Mabion Release: End Of The MabionCD20 Clinical Trial Is Getting Closer

Another positive review of Data and Safety Monitoring Board

On 29th August 2014 Mabion SA presented to the Data and Safety Monitoring Board (DSMB) – an independent committee of experts in the field of rheumatology, clinical pharmacology and statistics – the clinical and safety data obtained from patients participating in the study MabionCD20. DSMB Committee analyzed patients’ data gathered up to 30th June 2014 (date of database lock for the purpose of processing) contained in the submitted report, as well as data gathered after the date of database lock (not treated statistically – the raw data). Therefore presented clinical and safety data were obtained from about 62% of the total number of patients required to complete the study, of which 44,4% is a group of patients who received all drug administrations foreseen in the study protocol. In contrast the number of currently enrolled patients is 77.1% of the total number of patients required to complete the study, and 52.9% of patients is a group that received all drug administrations required in the study protocol.

The DSMB Committee is responsible for external supervision over the safety of patients participating in the study, as well as assessment of compliance of the investigating team work with the study protocol. The Committee meetings are held regularly within the study period. The DSMB Committee – the same way as after the first two meetings (in August 2013 and February 2014) – evaluated conducted study very positively. According to the opinion issued by the DSMB Committee clinical study procedures do not require any modifications. The MabionCD20 drug is well tolerated by patients both after the first and after subsequent administrations. There were no differences in the safety profile of MabionCD20 in comparison to the reference product MabThera among the analyzed group of patients. The current patients recruitment rate is in line with previous assumptions. The opinion of DSMB Committee allows to continue the clinical trial in accordance with the study protocol. After its successful completion Mabion SA will apply to the European Medicines Agency (EMA) for registration of the drug in the European Union.

„The study comparing MabionCD20 with the reference medicine MabThera is currently very advanced. According to the procedures the DSMB Committee monitors the safety of patients with rheumatoid arthritis participating in the study, and supervises the quality of the study. The fact that consecutive, third one Data and Safety Monitoring Board Committee review is so positive is very constructive. What is important, the Committee did not implement any modifications to our research process, confirming the high quality and attention to the smallest detail in the study. No differences observed up to the moment in the safety profile between MabionCD20 and the reference drug MabThera in such a precisely designed study is a good predictor for introduction of the drug to the international arena” – said Maciej Wieczorek, Mabion SA, President of the Board.

Clinical trials were designed and conducted in accordance with guidelines of the European Medicines Agency and with the principles of Good Clinical Practice (GCP), while the laboratory and biochemical evaluation will be performed in the standard of Good Laboratory Practice (GLP). Selected inclusion criteria seem to be very benefitial to recruitment rate and safety of patients participating in the study. Moreover, one of the Company’s objectives is the introduction of drugs into the U.S. market. In this case in November 2012 Mabion SA completed a parallel Scientific Advice procedure in the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) relating to qualitative and clinical development on MabionCD20. This is the possibility to start preparations of regulatory and marketing plans for the U.S. market. In addition Mabion signed the letter of intent with the Regulatory Compliance Association (RCA), that provides a comprehensive support with regard to compliance with FDA requirements. Among the RCA staff are persons experienced with work as FDA inspectors. Signed letter of intent includes detection of potential risks for the certification and providing solutions for their minimization in order to maximize the probability of starting production in Mabion SA Center for Science & Industrial Biotechnology in Konstantynów Lódzki within the prescribed period.

Mabion SA undertakes number of activities aiming at the most efficient registration of MabionCD20. In recent months Mabion:

• signed with Plexus Ventures LLC an agreement on the acquisition of new customers for purchase of MabionCD20. This concerns, inter alia, expansion into markets of: U.S., European Union, Canada, Australia, New Zealand and Japan.

• signed with Altiora d.o.o. a contract for conduction of clinical study in patients with lymphoma in the territory of Poland, Croatia, Bosnia, Serbia, Hungary, Bulgaria and Moldova. Expected date of the contract fulfillment is 31st December 2014.

• gained more than PLN 53 million from issue of shares. Funds will be devoted primarily to: adaptation and certification of the new Scientific&Industrial Complex of Medical Biotechnology to the requirements of the FDA, the coverage of the market-driven and medical cost increase of clinical study conducted by Mabion and to supplementation of working capital, mainly due to shifts in the settlements of EU funds and taxes.

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 intends to register MabionCD20 across the European Union on their own after completion of clinical trials in collaboration with dozens of centers in selected European countries.

In the case of 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 process by local leading pharmaceutical companies. Production will be carried out in Mabion’s factories in Poland, and the company will have shares in the 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.

www.mabion.eu

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