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.
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
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
For more information please visit: www.mundipharma.com
T: +44 (0) 23 81 247 327
T: +44 (0)1223 397 346
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.
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.
Communications Lead, Mundipharma
+44 (0) 1223 393 361
Tel: +44 (0) 2381 247 327
1Marinangeli F, et al. Adv Ther 2018;35:2081.
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.
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
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
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.
Communications Lead, Mundipharma International Ltd
Telephone: +44 (0) 1223 397 3361
Senior Account Manager, Havas SO
Tel: +44 (0) 20 3196 9919
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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