GlaxoSmithKline 2020: Preparing for the future

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Shingrix

GlaxoSmithKline is undergoing a two-year process to separate into two new leading companies in the areas of biopharma and consumer healthcare.

By Andrew Humphreys • [email protected]

glaxosmithkline-logo

 

GlaxoSmithKline plc

980 Great West Road
Brentford, Middlesex
TW8 9GS, United Kingdom
Telephone: +44 (0)20 8047 5000
Website: gsk.com

 

FINANCIAL PERFORMANCE

(All figures are in millions of dollars except EPS and were translated using the Federal Reserve Board’s average rate of exchange in 2019: £1.1.2768)

2019

Revenue $43,097 

Net income $5,931  

Diluted EPS $11.82  

R&D expense $5,832  

1H 2020

Revenue $21,340  

Net income $5,259  

Diluted EPS $0.97  

R&D expense $3,177 

BEST-SELLING Rx PRODUCTS

(All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2019: £1.2768)

2019

Triumeq $3,255   

Shingrix $2,311 

Advair/Seretide $2,209  

Tivicay $2,122  

Breo/Relvar Ellipta $1,240  

Ventolin $1,198   

Nucala $981  

Infanrix, Pediarix $936  

Bexsero $867  

Flovent/Flixotide $803 

Benlysta $783  

Augmentin $768 

Boostrix $746  

Avodart $733 

Lamictal $723  

Rotarix $712  

Fluarix, FluLaval $691 

Trelegy Ellipta $661  

Anoro Ellipta $656  

Synflorix $598  

1H 2020

Triumeq $1,467  

Shingrix $1,238  

Advair/Seretide $1,042 

Tivicay $1,002  

Breo/Relvar Ellipta $673  

Nucala $576  

Ventolin $507  

Trelegy Ellipta $494  

Benlysta $419 

Infanrix, Pediarix $382  

Rotarix $356 

Avodart $351  

Lamictal $347  

Bexsero $347  

Augmentin $343  

Anoro Ellipta $327  

Flovent/Flixotide $306  

Juluca $297  

Synflorix $289  

Boostrix $240  

 

Outcomes Creativity Index Score: 65
Manny Awards – 2
Cannes Lions – N/A
LIA: Health & Wellness – 8
Clio Health – 19
One Show: HW&P – 5
MM&M Awards – 24
Global Awards – 7
Creative Floor Awards – N/A

 

 

During early 2020, consistent with strategic priorities and previous announcements, a two-year program was started to prepare GSK for separation into two new leading companies. New GSK is a biopharma company with an R&D approach focused on science related to the immune system, use of genetics and new technologies. The new Consumer Healthcare company has category-leading power brands and innovation based on science and consumer insights.

“The fundamentals of GSK’s business remain strong and we are maintaining good momentum on our strategic priorities. This quarter (Q2 2020), we presented promising data and had positive regulatory reviews for new specialty pipeline medicines to treat HIV and Oncology; and made further progress with our Consumer Healthcare integration and Future Ready programs, both of which will prepare the company for separation. We continue to believe that multiple options will be needed to prevent and treat COVID-19 and are working at pace with our partners to develop potential adjuvanted vaccines and therapeutics to fight the virus. At the same time, we have made strategic investments in next-generation vaccine and antibody technologies, most recently through our new collaboration with CureVac.” —
Chief Executive Officer Emma Walmsley

“Our intention remains to separate around three years from the close of the transaction that resulted in the formation of our new Consumer Healthcare Joint Venture, which was in July 2019,” says GSK management. “The new program will use the unique catalyst of separation to reset the capabilities and cost base for both companies, and help support delivery of the significant value creation opportunities we see in both New GSK and new Consumer Healthcare. … We believe that increased investment in our pipeline and new products, together with effective implementation of our new two-year program, will set each new company up with strong foundations for future performance.” 

According to GSK CEO Emma Walmsley, “Our new program aims to use the unique catalyst we have of separation to set competitive capabilities and a cost base for both companies, and help to deliver the significant value creation for patients, consumers and shareholders.”

2020 Performance & Outlook

Group turnover during the 2020 first half totaled £16.71 billion ($21.34 billion), increasing 8% AER, 8% CER and flat on a pro-forma basis. On a pro-forma basis, Group turnover was flat, and rose 1% excluding the impact of divestments in Vaccines and brands divested or under review in Consumer Healthcare. The company’s sales performance reflects disruption from COVID-19 primarily in vaccines during second-quarter 2020.

Pharmaceuticals turnover in January-June 2020 amounted to nearly £8.5 billion ($10.85 billion), flat at both AER and CER. HIV sales were up 3% AER and 2% CER year-over-year to £2.39 billion ($3.05 billion), with growth in Juluca and Dovato partly offset by decreases in Tivicay and Triumeq. Respiratory sales for first-half 2020 improved 27% AER and 26% CER to £1.75 billion ($2.24 billion), on growth of Trelegy and Nucala. Sales of Established Pharmaceuticals were down 12% AER, 11% CER to £3.87 billion ($4.94 billion), reflecting decreased demand for antibiotics during the COVID-19 period.

Vaccines turnover for GSK during the first six months of 2020 fell 5% AER and 6% CER year-over-year to £2.94 billion ($3.75 billion), primarily driven by the adverse impact of the COVID-19 pandemic on Hepatitis, DTPa-containing, Meningitis and Shingles vaccines, partially offset by growth in Shingrix in the first quarter of 2020.

Reported Consumer Healthcare sales advanced 35% AER, 36% CER to £5.25 billion ($6.7 billion) during the 2020 first half, largely driven by the inclusion of the Pfizer portfolio (GSK completed the transaction with Pfizer to form a new world-leading Consumer Healthcare Joint Venture on Aug. 1, 2019). On a pro-forma basis, sales rose 2% CER and 7% CER, excluding brands divested/under review.

“As expected, our performance this quarter (Q2) was disrupted by COVID-19, particularly in our Vaccines business, as visits to healthcare professionals were limited due to lockdown measures,” Walmsley stated. “Overall, we are seeing good underlying demand for our major products and are confident this will be reflected in future performance when the impact of COVID measures eases.”

At the time of announcing full-year 2019 results on Feb. 5, 2020, GSK provided guidance with respect to expected full-year 2020 Adjusted EPS, with a projected decrease in the range of -1% to -4% at CER. “This guidance reflected our expectations for growth in key new products, and the start of a two-year period in which we would continue to increase investment in these products and in our R&D pipeline, alongside implementation of our new program which will prepare the Group for separation. The guidance excluded any impact in 2020 from any further material divestments beyond those previously announced and any potential impact on our business from the Coronavirus outbreak,” GSK management stated upon issuing the company’s first-half 2020 results in July. 

“While we are maintaining our 2020 Adjusted EPS guidance, there remain notable risks to business performance over the balance of the year. In particular, the outcome is dependent on the timing of a recovery in vaccination rates, particularly in the US, which we anticipate in the third quarter. If we were to experience a delay in this recovery we could see a significant impact in 2020. In the case of, for example, a three-month delay, the impact on Adjusted EPS would be up to 5 percentage points.”

GSK has multiple collaborations under way to develop adjuvanted COVID-19 vaccines. Announced on April 14, GSK joined forces with Sanofi, bringing together two of the world’s largest vaccines companies in an unprecedented collaboration to fight COVID-19. GSK and Sanofi have combined their innovative technologies to develop an adjuvanted COVID-19 vaccine, which entered clinical studies during September 2020. If successful and subject to regulatory considerations, the companies aim to complete the development required for availability by second-half 2021. Management says this would be a significantly faster timeline than for normal vaccine development and teams from both companies are working on this urgently. 

Sanofi and GSK finalized an advanced purchase agreement with the European Commission (EC) during September for the supply of up to 300 million doses of a COVID-19 vaccine after regulatory approval. 

Sanofi and GSK were selected in July for “Operation Warp Speed” to supply the U.S. government with 100 million doses of COVID-19 vaccine. The U.S. government will provide funding up to $2.1 billion for development including clinical studies, manufacturing, scale-up and delivery of an initial 100 million doses.

Another July agreement was reached with the UK government to supply up to 60 million doses of the Sanofi-GSK vaccine candidate. 

In addition to Sanofi, GSK is collaborating with the University of Queensland, Clover Biopharmaceuticals and Xiamen Innovax Biotech. Data from some of these collaborations are anticipated by year-end 2020. 

The scientific collaboration with Clover, using GSK’s pandemic adjuvant in combination with the COVID-19 vaccine candidate SCB-2019, moved into Phase I studies on June 19. 

Announced on July 7, GSK and the Canadian biopharmaceutical company Medicago are developing and evaluating a novel adjuvanted COVID-19 candidate vaccine. The COVID-19 candidate vaccine combines Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, enabling them to be recognized by the immune system. The companies are using Medicago’s innovative plant-based production technology to manufacture the COVID-19 vaccine antigen. The vaccine candidate entered into Phase I studies during mid-July. The collaboration will additionally explore vaccine development opportunities for other infectious diseases.

During Q2, GSK announced plans to make 1 billion doses of vaccine adjuvant available during 2021 to support the development of multiple adjuvanted COVID-19 vaccine candidates. GSK will manufacture, fill and finish adjuvant for use in COVID-19 vaccines at sites in the UK, United States, Canada and Europe. In September, Sanofi and GSK signed deals with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine.

GSK announced a collaboration in April to use Vir Biotechnology’s monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options for COVID-19. A Phase II/III trial started during August for the anti-SARS-CoV-2 antibody VIR-7831 for high-risk outpatients with COVID-19. According to industry analysts, if the Phase II/III study for VIR-7831 goes as planned, data could be available by year-end 2020 with potential marketing approval during first-half 2021.

GSK began a Phase II clinical study in May 2020 at U.S. sites to evaluate whether one of the company’s monoclonal antibodies in development can help treat patients who are affected by secondary complications associated with COVID-19. GSK also planned to conduct the study at sites in Europe, South America and Africa.

GSK started a Phase IIa proof-of-concept study of otilimab as a potential treatment for COVID-19. The first patient was dosed in the OSCAR study of the anti GM-CSF antibody in patients with severe pulmonary COVID-19 related disease. Data are anticipated during the firsthalf of 2021.

The Coalition for Epidemic Preparedness Innovations (CEPI) and GSK announced in February a collaboration to strengthen the worldwide effort to develop a vaccine for the 2019-nCoV virus. GSK will make the company’s established pandemic vaccine adjuvant platform technology available to enhance the development of an effective vaccine against 2019-nCoV.

Product Approvals & Pipeline Updates In 2020

When I became CEO, I made strengthening our R&D pipeline our first priority,” Walmsley says. “In 2019 we made significant progress. Under the leadership of Dr. Hal Barron, our Chief Scientific Officer, we delivered three major approvals, eight regulatory filings for new medicines, six positive readouts from assets in pivotal studies and progressed four new assets into pivotal studies, three of which are biologics.” 

As of late July 2020, 35 GSK medicines and 15 vaccines were undergoing clinical development. As of September, GSK had won six major medicine approvals during 2020 across areas of significant unmet medical need including cancer, HIV, respiratory and chronic kidney disease.

The U.S. Food and Drug Administration in August approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent, following a priority review for the company’s Biologics License Application. Blenrep represents the fifth major medicine approval for GSK during 2020. Blenrep is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere worldwide. An FDA Advisory Committee meeting voted unanimously in favor of the positive benefit/risk profile of belantamab mafodotin for relapsed/refractory MM patients.

Blenrep was approved for marketing in the European Union during August. Formerly known by the product code GSK2857916, Blenrep is a first-in-class treatment for RRMM patients whose disease has progressed despite the current standard of care. 

The antibody drug conjugate Blenrep comprises a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

During 2020, the first patient was dosed in the pivotal second-line MM Phase III trial, DREAMM-7, of belantamabcmafodotin in combination with bortezomib and dexamethasone. Also, the first patient was dosed in the pivotal third-line MM Phase III study, DREAMM-3, of belantamab mafodotin monotherapy.

The FDA approved Trelegy Ellipta on Sept. 9 as the first once-daily single inhaler triple therapy for treating both asthma and chronic obstructive pulmonary disease (COPD) in the United States. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) was cleared for marketing for the treatment of asthma in patients aged 18 years and older. Trelegy Ellipta was initially cleared for U.S. marketing in September 2017 for the long-term, once-daily maintenance treatment of patients with COPD. 

FF/UMEC/VI represents a combination of three molecules in one inhaler that only needs to be taken in a single inhalation, once daily. The medicine contains the inhaled corticosteroid fluticasone furoate, the long-acting muscarinic antagonist umeclidinium and the long-acting beta2-adrenergic agonist vilanterol, delivered in GSK’s Ellipta dry powder inhaler.

GSK announced in February that the filing was accepted by the European Medicines Agency for Trelegy Ellipta use in adult patients with asthma.

The novel attachment inhibitor Rukobia (fostemsavir), a first-in-class medicine for HIV in adults with few treatment options available, won FDA regulatory clearance in early July. Rukobia was approved for treating human immunodeficiency virus type 1 (HIV-1) infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations. In a Phase III trial, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need.

After oral administration of fostemsavir, the drug is converted to temsavir, which is then absorbed and exerts antiviral activity by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, thereby blocking HIV from attaching to host immune system CD4+ T-cells and preventing the virus from infecting those cells and multiplying. As Rukobia is the first antiretroviral therapy to target this step of the viral cycle, there is no demonstrated resistance to other classes of antiretrovirals, which may help patients who have become resistant to most other drugs.

ViiV Healthcare, which manages GSK’s HIV business, announced in January the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of fostemsavir for the treatment of HIV-1 infection. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted an accelerated assessment for the MAA for fostemsavir.

The U.S. FDA approved Zejula (niraparib) as the first once-daily oral poly (ADP-ribose) polymerase (PARP) inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status. The supplemental New Drug Application was approved in April under the FDA’s Real-Time Oncology Review pilot program. Zejula is the first oral monotherapy available as first-line maintenance treatment for women regardless of BRCA mutational status, addressing a high unmet need in ovarian cancer.

The CHMP adopted a positive opinion in September recommending Zejula as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status. GSK says Zejula has the potential to be the first monotherapy PARP inhibitor approved for first-line maintenance treatment following platinum response regardless of BRCA mutational status, addressing a high unmet need in ovarian cancer.

Niraparib is being evaluated in multiple pivotal studies. The company is building a robust niraparib clinical development program by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program includes several combination trials.

The U.S. regulatory agency approved the first-ever dispersible tablet formulation of dolutegravir, branded as Tivicay PD, as a once-daily treatment for children living with HIV. The FDA in June approved Tivicay PD tablets for oral suspension, which are used in combination with other antiretroviral agents for treating HIV-1 infection in pediatric patients aged at least 4 weeks and weighing at least 3kg. The FDA also approved an extended indication to expand the use of Tivicay 50mg film-coated tablet in pediatric HIV patients weighing 20kg and above.

Dolutegravir represents the first integrase inhibitor (INI) available as a dispersible tablet for oral suspension for children weighing at least 3kg and from 4 weeks of age. Dolutegravir was previously indicated in the United States for children from 6 years of age and weighing more than 30kg. ViiV says this step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children. ViiV is a global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi operating as shareholders.

Regulatory filings to the U.S. FDA and EMA were made during 2020 for Benlysta (belimumab) for a new indication, lupus nephritis. Benlysta is the world’s first biologic treatment approved for systemic lupus erythematosus (SLE). With Benlysta, GSK is the first company with a biologic treatment specifically developed and approved for adult and pediatric lupus.

Nucala was granted marketing clearance from the FDA for patients with hypereosinophilic syndrome (HES) following a priority review, as announced by GSK in September. The U.S. regulatory agency granted Fast Track and Orphan Drug designations for the use of Nucala in HES. Nucala is the first targeted biologic treatment available for patients with HES, a rare and life-threatening disease caused by eosinophilic inflammation. 

The approval for HES gives Nucala a third U.S. indication in an eosinophil-driven disease, according to GSK. The FDA previously approved Nucala for use as an add-on maintenance therapy for severe eosinophilic asthma and for treating eosinophilic granulomatosis with polyangiitis (EGPA). The medicine is being studied in several other eosinophil-driven diseases.

GSK during April announced that Nucala is the first anti-IL5 biologic to report positive Phase 3 results in patients with nasal polyps. The company is evaluation Nucala in the pivotal SYNAPSE study in patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). SYNAPSE represents the first study to investigate the benefit of biologic treatment for patients all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and were in need of additional surgery due to severe symptoms and increased size of their polyps.

The first regulatory approval for Duvroq (daprodustat) was received in Japan during June for patients with anemia due to chronic kidney disease. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) belongs to a new class of oral medicines indicated for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. Daprodustat has been developed to provide an orally convenient treatment option which avoids the administration challenges and cold storage requirements of injectable ESAs/recombinant human erythropoietin, according to GSK.

In another GSK approval in Japan, the country’s Ministry of Health, Labour and Welfare (MHLW) approved Dovato (dolutegravir 50 mg/lamivudine 300 mg) for treating HIV-1 infection in adults and adolescents older than 12 years of age weighing at least 40 kg, to be administered orally, with or without food. The once-daily, single-pill, two-drug regimen (2DR) for treatment-naïve HIV infection combines dolutegravir with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine.

Dovato is available in the United States as a complete, once-daily, single-tablet regimen of dolutegravir 50 mg and lamivudine 300 mg for the treatment of HIV-1 infection in adults with no ARV treatment history and with no known resistance to either dolutegravir or lamivudine. The product is authorized in the EU for treating HIV-1 infection in adults and adolescents older than 12 years of age weighing at least 40 kg, with no known or suspected resistance to the INI class, or lamivudine.

Cabenuva (cabotegravir and rilpivirine extended-release injectable suspensions) was refiled for approval review with the U.S. FDA as a treatment for HIV, with a regulatory decision anticipated during second-quarter 2021. Positive data from the CUSTOMIZE trial, the first-ever implementation research study on how best to integrate an investigational once-monthly injectable HIV treatment in U.S. healthcare practices, were showcased at the virtual 23rd International AIDS Conference. 

ViiV in March presented 96-week data from the global Phase III FLAIR study of the investigational, long-acting, injectable, 2-drug regimen of cabotegravir and Janssen’s rilpivirine for treating HIV. The study showed that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96.

The INI cabotegravir is being developed by ViiV for the treatment and prevention of HIV. The drug is being studied as a long-acting formulation for intramuscular injection and as a once-daily oral tablet for use as a lead-in, to establish the tolerability of cabotegravir before long-acting injection.

ViiV also presented in March positive 48-week data from the global Phase III ATLAS-2M study of the 2DR of cabotegravir and rilpivirine for HIV treatment. The clinical trial met the primary endpoint at Week 48, demonstrating that the antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks was non-inferior when compared to administration every four weeks.

In March, ViiV announced the first global regulatory approval of Cabenuva in Canada. Cabenuva represents the first complete, long-acting, regimen for the treatment of HIV.

Final data from the HPTN 083 trial presented at AIDS 2020 demonstrated that the investigational long-acting injectable cabotegravir administered every two months is 66% more effective than daily pills in the prevention of HIV-1 acquisition. The HPTN 083 study is a Phase IIb/III double blind trial designed to test the safety and efficacy of cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg).

Announced in May, a global HIV prevention study was to stop early after ViiV’s long-acting injectable form of cabotegravir dosed every two months demonstrated higher efficacy than daily oral PrEP. The HPTN 083 study achieved the primary objective of non-inferiority with the difference approaching superiority in favor of cabotegravir, pending final analysis.

The CHMP issued a positive opinion for Shingrix immunocompromised patients during 2020. According to GSK, the shingles vaccine had a remarkable 2019 with global sales of £1.81 billion ($2.31 billion) and represents the most successful biopharma launch of the last 10 years. The product additionally received the prestigious Prix Galien award for innovation.

GSK announced the first participant was vaccinated in a Phase 3 study of the company’s 5-in-1, meningitis ABCWY vaccine candidate. The clinical trial is assessing the safety, tolerability and immunogenicity of the MenABCWY vaccine candidate compared to GSK’s Bexsero and Menveo in adolescents and young adults. Study investigators planned to enroll 3,650 participants aged 10-25 years in the United States, Canada, Europe, Turkey and Australia.

In the United States, Bexsero is approved for use in individuals from 10 years through 25 years old. Bexsero is licensed in 40-plus countries. 

Two independent meningitis B studies were published during January in the New England Journal of Medicine that demonstrate the real-world impact of Bexsero in reducing disease in infants and underscore the need for individual protection among adolescents. According to Public Health England, during a three-year period the total amount of meningitis B cases decreased 75 percent. Per the UK study, these impact results even included cases caused by strains not predicted to be covered by Bexsero.

Additionally, results of the largest-ever study of adolescent carriage of meningococcal bacteria, “B Part of It,” demonstrated reduction in the number of cases among the trial population in South Australia but no effect on the carriage of bacteria in the nose or throat, a prerequisite of impacting transmission. This reinforces the necessity for vaccination of vulnerable individuals, particularly infants and adolescents, to help protect against meningococcal disease.

Two-year follow-up data for the first-in-class bifunctional immunotherapy bintrafusp alfa targeting TGF-β/PD-L1, in second-line NSCLC were shared at ASCO 2020.

Reported findings from studies into the anti-tumor potential of targeting the ICOS receptor through GSK’609 alone and in combination with immune checkpoint therapies for treating head and neck squamous cell carcinoma were presented at ASCO.

The FDA approved GSK’s Advil Dual Action with Acetaminophen for over-the-counter use in the United States. Cleared for marketing in March, the exclusive formula represents the first FDA-approved OTC combination of ibuprofen and acetaminophen in the United States and was made available over-the-counter nationwide during 2020.

GSK’s Voltaren Arthritis Pain won FDA marketing clearance in February for over-the-counter use in the United States. This product represents the first prescription-strength NSAID gel for arthritis pain to be made available for OTC use.

Other Partnerships & Collaborations in 2020

A strategic mRNA technology collaboration with CureVac was announced for the R&D, manufacturing and commercialization of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing messenger RNA capabilities with CureVac’s integrated mRNA platform.

A broad partnership with IDEAYA was announced during June in Synthetic Lethality, an emerging field in precision medicine oncology encompassing three IDEAYA synthetic lethality programs – MAT2A, Pol Theta and Werner Helicase, which are projected to reach clinical studies within the next three years. Synthetic Lethality is one of four core research focus areas for GSK in the oncology space. Cells tolerate the loss of single genes in isolation in synthetic lethality, but not together in combination. When tumor suppressor genes are functionally lost in cancer, this mode of action can be used to exploit tumor-specific vulnerabilities via new medicines for patients with cancer. 

GlaxoSmithKline and Samsung Biologics entered into a partnership during May. The partnership provides GSK with additional capacity to manufacture and supply the company’s innovative biopharmaceutical therapies. The agreement initially covers commercial production of Benlysta, with technology transfer beginning in 2020 and first commercial supply expected during 2022. The intention of the partnership is to expand to additional specialty-care products in the future. 

GSK announced on April 1 the completion of the divestment of Horlicks and other Consumer Healthcare nutrition products in India to Unilever, including the merger of its Indian listed entity, GlaxoSmithKline Consumer Healthcare Limited and Hindustan Unilever Limited. This transaction was previously announced during December 2018 and the deal’s completion follows the receipt of necessary legal and regulatory approvals. 

ViiV and UNC-Chapel Hill announced in March a five-year renewal of their innovative HIV cure partnership. The unique public-private collaboration provides continued funding for HIV Cure Center and Qura Therapeutics, a joint venture that brings together academic and pharma research scientists. 

In other March news, GSK unveiled that the European Commission formally approved a deal for the sale of the rights for the company’s ThermaCare business globally, excluding North America, to Angelini Pharma. The deal additionally includes the dedicated U.S. manufacturing site for ThermaCare in Albany, Georgia. The approval follows legally binding commitments made by GSK during July 2019 to divest the ThermaCare business as a condition of the EC’s antitrust clearance for the joint venture between GSK Consumer Healthcare and Pfizer Consumer Healthcare. 

GSK licensed the company’s tuberculosis vaccine candidate M72/AS01E to the Bill & Melinda Gates Medical Research Institute for continued development, per the company’s announcement in January. M72/AS01E demonstrated in a Phase IIb study the potential to reduce active pulmonary tuberculosis by half in adults with latent TB infection.