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 17th September 2013 Sanofi Aventis

Scottish Medicines Consortium (SMC) Accepts Once-Daily Lyxumia® (Lixisenatide) for Treatments of Type 2 Diabetes in Scotland

SMC issues the first UK health technology assessment for Lyxumia (lixisenatide), advising it be made available for use in NHS Scotland

[Guildford, UK – September 9, 2013] The Scottish Medicines Consortium (SMC) has issued advice on the use of Lyxumia (lixisenatide) within NHS Scotland, accepting it for restricted use in patients for whom a glucagon-like protein-1 (GLP-1) agonist is appropriate, as an alternative to existing GLP-1 agonists.

Lyxumia is a new treatment for Type 2 diabetes and is a once-daily GLP-1 receptor agonist with a predominant effect on post-prandial glucose (PPG).

This means that Lyxumia is the first once-daily GLP-1 receptor agonist with a predominantly prandial glucose-lowering effect to be approved for use on top of basal insulin as well as in combination with oral anti-diabetic medications.

NICE will be reviewing Lyxumia as part of the update to the Type 2 diabetes clinical guidelines, which are not anticipated until the end of 2014. The All Wales Medicines Strategy Group (AWMSG) will also be reviewing Lyxumia in Q4 2013.

Lyxumia is indicated for the treatment of adults with Type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and / or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

Lyxumia is less expensive than alternative GLP-1 agonists, and therefore this approval provides an opportunity for drug acquisition cost savings to the NHS in Scotland and the rest of the UK. If patients were treated with Lyxumia in preference to other GLP-1s approved for use in Scotland, up to 35% more patients could be treated with the same budget. Furthermore, the advice document reports the estimate that, in terms of acquisition costs, the net medicines budget impact is expected to be a saving of £197,300 in year 1 rising to £757,700 in year 5.

Between 2006 and 2012 the number of people diagnosed with diabetes in England has increased from 1.9 million to 2.5 million. Estimates suggest a further 850,000 people in the UK have diabetes but are either unaware, or have no confirmed diagnosis.

“I feel this advice in Scotland represents a real step forward in diabetes management. Clinicians now have access to a new option to help patients with Type 2 diabetes reduce their HbA1c, and access to new medicines will always be of clear benefit to patients. The advice indicates that the SMC consider the clinical and economic case for Lyxumia has been demonstrated,” said Anthony Barnett, Emeritus Professor of Medicine and consultant physician, University of Birmingham and Heart of England NHS foundation Trust, Birmingham, UK.

“As a prescribing practitioner, I am excited by this advice in Scotland. Lixisenatide, with its broad licence, represents a cost-effective, viable new treatment to help patients with Type 2 diabetes further reduce their HbA 1c. The once-per- day dosing should also improve the balance between patients’ quality of life and adherence to treatment," said Philip Newland-Jones, Advanced Specialist Pharmacist Practitioner, Southampton General Hospital.

The SMC has accepted Lyxumia based on results from the GetGoal clinical programme, which demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with Type 2 diabetes.

NOTES TO EDITORS

Type 2 diabetes Type 2 diabetes accounts for between 85 and 95% of all cases of diabetes and occurs when the pancreas either does not produce enough insulin, or the insulin it produces does not work as well as it should (insulin resistance), or a combination of the two.

About the SMC advice Lixisenatide (Lyxumia®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

SMC restriction: to use in patients for whom a glucagon-like protein-1 (GLP-1) agonist is appropriate, as an alternative to existing GLP-1 agonists.

About Lyxumia® (lixisenatide) Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with Type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com. Lyxumia® is the proprietary name licensed by the EMA for the GLP-1 RA lixisenatide.

About the GetGoal Clinical Trial Programme The GetGoal Phase III clinical program started in May 2008, enrolled more than 5,000 patients worldwide and consisted of 11 trials.

In all reported GetGoal studies to date, Lyxumia met the primary efficacy endpoint of HbA1c reduction and demonstrated a beneficial effect on body weight and a limited risk of hypoglycaemia. Results also showed that Lyxumia was well-tolerated overall, with the most commonly reported adverse events being mild and transient nausea and vomiting.

About Sanofi Diabetes Sanofi Diabetes strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalised solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with Type 1 or Type 2 diabetes.

About Sanofi Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Mark Seymour, Reynolds-MacKenzie, Mark@reynoldsmackenzie.com, Tel: 020 7861 2812

Christina Chalé, Sanofi, Christina.Chale@sanofi.com, Tel: 014 8355 4080


 

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