07.11.22
Headquarters: London, UK
twitter.com/GSK
www.gsk.com
Headcount: 90,096
Year Established: 2000
Pharma Revenues: $33,059 (+1%)
Net Income: $6,874 (-20%)
R&D: $7,120 (+4%)
TOP SELLING DRUGS
Driving GlaxoSmithKline’s modest growth in 2021, sales of Xevudy (sotrovimab), the monoclonal antibody treatment for Covid-19, reached $1.3 billion contributing approximately 6 percentage points to Pharmaceuticals growth for the year. However, as of April 5, 2022, the FDA suspended use of sotrovimab for Covid-19 treatment in the U.S., saying the antibody is unlikely to be effective against the Omicron BA.2 sub-variant. Meanwhile sales of Established Pharmaceuticals for the year were down 11% to $10.5 billion, and Vaccines turnover was down 3% to $9.1 billion, as a result of lower demand for routine adult vaccination.
In addition to Pandemic revenues, up 31% reflecting the ongoing fulfilment of Xevudy contracts, growth drivers in Respiratory, Immuno-inflammation, and Oncology also helped offset declines for several of GSK’s top selling products. Offsetting losses for legacy products, namely Advair and Ventolin, Respiratory sales were up 21% with sales of Trelegy and Nucala each exceeding $1.5 billion in annual sales for the first time. Sales of Nucala grew 15%, while Trelegy sales were up 49%. Immuno-inflammation sales were up 22% driven by Benlysta with $1.2 billion in sales and benefitting from lupus nephritis launches in U.S. and Japan in 2H20. Oncology sales were up 22% were driven by Zejula, a PARP inhibitor treatment for ovarian cancer, with sales of $532.8 million, up 17%. Also, Blenrep for the treatment of patients with relapsed or refractory multiple myeloma was approved and launched in the U.S. and Europe 3Q20, with ongoing launches throughout Europe in 2021. Blenrep sales globally totaled $120 million.
Following the demerger, GSK plans to focus purely on biopharmaceuticals, prioritizing investments in development of vaccines and specialty medicines. The company’s R&D approach will focus on the science of the immune system, use of human genetics, and advanced technologies.
Expanding its vaccines and oncology assets, GSK is spending more than $3.1 billion with two recent acquisitions. GSK recently entered an agreement to acquire Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, MA for $2.1 billion upfront and up to $1.2 billion in potential development milestones. The acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase 2 development and highly innovative MAPS technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines.
GSK also agreed to acquire Sierra Oncology, Inc., a CA-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare cancers, for approximately $1.9 billion. Sierra Oncology’s differentiated momelotinib has the potential to address the critical unmet needs of myelofibrosis patients with anaemia. Myelofibrosis is a fatal cancer of the bone marrow impacting the normal production of blood cells. Momelotinib complements GSK’s expertise in hematology, and Sierra Oncology anticipates U.S. regulatory submission in 2Q22 and EU submission in the 2H22.
Most recently, the U.S. FDA approved Priorix for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. Also, the FDA accepted GSK’s New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anemia in chronic kidney disease (CKD). Daprodustat was developed based on the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The FDA has assigned a Prescription Drug User Fee Act action date of February 1, 2023.
The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial, which included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anemia across the spectrum of CKD.
In the way of ongoing efforts to battle Covid-19, while GSK and development partner Vir Biotechnology, Inc. face uncertainty advancing sotrovimab, GSK’s partnered Covid-19 vaccine and booster remain on track. Sotrovimab, which was previously granted Emergency Use Authorization (EUA) by the U.S. FDA in May 2021, is an investigational single-dose intravenous infusion SARS-CoV-2 monoclonal antibody. Under the EUA, sotrovimab was authorized to treat mild-to-moderate Covid-19 in adults and pediatric patients. The companies planned to manufacture approximately two million doses globally in the first half of 2022 and additional doses in the second half of the year.
The U.S. distribution of the Covid-19 antibody has been on hold since the FDA pulled authorization in April. GSK previously announced that preclinical studies demonstrated sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron variant.
In January, the U.S. Government had purchased an additional 600,000 doses of sotrovimab to be delivered throughout the first quarter of 2022. This agreement was an amendment to an earlier commitment with the U.S. Government in November 2021.
While currently on hold, an application to the FDA was submitted for sotrovimab in the fourth quarter requesting an amendment to the EUA to include intramuscular administration. Also in the fourth quarter, the European Commission approved sotrovimab for the early treatment of Covid-19 in adults and adolescents 12 years and over who do not require supplemental oxygen and who are at increased risk of progressing to severe infection.
To date, GSK had received binding agreements for the sale of approximately 1.7 million doses worldwide. Separately, Vir and CDMO WuXi Biologics terminated their Covid antibody alliance as U.S. rollout faces an uncertain future.
GSK and partner Medicago, a biopharmaceutical company headquartered in Quebec, received approval from Health Canada for COVIFENZ, Covid-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted) for active immunization to prevent Covid-19 caused by SARS‑CoV‑2 in individuals 18 to 64 years of age.
Additionally, GSK and Sanofi plan to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for their Covid-19 vaccine. The Sanofi-GSK vaccine is supported by robust immune responses and a favorable safety profile. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels.
In the Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: 100% efficacy against severe Covid-19 disease and hospitalizations; 75% efficacy against moderate or severe Covid-19 disease; and 57.9% efficacy against any symptomatic Covid-19 disease, in line with effectiveness in dominated by variants of concern.
Finally, SK bioscience and GSK submitted a biologics license application for SKYCovione, a recombinant protein-based Covid-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety following positive Phase III clinical data. The vaccine candidate demonstrated superior neutralizing antibody titers over AstraZeneca’s Vaxzevria (control vaccine), a currently authorized Covid-19 vaccine, along with a clinically favorable safety profile.
twitter.com/GSK
www.gsk.com
Headcount: 90,096
Year Established: 2000
Pharma Revenues: $33,059 (+1%)
Net Income: $6,874 (-20%)
R&D: $7,120 (+4%)
TOP SELLING DRUGS
Drug | Indication | 2021 Sales | (+/-%) |
Triumeq | HIV | $2,539 | -18% |
Shingrix | shingles prophylaxis | $2,322 | -13% |
Tivicay | HIV | $1,863 | -10% |
Advair | asthma, COPD | $1,831 | -12% |
Trelegy | COPD | $1,642 | 49% |
Nucala | asthma | $1,540 | 15% |
Breo Ellipta | COPD | $1,512 | 5% |
Xevudy | COVID-19 | $1,292 | n/a |
Benlysta | systemic lupus erythematosus | $1,179 | 22% |
Ventolin | asthma | $969 | -9% |
Driving GlaxoSmithKline’s modest growth in 2021, sales of Xevudy (sotrovimab), the monoclonal antibody treatment for Covid-19, reached $1.3 billion contributing approximately 6 percentage points to Pharmaceuticals growth for the year. However, as of April 5, 2022, the FDA suspended use of sotrovimab for Covid-19 treatment in the U.S., saying the antibody is unlikely to be effective against the Omicron BA.2 sub-variant. Meanwhile sales of Established Pharmaceuticals for the year were down 11% to $10.5 billion, and Vaccines turnover was down 3% to $9.1 billion, as a result of lower demand for routine adult vaccination.
In addition to Pandemic revenues, up 31% reflecting the ongoing fulfilment of Xevudy contracts, growth drivers in Respiratory, Immuno-inflammation, and Oncology also helped offset declines for several of GSK’s top selling products. Offsetting losses for legacy products, namely Advair and Ventolin, Respiratory sales were up 21% with sales of Trelegy and Nucala each exceeding $1.5 billion in annual sales for the first time. Sales of Nucala grew 15%, while Trelegy sales were up 49%. Immuno-inflammation sales were up 22% driven by Benlysta with $1.2 billion in sales and benefitting from lupus nephritis launches in U.S. and Japan in 2H20. Oncology sales were up 22% were driven by Zejula, a PARP inhibitor treatment for ovarian cancer, with sales of $532.8 million, up 17%. Also, Blenrep for the treatment of patients with relapsed or refractory multiple myeloma was approved and launched in the U.S. and Europe 3Q20, with ongoing launches throughout Europe in 2021. Blenrep sales globally totaled $120 million.
Corporate news
In the most significant corporate change for the company in the last 20 years, on June 23, 2021 GSK confirmed its intention to separate its Consumer Healthcare business from the GSK Group to form Haleon plc, an independent consumer healthcare company. It’s proposed that the separation will be effected by way of a demerger of at least 80 percent. The Consumer Healthcare business is currently a joint venture between GSK and Pfizer Inc., with GSK holding a majority controlling interest of 68 percent and Pfizer holding 32 percent.Following the demerger, GSK plans to focus purely on biopharmaceuticals, prioritizing investments in development of vaccines and specialty medicines. The company’s R&D approach will focus on the science of the immune system, use of human genetics, and advanced technologies.
Expanding its vaccines and oncology assets, GSK is spending more than $3.1 billion with two recent acquisitions. GSK recently entered an agreement to acquire Affinivax, Inc., a clinical-stage biopharmaceutical company based in Cambridge, MA for $2.1 billion upfront and up to $1.2 billion in potential development milestones. The acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase 2 development and highly innovative MAPS technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines.
GSK also agreed to acquire Sierra Oncology, Inc., a CA-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare cancers, for approximately $1.9 billion. Sierra Oncology’s differentiated momelotinib has the potential to address the critical unmet needs of myelofibrosis patients with anaemia. Myelofibrosis is a fatal cancer of the bone marrow impacting the normal production of blood cells. Momelotinib complements GSK’s expertise in hematology, and Sierra Oncology anticipates U.S. regulatory submission in 2Q22 and EU submission in the 2H22.
Advancing R&D assets
GSK’s R&D pipeline currently includes 64 vaccines and specialty medicines in its four core therapeutic areas of infectious diseases, HIV, oncology and immunology/respiratory. The company’s late-stage R&D pipeline includes assets with the potential to be first-in-class or best-in-class, as well as offering strategic lifecycle opportunities, to help deliver sales through 2026 and beyond.Most recently, the U.S. FDA approved Priorix for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. Also, the FDA accepted GSK’s New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anemia in chronic kidney disease (CKD). Daprodustat was developed based on the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The FDA has assigned a Prescription Drug User Fee Act action date of February 1, 2023.
The daprodustat NDA is based on positive results from the ASCEND phase III clinical trial, which included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anemia across the spectrum of CKD.
In the way of ongoing efforts to battle Covid-19, while GSK and development partner Vir Biotechnology, Inc. face uncertainty advancing sotrovimab, GSK’s partnered Covid-19 vaccine and booster remain on track. Sotrovimab, which was previously granted Emergency Use Authorization (EUA) by the U.S. FDA in May 2021, is an investigational single-dose intravenous infusion SARS-CoV-2 monoclonal antibody. Under the EUA, sotrovimab was authorized to treat mild-to-moderate Covid-19 in adults and pediatric patients. The companies planned to manufacture approximately two million doses globally in the first half of 2022 and additional doses in the second half of the year.
The U.S. distribution of the Covid-19 antibody has been on hold since the FDA pulled authorization in April. GSK previously announced that preclinical studies demonstrated sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron variant.
In January, the U.S. Government had purchased an additional 600,000 doses of sotrovimab to be delivered throughout the first quarter of 2022. This agreement was an amendment to an earlier commitment with the U.S. Government in November 2021.
While currently on hold, an application to the FDA was submitted for sotrovimab in the fourth quarter requesting an amendment to the EUA to include intramuscular administration. Also in the fourth quarter, the European Commission approved sotrovimab for the early treatment of Covid-19 in adults and adolescents 12 years and over who do not require supplemental oxygen and who are at increased risk of progressing to severe infection.
To date, GSK had received binding agreements for the sale of approximately 1.7 million doses worldwide. Separately, Vir and CDMO WuXi Biologics terminated their Covid antibody alliance as U.S. rollout faces an uncertain future.
GSK and partner Medicago, a biopharmaceutical company headquartered in Quebec, received approval from Health Canada for COVIFENZ, Covid-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted) for active immunization to prevent Covid-19 caused by SARS‑CoV‑2 in individuals 18 to 64 years of age.
Additionally, GSK and Sanofi plan to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for their Covid-19 vaccine. The Sanofi-GSK vaccine is supported by robust immune responses and a favorable safety profile. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels.
In the Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: 100% efficacy against severe Covid-19 disease and hospitalizations; 75% efficacy against moderate or severe Covid-19 disease; and 57.9% efficacy against any symptomatic Covid-19 disease, in line with effectiveness in dominated by variants of concern.
Finally, SK bioscience and GSK submitted a biologics license application for SKYCovione, a recombinant protein-based Covid-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety following positive Phase III clinical data. The vaccine candidate demonstrated superior neutralizing antibody titers over AstraZeneca’s Vaxzevria (control vaccine), a currently authorized Covid-19 vaccine, along with a clinically favorable safety profile.