Mabion: Consultation On FDA Certification

Mabion SA – biopharmaceutical, Polish company dedicated to development of therapeutic proteins, mostly monoclonal antibodies – has completed series of consultations with representatives of the American company Regulatory Compiliance Associates (RCA). The purpose of the meeting was to discuss the compatibility of the project Scientific Industrial Complex Medical Biotechnology in Konstantynów Lódz, as well as the manufacturing process of the drug-MabionCD20 in new complexes with the requirements of the US Agency for Food and Drug Administration (FDA). Conversations proceed as intended and ended up successful.

Regulatory Compiliance Associates (RCA) is a company providing complete solutions involving regulations and requirements of FDA. Among of High qualified employees of RCA are people whose career was strictly related with FDA. A special intentional letter signed by Mabion and RCA’s representatives concerns the search of potential risks and providing solutions to minimize them. This will enable to launched the production as it has been planned.

The key goal of our company is to introduce MabionCD20 in as many global markets as possible. An important part of this process is obtaining the certificate of RCA onto our new Scientific-Industrial Biotechnological Complex in Konstantynów Lódzki. It will enable us to enter the US pharmaceutical market. Futhermore, all of our clinical trials are designed and implemented according to requirements of the European Medicines Agency and Good Clinical Practice. Selected inclusion criterias seem to be significant to recruitment rate and safety of patients participating in the study” – said Maciej Wieczorek, CEO of Mabion SA.

In November 2012 Mabion has successfully accomplished the parallel procedure of the Scientific Advice in the European Medicines Agency (EMA) and American Food and Drug Administration (FDA) relating to qualitative and clinical development of MabionCD20. This procedure allows to starti preparation of regulatory and marketing plans for the U.S market. Consultations attended by representatives of the FDA are the key step towards the registration of MabionCD20 in USA.

Mabion intends to register MabionCD20 on all global markets where reference drugs are sold. Geographically, it can be divided into three major regions: the United States, European Union countries and other countries of the world, where the registration is less strictly regulated. The company plans to make registration process of MabionCD20 across the European Union on its own On 29th August Mabion presented Data and Safety Monitoring Board Commission (DSMB) - an independent committee composed of specialists in the field of rheumatology, pharmacology and biostatistics - the clinical data obtained from approximately 62% of the total number of patients required to complete the study. The Commission - likewise on the previous two meetings , in February and in August - very positively assessed the research process. According to issued opinion procedures of clinical testing does not require any modification. The resulting opinion DSMB allows for the continuation of research in accordance with the company's planned protocol.

With regard to regions with a less strictly regulated system of registration - such as Africa or Asia - both the implementation of the sales and the entire registration procedure will be conducted by local leading pharmaceutical companies. The process of production will be carried out in Mabion’s Scientific-Industrial Biotechnological Complex in Poland, and the company will have share in the revenues from the sale of drugs by foreign distributors. By now Mabion signed:

• An agreement with a pharmaceutical company LYFIS reffering the territory of Iceland

• An agreement with the Ukrainian pharmaceutical company Farmak regarding to the region of Ukraine, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan

• An agreement with the Turkish pharmaceutical company ONKO in relation to the territory of Turkey

• An agreement with the Moroccan pharmaceutical company Sothema Laboratories concerning North Africa (Morocco, Algeria and Tunisia)

• An agreement with the Argentine pharmaceutical company LKM SA in relation to South America (Argentina, Colombia, Venezuela, Peru, Chile, Paraguay, Ecuador, Bolivia and Uruguay)

• A letter of intent with a pharmaceutical company from Lebanon reffering to the Middle East

• A letter of intent with a pharmaceutical company from Croatia in relation to the Balkan countries

MABION SA is a leading biotechnological Polish company focused on development and implementation of new generation biosimilar drugs based on humanized monoclonal antibodies and therapeutic proteins. Over the past few years Mabion has gained the ability to produce free-form biotechnology drugs starting from the design step, through the selection of a manufacturing platform and technology, to obtaining the final product. The process of humanization of monoclonal antibodies, which is the topmost achievement in the present biotechnology, enables production of targeted drugs that act specifically resulting in better effectiveness and lower toxicity of the therapy. The key goals of Mabion are to provide a wide range of biotechnological drugs (MabionCD20, MabionHER2, MabionVEGF and MabionEGFR), its registration and introduction to the market just as the basic license protection for reference drugs expires (in EU it will happen between 2014 and 2018). The first mAb MabionCD20 is used to treat blood cancer – lymphomas and leukemias as well as rheumatoid arthritis. second mAb MabionHER2 that is used for breast cancer is under process and analytical tools development. Clinical development of two next antibodies – anti VEGF and anti EGFR – is planned in 2012 – 2013.

Mabion SA is the only company located in CEE which developed its own technology platform of recombinant scaled therapeutics production in CEE and has successfully performed the first ever industrial scale (2500 l) recombinant CHO cells cultivation process using 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 U.S. Food and Drugs Administration (FDA). The total value of the worldwide market covered with drugs developed by Mabion is USD 20 billion. The company built experienced team consisting of professors, PhDs, MScs of biotechnology, molecular biology and chemistry who are ready to face every challenge regarding projecting and manufacturing biotechnological drugs, recombinant CHO cells and analog insulin.

The company intends to register MabionCD20 on all global markets where reference drugs are sold. Those can be divided geographically into several regions: EU, USA, other highly regulated countries: Japan, Canada, Australia, New Zeland and countries with less advanced regulations regarding biosimilars. Since April 2013 Mabion is listed on the Warsaw Stock Exchange and obtained PLN 61,8 million (approx. EUR 14,64 million) from the Initial Public Offering (IPO) and private issues emissions. The company also obtained nearly PLN 64 million (approx. EUR 15,17 million) from the European Union’s financial support program for innovative projects.

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