GlaxoSmithKline 2019: Innovation, Performance, and Trust

 

GlaxoSmithKline’s three long-term priorities are designed to create long-term value for patients, consumers, and shareholders.

 

 

GlaxoSmithKline plc

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

 

Best-Selling Products

Product	2018 Sales	2017 Sales
Triumeq	$3,539	$3,289
Advair/Seretide	$3,237	$4,183
Tivicay	$2,190	$1,876
Breo/Relvar Ellipta	$1,455	$1,344
Shingrix	$1,048	$29
Ventolin	$985	$1,025
Infanrix, Pediarix	$909	$993
Lamictal	$824	$869
Flovent/Flixotide	$795	$796
Bexsero	$780	$743
Avodart	$764	$819
Augmentin	$762	$784
Nucala	$752	$460
Fluarix, FluLaval	$699	$652
Rotarix	$696	$700
Boostrix	$691	$748
Anoro Elipta	$636	$457
Benlysta	$632	$501
Synflorix	$567	$680

All sales are in millions of dollars and were
translated using the Federal Reserve Board’s
average rate of exchange in 2018: £1.3363.

 

Financial Performance

	2018	2017
Revenue	$41,186	$40,338
Net income	$4,841	$2,047
Diluted EPS	$9.74	$4.14
R&D expense	$5,202	$5,981

	1H 2019	1H 2018
Revenue	$20,673	$19,419
Net income	$2,719	$1,649
Diluted EPS	$0.36	$0.20
R&D expense	$2,832	$2,444

All figures are in millions of dollars,
except EPS, and were translated using
the Federal Reserve Board’s average
rate of exchange in 2018: £1.3363.

 

Outcomes Creativity Index Score: 91
Manny Awards – N/A
Cannes Lions – 45
LIA: Health & Wellness – N/A
Clio Health – 7
One Show: HW&P – 3
MM&M Awards – 13
Global Awards – 15
Creative Floor Awards – 8

 

2018 was a year in which the strategic shape of GlaxoSmithKline in the future has been redefined. A renewed focus on R&D was set out by Emma Walmsley when she became CEO during 2017, and a new plan to improve the pipeline of innovative medicines was launched by the company’s Chief Scientific Officer Dr. Hal Barron.

During 2019, GlaxoSmithKline continues to evolve the company’s oncology business. This process includes an expanded pipeline and preparing launches of oncology medicines.

“Progress is most evident in oncology, with some promising assets in our own laboratories,” Walmsley says. “We have also acquired Tesaro, an oncology focused biotechnology company based in Boston, which has a marketed oncology product and several pipeline assets with development potential. Even more recently, we have proposed an alliance with Merck KGaA, Darmstadt, Germany to develop a promising new oncology medicine.”

GSK successfully completed the acquisition of Tesaro Inc. in January. The oncology-focused company based in Waltham, Mass., was acquired for an aggregate cash consideration of £4.0 billion ($5.1 billion). The transaction – which was announced on Dec. 3, 2018 – significantly bolsters GlaxoSmithKline’s pharma business and is anticipated to accelerate the build of GSK’s pipeline and commercial capability in oncology.

In addition to increasing investment in Pharmaceuticals, GlaxoSmithKline took steps to strengthen the Consumer Healthcare business during 2018. According to management, the first step was the buyout of the put option held by Novartis in respect of the company’s minority stake in GSK Consumer Healthcare, which was completed in June 2018. The second step was the December 2018 announcement to create a new Consumer Healthcare Joint Venture with Pfizer Inc.

GSK completed the transaction with Pfizer to combine the companies’ businesses into a new world-leading consumer healthcare joint venture on Aug. 1. GlaxoSmithKline and Pfizer announced on Dec. 19 their intention to combine the companies’ consumer health businesses into a new world-leading joint venture, with combined sales of £9.8 billion ($12.7 billion). GlaxoSmithKline holds a majority controlling equity interest of 68 percent and Pfizer has an equity interest of 32 percent.

According to GlaxoSmithKline, the proposed all-equity transaction represents a compelling opportunity to build on the recent buyout of Novartis’ stake in GSK Consumer Healthcare, to create a new world-leading consumer healthcare business and to deliver further significant shareholder value. The transaction supports GlaxoSmithKline’s key priority of strengthening the company’s pharma business during the next few years by increasing cashflows and providing an effective pathway through the separation of GSK Consumer Healthcare to build further support for investment in the R&D pipeline.

The joint venture unites two highly complementary portfolios of consumer health brands, including GSK’s Sensodyne, Voltaren and Panadol along with Pfizer’s Advil, Centrum, and Caltrate. Underpinned by science-based innovation, the joint venture becomes the worldwide leader in OTC products and holds No. 1 or 2 market share positions in all key geographies, including the United States and China.

Following the Aug. 1 announcement, the joint venture has concentrated on completing the integration of the two businesses, which is expected to realize annual cost savings of £500 million by 2022 for expected total cash costs of £900 million and non-cash charges of £300 million. Up to 25 percent of the cost savings are intended to be reinvested in the business to support innovation as well as other growth opportunities.

According to GSK Consumer Healthcare CEO Brian McNamara, “Now the deal has closed, our focus will be on completing the integration of these two businesses and leveraging their combined strength. With our portfolio of brilliant, science-based brands and strong talent and capabilities, we are well-positioned to create a world-leading consumer healthcare business with stronger sales, cash flow and contribution to earnings.”

GSK intends to demerge the joint venture from the company within three years and to list the GSK Consumer Healthcare business on the UK equity market.

“The completion of the joint venture with Pfizer marks the beginning of the next phase of our transformation of GSK. This is an important moment for the Group, laying the foundation for two great companies, one in Pharmaceuticals and Vaccines and one in Consumer Health,” stated Emma Walmsley, GSK CEO and chair of the joint venture.

On the executive leadership front, Jack Bailey decided to step down from his position as president, U.S. Pharmaceuticals, by year-end 2019. Bailey will be succeeded by Maya Martinez-Davis, who was regional president, Latin America Region at EMD Serono, the biopharmaceutical business of Merck KGaA. Martinez-Davis came aboard GlaxoSmithKline in mid-September and will assume responsibility of the U.S. Pharmaceuticals business at GSK on Jan. 1, 2020. Bailey remains as strategic consultant to GSK on the U.S. external environment through 2020.

2019 Performance and Outlook

GSK’s Group turnover during the first six months of 2019 rose 6 percent AER, 5 percent CER to £15.47 billion ($20.67 billion), with growth delivered by all three businesses: Pharmaceuticals, Vaccines, and Consumer Healthcare.

Pharmaceuticals turnover during the 2019 first half totaled £8.47 billion ($11.31 billion), increasing 3 percent AER, 1 percent CER versus the January-June 2018 performance. HIV sales advanced 4 percent AER, 1 percent CER, to £2.33 billion ($3.11 billion), with growth in Juluca and Dovato partly offset by a decrease in Triumeq. Respiratory sales during first-half 2019 grew 21 percent AER, 17 percent CER, to £1.38 billion ($1.85 billion) on growth of Trelegy Ellipta and Nucala. However, GSK says this performance was slightly offset by Established Pharmaceuticals sales, which fell 6 percent AER, 7 percent CER to £4.38 billion ($5.85 billion), including the impact of loss of U.S. exclusivity of Advair.

Vaccines turnover for first-half 2019 improved 25 percent AER, 22 percent CER year-over-year to £3.11 billion ($4.15 billion), primarily driven by Shingrix sales growth.

Meningitis vaccines and Established Vaccines additionally contributed to growth during 2019’s first six months.

Consumer Healthcare sales increased 2 percent AER, 2 percent CER to £3.9 billion ($5.21 billion) compared to the 2018 first-half result. Growth during the first six months of 2019 reflected improved results in all three regions during the second quarter.

Reflecting the company’s first-half 2019 results, GlaxoSmithKline reported full-year 2019 adjusted EPS to decline in the range of -3 percent to -5 percent at CER. This updated guidance represents an improvement to that previously announced during February of an expected decrease in adjusted EPS in the range of -5 percent to -9 percent at CER. The revamped guidance reflects improved operating performance, lower interest expense and a one-off benefit to the share of after tax profits of associates in first-quarter 2019. GSK management expects to maintain the dividend for full-year 2019 at the current level of 80p per share.

Product Approvals/Launches and Pipeline Updates During 2019

Six potential major regulatory submissions are anticipated by GlaxoSmithKline management during the second half of 2019: Zejula 1L for ovarian cancer, belantamab mafodotin in multiple myeloma; dostarlimab in endometrial cancer; Trelegy Ellipta in asthma; fostemsavir in HIV; and daprodustat for anemia (Japan).

The U.S. Food and Drug Administration accepted GSK’s application for Zejula (niraparib) in late-stage ovarian cancer with priority review, as announced by the company in June. The supplemental New Drug Application (sNDA) was filed by GlaxoSmithKline’s oncology-focused business Tesaro. With priority review status, the sNDA has an action date of Oct. 24, 2019. The marketing application supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or homologous recombination deficiency (HRD) and have progressed more than six months after the last platinum-based chemotherapy.

GSK provided positive results in July from PRIMA (ENGOT-OV26/GOG-3012), the Phase III randomized, double-blind, placebo-controlled trial of Zejula as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy. The clinical study met the primary endpoint of a statistically significant improvement in progression-free survival for women regardless of their biomarker status.

The oral, once-daily PARP inhibitor niraparib is being assessed in three pivotal studies. The ongoing development program for niraparib includes the Phase III PRIMA study; a Phase III clinical trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (BRAVO); and a registrational Phase II treatment study in patients with ovarian cancer (QUADRA). Several combination studies are additionally being conducted, including studies of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (TOPACIO) and niraparib plus bevacizumab in recurrent, platinum-sensitive ovarian cancer (ENGOT-OV24/AVANOVA). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer globally, excluding Japan.

Belantamab mafodotin (also known by the product code GSK2857916) is on track for U.S. regulatory submission by year-end 2019 after GlaxoSmithKline announced positive headline results in August from the pivotal DREAMM-2 study for multiple myeloma. The 196 patients in the clinical trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met the primary objective and showed a clinically meaningful overall response rate with belantamab mafodotin in the patient population.

GlaxoSmithKline says the safety and tolerability profile was consistent with that observed in DREAMM-1, the first time in human study of belantamab mafodotin. The company reported in March that 60 percent of patients with relapsed/refractory multiple myeloma receiving GSK2857916 in the DREAMM-1 study achieved an overall response rate (ORR).

GSK’s Tesaro reported during March clinical data from the Phase I/2 GARNET study indicating robust activity of dostarlimab in patients with advanced or recurrent endometrial cancer. GARNET is the single-largest clinical trial of an anti-PD-1 monotherapy in women with advanced or recurrent microsatellite instability-high (MSI-H) and microsatellite stable (MSS) endometrial cancer. The results show clinically meaningful and durable response rates of dostarlimab monotherapy, in MSI-H and MSS tumors. A BLA submission is on track for dostarlimab in endometrial cancer by the end of 2019.

The investigational humanized anti-programmed death (PD)-1 monoclonal antibody dostarlimab (TSR-042) binds with high affinity to the PD-1 receptor and effectively blocks its interaction with the ligands PD-L1 and PD-L2. If cleared for marketing, dostarlimab would be the first anti PD-1 therapy administered as monotherapy every 3 weeks for four doses then every 6 weeks thereafter.

Positive results were reported in May from the pivotal CAPTAIN study for Trelegy Ellipta in asthma. The Phase III trial is investigating the once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Breo/Relvar Ellipta (FF/VI) for the treatment of patients living with uncontrolled asthma. The study met the primary endpoint of showing a statistically significant 110mL improvement in lung function for FF/UMEC/VI 100/62.5/25mcg versus Breo/Relvar 100/25mcg and a statistically significant 92mL improvement in trough FEV1 for FF/UMEC/VI 200/62.5/25mcg compared to Breo/Relvar 200/25mcg.

Trelegy Ellipta combines three molecules in one single inhaler: the inhaled corticosteroid fluticasone furoate, the long-acting muscarinic antagonist umeclidinium, and the long-acting beta agonist vilanterol delivered in GSK’s Ellipta dry powder inhaler. FF/UMEC/VI 100/62.5/25 has been available in the United States under the brand name Trelegy Ellipta since 2017 for use in chronic obstructive pulmonary disease (COPD).

Trelegy Ellipta is approved in the United States for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The medicine is additionally indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Positive Week 96 results from the Phase III BRIGHTE trial of the investigational drug fostemsavir in heavily treatment-experienced adults with HIV-1 infection were presented by ViiV Healthcare during July. ViiV is the worldwide specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders. According to the company, in the randomized cohort, rates of virologic suppression and immunologic response increase from Week 48 to Week 96 in this difficult-to-treat population with multidrug resistant HIV-1. Fostemsavir is an investigational prodrug of temsavir, which binds directly to the gp120 subunit within the HIV-1 envelope glycoprotein gp160 complex and prevents the initial interaction between the virus and cellular CD4 receptors. This process prevents viral attachment to cellular CD4 receptors and entry into host cells. Temsavir is not approved by any regulatory authorities. Fostemsavir is being developed by ViiV as a treatment for HIV-1-infected heavily treatment-experienced patients in combination with other antiretroviral (ARV) agents.

GlaxoSmithKline announced during August the filing of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare. The approval application is seeking marketing clearance for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for treating patients with renal anemia due to chronic kidney disease (CKD).

Daprodustat has not yet been approved as a treatment for renal anemia or any other indication anywhere worldwide. If approved, daprodustat will be exclusively distributed in Japan by Kyowa Kirin Co. Ltd., following the strategic commercialization deal announced during 2018. Market launch activities, including engagement of healthcare professionals and commercial activities, are expected to be performed jointly by Kyowa Kirin and GlaxoSmithKline.

The first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults was cleared for U.S. marketing in April. Dovato won FDA approval for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either dolutegravir or lamivudine. The new medicine combines the antiretroviral dolutegravir 50 mg with the nucleoside analog reverse transcriptase inhibitor (NRTI) lamivudine 300 mg.

Dovato received EU marketing authorization in July 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. The approval was based on the landmark GEMINI 1 and 2 studies that showed non-inferior efficacy of dolutegravir + lamivudine versus a traditional dolutegravir-based, three-drug regimen, in HIV-1 infected, treatment-naïve adults.

ViiV reported Week 96 results from the company’s Phase III GEMINI 1 and 2 trials during July. The studies demonstrated that the 2DR of dolutegravir plus lamivudine continued to offer non-inferior efficacy to a 3-drug regimen of dolutegravir in combination with two NRTIs, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) with no cases of treatment emergent resistance in individuals with virologic failure.

The integrase inhibitor dolutegravir is used in combination with other antiretroviral agents for treating HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is additionally responsible for establishing chronic infection. Dolutegravir is available in more than 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.

Lamivudine, also known as 3TC, is a nucleoside analog used in combination with other antiretroviral agents for HIV infection treatment. Lamivudine is available in branded and generic formulations.

ViiV during July reported positive Week 48 results in the first clinical trial to evaluate treatment switch from a tenofovir alafenamide fumarate (TAF)-containing regimen with three or more drugs to a 2DR of dolutegravir/lamivudine for HIV-1 infection. The Phase III TANGO study met the primary endpoint for non-inferiority.

ViiV Healthcare revealed promising three-year results from the SWORD 1 and 2 clinical studies during April for Juluca (dolutegravir/rilpivirine). The SWORD clinical trials showed the long-term durable efficacy and tolerability of the first complete two-drug regimen for treating virologically suppressed adults with HIV.

Juluca has been approved for marketing in the United States, the European Union, and other countries as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) and have been on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Nucala (mepolizumab) became the first biologic to win U.S. approval for children 6 to 11 years with severe eosinophilic asthma. With FDA marketing clearance for this new indication, Nucala is the only targeted biologic to be approved for the condition in the 6-11 age group in the United States.

Nucala (100mg dose subcutaneous injection) was initially cleared for marketing during 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older. The September 2019 approval for a 40mg dose subcutaneous injection extends the current indication in the United States for Nucala to patients aged 6 to 11 years. The medicine has been approved for use as an add-on treatment for severe eosinophilic asthma (SEA) in patients 6 years and older in the European Union since August 2018.

The first-in-class monoclonal antibody mepolizumab targets IL-5. The drug is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this fashion reduces blood eosinophils without completely depleting them.

Mepolizumab has been developed for treating diseases that are driven by inflammation resulting from eosinophils. The medicine has been studied in more than 3,000 patients in 21 clinical studies across various eosinophilic indications. Mepolizumab is the only biologic with 4.8 years of safety and efficacy data in SEA. The product has been approved under the brand name Nucala in the United States, Europe, and in more than 20 other markets as an add-on maintenance treatment for patients with severe eosinophilic asthma. Mepolizumab is additionally the only anti-IL5 biologic therapy approved for pediatric use from ages 6 to 17 in Europe in severe eosinophilic asthma. In the United States, Japan, Canada and other markets, the drug is available as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA).

GlaxoSmithKline announced FDA approval in June and European Commission marketing authorization for two new methods of administering Nucala: a pre-filled pen and a pre-filled safety syringe. Nucala is the first anti-IL5 biologic to be licensed in the United States for at-home administration and the only respiratory biologic to be approved for administration via an autoinjector. The FDA marketing clearance allows healthcare professionals and people living with SEA or the rare disease EGPA the option for Nucala to be administered outside of a clinical setting by a patient or caregiver after their healthcare professional agrees this approach is appropriate. Nucala is the only monthly anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides that is appropriate.

Mepolizumab is being tested in clinical development for severe hypereosinophilic syndrome, nasal polyposis, and COPD.

FDA approved the IV formulation of Benlysta (belimumab) for children 5 years and older with lupus during April. Benlysta represents the first medicine approved in the United States for children with systemic lupus erythematosus (SLE). The supplemental Biologics License Application for the B-lymphocyte stimulator (BLyS)-specific inhibitor received FDA priority review.

The human monoclonal antibody binds to soluble BLyS and does not bind B cells directly. By binding BLyS, the drug inhibits the survival of B cells – including autoreactive B cells – and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Benlysta is the only medicine specifically developed and approved for the treatment of SLE. The product is registered as both an IV and SC formulation in the United States. The IV formulation of Benlysta is FDA-approved for use in adults and children, and the subcutaneous formulation of Benlysta is only approved for use in adults. The indication of the IV formulation of Benlysta is for the treatment of patients 5 years and older with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) during September issued a positive opinion recommending the use of intravenous Benlysta as an add-on therapy in children aged 5 years and older with active, autoantibody-positive SLE with a high degree of disease activity. A CHMP positive opinion is one of the final steps before a marketing authorization decision is rendered by the European Commission. If cleared for approval by the EC, children 5 years and older in Europe with lupus will for the first time have a medicine specifically developed and approved to treat this challenging autoimmune disease.

ViiV Healthcare announced the filing of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir for use in combination with Janssen’s once-monthly injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. The marketing application includes clinical data for cabotegravir oral tablets, intended for use as oral lead-in therapy before the commencement of injectable therapy.

Positive headline results were unveiled in August from the worldwide Phase III ATLAS-2M trial evaluating the two-drug regimen of ViiV’s cabotegravir and Janssen’s rilpivirine for treating HIV. The clinical trial was designed to demonstrate the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks versus every month over a 48-week treatment period in adults living with HIV-1 infection whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. The study met the primary endpoint, demonstrating that the long-acting regimen of cabotegravir and rilpivirine injected every two months was non-inferior to cabotegravir and rilpivirine administered every month at Week 48.

These results followed ViiV’s presentation in March of positive, 48-week data from two pivotal Phase III trials. The ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies demonstrated the cabotegravir-rilpivirine regimen has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection.

The cabotegravir and rilpivirine regimen is being jointly developed via a collaboration with Janssen Sciences Ireland UC and has also been filed with regulatory authorities in the United States and Canada. A Priority Review Designation for the once-monthly injectable regimen was granted by U.S. health authorities with an expected action date of Dec. 29, 2019. Rilpivirine is a prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland and has not yet been cleared for marketing by any regulatory authorities.

In other R&D news, GSK initiated the first Phase III program for the investigational anti-granulocyte macrophage colony-stimulating factor (anti GM-CSF) monoclonal antibody otilimab for rheumatoid arthritis. ContRAst represents the first Phase III program in RA to include head-to-head comparisons with current treatments across all pivotal studies in a broad range of difficult-to-treat RA patients. The contRAst program compares otilimab against two treatments with different modes of actions: the janus kinase (JAK) inhibitor tofacitinib and the anti-IL6 sarilumab. The program additionally enrolls a broad range of difficult-to-treat patients who have had an inadequate response to or have been unable to tolerate currently available medicines.

GM-CSF acts on cells, including macrophages (an immune cell type that plays a significant role in the inflammatory process), resulting in inflammation, joint damage and pain. Otilimab neutralizes the biological function of GM-CSF by blocking the interaction of the protein with its cell surface receptor.

Shingrix was approved in China for the prevention of shingles in adults aged 50 years and older during May. The recombinant subunit adjuvanted vaccine is administered intramuscularly in two doses. Shingrix combines the antigen glycoprotein E and the adjuvant system AS01B to generate a strong and long-lasting immune response that can help overcome the decline in immunity that occurs as people age. The herpes zoster vaccine is additionally licensed for use in the United States, European Union, Canada, Japan, and Australia.

GSK was the recipient of a positive CHMP opinion for intravenous zanamivir for treating complicated influenza, as announced on March 1. The marketing authorization application was filed under the EU’s exceptional circumstances regulatory legislation. If approved, the intravenous form of zanamivir will be branded as Dectova.

Other Alliances & Collaborations During 2019

GSK and Germany’s Merck KGaA during February announced a worldwide alliance to jointly develop and commercialize the novel immunotherapy bintrafusp alfa (M7824). The investigational bifunctional fusion protein immunotherapy M7824 is undergoing clinical development, including potential registration studies, for multiple difficult-to-treat cancers. This includes a Phase II study to evaluate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer. According to GSK’s first-half 2019 results report, M7824 had advanced into a pivotal Phase III study in biliary tract cancer

Bintrafusp alfa is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. Bifunctional antibodies are intended to increase efficacy above and beyond that achieved with individual therapies or combinations of individual therapies. M7824 has the potential to offer new ways to combat difficult-to-treat cancers beyond the established PD-1/PD-L1 drug class. In addition to use as a single agent, M7824 is being considered for use in combination with other assets from the pipelines of GSK and Merck KGaA.

GlaxoSmithKline announced during June a five-year collaboration with the University of California to establish a state-of-the-art laboratory for CRISPR technologies. The Laboratory for Genomics Research (LGR) is exploring how gene mutations cause disease and develop new technologies using CRISPR to rapidly accelerate the discovery of new medicines.