Mabion SA – Polish, biopharmaceutical Company dedicated to development of therapeutic proteins, mostly monoclonal antibodies – signed an agreement with Altiora d.o.o. for the realization of a clinical research involving the drug MabionHER2 with the participation of patients suffering from breast cancer. The estimated value of the agreement amounts to approximately 5.25 - 6.5 million euros.
The agreement with Altiora regarding the clinical trial of MabionHER2 means that Mabion SA will start the study on its next own biosimilar drug. The first product developed by the Company – MabionCD20 – biosimilar to MabThera, is in advanced phase of clinical trial. Once the study will be finished the Company will apply to the European Drug Agency and register MabionCD20 in European Union.
Mabion SA – Polish, biopharmaceutical Company dedicated to development of therapeutic proteins, mostly monoclonal antibodies – signed an agreement with Altiora d.o.o. for the realization of a clinical research involving the drug MabionHER2 with the participation of patients suffering from breast cancer. The estimated value of the agreement amounts to approximately 5.25 - 6.5 million euros.
The agreement with Altiora regarding the clinical trial of MabionHER2 means that Mabion SA will start the study on its next own biosimilar drug. The first product developed by the Company – MabionCD20 – biosimilar to MabThera, is in advanced phase of clinical trial. Once the study will be finished the Company will apply to the European Drug Agency and register MabionCD20 in European Union.
Herceptin is used in the following diseases:
1. Metastatic breast cancer (MBC - Metastatic Breast Cancer) – drug is indicated for the treatment of patients with metastatic breast cancer who were found to overexpress receptor HER2.
• as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease,
• in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for metastatic disease and for whom an anthracycline is not suitable,
• in combination with docetaxel for the treatment of those patients who have not received chemotherapy for metastatic disease,
• in combination with an aromatase inhibitor for the treatment of postmenopausal women with positive test for the presence of hormone receptors, in whom there has been a the development of progression of cancer, not previously treated with trastuzumab.
2. Early-stage breast cancer (EBC - Early Breast Cancer) – Herceptin is indicated for the treatment of patients with HER2-positive breast cancer:
• after surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if used),
• after adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel,
• in combination with adjuvant chemotherapy with docetaxel and carboplatin,
• in combination with neoadjuvant chemotherapy and followed by adjuvant therapy based on locally advanced Herceptin (including inflammatory) breast tumor, or in the case of a tumor with 2 cm diameter.
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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