Mabion Files Application To The Main Pharmaceutical Inspectorate

Application for authorization to manufacture investigational medicinal products in Konstantynów Lódzki

Mabion SA – the Polish biopharmaceutical company that develops and brings to market latest generation biosimilar drugs – submitted an application to the Main Pharmaceutical Inspectorate for authorization to produce investigational medicinal products in the Scientific-Industrial Complex of Medical Biotechnology. Following the completion of building works in Konstantynów Lódzki, the plant was granted permission for use in May 2015. MabionCD20 will be the first medicine produced commercially at the investment. Mabion has started pre-registration scientific advice for the MabionCD20 drug – for use in the treatment of blood cancers and rheumatoid arthritis (RA) – with the European Medicines Agency, this is a preliminary stage prior to the formal application for the registration of the drug.

The biotechnology facility in Konstantynów Lódzki is a modern investment occupying 6,500m2 in the Lódz 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 but a few in the world. It is the only plant designed for the production of biopharmaceuticals fully based on ‘disposable’ technology (eliminating contact between the product and the manufacturing equipment and environment) in 100% of the manufacturing chain. It is the largest facility utilizing this technology in the world. Furthermore, the factory is equipped with the world's only robotic production line for sterile filling that does not come into contact with the product.

“In order to receive permission for the production of biosimilars, Mabion filed an application to the Main Pharmaceutical Inspectorate for authorization to manufacture investigational medicinal products. The permit from the Main Pharmaceutical Inspectorate will allow – following registration on the market – the commencement of the commercial production of the MabionCD20 drug, used in the treatment of blood cancers and rheumatoid arthritis (RA). While awaiting the decision of the Main Pharmaceutical Inspectorate regarding the Complex in Konstantynów Lódzki, we began pre-registration scientific advice with the European Medicines Agency for MabionCD20 – this is a preliminary stage preceding a formal application for the registration of a drug in the European Union. To expedite bringing the MabionCD20 drug to market, the company is perfecting the manufacturing processes for pharmaceuticals and is constantly expanding its activities. Mabion’s innovative large-scale plant is one of the few places in Europe where a new biotechnology drug could be produced throughout all stages of the process – from the design of a protein material, through the development of manufacturing technology and analytical methods for characterizing the product, to the production of the final drug”, said Maciej Wieczorek, CEO of Mabion SA.

Mabion also has a Research & Development Centre – a small-scale production plant of approximately 650m2. It comprises a plant for the production of sterile forms of biotechnology drugs – recombinant proteins – in GMP (Good Manufacturing Practice) and laboratories: molecular biology and genetic engineering, analytical, biochemical and cell cultures. At the Mabion SA Research & Development Centre, production of up to 500 litres of cultivation is possible, a scale sufficient for the industrial production of certain biopharmaceuticals. Many biotech drugs, especially those used in oncology, require larger scale of production with volumes of several thousand litres.

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 at 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 following North African countries: Morocco, Algeria and Tunisia.
• An agreement with the Argentine pharmaceutical company LKM SA for the following 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 Brasil.

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 developed the capacity 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 between 2014–2018). 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.

www.mabion.eu

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