PRESS RELEASE FOR UK MEDICAL AND PHARMACEUTICAL MEDIA
Cambridge company will assume responsibility for the promotion of Invokana® (canagliflozin) and Vokanamet▼® (canagliflozin, metformin) indicated for patients living with Type 2 diabetes mellitus
Cambridge UK: 06 September 2017 – Napp Pharmaceuticals Limited today announced that the company and Janssen Pharmaceutica NV have entered into an exclusive distribution agreement for Invokana® and Vokanamet® in the UK. An agreement has been reached that, from 16th September 2017, the co-promotion agreement between Napp and Janssen, entered into in May 2016, will terminate and Napp will become the exclusive distributor of Invokana® and Vokanamet® in the UK.
Invokana® is a once-daily oral treatment for adult patients with Type 2 diabetes, to reduce blood glucose when diet and exercise alone do not provide adequate blood glucose control, or when the use of metformin (another Type 2 diabetes treatment) is contraindicated or not suitable.1,2
Vokanamet® is a fixed-dose combination of canagliflozin and metformin, another broadly used medicine in Type 2 Diabetes.3
This new agreement reiterates Napp’s commitment to delivering medicines that meet genuine patient need and the GP and hospital specialists who treat them. “Our business is founded on partnership with the NHS, and in helping doctors address the needs of patients with long-term chronic conditions,” said Hywel Day, Managing Director of Napp. “We understand the challenges faced in tackling Type 2 diabetes and after a successful year of co-promoting Invokana®, we look forward to fully utilising our experience to the benefit of the NHS and patients.”
Type 2 diabetes is one of the most common long-term health conditions in the UK4, with the NHS spending more than £1.5m an hour on treating the disease.5 “Our structure and approach here at Napp allows us to focus on delivering the best local support and bring innovative medicines, such as Invokana®, to help our NHS partners continue to deliver sustainable care” said Paul Schofield, Napp Medical Director.
Notes to editors:
About Invokana® (canagliflozin)
Invokana® is a member of a class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors.1
SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney.1 As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream.1,6 An important transport carrier in the kidneys for this reabsorption is called sodium glucose co-transporter 2 (SGLT2).1 Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes.6,7 This mechanism of action is independent of insulin.7
In November 2013, the European Commission approved Invokana® in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic (i.e blood sugar) control.2,6
Canagliflozin has been studied as monotherapy and in combination with other type 2 diabetes therapies including insulin.2 It is recommended to start canagliflozin at 100mg once daily and if tolerated this can be increased to 300mg for tighter blood glucose control in patients with adequate kidney function (eGFR > 60ml/min/1.73m2).2 The Phase 3 programme evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies.6,8 Three studies have compared canagliflozin to current standard treatments; two of which compared canagliflozin to sitagliptin (Januvia®) which showed non-inferior efficacy measured by HbA1c reduction (a marker of blood glucose control) at the 100mg dose, and a superior HbA1c reduction at the 300mg once daily dose, together with a similar tolerability profile.2,9,10 The third study compared canagliflozin to glimepiride (Amaryl®) as dual therapy with metformin which showed a lower risk of hypoglycaemia.11 The Phase 3 programme also included two large studies in special populations: patients over age 55 with type 2 diabetes and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.12,13
Common adverse drug reactions associated with the use of Invokana® include urinary tract infections (UTIs), hypoglycaemia, nausea, constipation, thirst, polyuria or pollakiuria, vulvovaginal candidiasis, balanitis or balanoposthitis, dyslipidemia and increased haematocrit.2
Vokanamet® is a twice daily oral medication which contains a combination of canagliflozin and metformin.3,14 Both medications work together in different ways to lower blood glucose levels in adults with type 2 diabetes, as an adjunct to diet and exercise.3,14 Vokanamet® can be used in patients who are not adequately controlled by metformin alone, in patients whose doses of metformin and other glucose-lowering medications do not provide adequate glycaemic control and finally for patients already being treated with the combination of separate tablets of canagliflozin and metformin.3,14
About Type 2 Diabetes
Type 2 diabetes is a chronic condition that results in the body being unable to metabolise sugar (glucose).4 A number of factors can increase the risk of developing type 2 diabetes, including obesity.4,15 Obesity, specifically excess abdominal fat can make the body less sensitive to insulin, causing a resistance by disrupting the function of insulin responsive cells and therefore the cells ability to respond to insulin, causing higher blood sugar levels (hyperglycemia).4,15 If left uncontrolled, type 2 diabetes can lead to long-term complications such as heart attack, stroke, kidney damage (nephropathy), eye disease (retinopathy) and peripheral nerve damage (neuropathy).4
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a UK company based in the heart of the Cambridge science community, and part of a worldwide network of independent associated companies across 48 countries. Napp has grown up with the NHS, providing innovative medicines to patients in the UK since the 1920s. Napp is committed to improving patient outcomes and ensuring the sustainability of healthcare. At Napp, we are proud of our heritage, which began in the treatment of chronic pain and has expanded into respiratory medicine, diabetes, oncology and inflammatory disorders.
For more information, please visit http://napp.co.uk/.
1 Diabetes.co.uk. Invokana (Canagliflozin). Available at: http://www.diabetes.co.uk/diabetes-medication/invokana-canagliflozin.html. [Last Accessed: August 2017]
2 Summary of Product Characteristics. Invokana 100 mg and 300 mg film-coated tablets. Available at: https://www.medicines.org.uk/emc/medicine/28400. [Last Accessed: August 2017]
3 Summary of Product Characteristics. Vokanamet 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg and 150 mg/1000 mg film coated tablets. Available at: https://www.medicines.org.uk/emc/medicine/29368 [Last Accessed: August 207]
4 Diabetes.co.uk. Type 2 Diabetes. Available at: http://www.diabetes.co.uk/type2-diabetes.html [Last Accessed: August 2017]
5 Diabetes.co.uk. Cost of Diabetes. Available at: www.diabetes.co.uk/cost-of-diabetes.html [Last Accessed: August 2017]
6 European Medicines Agency. EPAR Summary for the Public: Invokana canagliflozin. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002649/WC500156455.pdf. [Last Accessed: August 2017]
7 Bays H. Sodium Glucose Co-transporter Type 2 (SGLT2) Inhibitors: Targeting the Kidney to Improve Glycemic Control in Diabetes Mellitus. Diabetes Therapy. 2013; 4(2): 195–220.
8 Stenlof K et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372-82
9 Schernthaner G et al. Canagliflozin Compared With Sitagliptin for Patients With Type 2 Diabetes Who Do Not Have Adequate Glycemic Control With Metformin Plus Sulfonyluea. Diabetes Car. 2013; 36(9): 2508-2515
10 Lavelle- Gonzalez F J et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013; 56(12): 2582–2592
11 Cefalu W T et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. 2013; 382 (9896):941-950
12 Bode B et al. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013. 41(2):72-84
13 Neal B et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. NEJM. 2017; 377:644-57
14 EMA. Summary Of Product Characteristics – Vokanamet. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/SGLT2_inhibitors__20/European_Commission_final_decision/WC500206514.pdf [Last Accessed: August 2017]
15 Diabetes.co.uk. Diabetes and Obesity. Available at: http://www.diabetes.co.uk/type2-diabetes.html [Last Accessed: August 2017]