May 13 2019
Cambridge, UK, 13th May 2019 – Mundipharma has entered into an exclusive distribution agreement with Egis Pharmaceuticals for Pelmeg, a pegfilgrastim biosimilar treatment. The agreement covers Hungary, Romania, Latvia and Lithuania, where Mundipharma does not have a direct commercial presence.
Pelmeg is a pegfilgrastim biosimilar that is delivered subcutaneously to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).1 Neutropenia refers to an abnormally low number of neutrophils (a type of white blood cell) which can increase the risk of life-threatening infections and is a common side effect of some chemotherapeutic regimes.2 Pelmeg was approved in the European Union in November 2018.1
Egis Pharmaceuticals is one of the leading branded generic companies in the CEE and CIS regions, belonging to Servier Group, with a strong presence in the biosimilars market. Egis launched its first biosimilar monoclonal antibody medicine in 2013 and, since then, has launched three biosimilars for the treatment of autoimmune conditions, oncology and oncohaematology.
Alberto Martinez, CEO, Mundipharma in Europe, commented, “As a European leader in the biosimilar market we’re excited to build this alliance with Egis, who are leaders in the Central and Eastern Europe region. Our long-term partnership demonstrates our determination to move medicine forward and will expand the reach of this much needed treatment and contributing to reducing healthcare costs in the region.
Egis CEO Istvan Hodasz commented, “Egis is looking forward to expanding its three-drug biosimilar monoclonal antibody portfolio with Pelmeg in Central Eastern Europe. We are highly committed to improve patient access to affordable, high-end therapeutic options in CEE and CIS countries. The agreement with Mundipharma further strengthens the stable partnership between our companies.”
Pelmeg is the fourth biosimilar medicine to be commercialised by the Mundipharma network. It was developed by Cinfa Biotech which was acquired by the Mundipharma network in 2018. The acquisition of Cinfa Biotech provides Mundipharma with global reach and expanded development and network capability for biosimilars.
▼ This medicinal product is subject to additional monitoring
Pelmeg is a pegfilgrastim biosimilar.3 Pegfilgrastim is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the incidence of febrile neutropenia. It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy.3
About neutropenia and febrile neutropenia
People taking some chemotherapeutic regimes for cancer treatment are at risk of dangerously low levels of a type of white blood cell called a neutrophil. Neutrophils play an important role in the immune system guarding against infection. Febrile neutropenia is a low level of neutrophils in the blood accompanied by a fever.2
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 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 more information please visit: www.mundipharma.com
T: +44 (0) 23 81 247 327
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1European Medicines Agency. Available online at: https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg Last accessed May 2019
2Patel K & West H. JAMA Oncol. 2017;3(12):1751. doi:10.1001/jamaoncol.2017.111
3EMA website. SmPC Neulasta. Available online at: https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta Last accessed May 2019
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