07.15.19
Headquarters: Brentford, Middlesex, UK
twitter.com/GSK
www.gsk.com
Headcount: 95,490
Year Established: 2000
Revenues: $40,992 (+1%)
Pharma Revenues: $30,807 (+2%)
Net Income: $5,381 (-2%)
R&D: $5,178 (-14%)
TOP SELLING DRUGS
GlaxoSmithKline (GSK) reported revenue of $40.9 billion, up just 1% from the year before. The standout was Shingrix, GSK’s vaccine for shingles, which had sales of $1.0 billion in its launch year. HIV medicines also continued to grow with $3.5 billion in sales for Triumeq, GSK’s new top seller, and $2.2 billion for Tivicay.
With the decline if its flagship product Advair, GSK continues to build its new respiratory portfolio with Trelegy Ellipta, the new three-in-one medicine for chronic obstructive pulmonary disease (COPD), and Nucala, GSK’s biologic medicine for severe asthma. In addition to the positive launches of Shingrix and Trelegy Ellipta, GSK reported a strong start to sales of HIV drug Juluca.
During the year GSK implemented a new R&D approach to focus on science of the immune system, human genetics and advanced technologies. In fact, it made significant progress in reshaping its pharmaceuticals R&D portfolio to reflect this new strategy with 33 of 46 new medicines now targeting modulation of the immune system.
As part of the its ongoing prioritization and strengthening of its pharmaceuticals pipeline, GSK transferred its portfolio of approved and investigational rare disease gene therapies to Orchard Therapeutics. GSK became an investor in Orchard as a result, receiving a 19.9% equity stake along with a seat on the company’s board. GSK and Orchard will exchange manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.
In other business news, GSK entered a deal to create a consumer healthcare joint venture with Pfizer and bought out Novartis’ stake in GSK Consumer Healthcare. The combination of the iconic brands of GSK and Pfizer will create one of the largest consumer healthcare players in key geographies including the U.S., Europe, China, India and Australasia. Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion. Pfizer receives a 32% equity stake in the joint venture.
The joint venture will be a category leader in pain relief, respiratory, vitamin and mineral supplements, digestive health, skin health and therapeutic oral health.
Following the integration, GSK said it intends to separate the joint venture as an independent company. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO.
Pumped up pipeline
GSK strengthened its pipeline through business development initiatives with 23andMe and Tesaro. First, bolstering its cancer assets, GSK added the ovarian cancer drug Zejula to its portfolio when it paid $5.1 billion for Tesaro. The deal significantly strengthens GSK’s pharmaceutical business, accelerating the build of its pipeline and commercial capability in oncology. Zejula (niraparib), a major marketed product, is an oral poly ADP ribose polymerase (PARP) inhibitor that is currently approved in the U.S. and Europe. Clinical trials to assess the use of Zejula in “all-comers” patient populations, as a monotherapy and in combinations, for the significantly larger opportunity of first line maintenance treatment of ovarian cancer are also underway.
With 23andMe, GSK entered a multi-year collaboration expected to identify novel drug targets, tackle new subsets of disease and enable rapid progression of clinical programs. The four-year collaboration will focus on research and development of innovative new medicines and potential cures, using human genetics as the basis for discovery. The collaboration will combine 23andMe’s large-scale genetic resources and advanced data science skills, with the scientific and medical knowledge and commercialization expertise of GSK. The goal of the collaboration is to gather insights and discover novel drug targets driving disease progression and develop therapies for serious unmet medical needs based on those discoveries.
With over 5 million customers, 23andMe offers those with an interest in genetics the opportunity to learn more about their personal genetic profile. 23andMe customers can also choose to participate in research and contribute their information to a unique and dynamic database, which is now the world’s largest genetic and phenotypic resource.
GSK brings extensive drug discovery and development capabilities across a broad range of diseases and modalities, including small molecule, biopharmaceuticals and cell and gene therapies. It will apply its technologies, including access to additional data sources, in-house target validation and genetics expertise, and utilize its manufacturing, commercial operations and scale to support partner activities across research and development.
R&D alliances
GSK entered several research collaborations during the year, some of which are highlighted here. A research pact with Fimbrion Therapeutics led to the identification of an orally available, small molecule development candidate for the treatment and prevention of urinary tract infections. The discovery partnership began its joint research efforts in July 2016.
A three-year extension was made to a tie-up with Neomed-Labs. Under the terms of this renewed agreement, Neomed-Labs will develop immunotools (antigens), immunochemical assays as well as functional assays and undertake the clinical testing for several GSK vaccine projects at the clinical stage.
Neomed-Labs is a spin-out from GSK’s Clinical Laboratory Services since April 2015 with a three-year original agreement. Following a successful transition from GSK, Neomed-Labs became a fully independent CRO in 2017 and is now collaborating with major global vaccine manufacturers.
With Syngene International, another global contract research services company, GSK formed a multiyear R&D agreement that will focus on accelerating the discovery of new drug candidates using Syngene’s discovery services platforms. Syngene will set-up a customized discovery research laboratory to support projects across several therapeutic areas. A team of Syngene scientists will work closely with GSK’s global R&D teams on discovery research projects to identify new drug candidates with the potential to address some of the world’s most pressing healthcare needs.
Lastly, GSK entered a technology agreement with LabCorp’s Covance Drug Development business. GSK will use Covance’s Xcellerate Monitoring, Xcellerate Insights, and Xcellerate Clinical Data Hub solutions in a software-as-a-service (SaaS) model. A key component of the technology licensed by GSK is Xcellerate Monitoring, Covance’s implementation of risk-based monitoring, which enables assessment and mitigation of risk at the study, site and patient level. It also allows sponsors to strategically guide site monitoring resources and build quality and efficiency into their clinical trials, from commencement to completion.
twitter.com/GSK
www.gsk.com
Headcount: 95,490
Year Established: 2000
Revenues: $40,992 (+1%)
Pharma Revenues: $30,807 (+2%)
Net Income: $5,381 (-2%)
R&D: $5,178 (-14%)
TOP SELLING DRUGS
| Drug | Indication | 2018 Sales | (+/-%) |
| Triumeq | HIV | $3,535 | 11% |
| Seretide/Advair | COPD | $3,234 | -20% |
| Tivicay | HIV | $2,188 | 21% |
| Breo Ellipta | COPD | $1,454 | 12% |
| Hepatitis franchise | Hepatitis A, B | $1,079 | 21% |
| Shingrix | Shingles prophylaxis | $1,047 | n/a |
| Ventolin | asthma | $984 | 0% |
| Pediarix | pediatric vaccine | $908 | -5% |
| Lamictal | anti-epileptic | $824 | -2% |
| Flovent | respiratory | $794 | 3% |
GlaxoSmithKline (GSK) reported revenue of $40.9 billion, up just 1% from the year before. The standout was Shingrix, GSK’s vaccine for shingles, which had sales of $1.0 billion in its launch year. HIV medicines also continued to grow with $3.5 billion in sales for Triumeq, GSK’s new top seller, and $2.2 billion for Tivicay.
With the decline if its flagship product Advair, GSK continues to build its new respiratory portfolio with Trelegy Ellipta, the new three-in-one medicine for chronic obstructive pulmonary disease (COPD), and Nucala, GSK’s biologic medicine for severe asthma. In addition to the positive launches of Shingrix and Trelegy Ellipta, GSK reported a strong start to sales of HIV drug Juluca.
During the year GSK implemented a new R&D approach to focus on science of the immune system, human genetics and advanced technologies. In fact, it made significant progress in reshaping its pharmaceuticals R&D portfolio to reflect this new strategy with 33 of 46 new medicines now targeting modulation of the immune system.
As part of the its ongoing prioritization and strengthening of its pharmaceuticals pipeline, GSK transferred its portfolio of approved and investigational rare disease gene therapies to Orchard Therapeutics. GSK became an investor in Orchard as a result, receiving a 19.9% equity stake along with a seat on the company’s board. GSK and Orchard will exchange manufacturing, technical and commercial insights and learnings on the development of gene therapy medicines to ensure the success of the assets.
In other business news, GSK entered a deal to create a consumer healthcare joint venture with Pfizer and bought out Novartis’ stake in GSK Consumer Healthcare. The combination of the iconic brands of GSK and Pfizer will create one of the largest consumer healthcare players in key geographies including the U.S., Europe, China, India and Australasia. Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion. Pfizer receives a 32% equity stake in the joint venture.
The joint venture will be a category leader in pain relief, respiratory, vitamin and mineral supplements, digestive health, skin health and therapeutic oral health.
Following the integration, GSK said it intends to separate the joint venture as an independent company. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO.
Pumped up pipeline
GSK strengthened its pipeline through business development initiatives with 23andMe and Tesaro. First, bolstering its cancer assets, GSK added the ovarian cancer drug Zejula to its portfolio when it paid $5.1 billion for Tesaro. The deal significantly strengthens GSK’s pharmaceutical business, accelerating the build of its pipeline and commercial capability in oncology. Zejula (niraparib), a major marketed product, is an oral poly ADP ribose polymerase (PARP) inhibitor that is currently approved in the U.S. and Europe. Clinical trials to assess the use of Zejula in “all-comers” patient populations, as a monotherapy and in combinations, for the significantly larger opportunity of first line maintenance treatment of ovarian cancer are also underway.
With 23andMe, GSK entered a multi-year collaboration expected to identify novel drug targets, tackle new subsets of disease and enable rapid progression of clinical programs. The four-year collaboration will focus on research and development of innovative new medicines and potential cures, using human genetics as the basis for discovery. The collaboration will combine 23andMe’s large-scale genetic resources and advanced data science skills, with the scientific and medical knowledge and commercialization expertise of GSK. The goal of the collaboration is to gather insights and discover novel drug targets driving disease progression and develop therapies for serious unmet medical needs based on those discoveries.
With over 5 million customers, 23andMe offers those with an interest in genetics the opportunity to learn more about their personal genetic profile. 23andMe customers can also choose to participate in research and contribute their information to a unique and dynamic database, which is now the world’s largest genetic and phenotypic resource.
GSK brings extensive drug discovery and development capabilities across a broad range of diseases and modalities, including small molecule, biopharmaceuticals and cell and gene therapies. It will apply its technologies, including access to additional data sources, in-house target validation and genetics expertise, and utilize its manufacturing, commercial operations and scale to support partner activities across research and development.
R&D alliances
GSK entered several research collaborations during the year, some of which are highlighted here. A research pact with Fimbrion Therapeutics led to the identification of an orally available, small molecule development candidate for the treatment and prevention of urinary tract infections. The discovery partnership began its joint research efforts in July 2016.
A three-year extension was made to a tie-up with Neomed-Labs. Under the terms of this renewed agreement, Neomed-Labs will develop immunotools (antigens), immunochemical assays as well as functional assays and undertake the clinical testing for several GSK vaccine projects at the clinical stage.
Neomed-Labs is a spin-out from GSK’s Clinical Laboratory Services since April 2015 with a three-year original agreement. Following a successful transition from GSK, Neomed-Labs became a fully independent CRO in 2017 and is now collaborating with major global vaccine manufacturers.
With Syngene International, another global contract research services company, GSK formed a multiyear R&D agreement that will focus on accelerating the discovery of new drug candidates using Syngene’s discovery services platforms. Syngene will set-up a customized discovery research laboratory to support projects across several therapeutic areas. A team of Syngene scientists will work closely with GSK’s global R&D teams on discovery research projects to identify new drug candidates with the potential to address some of the world’s most pressing healthcare needs.
Lastly, GSK entered a technology agreement with LabCorp’s Covance Drug Development business. GSK will use Covance’s Xcellerate Monitoring, Xcellerate Insights, and Xcellerate Clinical Data Hub solutions in a software-as-a-service (SaaS) model. A key component of the technology licensed by GSK is Xcellerate Monitoring, Covance’s implementation of risk-based monitoring, which enables assessment and mitigation of risk at the study, site and patient level. It also allows sponsors to strategically guide site monitoring resources and build quality and efficiency into their clinical trials, from commencement to completion.
