Mabion submits registration dossier in Argentina

Mabion SA – the Polish biopharmaceutical Company that develops new generation of biosimilar drugs – is one step closer to releasing its MabionCD20 drug in Argentina. Together with the intermediary company LKM SA, a petition was submitted in Argentina for approval to start the registration procedure of MabionCD20, a drug used in the treatment of blood cancers and rheumatoid arthritis (RA). All the required research and legal documentation was submitted to the Argentine Ministry of Health - the central body responsible for registration of drug products as well as for marketing authorisation. LKM SA is a partner of Mabion for registration and future sales of MabionCD20 in the following markets: Argentina, Venezuela, Peru, Chile, Uruguay, Ecuador, Colombia, Bolivia and Paraguay.

The documentation submitted by LKM SA includes a characteristics comparison of MabionCD20 with the reference drug MabThera; technological, analytical and qualitative documentation; the results of laboratory tests; and the effects of tests conducted on animals. The documentation does not include the clinical module (the results of clinical trials) and consequently can not currently provide the basis for the registration of the MabionCD20 drug. The data currently available is only sufficient to initiate the registration procedure. The documentation will be regularly updated with additional data as they are obtained by the company.

“Work on the MabionCD20 drug is already at a very advanced stage – we are concluding phase III of clinical trials. Argentina is the latest country in which our drug’s registration procedure is underway. We are successively executing our plan to register and release the drug on markets with less stringent registration regulations. The submission of a preliminary version of the registration dossier will allow the Argentine Ministry of Health to familiarise itself with the drug during clinical trials, evaluation will then only require conclusion of the clinical module. The documentation submitted does not provide a basis for registration of the drug but, in our opinion, will accelerate the procedure by up to several months” – said Maciej Wieczorek, CEO of Mabion SA.

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’s Scientific-Industrial Biotechnological Complex in Poland, and the company will have shares in revenue from the sale of drugs by foreign distributors. So far, Mabion 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

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 higher efficacy and lower toxicity of therapies. The key goal of Mabion 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’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 reference drugs are sold. These can be divided geographically into several regions: EU; 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 issues emissions. 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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