Mabion has permission to study patients with lymphoma in Croatia, Bosnia and Herzegovina, Serbia and Poland

Łódź, November 25th 2014 - Mabion SA – Polish, biopharmaceutical Company dedicated to development of therapeutic proteins, mostly monoclonal antibodies – obtained the consent of appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to perform the clinical trial in patients with Diffuse Large B-cell Lymphoma. The study will be carried out in four clinical centers in each the above mentioned countries in cooperation with Altiora d.o.o. Simultaneously Mabion is close to obtain approval to conduct clinical trial in: Bulgaria, Romania, Moldova, Ukraine, Georgia and Hungary. The study regarding lymphoma will be executed jointly at more than 140 patients. The basic study performed by the company is a multicenter study which takes place in 9 European countries with participations of about 700 patients with heumatoid rthritis – it is the main study required in the registration process of the drug MabionCD20.

In May 2014, Mabion signed the agreement for the implementation of the clinical trial MabionCD20 in patients with diffuse lymphoma in 10 different European countries. Additionally, Mabion has expanded an agreement with Altiora concerning clinical study on MabionCD20 in patients with rheumatoid arthritis. As a result, around 10 new medical sites will be involved in the study in Poland.

„Clinical trial in patients with lymphoma is supporting study with the participation of only 140 patients. Its purpose is to demonstrate clinical biosimilarity between MabionCD20 and MabThera. We have not hurried with the start of this study because it does not require such a long observation, as in the case of RA. Due to extension of the agreement with Altiora – we are optimistic with assumptions regarding the recruitment of patients, and thus the initiation of research within the prescribed schedule” – said Maciej Wieczorek, CEO of Mabion SA.

In May 2014 Mabion SA obtained over 53 million PLN from issue of stock. The capital stock will be used including: adaptation and certification of the new Science and Industrial Complex Medical Biotechnology to the requirements of the FDA (American Food and Drug Administration). Additionally, Mabion signed a letter of intent with Regulatory Compiliance Associates, which provides a comprehensive solution for regulation and compliance with the requirements of the FDA. Among the highly qualified employees of RCA there(?) are people Involved in the past in the activities of the FDA. Signed letter of intent includes among others: identification of potential risks and providing solutions to minimize them in order to start production in Industrial-Scientific Complex of Medical Biotechnology in Konstantynów Łódz in defined time. established term.

Mabion intends to register MabionCD20 on all global markets where reference drug is 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 intends to register MabionCD20 across the European Union on its own.

On August 29th 2014 Mabion SA presented to the Data and Safety Monitoring Board (DSMB) – an independent committee composed of experts in the field of rheumatology, pharmacology and biostatistics – the clinical and safety data from about 62% of the total number of patients needed to complete the study, including 44,4% of patients who have already completed required procedures.

Commission – likewise after the first two meetings (in August 2013 and in February 2014) – very positively assessed research process.. According to the issued opinion, procedure of the clinical trial does not require any modification. The current patient recruitment runs smoothly and asforeseen. The opinion of DSMB allows for the continuation of clinical trials in accordance with the protocol.

With regard to regions with a less strictly regulated system of registration - such as Africa or Asia - Mabion SA is planning both, implementation of sales and the entire registration procedure 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 shares in he revenues from the sale of drugs by foreign distributors. By now Mabion has signed:

• An agreement with the pharmaceutical company LYFIS for the territory of Iceland
• An agreement with the Ukrainian pharmaceutical company Farmak in relation to Ukraine, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan and Uzbekistan
• An agreement with the Turkish pharmaceutical company ONKO referring to the territory of Turkey
• An agreement with the Moroccan pharmaceutical company Sothema Laboratories for countries of 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 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 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.

To read more Press Release articles, click here.