Mabion begins pre-registration scientific advice with the EMA

The first step to the registration of biosimilar drug MabionCD20 with the European Medicines Agency Mabion – the Polish biopharmaceutical company that develops and brings to market latest generation biosimilar drugs – is receiving scientific advice from the European Medicines Agency (EMA) regarding the MabionCD20 drug, used in the treatment of blood cancers and rheumatoid arthritis (RA). This is a preliminary stage prior to the formal application for registration of the drug intended to eliminate obstacles to registration.

The scientific advice includes confirmation of the scope of the biosimilarity study and of the method of statistical analysis from clinical trial data. Within the scope of scientific cooperation is the potential extension of the range of analysed data with regard to the substitutability of MabionCD20 and MabThera; a comparative approach to the drug when produced at the target scale versus its use in a clinical trial is also undertaken. A further benefit will be the opportunity to consult with the EMA regarding the possibility of reducing the number of patients required in the clinical trial if the actual variability of the data and the statistical power are greater than anticipated.

“The scientific advice from the EMA, which is now underway, provides us with an opportunity for a smooth passage through the process of registration for the European Union market of the biosimilar drug MabionCD20. We want to meet all the requirements at the initial stage. The EMA will also be consulted regarding the potential extension of the analysed data range for substitutability of the reference drug MabionCD20 and MabThera, which will be helpful for Mabion in the future. This preliminary stage, before registration of the drug, makes accurate documentation possible, greatly expediting further stages in the drug’s registration. The Agency provides scientific advice and helps with regulatory issues for new medicinal products to encourage innovation and research in the pharmaceutical industry, this closely corresponds to the activity of our company”, said Maciej Wieczorek, CEO of Mabion SA.

In order to quickly bring the MabionCD20 drug to market, the company is perfecting the manufacturing processes for pharmaceuticals and is constantly expanding its activities, incorporating necessary innovations as required. In May 2015, Mabion SA was granted permission for a mass production facility – the Scientific-Industrial Complex of Medical Biotechnology. The first drug to be produced at the newly-built Konstantynów Łódź site will be MabionCD20. Manufacturing the drug for clinical trials at the Complex will facilitate its registration as the place of in the Łódź Special Economic Zone. The total value of the investment, including equipment, is over PLN 70 million. It is the only advanced manufacturing facility for biotechnology drugs of its kind in Poland, and one of just a few in the world. It is the only plant prepared for the production of biopharmaceuticals using 100% ‘disposable’ technology (eliminating contact between the product and the manufacturing environment and equipment) throughout the entire production line. It is also the world's largest facility employing this technology. The Park is equipped with high-specification installations for both building functions and the preparation of culture media, e.g. ultra-high quality ‘clean room’ walls that protect the sterility of operations.

In the first half of May, Mabion participated in a series of meetings with Brazilian authorities as part of its ongoing efforts to register the drug MabionCD20 on the Brazilian market and secure the company’s inclusion in a public-private partnership program (PDP). The Management Board of Mabion and representatives of Biolotus, together with the director of the Instituto Vital Brasil (IVB), met the Governor; the Secretary of State; and the Secretary of State for Health from the state of Rio de Janeiro. Talks were also held with national representatives of the Ministry of Health and the Ministry of Development, Industry and Foreign Trade. The meetings were concerned with releasing the MabionCD20 drug to market in the largest country in South America, within the framework of a public-private partnership. The partnership will be based on the transfer of knowledge and technology in cooperation with local pharmaceutical companies.

Mabion SA intends to register MabionCD20 on all global markets where the reference drugs are sold. These can be divided geographically into 3 main regions: the United States, the European Union countries and the rest of the world, where registration is less strictly regulated. In regard to regions with less restrictive registration systems, such as Africa or Asia, Mabion SA is planning both the implementation of sales and the entire registration procedure in cooperation with leading local pharmaceutical companies. Production will take place in Mabion SA’s Scientific-Industrial Complex of Medical Biotechnology in Poland, and the company will have shares in revenue from the sales of the drugs by foreign distributors. So far, Mabion SA has signed:

• An agreement with the pharmaceutical company LYFIS for Iceland.
• An agreement with the Ukrainian pharmaceutical company Farmak for Ukraine, Armenia, Azerbaijan,
Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan.
• An agreement with the Turkish pharmaceutical company ONKO for Turkey.
• An agreement with the Moroccan pharmaceutical company Sothema Laboratories for the North
African countries Morocco, Algeria and Tunisia.
• An agreement with the Argentine pharmaceutical company LKM SA for the South American countries
Argentina, Colombia, Venezuela, Peru, Chile, Paraguay, Ecuador, Bolivia and Uruguay.
• A letter of intent with a pharmaceutical company from Lebanon in relation to the Middle East.
• A letter of intent with a pharmaceutical company from Croatia in relation to the Balkan countries.
• A letter of intent with the pharmaceutical company Biolotus BioTech in relation to the Brasil.

Company information:
MABION SA is a leading Polish biotechnology company focused on the development and implementation of a new generation of biosimilar drugs based on humanised monoclonal antibodies and therapeutic proteins. Over the past few years, Mabion has gained the ability to produce free-form biotechnology drugs from the design phase, through the selection of a manufacturing platform and technology, to producing finished products. The process of humanisation of monoclonal antibodies, considered at the forefront of present biotechnology, enables production of targeted drugs that act specifically, resulting in the higher efficacy and lower toxicity of therapies. The key goal of Mabion SA is to provide a wide range of registered biotechnological drugs (MabionCD20, MabionHER2, MabionVEGF and MabionEGFR) ready for release to market just as basic license protection for the reference drugs expires (in the EU this will be between 2014 and 2018). The first of these drugs- mAb MabionCD20 is used to treat blood cancer, lymphomas and leukemias as well as rheumatoid arthritis; the second mAb MabionHER2 is designed for the treatment of breast cancer and is in clinical trials. Clinical development of two further antibodies, anti VEGF and anti EGFR, is also planned.

Mabion SA is the only company located in CEE that has developed its own technology platform of recombinant scaled therapeutics production and has successfully performed the first ever industrial scale (2500 l) recombinant CHO cells cultivation process using a bioreactor fully based on disposable technology. It is also one of the most advanced companies with regard to clinical development of top quality biosimilars compliant with standards of the European Medicines Agency (EMA) and the U.S. Food and Drugs Administration (FDA). The total value of the worldwide market of the reference drugs that Mabion SA’s own drugs could replace is USD 20 billion. The company has built an experienced team comprising professors, PhDs, MScs of biotechnology, molecular biology and chemistry who are prepared for every challenge in the development and manufacture of biotechnological drugs, recombinant CHO cells and analog insulin. The company intends to register MabionCD20 on all global markets where the reference drugs are sold. These can be divided geographically into several regions: the EU; the USA; and other highly regulated countries- Japan, Canada, Australia, New Zealand; and countries with less restrictive regulations regarding biosimilars. Since April 2013, Mabion has been listed on the Warsaw Stock Exchange, it raised PLN 61.8 million (approx. EUR 14.64 million) from its Initial Public Offering (IPO) and private placement. The company also received almost PLN 64 million (approx. EUR 15.17 million) from the European Union’s financial support program for innovative projects.

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