Mundipharma announces exclusive license and supply agreement with Prestige Biopharma for Tuznue (HD201)
The Mundipharma network has acquired the right to launch Tuznue?, a trastuzumab
biosimilar treatment, from Prestige BioPharma, in selected European markets
? This long-term partnership reinforces Mundipharma?s leadership in the biosimilars
marketplace
? With agreements in place with three companies to deliver biosimilars, Mundipharma is
fast becoming the partner of choice in Europe for companies seeking local commercial
expertise
Cambridge, UK, 2 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.1The 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
FOR EUROPEAN BUSINESS/TRADE MEDIA ONLY
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
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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
FOR EUROPEAN BUSINESS/TRADE MEDIA ONLY
Alison Dyson
alison.dyson@mundipharma.com
T: +44 (0)1223 397 346
References
1. European Medicines Agency. Available online at:
https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin Last accessed June 2019
2. European Medicines Agency MAA. https://www.ema.europa.eu/en/medicines/medicines-underevaluation#2019-section
3. Pivot X, et al. Clin Ther. 2018; 40(3):396-405.e4.