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GlaxoSmithKline: New Business Priorities

Written by: | andrew.humphreys@medadnews.com | Dated: Wednesday, October 11th, 2017

 

Management set out a series of new priorities to 2020 to improve innovation, performance and trust in GlaxoSmithKline.

 

glaxosmithkline-logo

 

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 2016 Sales 2015 Sales
Advair/Seretide $4,724 $4,990
Triumeq    $2,352 $990
Tivicay    $1,292 $797
Ventolin $1,064 $840
Infanrix, Pediarix $1,042 $994
Flovent/Flixotide $863 $844
Avodart $861 $891
Breo/Relvar Ellipta $840 $348
Lamictal $832 $720
Epzicom, Kivexa $770 $946
Augmentin $763 $716
Synflorix $683 $516
Boostrix $637 $485
Rotarix $636 $565
Fluarix, FluLaval $561 $363
Bexsero $529 $156

All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2016: £1.3555.

 

Financial Performance

  2016 2015
Revenue $37,804 $32,428
Net income $1,440 $11,348
Diluted EPS $2.52 $2.34
R&D expense $4,070 $4,297
  1H2017 1H2016
Revenue $19,931 $17,298
Net income $1,541 $(190)
Diluted EPS $0.24 $(0.04)
R&D expense $3,009 $2,308

All sales are in millions of dollars, except EPS, and were translated using the Federal Reserve Board’s average rate of exchange in 2016: £1.3555.

 

 

Upon announcing the company’s financial results for the second of quarter 2017, GlaxoSmithKline management outlined a set of new business priorities to 2020.

“Today we are updating our full-year earnings guidance to reflect the investments we have made to accelerate the review of our new two-drug regimen in HIV,” stated GlaxoSmithKline CEO Emma Walmsley on July 26, 2017. “We are also providing an update to investors on the longer-term outlook for the Group and our priorities to improve innovation, performance and trust in GSK.”

GSK’s new business priorities to 2020:
• New priorities to strengthen innovation, improve performance and build trust
• Pharmaceutical R&D pipeline reviewed with target over time to allocate 80 percent of capital to priority assets in two current (Respiratory and HIV/infectious diseases) and two potential (Oncology and Immuno-inflammation) therapy areas; more than 30 preclinical and clinical programs to be stopped
• Extended cost reduction program expected to deliver additional £1 billion annual cost savings by 2020 driven by new business priorities, improved supply chain efficiency and reduced administrative costs
• Enhanced focus on improved cash generation and strengthening credit profile
• Dividend of 80p expected for 2018 in conjunction with new dividend policy
• Group outlook for 2020: Expected 5 year percentage CAGR to 2020 on a CER basis for sales of low-to-mid-single digits and Adjusted EPS of mid-to-high single digits

GSK affirmed its commitment to developing innovative healthcare products for patients and consumers across Pharmaceuticals, Vaccines and Consumer Healthcare. Earnings and cash flows from this business combination offer balance to the company and provide a level of sustainability to GSK’s performance, the ability to invest in future growth and in its returns to shareholders.

The recent performance of the three businesses has shown the benefits of the transaction with Novartis in 2015 as well as the impact of more effective introductions of new products, particularly new Respiratory and HIV medicines and vaccines to prevent meningitis. Better performance, coupled with cost savings, has additionally resulted in improved margins and cash flows for all three businesses during the previous 18 months.

“All three businesses need to perform but the priority for GSK is to improve in Pharmaceuticals,” company management says.

“Delivering full value from recent and imminent product launches, together with cost base improvements, is required to help mitigate the impact of pricing pressures to its current portfolio. Strengthening the Pharmaceuticals pipeline is a key objective for the Group.

“Beyond Pharmaceuticals, the Group aims to realize further benefits from its newly scaled Consumer Healthcare and Vaccines businesses. The Group is also aiming to increase investment flexibility with a series of measures to improve cash generation and clearer capital allocation priorities.”

Heading forward, GSK intends to concentrate on three long-term priorities: Innovation, Performance, and Trust. Company officers say innovation is important for all three businesses.

Executives note that a key near-term focus is to maximize value from new products and three other material new launch opportunities: Shingrix, a potential new vaccine for shingles; Trelegy Ellipta, a recently approved 3-in-1 respiratory medicine; and new two-drug regimens in HIV.

“In its Pharmaceuticals pipeline, GSK has developed a priority list of assets to invest behind. This priority list will evolve as data reads out. The Group has also set a target to deploy over time 80 percent of its Pharmaceuticals R&D capital to priority assets in two current therapy areas: Respiratory and HIV/infectious diseases; and two potential areas: Oncology and Immuno-inflammation. Significant data is expected from these priority assets over the next three years which will be used to inform R&D investment decisions and how best to generate value from these assets. GSK also expects to pursue disciplined business development to augment its early-stage pipeline in these priority areas.”

As part of the company’s efforts to prioritize and allocate resources in R&D, GSK is terminating development programs that are unlikely to generate sufficient returns. The company has made decisions to terminate, partner, or divest more than 30 pre-clinical and clinical programs. The company has additionally undertaken a strategic review of its Rare Diseases unit and is considering options for future ownership of these assets.

Also, the company is taking steps to improve the partnership between R&D and its commercial organization as well as its governance around pipeline decision-making with the establishment of a new Development Advisory Board and a new Board Scientific Committee.

GSK’s second priority is a new company-wide focus on delivering sustainable, ethical and more competitive performance.

“The Group is making a number of choices to prioritize the strongest assets and markets in its portfolio and move capital and resources away from those that offer more limited opportunities,” GSK officials say. “It is prioritizing investment to support commercial execution in the US market and is implementing a new operating model for Emerging Markets to increase competitiveness and support long-term profitable growth in these markets. The Group has also decided to terminate its collaboration on sirukumab with Janssen Biologics and progressively withdraw its support for Tanzeum.”

GSK is putting in place plans to improve its cash generation and is expanding its current cost saving program. Management is targeting delivery of an additional £1 billion in annual cost savings by 2020 at constant exchange rates. These new cost savings will be used to fund new product launches, research and development investments and to help mitigate pricing pressure on margins.

“A key driver of the new savings will be through realizing efficiency improvements in the Group’s supply chain,” according to company executives. “This will include changes to GSK’s manufacturing network, divestment and exit of more than 130 non-core tail brands (£0.5 billion in annual sales), reductions in overheads, improved procurement savings and more strategic supplier relationships.”

GSK is additionally seeking to strengthen its capabilities via investments in people and appointment of external talent. One of the key areas will be in digital, data and analytics, with the company aiming to leverage technology to improve clinical outcomes, develop real-world data and make a step-change in its customer and consumer engagement.
Management expects sales to increase at CER at a low-to-mid single digits percentage CAGR and adjusted EPS to grow at a mid-to-high single digits percentage CAGR for the 2016-2020 period. These outlooks are based on 2015 exchange rates and take into account that at least one version of generic Advair will be launched in the United States before 2020. The outlook includes the divestments announced in July 2017 and those executed since 2015 (£0.9 billion in annual sales).

 

2017 Performance

After its Pharmaceuticals, Vaccines and Consumer Healthcare businesses generated combined global turnover of £27.89 billion ($37.8 billion) in 2016, Group turnover during the first six months of 2017 increased 15 percent at annual exchange rates (AER) and 4 percent at constant exchange rates (CER) to £14.70 billion ($19.93 billion), with growth in all three businesses.

Pharmaceuticals sales for the 2017 first half improved 14 percent AER and 4 percent CER to £8.55 billion ($11.58 billion). This performance reflected the continued strong growth of new products, driven particularly by Triumeq (abacavir/dolutegravir/lamivudine), Tivicay (dolutegravir) and Breo/Relvar Ellipta (fluticasone furoate/vilanterol), partly offset by the impact of recent divestments. Nucala (mepolizumab) additionally contributed significantly to total Respiratory growth of 16 percent AER, 4 percent CER.

Vaccines sales advanced 23 percent AER and 10 percent CER over the first half of 2016 to £2.26 billion ($3.07 billion). The sales growth was bolstered by a strong performance from Meningitis vaccines and higher demand for Established Vaccines as well as the benefit of favorable year-on-year US CDC stockpile movements.

First-half 2017 Consumer Healthcare sales rose 13 percent AER and 1 percent CER to £3.9 billion ($5.28 billion), reflecting strong performances from power brands, particularly in Pain relief and Oral health, largely offset by a weaker US allergy performance, and a broader slow down in key categories, especially in International markets.

Sales of New Pharmaceutical and Vaccine products in the first half of 2017 amounted to £3.12 billion ($4.23 billion), an improvement of 67 percent AER and 49 percent CER.

Pharmaceuticals

First-half 2017 US Pharmaceuticals sales growth of 22 percent AER, 9 percent CER was driven by the HIV portfolio and new Respiratory products. Europe sales improved 7 percent AER but decreased 3 percent CER, reflecting continued generic competition to Seretide and the disposal of the Romanian distribution business during the fourth quarter of 2016. International sales growth was impacted by the benefit to first-quarter 2016 of the accelerated sale of inventory under supply agreements to Novartis as well as the disposal of the thrombosis and anesthesia businesses to Aspen in first-quarter 2017, which reduced growth in Emerging Markets (including HIV) by two percentage points to 12 percent AER, 4 percent CER. Sales in Japan rose 16 percent AER, 3 percent CER.

Total Respiratory portfolio sales for the 2017 first half increased 16 percent AER, 4 percent CER, with the US up 20 percent AER, 7 percent CER. Europe advanced 7 percent AER but went down 2 percent CER and International improved 17 percent AER, 5 percent CER. Growth of the new Respiratory products more than offset the decline in Advair/Seretide.

The new Respiratory products generated combined sales of £864 million ($1.17 billion), with sales of Ellipta products up 87 percent AER, 67 percent CER driven by continued market share growth in all regions and the ongoing roll-out across Europe and International. Sales of Nucala were £132 million ($179 million), a Sterling increase of £105 million ($142 million) over the first-half 2016 result, including US sales of £92 million ($125 million).

The aggregate growth of the Ellipta products was primarily driven by the US, where sales were up 96 percent AER, 75 percent CER compared to the 2016 first half. Total Breo/Relvar Ellipta sales rose 89 percent AER, 69 percent CER with the US more than doubling at AER and increasing 92 percent CER to £294 million ($399 million). Sales of Breo/Relvar in Europe went up 57 percent AER, 43 percent CER, and in International 61 percent AER, 42 percent CER, aided by ongoing launches. Anoro Ellipta sales during first-half 2017 rose 86 percent AER, 67 percent CER to £147 million ($199 million), reflecting particularly US market share gains. The Ellipta products Breo, Anoro and Incruse all continued to increase US market share throughout the first six months of 2017.

GSK’s top-selling product Advair/Seretide fell 3 percent AER, 13 percent CER to £1.6 billion ($2.17 billion) during the 2017 first half. US sales dropped 1 percent AER, 12 percent CER (8 percent volume decline and a 4 percent negative impact of price), with payer rebate adjustments favorably impacting growth in first-half 2017. In Europe, Seretide sales declined 12 percent AER, 19 percent CER to £388 million/$526 million (10 percent volume decrease and a 9 percent negative impact of price), reflecting continued competition from generics and the transition of the Respiratory portfolio to newer products. In International, sales of Seretide rose 2 percent AER but decreased 8 percent CER to £397 million ($538 million), additionally reflecting increased generic competition and the transition to the newer Respiratory products.

Ventolin sales in first-half 2017 advanced 10 percent AER year-over-year, but fell 1 percent CER to £393 million ($533 million), primarily reflecting unfavorable RAR adjustments in the United States. Flovent/Flixotide sales increased 7 percent AER, but decreased 3 percent CER to £309 million ($419 million), with growth in International only partly offsetting the product’s US decline.

In the HIV category, sales rose 32 percent AER, 18 percent CER to £2.10 billion ($2.85 billion) during the first two quarters of 2017, with the US rising 39 percent AER, 24 percent CER, Europe increasing 13 percent AER, 2 percent CER and International improving 43 percent AER, 27 percent CER. The growth in all three regions was fueled by the continued upswing in market share for Triumeq and Tivicay, offset by the impact of generic competition to Epzicom/Kivexa, particularly affecting the European market. The ongoing increase in patient numbers for Triumeq and Tivicay led to sales of £1.19 billion ($1.61 billion) and £641 million ($869 million), respectively, during H1 2017.

The innovative integrase strand transfer inhibitor Tivicay (dolutegravir) is approved in more than 100 countries for use in combination with other antiretroviral agents for the treatment of HIV.

 

Epzicom/Kivexa sales were down 55 percent AER, 59 percent CER to £141 million ($191 million), reflecting the continued growth in generic competition since third-quarter 2016.

Among Immuno-inflammation products, sales for Benlysta improved 29 percent AER, 15 percent CER to £184 million ($249 million), paced by a strong US performance.

In the Established Pharmaceuticals category, first-half 2017 sales amounted to £2.78 billion ($3.76 billion), rising 2 percent AER, but decreasing 6 percent CER, impacted by the accelerated sale of inventory under supply agreements to Novartis during Q1 2016 as well as the disposal of the thrombosis and anesthesia businesses to Aspen in first-quarter 2017 and the disposal of the Romanian distribution business in the last quarter of 2016.

The Avodart franchise improved 3 percent AER versus H1 2016, but decreased 8 percent CER to £320 million ($434 million) primarily due to the loss of US exclusivity and the impact of favorable RAR adjustments during 2016.

Dermatology sales advanced 22 percent AER and 11 percent CER to £224 million ($304 million), via improved supply in Emerging Markets, while Augmentin sales went up 8 percent AER, 1 percent CER to £296 million ($401 million).

Vaccines

GSK said Vaccines turnover delivered strong growth of 23 percent AER, 10 percent CER to £2.26 billion ($3.07 billion) in first-half 2017 with continued momentum from Meningitis vaccines across all regions. Growth additionally benefited from the performance of Established Vaccines, driven by higher demand, particularly Boostrix, Synflorix and Hepatitis, partly offset by rising competitive pressures on Infanrix and Pediarix. Favorable year-on-year CDC purchases and stockpile movements in the United States additionally contributed to growth.

Meningitis vaccines sales during the 2017 first half rose 49 percent AER, 33 percent CER to £391 million ($530 million). Bexsero sales growth of 67 percent AER, 50 percent CER was primarily fueled by private market sales, regional tenders, and new national immunization programs in Europe as well as growing demand and share gains in the United States, combined with continued progress in private market sales in International. Menveo sales improved 25 percent AER, 11 percent CER versus H1 2016, driven by tenders awarded in International, partly offset by some supply constraints.

In terms of Influenza vaccines, Fluarix/FluLaval sales jumped up 31 percent AER, 8 percent CER to £34 million ($46 million), mainly driven by rebate adjustments in Europe.

In the Established Vaccines area, sales of the DTPa-containing vaccines (Infanrix, Pediarix and Boostrix) climbed up 27 percent AER, 14 percent CER to £651 million ($882 million).

Hepatitis vaccines shot up 21 percent AER, 9 percent CER to £322 million ($436 million) during H1 2017 due to a competitor supply shortage and higher demand in the US, partly offset by the impact of supply constraints in Europe and International.
Synflorix sales improved 25 percent AER, 12 percent CER over the 2016 first half to £284 million ($385 million) because of stronger demand and favorable phasing in International.

Consumer Healthcare

Consumer Healthcare sales in the first six months of 2017 improved 13 percent AER, 1 percent CER year over year to £3.9 billion ($5.28 billion), partly impacted by more challenging market conditions. A strong performance of the power brands in Pain relief and therapeutic Oral health and good Cold & flu seasonal sales were offset by a weaker US allergy performance and slower consumption in key categories, particularly in International markets but also in the US, according to GSK.

Sales from new GSK innovations (product introductions within the last three years on a rolling basis) represented 14 percent of sales during H1 2017. Notable launches in 2017 have included parodontax and Flonase Sensimist in the US, the continued worldwide roll out of Flonase OTC and next generation Sensodyne Rapid.

In the Wellness category sales improved 13 percent AER, 1 percent CER to £2 billion ($2.7 billion). This result reflected a strong performance from Voltaren and Cold & flu seasonal products partly offset by a weaker US allergy performance. Respiratory sales were up 10 percent AER but down 1 percent CER compared to first-half 2016 as heightened competitive pressure in the US for Flonase OTC from private label and new market entrants offset strong growth on Theraflu and Otrivin, particularly in Europe.
Pain relief sales during the first six months of 2017 improved 15 percent AER, 3 percent CER, driven by a strong performance on Voltaren.

Oral health sales were up 16 percent AER, 5 percent CER year over year to £1.23 billion ($1.67 billion) with Sensodyne continuing to drive performance, generating growth of 19 percent AER, 8 percent CER, with strong delivery in all regions following the roll out of next generation Sensodyne Rapid and the market launch of Pronamel Strong & Bright. Sales of parodontax continued to improve strongly, reflecting double-digit performances in Europe and International, driven by dentist recommendations and share gains, as well the US introduction in the first quarter.

Nutrition sales rose 3 percent AER but declined 9 percent CER to £347 million ($470 million), adversely impacted by the sale of the Nigeria beverages business during 2016 and de-stocking in India ahead of the July 1st implementation of GST, as well as continued competitive pressures for Horlicks in India.

Skin health sales were up 12 percent AER, 1 percent CER to £320 million ($434 million) with low single-digit growth in Europe and International partly offset by US de-stocking.

 

Product Approvals/Launches & Pipeline Updates During 2017

R&D expenditure for GSK during first-half 2017 totaled £2.22 billion ($3 billion), representing about 15 percent of the Group’s turnover, 30 percent higher than in H1 2016 on a Sterling basis and 21 percent higher on a CER basis. This reflected the impact of the Priority Review Voucher as well as increased investment in the progression of various mid-stage and late-stage programs in HIV, respiratory and anemia.

The US Food and Drug Administration on Sept. 18th approved the once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) under the brand name Trelegy Ellipta. The new medicine is indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of FF/VI for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving UMEC and a fixed-dose combination of FF/VI.

Trelegy Ellipta is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist, delivered once per day via GSK’s Ellipta dry powder inhaler.

GlaxoSmithKline and Innoviva Inc. on Sept. 15 announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for FF/UMEC/VI as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

Trelegy Ellipta is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP. The proposed dosage strength is FF/UMEC/VI 100/62.5/25 mcg.

Regulatory applications have been filed and are under assessment in various other countries, including Australia and Canada.
Innoviva’s portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited, including Breo/Relvar Ellipta and Anoro Ellipta, which were jointly developed by the two companies.

On Sept. 20, GSK and Innoviva reported positive headline results from the landmark Phase III IMPACT study of Trelegy Ellipta. The clinical trial, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) versus two once-daily dual COPD therapies from GSK’s existing portfolio.

Another positive CHMP opinion was granted to GSK on Sept. 15th: for a new subcutaneous form of Benlysta (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.

The human monoclonal antibody has been licensed as an intravenous treatment for SLE in Europe since 2011. In this form, GSK says the product is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg via a one-hour infusion in a hospital or clinical setting every four weeks (following an initial loading Phase given on days 0, 14 and 28).

The regulatory filing is seeking approval for Benlysta subcutaneous formulation in two presentations, as a single-dose prefilled syringe and as a single-dose autoinjector.

As of September, the Benlysta subcutaneous formulation had only been approved for use in the United States, with FDA marketing clearance granted in July 2017. Additional regulatory submissions are under review or planned in other countries throughout 2017. The Benlysta intravenous formulation is licensed for use in more than 70 countries, including the US and EU countries.

Benlysta is the first medicine specifically developed and approved for SLE. A BLyS-specific inhibitor, Benlysta binds to soluble BLyS. Benlysta does not bind directly to B cells. 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.

The BLyS-specific inhibitor Benlysta is the first medicine specifically developed and approved for systemic lupus erythematosus (SLE).

 

GlaxoSmithKline revealed during September that FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 years and over. The Biologics License Application was filed with US regulators during October 2016. Other regulatory submissions in the European Union, Canada, Australia and Japan are under way. Japan Vaccine Co. Ltd., a joint venture of GlaxoSmithKline and Daiichi Sankyo Co. Ltd., during April filed a New Drug Application in Japan.

The non-live, recombinant subunit vaccine candidate is intended to help prevent shingles and its complications, including postherpetic neuralgia, in adults 50 years of age and older. Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.

During June, GSK presented new results from a clinical trial demonstrating that Shingrix induces a strong immune response in older adults who have previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine (ZVL).

In other September news for GlaxoSmithKline, the company announced the publication of full results from the Phase III studies for mepolizumab in COPD in the New England Journal of Medicine (NEJM). Data from the investigational clinical development program demonstrated that treating eosinophilic COPD patients with the biologic medicine mepolizumab in addition to maximal guideline-recommended therapy reduced exacerbations in these difficult-to-treat patients. Based on the full data, discussions with external experts and the recognized unmet medical need in this patient population, regulatory submissions were planned for 2017. Mepolizumab is not approved for use anywhere globally for COPD.

The first-in-class humanized IgG1 monoclonal antibody mepolizumab targets the signaling protein IL-5. The drug binds to IL-5, preventing it from binding to its receptor on the surface of white blood cells known as eosinophils. Inhibiting IL-5 binding in this manner reduces blood eosinophils.

Mepolizumab is FDA-approved under the brand name Nucala as an add-on maintenance treatment for patients with severe asthma 12 years and older, and with an eosinophilic phenotype. Nucala has additionally been approved for severe eosinophilic asthma in the EU, Japan and other countries.

Mepolizumab was filed for U.S. regulatory review during June as an add-on therapy to corticosteroids for treating adult patients with eosinophilic granulomatosis with polyangiitis (EPGA, also referred to as Churg-Strauss syndrome). Regulatory submissions in other countries are planned during the course of 2017 and 2018. Mepolizumab as of late September had not been approved anywhere in the world for EGPA, a rare disease characterized by widespread inflammation in the walls of small blood vessels (vasculitis) that may lead to tissue and organ damage.

Mepolizumab is additionally being studied for severe hypereosinophilic syndrome, nasal polyposis and atopic dermatitis. The Phase III study with mepolizumab for patients with severe hypereosinophilic syndrome (HES) was initiated in March. In June, GSK announced the start of a Phase III trial for the interleukin 5 (IL-5) antagonist in patients with severe bilateral nasal polyps.
During February, GlaxoSmithKline and Innoviva revealed positive headline results from a non-inferiority lung function study showing that patients with well-controlled asthma were able to switch to once-daily Relvar Ellipta from twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50, without compromising their lung function.

Relvar Ellipta is a dual combination treatment consisting of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol in a single inhaler, the Ellipta. Relvar Ellipta is indicated in Europe in the regular treatment of patients aged 12 years and older with asthma who are not adequately controlled on both inhaled corticosteroid and ‘as-needed’ short-acting β2-agonist and where use of a combination product is appropriate. During July, GSK filed an EU application for extended use of Relvar Ellipta in patients already adequately controlled on an ICS/LABA combination. Relvar Ellipta is known as Breo Ellipta in the United States, where it is approved for the once-daily treatment of asthma in patients aged 18 years and older.

A supplementary New Drug Application was filed in July with the FDA for the use of Arnuity Ellipta as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years (inclusive).

The sNDA is seeking marketing clearance for a dose of 50mcg once daily, delivered using the Ellipta inhaler in this group of patients. Arnuity Ellipta (fluticasone furoate 100mcg and 200mcg) was initially approved by FDA in August 2014 for the maintenance treatment of asthma in patients aged 12 years and older.

The EMA’s CHMP issued a positive opinion during June for a new four-dose vial presentation of GSK’s Synflorix pneumococcal vaccine. According to the company, the decision is the first step in the process to deliver the new vaccine presentation through Gavi, the Vaccine Alliance, in developing countries.
Synflorix is licensed in more than 125 countries and is the vaccine of choice in more than 53 national or regional immunization programs. Synflorix is indicated for active immunization against invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks through 5 years of age.

GSK and the Medicines for Malaria Venture announced in June positive results from two Phase III trials of tafenoquine, an investigational 8-aminoquinoline, for the prevention of relapse of Plasmodium vivax malaria. The headline results demonstrated that a single-dose of 300mg tafenoquine, when given with a three-day blood-stage chloroquine treatment, reduced the risk of relapse in patients with P. vivax malaria significantly more than placebo when given with chloroquine.

ViiV Healthcare, the global specialist HIV company that is majority owned by GSK – with Pfizer Inc. and Shionogi Ltd. as shareholders – filed a regulatory application, as announced on June 1, with the FDA and EMA for the first HIV maintenance regimen comprising only two medicines. The single-tablet, two-drug regimen consists of dolutegravir and rilpivirine (marketed as Edurant by Janssen Sciences Ireland UC) for the maintenance treatment of HIV-1 infection.

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