Mundipharma presents wealth of data for Penthrox®▼(methoxyflurane) at EUSEM Congress, demonstrating superiority compared to standard of care in trauma pain in adults

Swissmedic reviewing licence extension for the SGLT2 inhibitor Invokana® (canagliflozin) in fast-track procedure

Cidara Therapeutics and Mundipharma Form Strategic Partnership to Develop and Commercialize Rezafungin

Mundipharma Welcomes the New Guidelines from ESC/EASD Recommending First-Line use of Sodium-Glucose Co-transporter-2 Inhibitors for Type 2 Diabetes Patients with Cardiovascular Disease

Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency

Mundipharma announces exclusive license and supply agreement with Prestige Biopharma for Tuznue® (HD201)

Cambridge, UK, 2nd July 2019 – Mundipharma has entered into an exclusive license and supply agreement with Prestige Biopharma for Tuznue, a trastuzumab biosimilar treatment. The agreement will enable the Mundipharma network to distribute, market and sell Tuznue in selected European countries following marketing authorisation, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.

Tuznue is a trastuzumab biosimilar treatment to Roche’s Herceptin® which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.1 The European Medicines Agency (EMA) recently accepted a Marketing Authorisation Application for Tuznue.2 This application was based on positive top-line results from global clinical trials of Tuznue, which confirmed that it is biosimilar to Herceptin in terms of clinical response and pharmacokinetics, in addition to having a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.3

Alberto Martinez, CEO, Mundipharma Europe, commented, “Across Europe, we now partner with three different companies to deliver market leading biosimilar medicines to patients, in addition to our own in-house development, regulatory, IP and commercialisation capabilities.

Today’s announcement cements our position as the biosimilar partner of choice for companies looking to bring their biosimilar medicines to the European market.

By partnering with Prestige, we can continue to move medicine forward. Using our collective expertise, Prestige in development, and us in commercialisation we can continue to reduce the financial burden for even more healthcare systems, while widening access to this important treatment for cancer patients.”

Prestige Biopharma CEO, Dr Lisa S. Park commented, “We are very pleased to partner with Mundipharma to commercialise our lead biosimilar in the selected European markets. This partnership is an important milestone for Prestige BioPharma, which will further increase the global availability of our Trastuzumab biosimilar so that more patients can benefit from its quality and accessibility. We envisage the partnership with Mundipharma to grow strong to encompass more programs in the future”

Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics and has several additional biosimilars currently in development.

Notes to editors:

About Tuznue®

Tuznue, trastuzumab biosimilar treatment to Roche’s Herceptin®, is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2). In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably.  A biosimilar is defined by the EMA as a biological medicine highly similar to another already approved biological medicine (the reference medicine).  Approved biosimilars have been through rigorous testing to show that they have no clinically meaningful differences from their reference medicines. They are also manufactured to the same meticulous standards to ensure consistent quality, often at a significantly reduced price to healthcare systems.

About HER2-overexpressing breast cancer and gastric cancer

The introduction of Herceptin (trastuzumab) revolutionised the treatment of breast cancer. Prior to its introduction there were few treatment options available to women with HER2-overexpressing breast cancer.  HER2-overexpressing means that a protein called HER2 is produced in large quantities, making the cancer cells grow quickly. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.1

About the Mundipharma network

Mundipharma is a network of privately-owned independent associated companies whose purpose is to move medicine forward.

With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

About Prestige BioPharma

Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 Trastuzumab biosimilar, is under Phase 3 clinical development and has been filed with EMA while USFDA filing is in progress. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase 3, an Adalimumab biosimilar (PBP1502) and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer ready for clinical development. Manufacturing facilities for global commercial supply are located in Osong, South Korea. For more information, please visit www.prestigebiopharma.com or contact:

Global Communication Team
Ms. Felicia Ang
Tel: +65 6924-6535
Email: info@pbpsg.com

For more information please visit: www.mundipharma.com

For further information please contact:                                        

Helen Rae
helenrae@makarahealth.com
T: +44 (0) 23 81 247 327

Alison Dyson
alison.dyson@mundipharma.com
T: +44 (0)1223 397 346

 

References

1European Medicines Agency. Available online at: https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin Last accessed June 2019

2European Medicines Agency MAA. https://www.ema.europa.eu/en/medicines/medicines-under-evaluation#2019-section

3Pivot X, et al. Clin Ther. 2018; 40(3):396-405.e4.

Invokana® (canagliflozin) Significantly Reduced Major Cardiovascular Events and Kidney Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in New CREDENCE Analysis

CAMBRIDGE, UK: 11.06.19 – Mundipharma welcomes the results of a new subgroup analysis from the landmark Phase III CREDENCE study which shows Invokana® (canagliflozin) significantly reduced the risk of major cardiovascular (CV) events and kidney failure in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) in patients with and without known cardiovascular (CV) disease.1 These results were presented today at the American Diabetes Association’s 79th Scientific Sessions in San Francisco, USA.

“Cardiovascular disease and kidney disease are two serious complications of type 2 diabetes that may shorten life expectancy by several years. This latest analysis of the CREDENCE study demonstrates that for patients with type 2 diabetes and chronic kidney disease, canagliflozin reduced the risk of a cardiovascular event, whether or not patients had already experienced one. Thus, early treatment may help to prevent clinical manifestations of cardiovascular disease – an important message for healthcare professionals managing these patients.” said David Wheeler, Professor of Kidney Medicine at University College London, UK and Honorary Consultant Nephrologist at the Royal Free London NHS Foundation Trust.

The Phase III CREDENCE study evaluated CV and renal outcomes in patients with T2DM and CKD taking either canagliflozin or placebo, in addition to standard of care. The primary results were recently added to the American Diabetes Association’s Standards of Medical Care in Diabetes and published in The New England Journal of Medicine in April this year.

In the new subgroup analysis of the clinical trial results, researchers specifically examined CV and renal outcomes in a primary prevention group, which included participants with CV risk factors but no history of CV disease (n=2,181; 49.6%) and a secondary prevention group, including patients defined as having a history of coronary, cerebrovascular or peripheral vascular disease (n=2,220; 50.4%).1

Building on the initial CREDENCE results presented at the World Congress of Nephrology in Melbourne in April 2019, this subgroup analysis showed that the CV results observed in the overall study population were consistent across the primary and secondary prevention groups, including all clinical subgroups and across groups defined by renal function. For CV death, heart attack and stroke, there was no evidence of heterogeneity between the primary and secondary prevention groups (p=0.25). Specifically, canagliflozin reduced the risk of the composite of CV death, heart attack and stroke by 32% in the primary prevention group (HR: 0.68; 95% CI: 0.49 to 0.94) and 15% in the secondary prevention group (HR: 0.85; 95% CI: 0.69 to 1.06).1

Furthermore, the renal results observed in the overall study population were consistent across the primary and secondary prevention groups. Specifically, canagliflozin reduced the risk of ESKD by 31% (HR: 0.69; 95% CI: 0.51 to 0.95; P-interaction: 0.89) and 33% (HR: 0.67; 95% CI: 0.47 to 0.96; P-interaction: 0.89) in the primary and secondary prevention groups, respectively.1

The full results showed that the CREDENCE study met its primary endpoint by demonstrating that canagliflozin reduced the risk of composite doubling of serum creatinine, end-stage kidney disease (ESKD) and renal or CV death by 30% [HR: 0.70; 95% CI: 0.59 to 0.82; p=0.00001].6 Furthermore, the CV results from CREDENCE found canagliflozin significantly reduced major CV events in the overall study population, including reducing the risk of CV death, heart attack or stroke by 20% (HR: 0.80; 95% CI: 0.67 to 0.95; p=0.01) and risk of CV death or hospitalization for heart failure by 31% (HR: 0.69; 95% CI: 0.57 to 0.83; p<0.001) and hospitalization for heart failure alone by 39% (HR: 0.61; 95% CI: 0.47 to 0.80; p<0.001).6

In addition, CREDENCE found the incidence rates of adverse events and serious adverse events were numerically lower for patients treated with canagliflozin as compared to placebo.6 For the subgroup analysis, safety outcomes were similar in both primary and secondary prevention groups. Of note, there was no difference in fracture risk or incidence of amputations in the primary and secondary prevention groups.1

“We are delighted the results from this subgroup analysis show canagliflozin can offer clinicians and their T2DM patients with chronic kidney disease protection from both CV and kidney disease, which are both high risk for this patient population” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead. “As the first type 2 diabetes medicine to show this benefit to patients with or without known CV disease, there is a potential to positively improve the outcomes for patients living with type 2 diabetes.”

In Europe, canagliflozin is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise. The initiation dose is 100mg once daily in adults with an eGFR of ≥ 60 mL/min/1.73 m2 and can be increased to 300mg once daily orally if tighter glycaemic control is needed. Canagliflozin should not be initiated if eGFR is < 60 mL/min/1.73 m2.  In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m2 the dose should be adjusted to or maintained at 100mg once daily. Canagliflozin should be stopped if eGFR falls persistently below 45 mL/min/1.73 m27

Currently, 58 million people in Europe currently live with T2DM, which is set to rise to 67 million by 2045.3 Approximately 40% of these patients will develop diabetic kidney disease (DKD),2 which is associated with a high risk of CV disease (heart attack, heart failure and stroke) and also amplifies the risk of other diabetes complications including; a reduced quality of life, infections, fatigue, depression, adverse drug reactions and premature death.4,5

-END-

 Notes to the editors:

About the CREDENCE Clinical Trial6

The CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study was the first dedicated and full recruited renal outcome trial evaluating renal and cardiovascular outcomes in people with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) with a sodium glucose co-transporter 2 (SGLT2) inhibitor. It was a Phase III randomised, double-blind, event-driven, placebo-controlled, parallel-group, 2 arm multi-centre study of the effects of canagliflozin on renal and cardiovascular outcomes in subjects with T2DM and CKD.  In particular, it compared the efficacy and safety of canagliflozin versus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with T2DM and CKD when used in addition to standard of care, including a maximum tolerated daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

About Canagliflozin7

Canagliflozin is an oral, once-daily medication which belongs to a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by inhibiting SGLT2, which promotes the loss of glucose via the urine, lowering blood glucose levels in adults with T2DM. Canagliflozin was approved in the European Union by the European Commission in November 2013. It is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes. Approval was based on a comprehensive global Phase III clinical trial programme.

About the Mundipharma network

Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward.  With a high performing and learning organization that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

For further information please contact:

 Patrice Grand

European Director of Corporate Communications, Mundipharma Ltd

Email: Patrice.Grand@Mundipharma.com

Abbie Bell

Senior Account Manager, Havas SO

E-mail: Mundipharma@HavasSO.com

Tel: +44 (0) 20 3196 9919

References

1 American Diabetes Association’s 79th Scientific Sessions. Sponsored symposium ‘CREDENCE and CARMELINA—Results from Two Major Clinical Trials in Kidney and Cardiovascular Disease in Diabetes’. Presented at 7:30 a.m. – 9:30 a.m. (PT) on 11th June, 2019

2 Alicic R., et al. Diabetic Kidney Disease: Challenges, Progress, and Possibilities. Clin J Am Soc Nephrol. 2017; 12(12):2032-2045

3 IDF Diabetes Atlas Eighth Edition 2017. Available at: http://diabetesatlas.org/resources/2017-atlas.html. Last accessed June 2019.

4 CDC. National Chronic Kidney Disease Fact Sheet, 2017. Available at: https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf Last accessed June 2019

5 Thomas M., Cooper M., and Zimmer P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nature Review Nephrology. 2016; (12): 73-81

6 Perkovic, V. et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. The New England Journal of Medicine. 2019; DOI: 10.1056/NEJMoa1811744

7 Canagliflozin SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/invokana-epar-product-information_en.pdf Last accessed June 2019

Invokana® (canagliflozin) Significantly Reduces the Risk of Renal Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in the Landmark Phase 3 CREDENCE Study

CAMBRIDGE, UK: 15.04.19 – The Mundipharma network of independent associated companies welcomes the CREDENCE study data which successfully demonstrated that Invokana® (canagliflozin) reduces the risk of renal and cardiovascular (CV) events and has an acceptable safety profile consistent with previous studies when added to standard of care in subjects with type 2 diabetes mellitus (T2DM).1 The study met its primary endpoint showing that canagliflozin reduced the risk of composite doubling of serum creatinine, end-stage kidney disease (ESKD) and renal or CV death by 30% [HR: 0.70; 95% CI: 0.59 to 0.82; p=0.00001].1 These findings were consistent across the individual components of the primary composite endpoint, as well as across all 15 subgroups tested.1

In addition, canagliflozin reduced the risk of the secondary renal endpoint composite of doubling of serum creatinine, ESKD, and renal death by 34% [HR:0.66; 95% CI: 0.53 to 0.81; p<0.001].1
The study also showed that canagliflozin reduced the risk of major adverse cardiac events (MACE) (composite of non-fatal myocardial infarction, non-fatal stroke and CV death) by 20% [HR: 0.80; 95% CI: 0.67 to 0.95; p=0.01], the risk of CV death and hospitalization for heart failure by 31% [HR: 0.69; 95% CI: 0.57 to 0.83; p<0.001], and the risk of hospitalization for heart failure alone by 39% [HR: 0.61; 95% CI:

0.47 to 0.80; p<0.001].1 In regard to safety data, the incidence rates of adverse events and serious adverse events were numerically lower for patients treated with canagliflozin as compared to placebo. There were no observed differences in the incidence of lower limb amputations (HR: 1.11; 95% CI: 0.79 to 1.56) or adjudicated fractures (HR: 0.98; 95% CI: 0.70 to 1.37). 1

As the first dedicated clinical trial to investigate a SGLT2 inhibitor for renal protection in patients with T2DM with CKD, the data from CREDENCE1 provides the first significant update in nearly 20 years regarding slowing the progression of CKD for this group of patients. The trial, which was stopped early in July 2018 due to a signal of overwhelming efficacy in the prevention of the primary endpoint, was conducted in more than 4,400 adults with T2DM at 690 sites in 34 countries across North America, Latin America, Europe, South Africa and Asia Pacific.1

In Europe, canagliflozin is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. The initiation dose is 100mg once daily in adults with an eGFR of ≥ 60 mL/min/1.73m2 and can be increased to 300mg once daily orally if tighter glycaemic control is needed. Canagliflozin should not be initiated if eGFR is < 60 mL/min/1.73 m2. In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m2 the dose should be adjusted to or maintained at 100mg once daily. Canagliflozin should be stopped if eGFR falls persistently below 45 mL/min/1.73 m2.4

“Canagliflozin is the first medical breakthrough in nearly 20 years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure” said Professor Vlado Perkovic, Study Author and Executive Director of The George Institute, Australia, Professor of Medicine at UNSW Sydney. “These impressive results from the CREDENCE study have significant clinical implications for preventing kidney failure and improving health for millions of people living with chronic kidney disease and type 2 diabetes.”

Approximately 58 million people in Europe currently live with T2DM, which is set to rise to 67 million by 2045.2 If left untreated, patients are at greater risk of
developing serious complications, such as CV disease and diabetic kidney disease (DKD).3 DKD is the leading cause for progression to ESKD, accounting for 50% of cases in the developed world.5 It is associated with a high risk of CV disease (heart attack, heart failure and stroke) and also amplifies the risk of other diabetes complications including; a reduced quality of life, infections, fatigue, depression, adverse drug reactions and premature death.6,7

“With nearly 24 million type 2 diabetes patients in Europe likely to develop diabetic kidney disease, we are delighted with the results from the CREDENCE study which demonstrated superiority of canagliflozin, when added to the standard of care,” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead. “Type 2 diabetes is a growing epidemic in Europe and effective treatments are needed to help reduce the burden of the disease in patients. In particular, treatments are called for to improve renal outcomes which is of real importance in this disease.”

-END-

Notes to the editors:

About the CREDENCE Clinical Trial1
The CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study was the first dedicated and full recruited renal outcome trial evaluating renal and cardiovascular outcomes in people with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) with a sodium glucose co-transporter 2 (SGLT2) inhibitor. It was a phase 3 randomised, double-blind, event-driven, placebo-controlled, parallel-group, 2 arm multi-centre study of the effects of canagliflozin on renal and cardiovascular outcomes in subjects with T2DM and CKD. In particular, it compared the efficacy and safety of canagliflozin versus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with T2DM and CKD when used in addition to standard of care, including a maximum tolerated daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

About Canagliflozin
Canagliflozin is an oral, once-daily medication which belongs to a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by inhibiting SGLT2, which promotes the loss of glucose via the urine, lowering blood glucose levels in adults with T2DM. Canagliflozin was approved in the European Union by the European Commission in November 2013. It is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes. Approval was based on a comprehensive global Phase III clinical trial programme.4

About the Mundipharma network
Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward. With a high performing and learning organization that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic

For further information please contact:

Tiffany Fretwell
Communications Lead, Mundipharma International Ltd
Email: Tiffany.Fretwell@Mundipharma.com
Tel: +44 (0) 7773 199 422

Abbie Bell
Senior Account Manager, Havas SO
E-mail: Mundipharma@HavasSO.com
Tel: +44 (0) 737 680 2980

References

1 Perkovic, V. et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 DOI: 10.1056/NEJMoa1811744

3 IDF Diabetes Atlas Eighth Edition 2017. Available at: http://diabetesatlas.org/resources/2017-atlas.html. Last accessed March 2019.

3 Update to International Diabetes Federation, 2016, Complications of Diabetes [Online] Available at: https://www.idf.org/aboutdiabetes/what-is-diabetes/complications.html Last accessed March 2019.

4 Canagliflozin SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/invokana-epar-product-information_en.pdf Last accessed April 2019

5 Tuttle KR., et al. Diabetic kidney disease: a report from an ADA Consensus Conference. Diabetes Care. 2014; 37(10):2864-83.

6 CDC. National Chronic Kidney Disease Fact Sheet, 2017. Available at: https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf Last accessed July 2018

7 Thomas M., Cooper M., and Zimmer P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nature Review Nephrology. 2015; (12): 73-81.

Mountain rescue study launches to investigate use of Penthrox® (methoxyflurane) for trauma-related pain in hostile environments

Cambridge, UK, 27 March 2019

The Mundipharma network of independent associated companies announced today that the first patient has been enrolled into a new study investigating the efficacy of Penthrox® q (methoxyflurane, MEOF) in conscious, stable adult patients with moderate-to-severe trauma-related pain rescued from hostile, mountainous areas.1 The METEORA trial is a Phase IIIb, prospective, single-arm, multicentre trial in 200 adult patients with limb trauma who are rescued by the Helicopter Emergency Medical Service (HEMS) in Italy.1

The trial will assess the reduction in pain intensity (using the visual analogue scale [VAS] 0-100 mm) for patients treated with inhaled MEOF; and whether additional pain-relieving medication is needed.1 The practicality of MEOF use in an emergency rescue situation, patient satisfaction and any adverse events will also be evaluated.1 The primary endpoint is the percentage of patients achieving at least 30% improvement in VAS pain intensity within the first 10 minutes of MEOF administration.1

Lead Investigator, Professor Franco Marinangeli commented: “In emergency rescue situations rapid, effective pain relief is vital. Not only does it reduce the patients’ stress and discomfort, it can also make it easier to assess, treat and transport them. Research shows that under-treatment of trauma pain in the pre-hospital emergency setting remains a significant problem. I am pleased to be leading this study into the use of Penthrox in this new setting.”

Antonella Sblendido, Medical Advisor, Mundipharma added: “Penthrox has been widely used by Ambulance services in Australia since 1975 and is now approved in Europe for the emergency relief of moderate to severe trauma-related pain in conscious adults. Given its portability, ease of use and rapid onset, we felt it was important to investigate its use in hostile environments, where more pain-relief options are needed.”

Giovanni Sbrana, Principal Investigator, Grosseto Helicopter Emergency Medical Service said: ‘‘We are excited to be involved in the study and to have enrolled the first patient. Our Helicopter Service operates in a rural area in Tuscany with a very low-density population where we perform more than 1,000 rescue missions a year. Helicopter is the only way to reach some patients and to give them lifesaving therapies and pain relief. As was the case with our first METEORA patient, we often have to deal with challenging weather conditions which means that we need to stabilise the patient quickly and remove them in order to avoid a helicopter becoming unavailable. Therefore we need a treatment with fast onset and convenient administration, and we look forward to seeing the results as the study progresses.”

To find out more about the study visit: https://link.springer.com/article/10.1007/s12325-018-0816-8

To read the full press release please visit: www.mundipharma.com/media/news/

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get to your local medicines regulatory authority.

PENTHROX® is a registered trade mark of Medical Developments International Limited and is used under licence.

-Ends-

Contact:

Tiffany Fretwell
Communications Lead, Mundipharma
Tiffany.fretwell@mundipharma.com
+44 (0) 1223 393 361

Eleanor Craven
Makara Health
eleanor@makarahealth.com
Tel: +44 (0) 2381 247 327

Reference

1Marinangeli F, et al. Adv Ther 2018;35:2081.

Mundipharma Announces Launch of INVOKANA® and VOKANAMET® in Norway for the Treatment of Type 2 Diabetes as Part of Exclusive Distribution Agreement with Janssen

CAMBRIDGE, UK: 19.03.19 – The Mundipharma network of independent associated companies is pleased to launch the type-2 diabetes mellitus (T2DM) treatments Invokana® (canagliflozin) and Vokanamet® (canagliflozin, metformin) in Norway. In line with the partnership with Janssen Pharmaceutica NV, Mundipharma now exclusively distributes and markets these treatments across 18 countries in the European Economic Area (EEA) and Switzerland. With the launch in Norway, Invokana and Vokanamet are now available across the whole of Scandinavia, following the launches in Sweden and Denmark.

Invokana, a once-daily oral tablet, is part of the sodium glucose co-transporter 2 (SGLT2) inhibitor class and has been approved in the European Union since 2013.2 Vokanamet combines two oral glucose-lowering medicinal products (canagliflozin and metformin) with different and complementary mechanisms of action.

“We are delighted to extend our European footprint for Invokana and Vokanamet to provide healthcare professionals in Norway with two new treatment options to manage type 2 diabetes,” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead. “Type 2 diabetes is a growing epidemic in Europe and effective treatments are needed to help reduce the burden of the disease in patients. Invokana and Vokanamet have shown improvement in glycaemic control and reduction of cardiovascular morbidity and mortality as well as improvements in renal outcomes which is of real importance in this disease.”

Approximately 58 million people in Europe currently live with T2DM, which is set to rise to 67 million by 2045. 1 If left untreated, patients are at greater risk of developing serious complications, such as cardiovascular (CV) disease and kidney failure.4

Last year, the European Medicines Agency (EMA) approved label updates for Invokana and Vokanamet to include data on the reduction in major adverse CV events in patients with T2DM who had either a history of CV disease or at least two CV risk factors.5 The label update was supported by the results from the CANVAS clinical trial, the largest completed CV outcomes trial to date for an SGLT2 inhibitor.6 The American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) also issued a Consensus Report in October 2018 which recommends SGLT2 inhibitors with a proven CV benefit as the preferred oral treatment after metformin for T2DM patients with chronic kidney disease (CKD) or clinical heart failure and atherosclerotic CV disease.7

New data for canagliflozin from the CREDENCE study will be presented at the upcoming World Congress of Nephrology during the late-breaking abstract session on Monday 15th April. The study evaluated the effect of canagliflozin on renal protection in patients with T2DM and CKD.

-END-

Notes to the editors:

About INVOKANA®

Invokana® (canagliflozin) is an oral, once-daily medication which belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by inhibiting SGLT2, which promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes. Canagliflozin was approved in the European Union by the European Commission in November 2013. Invokana® is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes. Approval was based on a comprehensive global Phase III clinical trial programme.2

About VOKANAMET®

Vokanamet® (a fixed-dose combination of canagliflozin and metformin) is approved in the European Union for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Vokanamet® combines two oral glucose-lowering medicinal products with different and complementary mechanisms of action.3

 

About the Mundipharma network

Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward.

With a high performing and learning organization that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

 

For further information please contact:

 Tiffany Fretwell

Communications Lead, Mundipharma International Ltd

Email: tiffany.fretwell@mundipharma.com

Telephone: +44 (0) 1223 397 3361

 

Abbie Bell

Senior Account Manager, Havas SO

E-mail: Abbie.Bell@HavasSO.com

Tel: +44 (0) 20 3196 9919

References

1IDF Diabetes Atlas Eighth Edition 2017. Available at: http://diabetesatlas.org/resources/2017-atlas.html. Last accessed March 2019

2INVOKANA SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002649/WC500156456.pdf  Last accessed February 2019.

3VOKANAMET SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002656/WC500166670.pdf  Last accessed February 2019.

4Update to International Diabetes Federation, 2016, Complications of Diabetes [Online] Available at: https://www.idf.org/aboutdiabetes/what-is-diabetes/complications.html Last accessed February 2019.

5INVOKANA Label. Available at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVOKANA-pi.pdf Last accessed February 2019.

6Neal B et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. The New England Journal of Medicine (2017);377:644-657

7Davies, M,J. et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care (2018) Dec; 41(12):2669-2701

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Pharmaceutical market access in Europe, by Will Dunlop

The pharmaceutical regulatory process in Europe is not a one size fits all. 

Europe’s payers share a quest for value, but differ in their approaches. Local expertise and partnering is critical.

Gaining market access in pharma across Europe has always presented challenges to pharmaceutical firms. The region has a common regulator, the European Medicines Agency, and most of its citizens receive healthcare from government-funded, often country-wide, health systems. Yet behind this top-level homogeneity lies a series of very different national and regional markets. Each of these has its own set of health policies and practices, its own culture and language, and its own tough pricing and reimbursement hurdles.

Efforts are underway to harmonize European health technology assessment methods and requirements. But they can only go so far (read more on this). Health systems reflect national health policy, clinical practices, social priorities and ultimately the wishes of voting citizens of each nation. The upshot is that clinical and economic data that is accepted in one market may not cut it in another. The standard-of-care in Germany for a particular condition may differ from that in France. Economic models that convince UK payers might not impress those in the Netherlands. The financial health of particular countries or regions will also heavily influence their willingness and ability to pay for new medicines.

What European payers all do share, however, is an aggressive quest for value. Often, they apply similar criteria (1). Because most European purchasers are tax-payer funded, that quest is more urgent than in the US market, where a far greater proportion of citizens are covered by commercial (private or employer-sponsored) insurers. Europe houses some of the most globally influential Health Technology Assessment (HTA) agencies – for example, guidance from the UK’s National Institute of Care & Health Excellence (NICE) will reach international audiences with countries also actively adopting NICE methodology.

Biosimilars – Highlight market access challenges across Europe 

Biosimilars nicely illustrate both the similarities and differences among European payers. Biosimilars are lower-priced, close-copies of specialist drugs like Herceptin® or Remicade®.  The financial pressure faced by many European governments was in large part what drove Europe to embrace these medicines in the mid 2000s, almost a decade ahead of the US. The EMA approved its first biosimilar in 2006, and around 40 more since. The US Food and Drug Administration (FDA) has approved 11. (2)

Today, amid growing competition, price discounts on biosimilar drugs in Europe range from approximately 15 to over 50%. (3).With more in the pipeline as patents on originator drugs expire, biosimilars are becoming one of the most important treatment classes for patients and health systems.

Deep local knowledge is crucial when developing market access strategies 

Of course, biosimilar uptake (like that of any other drug class) isn’t homogenous across Europe. These are complex treatments for often serious diseases, and Europe’s national payers, and clinician-prescribers don’t all share the same attitude toward them. Appropriate education, high-quality data, and a deep understanding of local concerns, practices and regulations are key to ensuring that these important medicines are safely integrated into health systems. Equally important is understanding the local purchasing or tendering system. There is substantial variation across Europe in how biosimilars are procured, with almost exclusively national tendering in some countries, and regional or local tendering in others.

Such local knowledge is key to successful market access and uptake of all medicines in Europe, biosimilar or otherwise. Partnering with experts that have their feet on the ground and a finger on the pulse in each market offers international R&D-based organisations an effective way to ensure that European patients can access their medicines.

For all its challenges, Europe is too important for any drug company to ignore. With an ageing population of over 700 million in Europe and five of the world’s top pharmaceuticals markets by value (4), Europe’s healthcare systems need, more than ever, therapies that can demonstrably improve health outcomes.

For more information on how to navigate Europe’s complex healthcare systems, contact: businessdevelopment@mundipharma.com

References:

1. Dunlop, W.C.N., Mullins, C.D., Pirk, O. et al. PharmacoEconomics (2016) 34: 1051. https://doi.org/10.1007/s40273-016-0427-

2.Cohen, J. (2018) What’s Holding Back Market Uptake of Biosimilars? Forbes, June 20, 2018. https://webcache.googleusercontent.com/search?q=cache:u_xncKPArUwJ:https://www.forbes.com/sites/joshuacohen/2018/06/20/whats-holding-back-market-uptake-of-biosimilars/+&cd=20&hl=en&ct=clnk&gl=lu&client=safar

3. Mullard, A. (2017) Bracing for the biosimilar wave. Nature Reviews Drug Discovery, March 2017. http://www.nature.com/articles/nrd.2017.36

4. https://www.worldatlas.com/articles/countries-with-the-biggest-global-pharmaceutical-markets-in-the-world.html