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GSK presents new data for once-weekly Tanzeum/Eperzan (albiglutide) showing blood glucose lowering up to three years in type 2 diabetes

Issued: Saturday 14 June 2014, London

New data from secondary analyses of four randomised phase III studies being presented at the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco show that patients enrolled in the studies who remained on Tanzeum/Eperzan (albiglutide), a once-weekly glucagon-like peptide (GLP-1) receptor agonist, continued to show blood glucose lowering at three years, consistent with results at the one year (52 week) primary endpoint.

In the four studies, the primary endpoint of blood glucose lowering, defined as the reduction of HbA1c (glycatedhaemoglobin, a measure of blood glucose levels) from baseline was assessed at 52 weeks (results previously announced). Those patients who remained in the study until year three continued to receive randomised treatment, as pre-specified in the study protocol, to further assess the efficacy and safety profile of albiglutide. Safety data for albiglutide in these studies were also consistent with the results observed up to year one. Commonly reported adverse reactions included nausea, diarrhoea, and injection site reactions.

Vlad Hogenhuis, Senior Vice-President and Head, Cardiovascular, Metabolic and Neurosciences Franchise, GSK, said: “While many phase III trials in type 2 diabetes are typically six months in duration, we set out to assess weekly-administered albiglutide for up to three years. We are proud to be able to present these data which further characterise the efficacy and safety profile of albiglutide.”

The four phase III studies, entitled Harmony 1, 2, 4 and 5, evaluated albiglutide in monotherapy as well as in combination with OADs, against placebo, insulin glargine and a thiazolidinedione (pioglitazone). The studies enrolled patients at various stages of the disease, rangingfrom those with early stage disease to those whose type 2 diabetes had advanced to a point requiring insulin therapy.

GSK also released at the ADA additional analyses of data related to gastrointestinal adverse events from four pooled, placebo-controlled phase III studies, medication compliance data from three phase III studies and two subpopulation efficacy and safety analyses in Hispanic and African-American populations.

About Harmony Harmony is the phase III clinical programme for albiglutide, comprising eight trials (entitled Harmony 1-8) and involving over 5,000 patients. These data refer to four of the five Harmony trials (Harmony 1, 2, 4 and 5) that were conducted for three years.

At year one, in each of the four studies, albiglutide met the primary efficacy endpoint (the change from baseline in HbA1c compared to placebo and/or active comparators), demonstrating statistically significant HbA1c reductions over placebo (Harmony 1 and 2) and non-inferiority to insulin glargine (Harmony 4), however it did not meet the criteria for non-inferiority to pioglitazone (Harmony 5). The data at 156 weeks presented at ADA is consistent with these results.

Harmony 1 (Abstract number: 2014-960-P) is a three-year (primary endpoint at one year), randomised, double-blind, placebo-controlled study which evaluated the efficacy and safety of albiglutide against placebo in patients inadequately controlled (HbA1c 7-10%) on pioglitazone ± metformin.

Harmony 2 (Abstract number: 2014-959-P) is a three-year (primary endpoint at one year), double-blind, placebo controlled study which examined the efficacy and safety of albiglutide at 30mg and 50mg versus placebo in patients inadequately controlled (HbA1c 7-10%) on diet and exercise.

Harmony 4 (Abstract number: 2014-961-P) is a three-year (primary endpoint at one year), randomised, open label study which assessed the efficacy and safety of albiglutide 30mg once weekly versus insulin glargine in type 2 diabetes mellitus patients inadequately controlled (HbA1c 7-10%) on metformin ± sulphonylurea.

Harmony 5 (Abstract number: 2014-963-P) is a three-year (primary endpoint at one year), randomised, double-blind, multicentre study which evaluated the efficacy and safety of albiglutide versus placebo and versus pioglitazone in people inadequately controlled (HbA1C 7.0-10.0%) on background dual therapy of metformin and glimepiride.

[Data from the fifth three-year Harmony trial (Harmony 3) is being presented at ADA on Monday 16 June 2014 as an oral session (Abstract number: 2014-329-OR).]

About albiglutide Albiglutide (TanzeumTM/Eperzan®) is a glucagon-like peptide-1 receptor agonist (GLP-1), a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle.

Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is reduced or absent.

In the US, albiglutide has been approved by the FDA (April 2014) with the brand name TanzeumTM and is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.1

In Europe, albiglutide has been approved by the EMA (March 2014), as Eperzan®, and is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as: 2

  • Monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance
  • Add-on combination therapy, in combination with other glucose-lowering medicinal products, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

LIMITATIONS OF USE Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Tanzeum is not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Tanzeum has not been studied in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin.

Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use is available at http://us.gsk.com. In addition, a copy of the label may be requested from the GSK Media or Investor Relations contacts listed in the “GlaxoSmithKline Inquiries” section at the end of this document.

Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis. A non-promotional factsheet, reviewed by the FDA, with more detailed safety information is available at www.TANZEUMREMS.com.

Important Safety information for Tanzeum (albiglutide) The following information is taken from the highlights section of the US Prescribing Information. Please see full Prescribing Information including boxed warning.

BOXED WARNING: RISK OF THYROID C-CELL TUMOURS

Thyroid C-cell tumours have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether Tanzeum causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans. Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

CONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.

WARNINGS AND PRECAUTIONS Pancreatitis: Discontinue promptly if suspected. Do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycaemia: Can occur when used in combination with insulin secretagogues (e.g. sulfonylureas) or insulin. Consider lowering sulfonylurea or insulin dosage when starting Tanzeum.

Hypersensitivity Reactions: Discontinue Tanzeum if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve.

Renal Impairment: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Tanzeum or any other antidiabetic drug.

ADVERSE REACTIONS Adverse reactions, reported in ≥10% of patients treated with Tanzeum and more frequently than in patients on placebo, were upper respiratory tract infection, diarrhoea, nausea, and injection site reaction.

TanzeumTM and Eperzan® are trademarks of the GlaxoSmithKline group of companies.

Notes to editors Harmony 3, (Abstract number: 2014-329-OR), will be presented at ADA, as an oral presentation, on Monday 16 June. Harmony 3 is a three-year, randomised, double-blind, placebo controlled, study examined albiglutide versus placebo, sitagliptin or glimepiride in patients with type 2 diabetes mellitus inadequately controlled (HbA1C 7-10%) on metformin.

Available on request:

  • Harmony one-year primary endpoint data publications
  • ADA albiglutide data abstracts/posters

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

References 1. Tanzeum US Prescribing Information

2. Eperzan EU Summary of Product Characteristics.

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Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.

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