscience.co.kr/en/main
     

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