Drug Development

through consistently excellent

launches of

Remsima® (infliximab), Truxima® (rituximab), and Herzuma® (trastuzumab). The acquisition of Cinfa Biotech’s Pelmeg® (Pegfilgrastim) in 2018 is yet another enhancement to Mundipharma’s port- folio of biosimilars and, to date, we have con- tributed to an estimated one billion Euros saving to the European healthcare systems. Our strategy has been to identify opportunities

to expand into European markets where there is unmet patient need and a demand for cost-effective treatment options. The Central and Eastern Europe (CEE) region has been particularly impor- tant for us recently and in June 2019 we agreed an exclusive outsourcing distribution arrangement with Egis Pharmaceuticals for it to launch our peg- filgrastim biosimilar treatment, Pelmeg®, in Hungary, Romania, Latvia and Lithuania – coun- tries where we do not have a commercial presence. Pelmeg (pegfilgrastim), approved in the

European Union in November 2018 as a biosimilar of Neulasta®, was developed to reduce the dura- tion of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotox- ic chemotherapy for malignancy (with the excep- tion of chronic myeloid leukaemia and myelodys- plastic syndromes). 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. Setting this long-term partnership in place means that more patients will now be able to access this medicine. Another recent partnership in the biosimilars

sphere is with Prestige Biopharma. In contrast to the previous example, our role in this partnership will be to distribute, market and sell the trastuzum- ab biosimilar Tuznue® in selected European coun- tries 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 gas- troesophageal junction adenocarcinoma.

Moving medicine forward Partnerships are nothing new in the field of health- care. Early stage innovation, clinical research, mar- ket access, medical education, advocacy – these have always required a degree of collaboration, with organisations and individuals working together to achieve the optimum outcome for patients. However, recent years have seen a more


structured approach to partnerships with success- ful pharmaceutical companies taking steps to evolve their approach to R&D, licensing and dis- tribution to stay commercially viable. In the case of Mundipharma, this has played to

our strengths as a global network and we have been able to embrace the new healthcare landscape in which we find ourselves thanks to the flexibility of our structure and our drive to uncover new opportunities. We are proud supporters of the Babraham Research Campus accelerator pro- gramme, through a financial grant and coaching, helping to provide opportunities for start-up com- panies in the field of life science. We have also found that being able to offer value from both sides of the equation, with our R&D capabilities to support in development and our commercialisation know-how to expand market access, has made us an attractive partner for many. Even given that, we have had to make our own adjustments in our approach to drug development and there has been considerable restructuring along the way. We have also had to learn which partnerships are the ones worth pursuing, understanding that the right part- nerships are those that fit with our stated purpose as an organisation. Just as some treatments do not make it to market,

not every partnership we have explored has come to fruition, however those that have continue to yield considerable benefits, not only commercially, but also in terms of moving medicine forward. DDW

Dr Brian Sheehan is Senior Vice President, Innovation at Mundipharma. He joined Mundipharma in 2015 as Director of Projects and held a number of R&D roles in Cambridge and in Tokyo from Executive Director of Projects to Executive Director of Innovation and new product development. Brian brings 20 years of experience in the pharmaceutical industry at companies such as Schering Plough and MSD with a track record of new product development and approvals in oncology and infectious diseases. He has success- fully led R&D organisations and teams in Europe and in Asia (Japan and Singapore) and is a big advocate of teamwork, his motto being ‘great things happen when we work collaboratively together!’ Brian started his career in the academic sector, including research positions at the Institute Pasteur in Paris and the Imperial College in London and,

immediately prior to joining

Mundipharma, spent five years on the leadership team of the Cancer Research UK Centre for Drug

Drug Discovery World Winter 2019/20

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