GSK plc operates as a healthcare company, which engages in the creation and discovery, development, manufacture and marketing of pharmaceutical products, vaccines, over-the-counter (OTC) medicines and health-related consumer products.
The company’s principal pharmaceutical products include medicines in the following therapeutic areas: respiratory, HIV, immuno-inflammation, oncology, anti-virals, central nervous system, cardiovascular and urogenital, metabolic, anti-bacterials and dermatology....
GSK plc operates as a healthcare company, which engages in the creation and discovery, development, manufacture and marketing of pharmaceutical products, vaccines, over-the-counter (OTC) medicines and health-related consumer products.
The company’s principal pharmaceutical products include medicines in the following therapeutic areas: respiratory, HIV, immuno-inflammation, oncology, anti-virals, central nervous system, cardiovascular and urogenital, metabolic, anti-bacterials and dermatology.
Segments
The company operates through four segments: Pharmaceuticals, Pharmaceuticals R&D (Research and Development), Vaccines; and Consumer Healthcare.
Pharmaceuticals segment
This segment has a portfolio of medicines in respiratory, HIV, immuno-inflammation and oncology. This segment focuses on immunology, human genetics and advanced technologies to help the company deliver medicines for patients.
The company’s R&D pipeline contains 39 potential new medicines, including 15 clinical oncology assets. The company received approvals for three medicines: Dovato, an HIV treatment; Dectova, a treatment for influenza A or B; and new self-administration options for its respiratory biologic, Nucala. The company also received expanded indications for medicines including Zejula, its oral poly ADP-ribose polymerase (PARP) inhibitor for ovarian cancer and Benlysta, a biologic treatment for systemic lupus erythematosus (SLE or ‘lupus’). The company submitted eight filings for regulatory approval.
The company submitted cabotegravir and rilpivirine, the first once-monthly, complete long-acting HIV regimen for regulatory review in the U.S. and EU. This followed the global ATLAS and FLAIR pivotal phase III studies which demonstrated that the therapy was as effective as a daily oral three-drug regimen in maintaining viral suppression. In December 2019, the company received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the U.S. submission and would work with the regulatory authority to determine appropriate next steps. Regulatory review in the EU is ongoing.
In 2019, the company launched the year-long CUSTOMIZE study to identify and evaluate ways of implementing a once-monthly HIV regimen into clinical practice. The programme involves ViiV Healthcare employees working with clinical staff, healthcare providers and people living with HIV across the U.S.
In December 2019, the company filed for the U.S. regulatory approval for fostemsavir, its attachment inhibitor for heavily treatment-experienced adults with HIV-1 infection, including those who are failing on antiretroviral regimens and have exhausted all treatment options. The submission followed positive results from the 96-week phase III BRIGHTE study.
Oncology Assets
Zejula, the company’s oral PARP inhibitor, is approved in the U.S. and Europe for women with recurrent ovarian cancer.
Following a priority review, in October 2019, the FDA approved an expanded indication for Zejula as a late-line treatment for women whose advanced ovarian cancer is associated with homologous recombination deficiency. The approval was supported by the positive results of the phase II QUADRA study. This approval allows the company to address the unmet clinical need and demonstrates that Zejula is active as a late line therapy for women beyond those with BRCA mutations. In December 2019, the company also filed for the U.S. approval of Zejula in first-line maintenance therapy of women with platinum responsive ovarian cancer. The submission, which has been accepted by the FDA, was based on positive results from the phase III PRIMA study which showed a significant reduction in disease progression for women, irrespective of their biomarker status.
Belantamab mafodotin, the company’s humanised immunoconjugate against B-cell maturation antigen (anti-BCMA), is being studied for the treatment of multiple myeloma, the second most common blood cancer, for which there is no cure. In December 2019, the company filed for regulatory approval following positive results from the pivotal DREAMM-2 study, which explored belantamab mafodotin in patients with relapsed/refractory multiple myeloma, and subsequently been granted a priority review by the FDA.
In the second-line setting, the company’s phase I/II DREAMM-6 study is assessing belantamab mafodotin in combination with standard of care. The results would inform pivotal second-line studies, which are due to start in the second half of 2020. The company also started two other studies: DREAMM-5, a fourth-line, phase I/II study exploring use in combination with novel agents, and DREAMM-9, a phase III first-line study in combination with standard of care.
Dostarlimab is a PD-1 inhibitor targeting endometrial cancer, the sixth most common cancer in women. It is being evaluated for use as a monotherapy and in combination with other immuno-oncology agents. The company filed for regulatory approval in a second-line endometrial cancer setting in late 2019, following positive results from the GARNET study, the largest ever trial of an anti-PD-1 monotherapy in patients with advanced or recurrent endometrial cancer. In September 2019, the company enrolled the first patients in RUBY, a first-line study of dostarlimab in combination with chemotherapy.
In February 2019, the company announced a global alliance with Merck KGaA to jointly develop bintrafusp alfa, an investigational bifunctional fusion protein immunotherapy in development for multiple difficult-to-treat cancers. The most advanced potential registration study is in second-line biliary tract cancer, a group of rare, aggressive gastrointestinal cancers associated with limited treatment options and poor outcomes.
The company’s anti-ICOS agonist antibody, GSK3359609, is designed to selectively enhance the function of T-cells. The company is studying the antibody alone and in combination with other therapies, due to its considerable potential across a range of tumour types. Following the positive results of the INDUCE-1 study, the company initiated a phase II/III study with registration potential in combination with pembrolizumab in first-line recurrent/metastatic head and neck squamous cell carcinoma.
The company’s primary T-cell immunotherapy, GSK3377794, targets the NY-ESO-1 antigen that is expressed across multiple cancer types. The therapy is on an accelerated development path, having received both European PRIME and U.S. FDA breakthrough status, with ongoing phase II studies in synovial sarcoma, lung cancer and multiple myeloma. This asset, along with its other cell therapies, could be enhanced by leveraging the technologies available to the company through its new collaboration with Lyell Immunopharma.
Respiratory
The company has launched six new treatments since 2012, establishing a portfolio of once-daily, inhaled respiratory medicines.
In 2019, the company continued the roll out of Trelegy Ellipta, its single inhaler triple therapy for chronic obstructive pulmonary disease (COPD). It is available in approximately 40 markets, with key launches in 2019 that included Japan and China. Following positive results from the phase III CAPTAIN study, which showed the effect of Trelegy in treating patients with asthma, the company filed for this new indication in the U.S. and Japan.
Nucala, the company’s first-in-class biologic for patients with severe eosinophilic asthma (SEA), continued to strengthen its clinical profile with approval in the U.S. and EU of two new self-administration options, and early data from the REALITI-A study showing Nucala significantly reduces exacerbations in a real-world setting. Approval in the U.S. for use in children with SEA aged six to 11 provided a new option for this difficult to treat patient population.
Immuno-Inflammation
The company’s research focuses on the biology of the immune system, reflecting its aim to develop immunological-based medicines that alter the course of inflammatory disease.
The company offers a biologic treatment, Benlysta, specifically developed and approved for adult and paediatric lupus. In 2019 the medicine was approved for adults in China. During the year intravenous Benlysta became the first biologic treatment to be approved in the U.S., EU and Japan for children who have limited treatment options for this disease. The company also announced positive results from the pivotal BLISS-LN study showing the effect of Benlysta in active lupus nephritis, an inflammation of the kidneys caused by SLE.
The company announced the start of the phase III study of otilimab, its anti GM-CSF antibody, in patients with rheumatoid arthritis, following results from the phase II BAROQUE study.
Infectious Diseases
The company started two phase III studies for gepotidacin, the first in a new chemical class of antibiotics to treat drug resistant bacteria, in urogenital gonorrhoea and uncomplicated urinary tract infection. This marks the first time these infections have been addressed by new oral antibiotics in 20 years. First results are expected by the end of 2021.
The company received EU approval for Dectova for the intravenous treatment of influenza A or B which could cause epidemic seasonal infections. The innovation, intended for hospitalised patients, complements its oral version of this neuraminidase inhibitor, which the company markets as Relenza.
Additional Programmes
In Japan, the company filed for regulatory approval for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for patients with anaemia associated with chronic kidney disease. If approved, daprodustat would provide a new and convenient oral treatment option for these patients.
Pharmaceuticals R&D segment
This segment focuses on the science related to the immune system, the use of human genetics, and other advanced technologies. The pipeline includes 14 assets progressing or being added, 8 terminations and 3 medicines being approved in 2019, resulting in 39 medicines being developed.
Vaccines segment
This segment offers vaccines that protect people at all stages of life. The company’s R&D focuses on developing vaccines against infectious diseases that combine high medical need and market potential.
The company has 15 assets in clinical development, with key data readouts on various candidate vaccines expected in 2020. The company classifies its vaccine pipeline in three categories (life-cycle management, new commercial assets and global health assets) to ensure it allocates the appropriate resources to priority vaccine development programmes that deliver the best value to society and support the Group’s strategy.
In 2019, the company accelerated the development of its candidate vaccines against respiratory syncytial virus (RSV), and advanced its therapeutic candidate vaccine against chronic obstructive pulmonary disease (COPD). The company progressed four new strategic candidate vaccines into human trials; one for RSV in older adults, the second against Clostridium difficile which could help to address antimicrobial resistance, the third, testing its SAM technology in a rabies model, and the fourth, its therapeutic candidate vaccine against chronic hepatitis B.
RSV
The company has a portfolio of three different candidate vaccines against RSV, the most common cause of lower respiratory tract infection. Each of its three RSV candidate vaccines is tailored to meet the specific needs of its target group: maternal, paediatric and older adults. Given their promising early results and the strong medical need, all three RSV candidate vaccines have been FDA fast tracked in 2019. They are in phase I/II trials with key data readouts expected in 2020. The company’s maternal RSV candidate is based on a recombinant pre-fusion antigen, its paediatric RSV candidate harnesses its adenovirus vector technology and its older adult RSV candidate, for people approximately 60, leverages the recombinant pre-fusion antigen combined with its AS01 adjuvant system, which is a key ingredient in Shingrix, enabling its efficacy and success in market.
COPD
The company’s COPD candidate is a therapeutic vaccine aimed at reducing the frequency of acute exacerbations and slowing disease progression in COPD sufferers. It contains four bacterial antigens and its AS01 adjuvant system. The company has demonstrated that its adjuvanted COPD vaccine candidate is safe and highly immunogenic. In 2019, enrolment for its phase IIb study in adults was completed ahead of plan and the study results are due in 2020.
Meningitis
The company offers vaccines against meningococcal meningitis, including its complementary portfolio of Bexsero, targeting serogroup B, and Menveo, against serogroups A, C, W, and Y. In the US, where Bexsero is licensed for 10 to 25 year olds, a phase III trial is evaluating lowering the age indication to two months. Simultaneously, an alternative, liquid presentation of Menveo is progressing through phase II trials to simplify vaccine preparation steps for healthcare providers. The U.S. FDA approved the indication of a single booster dose administration of Menveo to individuals aged 15 to 55 years who are at continued risk of meningococcal disease if at least four years have elapsed since a previous dose.
Consumer Healthcare segment
This segment combines science and consumer insights to create everyday healthcare brands that consumers trust and experts recommend for oral health, pain relief, cold, flu and allergy relief, digestive health, and vitamins, minerals and supplements.
The company combines consumer insights and scientific and technical expertise to deliver innovations across each of its categories. In oral health, the company launched its formulation for enamel care, Pronamel Intensive Enamel Repair toothpaste, in the U.S., the U.K. and Germany. This formula helps to repair acid-weakened enamel to help people strengthen and protect their teeth.
Another launch in 2019 was Sensodyne Sensitivity & Gum, which was developed for approximately one third of the adult population that experience tooth sensitivity, with over half of them also experiencing gum problems. The new offering provides dual relief for sensitivity and bleeding gums, all in one daily toothpaste. It launched in approximately 30 markets, including the U.K. and Turkey.
For denture care, the company developed Polident Cushion and Comfort, which provides cushioning and comfort for tired and tender gums, as well as providing a denture adhesive. In 2019, it launched in 14 markets, including Italy and Spain.
In pain relief, the company gained approval from the FDA in February 2020 for Voltaren Arthritis Pain as an OTC product for the temporary relief of arthritis pain. Voltaren Arthritis Pain is the first prescription strength, nonsteroidal anti-inflammatory topical gel for arthritis pain available OTC in the U.S. to people with osteoarthritis.
The company also offers TUMS Chewy Bites with Cooling Sensation; it offers a cooling sensation so consumers could cool down and fight heartburn fast.
Strategy
The company’s strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with its three global businesses, scientific and technical know-how and talented people.
Research and Development (R&D)
The company’s total R&D expenditure was £4,568 million in 2019.
Significant Event
In July 2020, Sengenics entered into a research collaboration agreement with the company. The collaboration would combine Sengenics' functional proteomics capabilities with GSK's scientific expertise in immunology, especially in drug discovery. The collaboration would utilize Sengenics' proprietary KREX technology to validate novel autoantibody biomarkers in patients with autoimmune diseases. These biomarkers were identified using the IMMUNOME protein array, a KREX-based array with functionally validated, full-length, correctly folded proteins.
In July 2020, the company and Medicago announced a collaboration to develop and evaluate a COVID-19 candidate vaccine combining Medicago's recombinant coronavirus virus-like particles (CoVLP) with the company’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognised by the immune system. Pre-clinical results with Medicago's CoVLP vaccine candidate demonstrated a high level of neutralizing antibodies following a single dose when administered with adjuvant. Phase 1 clinical testing is planned to start in mid-July and will evaluate the safety and immunogenicity of three different dose levels of antigen combined with GSKs pandemic adjuvant and in parallel with an adjuvant from another company, administered on a one- and two-dose vaccination schedule, given 21 days apart. Subject to successful clinical development and regulatory considerations, the companies aim to complete development and make the vaccine available, in the first half of 2021. Both companies would also evaluate expanding their collaboration to develop a post-pandemic vaccine COVID-19 candidate, should the need arise based on the further development of COVID-19 after the pandemic, and other infectious diseases.
History
The company was founded in 1715. The company was incorporated in 1999. The company was formerly known as GlaxoSmithKline plc and changed its name to GSK plc in 2022.
