Mabion files application to the Main Pharmaceutical Inspectorate

Application for authorisation to manufacture investigational medicinal products in Konstantynów Łódzki

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 authorisation to produce investigational medicinal products in the Scientific-Industrial Complex of Medical Biotechnology. Following the completion of building works in Konstantynów Łódzki, 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 Łódzki is a modern investment occupying 6,500m2 in the Łódź 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 utilising 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 Łódzki, 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.

Sławomir Jaros honored in the “Young Wolves Stock Exchange” ranking of the Parkiet newspaper

Sławomir Jaros, Member of the Board Mabion SA, was selected as one of the top ten among the youngest members of the boards of large companies listed on the Stock Exchange.

From the group of more than 70 the youngest members of the boards of companies listed on the WSE jury, comprised of journalists and editors of newspapers “Parkiet” and “Rzeczpospolita”, has emerged 25 people. For the final result of the ranking had an impact a probe published on the website of the Parkiet newspaper, as a result of which the readers selected the top ten.

Sławomir Jaros is educated biotechnologist, He graduated from the Warsaw University of Life Science, a PhD in biological sciences acquired in the Polish Academy of Sciences in Warsaw. For the purposes of the implementation of Mabion projects also collaborated with the Medical University in Łódź. He has participated in many biotechnological projects – including the creation of recombinant proteins and vaccines. Slawomir Jaros is associated with the company Mabion since late 2007 and is responsible for developing technologies and products of Mabion.

Mabion meets institutions in Brazil

Discussions held with representatives of the Brazilian Ministry of Health; the Ministry of Development, Industry and Foreign Trade; and government officials from the State of Rio de Janeiro, regarding the participation of Mabion SA in a public-private partnership program (PDP)

Mabion SA—the Polish biopharmaceutical company that develops and brings to market latest generation biosimilar drugs—is pressing forwards with the registration of the MabionCD20 drug on the Brazilian market and the company’s inclusion in a public-private partnership program (PDP). Hence a series of meetings with Brazilian authorities in the first half of May. The Management Board of Mabion and representatives of Biolotus, together with the director of the Instituto Vital Brasil (IVB), met the Governor; the Secretary of State; and the Secretary of State for Health from the state of Rio de Janeiro. Talks were also held with national representatives of the Ministry of Health and the Ministry of Development, Industry and Foreign Trade. The meetings were concerned with releasing the MabionCD20 drug to market in the largest country in South America, within the framework of a public-private partnership. The partnership is based on the transfer of knowledge and technology in cooperation with local pharmaceutical companies.

The Brazilian biotechnology market is one of the fastest growing in the world today and is a key component of the national economy. Its attractiveness for foreign investors and pharmaceutical companies is primarily driven by a public-private partnership program, coordinated by the Ministry of Health for Brazil. Companies included in the program can count on opportunities for long-term technological cooperation with their South American counterparts and guaranteed participation in the local market for biosimilar products.

“The huge potential of the Brazilian biotechnology sector; its rapid development; and the opportunities for pharmaceutical companies, have triggered initiatives by Mabion to introduce its own medicinal products in the country. All procedures related to the legalization and distribution of our drug MabionCD20 will be implemented within the framework of a public-private partnership between the Brazilian Ministry of Health, the Instituto Vital Brasil (IVB), Biolotus and Mabion. It needs to be emphasized that the process of joining the public-private partnership is time-consuming and complicated. The Ministry of Health is responsible for the recommendation of a specific company to the Brazilian government. However, it is the Instituto Vital Brasil that selects the provider of technology and—following the presentation of our research and technology—has chosen Mabion as the partner in the field of biosimilar medicine MabionCD20. IVB is a Brazilian research center with a very long tradition which implements public-private partnership programs in Brazil. Biolotus, with whom we cooperate, will ensure the correct procedures are followed for the registration and distribution for the MabionCD20 drug in Brazil and also for the building of factories and analytical laboratories there to allow finished drugs to be produced locally. As a company with great technological potential, we recognize the opportunities and are certain that participation in the program will guarantee our success in South America, a conviction bolstered by a declaration of support from the Governor of the state of Rio de Janeiro. Therefore, we are confident that our innovative, authorial technologies will fulfill the expectations of the Brazilian Ministry of Health.”, said Maciej Wieczorek, CEO of Mabion SA.

Biolotus is a pharmaceutical company specializing in research, development, registration, manufacturing, promotion, distribution and worldwide commercialization of pharmaceutical and biotechnological products. Mabion’s cooperation with this Brazilian partner allows more than just the exchange of know-how. Thanks to inclusion in the public-private partnership program, representatives of Mabion are hoping for the rapid conclusion of the registration processes and the subsequent distribution of the MabionCD20 drug in Brazil.

Instituto Vital Brasil was established on 3rd June 1919 in Niterói (Rio de Janeiro). It was founded by Vital Brazil Mineiro da Campanha (1865-1950). The Institute worked on, amongst others, a vaccine for tuberculosis; and currently operates not only in production, but primarily in research and training. In 1930, it became a private institution, but continues to work closely with the government of the state and for the benefit of public health. The mission of the Institute is to contribute to the promotion of health through research; the dissemination of scientific knowledge; and the production of pharmaceuticals, according to ethical guidelines and in a socially and environmentally responsible manner.

In the case of regions with less restrictive registration systems—such as Africa or Asia—Mabion SA is planning both the entire sales and registration procedure in cooperation with leading local pharmaceutical companies. Production will be undertaken at 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 Costa Rican pharmaceutical company for the Central American countries (Costa Rica, Honduras, Nicaragua, Belize, Dominican Republic, El Salvador, Trinidad and Tobago and Panama).
  • 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.

Mabion: extension of the contract with Altiora

Changing the structure of conducting clinical trials of MabionCD20 in RA will allow lowering the costs

Mabion SA – the Polish biopharmaceutical company that develops and releases latest generation biosimilar drugs – has changed the structure of conducting clinical trials of MabionCD20 in RA (rheumatoid arthritis). All the actions were taken over by Altiora, which until now was responsible for works in area of diffuse lymphoma in Poland, Serbia, Bosnia and Herzegovina, Croatia, Bulgaria, Moldova, Romania, Ukraine, Georgia and Hungary, and also partially for RA testing. The acquisition of an additional range of tasks by Altiora will be smooth and will allow lowering the total cost of clinical trials.

We recruited a large number of patients in the pivotal trial (RA) of MabionCD20, which allows us to gradually reduce the geographical areas of the project. In order to swiftly continue further actions it is sufficient to cooperate with one entity. Above all, for company this means simplification of operational activities, lowering logistics costs and the possibility of a smooth completing the final phase of studies. So far, the collaboration with Altiora is very fruitful and, additionally, economically effective– said Maciej Wieczorek, CEO of Mabion SA.

Moreover, the company received permission to use the Scientific-Industrial Complex of Medical Biotechnology – a mass production facility. The first drug to be produced at the newly-built Konstantynów Łódź site will be MabionCD20. Manufacturing the drug for clinical trials at the Complex will facilitate its registration as the place of manufacture for MabionCD20. In the first half of this year, the company plans to begin the certification process for the facility according to the requirements of the Main Pharmaceutical Inspectorate.

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 in 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 Costa Rican pharmaceutical company for the Central American countries (Costa Rica, Honduras, Nicaragua, Belize, Dominican Republic, El Salvador, Trinidad and Tobago and Panama).
  • 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.
  • A letter of intent with the pharmaceutical company Biolotus BioTech in relation to the Brazil.

Mabion: permission granted for mass production facility

MPI certification for the Scientific-Industrial Complex of Medical Biotechnology this year

Mabion SA – the Polish biopharmaceutical company that develops and releases latest generation biosimilar drugs – has been granted a permission to use the Scientific-Industrial Complex of Medical Biotechnology – a mass production facility. The first drug to be produced at the newly-built Konstantynów Łódź site will be MabionCD20. Manufacturing the drug for clinical trials at the Complex will facilitate its registration as the place of manufacture for MabionCD20. In the first half of this year, the company plans to begin the certification process for the facility according to the requirements of the Main Pharmaceutical Inspectorate (MPI).

The biotechnology facility in Konstantynów Łódź is a modern investment occupying 6,500 sq. m. in the Łódź 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 adjusted to the production of biopharmaceuticals fully based on „disposables” technology (eliminating contact of the product with manufacturing environment and equipment) in 100% of the manufacturing chain. It is also the world’s largest facility employing in this technology. In addition, worth mentioning is the use of ultra-high quality walls of a „clean room” that protect the sterility of operations. The Park is equipped with high-specification installations for both building functions and the preparation of culture media. It is also equipped with:

  • an extensive ventilation system
  • an advanced compressed air generator
  • its own waste water treatment
  • a technical gases installation
  • a state-of-the-art process water system for so-called ‘Water for Injection’

The finishing work at the Scientific-Industrial Complex of Medical Biotechnology went well. At present, we are gathering the documentation and certification in accordance with the requirements of the Main Pharmaceutical Inspectorate. In the second half of 2015, at our new facility, we assume that we will begin mass production of the drugs currently being working on to meet the needs of the global market. The first priority will be to manufacture MabionCD20 for trials so that the Complex can be registered as the drug’s place of manufacture at once. This will significantly accelerate the possibility of immediately fulfilling orders for MabionCD20 on a large scale. The launch of the production facility will not only allow industrial production of MabionCD20, but also—thanks to the significant increase in production capacity—ensure continued work on MabionHER2 and increase the intensity of clinical trials for other drugs” – said Maciej Wieczorek, CEO of Mabion SA.

Mabion’s innovative new facility is one of the few places in Europe where you can conduct the entire process of new biotechnology drug development: from the design of the client’s desired protein material, the development of manufacturing technology, the development of analytical methods necessary to characterize the product, the medium-scale production of the drug for clinical trials, to finished products for the pharmaceutical market. The factory is equipped with the world’s only robotic production line for sterile filling which does not come into contact with the product (only disposable materials are in contact with the drug), allowing the product to be dispensed to a great variety of packaging formats and changes to be made in the format and size of the package during the dispersion process.

Mabion also has a Research & Development Center—a small-scale production plant— of approximately 650 sq. m., comprising 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. In Mabion SA’s Research & Development Center, a scale of production up to 500 liters of cultivation is possible. This scale is sufficient for the industrial production of certain biopharmaceuticals. Many biotech drugs, especially for use in oncology, require larger volumes of production, on a scale of several thousand liters.

  • Biosimilar drugs being developed by Mabion:
  • MabionCD20—an oncological drug biosimilar to MabThera / Rituxan, widely used in the treatment of blood cancer (lymphomas, leukemias), and rheumatoid arthritis. Annual sales of MabThera / Rituxan exceeded USD 6 billion in 2011.
  • MabionHER2—an oncological drug biosimilar to Herceptin, which is used in the treatment of breast cancer.
  • MabionEGFR—a drug biosimilar to Erbitux, used to treat colorectal cancer and cancers of the head and neck.
  • MabionVEGF—a drug biosimilar to Avastin, used in the treatment of tumors of the colon or rectum with metastatic cancers of the lungs, breasts and kidneys.

 Recombinant proteins / insulin analogues

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 in 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 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.
  • A letter of intent with the pharmaceutical company Biolotus BioTech in relation to the Brasil.

Mabion – positive opinion from Data and Safety Monitoring Board

The final phase of clinical trials

On 27th February 2015 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. Until 15th December 2014, the data were obtained from about 107% of the total number of patients required to complete the study, of which 74% is a group of patients who received all drug administrations foreseen in the study protocol. The DSMB Committee –as well as during the first three meetings (in August 2013, February 2014 and August 2014) – evaluated conducted study very positively

The Committee meetings are held regularly within the study period. The committee members have the opportunity to, among others, grant scientific advice related to study and suggest changes in the protocol of the clinic research. The DSMB Committee – as well as during the first three meetings (in August 2013, February 2014 and August 2014) – evaluated conducted study very positively. 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.

This is the fourth meeting of experts, during which clinical data were evaluated in terms of safety therapy. Until February 27, we recruited 109% of the total number of patients required to complete the study, of which 75% is a group of patients who received all drug administrations foreseen in the study protocol. Values above 100% arise from the fact that the standard procedure in clinical trials is the inclusion of an additional group of patients, whose task is to balance the loss of those patients who began the study, but potentially can’t finish it (e.g. by breaking protocol by a research center and the need to exclude part of the trials). According to the opinion issued MabionCD20 clinical testing procedure do not require any modification. Recruitment of patients proceeds smoothly and as expected, and the resulting opinion from DSMB allows to complete the clinical trials in accordance with a protocol. Currently, the clinical trial is active in Poland, Ukraine, Georgia, Bosnia-Herzegovina and Serbia. With regard to the advanced level of the study its territorial scope will be systematically reduced. No differences in the safety profile of MabionCD20 to the reference drug MabThera in such a precisely designed study is a good predictor for the introduction of the drug to the international arena” – says Maciej Wieczorek, CEO of Mabion SA.

Mabion SA is now in the final phase of clinical trials of related with MabionCD20 drug. Among the key objectives of the company, which has managed to achieve so far are:

  • Advanced level of clinical studies in the basic study in rheumatoid arthritis (RA), carried out on approx. 700 patients and follow-up study conducted on approx. 140 patients with diffuse large. Their completion will allow for the preparation of quality and research documentation, an important part of the drug registration dossier. The documentation will be submitted to the European Medicines Agency (EMA) in the process of approving MabionCD20 for trading. Successfully conducted studies will enable registration and distribution of MabionCD20 in Europe.
  • Advanced stage of the implementation of the Scientific-Industrial Complex of Medical Biotechnology (a mass production facility), whose occupancy permit and certification by the Main Pharmaceutical Inspectorate is scheduled even in the first half of 2015. By increasing the scale of production of monoclonal antibodies from 2×250 to 2×2500 liters, production of the drug and thus its administration to patients participating in the study will be faster. The first drug, which will be produced in a mass production facility in Konstantynów Łódź will be MabionCD20, which is currently at an advanced stage of clinical trials. Pharmaceutical manufacturing of MabionCD20 for clinical trials already in the new facility will facilitate the registration of the drug on a new target manufacturing facility at once. The complex is currently adapted to the requirements of the US Agency for Food and Drug Administration (FDA). Customization of the Science and Industrial Complex to the requirements of the FDA already at the stage of research and equipment will significantly reduce certification costs and streamline the entire process. Completion of work and certification of the Konstantynów Łódź’s facility will enable to relocate the production of the drug MabionCD20 and therefore release the production capacity of the Research and Development Center in Łódź to work on the preparation of MabionHER2.
  • Continuation of activities intended to register the drug MabionCD20 on less strictly regulated markets, where the distribution will take place through local partners. These are mainly regions of Central and South America, North Africa, the Middle East and Balkan Countries. The Company together with LKM SA has submitted in the last few months a petition, for an approval to start the registration procedure of MabionCD20 in Argentina, a drug used in the treatment of blood cancers and rheumatoid arthritis (RA). All the required research and legal documentation were submitted to the Argentine Ministry of – central unit evidencing clinical research in this country.

Clinical trials are designed and conducted in accordance with the guidelines of the European Agency for Drugs, and in accordance 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 criteria of inclusion the patients in the study proved to be very beneficial to the pace of their recruitment and their safety in the study. Additionally, one of the goal of the company is to introduce drugs into the US market. Accordingly, in November 2012. Mabion finished positively the common procedure of the Scientific Advice in EMA and the US Agency Food (FDA) for the quality and clinical development of the drug MabionCD20. This confirmed the possibility to start preparing regulatory and marketing plans on the US market. Additionally Mabion SA signed a letter of intent with regulators Compliance Associates, which provides a complete solution for the regulation and compliance with the requirements of the FDA. Among the RCA executives there are former FDA auditors. Signed letter of intent includes inter alias: identifying of potential risks for the certification and suggesting the ways to minimize them in order to maximize the probability of starting production in the Scientific and Industrial Complex of Medical Biotechnology Konstantynów Łódź in a given period.

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 in 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 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.

Mabion: Scientific-Industrial Complex of Medical Biotechnology

The report about the progress of works

Mabion SA – the Polish biopharmaceutical company that develops new generation of biosimilar drugs – is at an advanced stage of implementation the Scientific-Industrial Complex of Medical Biotechnology (a mass production facility), whose occupancy permit and certification by the Main Pharmaceutical Inspectorate is scheduled even in the first half of 2015. The complex is currently adapted to the requirements of the US Agency for Food and Drug Administration (FDA). This is a modern investment with an area of 6.5 thousand sq. m., located in Łódź Special Economic Zone. The total value of the venture, together with the equipment will be approx. 70 million PLN. It is the only advanced manufacturing facility for biotechnology drugs of its kind in Poland, and one of but a few in the world.

The first drug, which will be produced in the mass production facility in Konstantynów Łódź will be MabionCD20, which is currently at an advanced stage of its clinical trials. Their completion will allow for the preparation of quality and research documentation, which constitutes important part of the drug registration dossier. The documentation will be submitted to the European Medicines Agency (EMA) in the process of approving MabionCD20 for trading. Manufacturing MabionCD20 for clinical trials at the Complex will facilitate its registration right away with a new target manufacturing plant. In the Scientific-Industrial Complex of Medical Biotechnology there have been applied innovative technologies of production of biotech drugs on an industrial scale. Unique technologies that were used so far at the Centre for Research and Development, will be implemented in the Scientific-Industrial Complex of Medical Biotechnology – these are inter alias:

  • disposable” – an industrial process of recombinant CHO cells by the use of the bioreactor Kuhner 2500l technology based on disposable technology,
  • orbital shaking” – a procedure enabling mixed breeding in an orbital system, which gives a possibility to optimize development costs of the biodigestion processes. These solutions significantly improve the quality of production and its cost-effectiveness.

During the implementation of the new investment emphasis was put also on issues such as:

  • Increasing the scale of production – increasing the scale of production of monoclonal antibodies from 2×250 to 2×2500 liters in the course of cell culture without any differences in quality characteristics of proteins obtained in this way,
  • Sterility and purity class – an extensive ventilation system, a state-of-the-art process water installations of other process fluids (e.g. gas) and advantages of disposable materials, for a more cost-effective industrial production of biopharmaceuticals,
  • Ecology – implementation of an integrated wastewater treatment plant, which innovative methods will allow to reduce the cost of disposing of waste generated, and applied technologies are characterized by low energy consumption.

In order to adapt the Science and Industrial Complex, as well as the drug manufacturing process MabionCD20 to the requirements of the US Agency for Food and Drug Administration (FDA) in November last year Mabion SA conducted a series of consultations with representatives of the American company Regulators Compiliance Associates (RCA). Customization of the Science and Industrial Complex to the requirements of the FDA already at the stage of research and equipment will significantly reduce certification costs and streamline the entire process. Obtaining the certification of US Agency for Food and Drug Administration (FDA) for – the rising in Konstantynów Łódź – the Scientific-Industrial Complex will open in the future the way for Mabion’s drugs to expand on the US market and will have a positive impact on the registration of MabionCD20 drug.

The implementation of the Scientific-Industrial Complex of Medical Biotechnology – a mass production facility – is now at the final stage. In the first half of this year, we are planning to commencement a certification of the production plant in accordance with the requirements of the Main Pharmaceutical Inspectorate. Our new investment has been provided with an innovative device that will support our technology to facilitate its operation – maximizing the accuracy and repeatability of the results. In the Complex we have implemented also its own, partly proprietary technologies in the field of genetic engineering – disposable and orbital shaking – whereby we obtain a high degree of cost-effectiveness. Production works will begin immediately after receiving the authorization and certification from MPI. The first priority will be to manufacture MabionCD20 for trials, so the Complex can be immediately registered as the drug’s place of manufacture at once. This will significantly accelerate the possibility of immediately fulfilling orders for MabionCD20 on a large scale after receipt of the orders. The launch of the production facility will not only allow industrial production of MabionCD20, but also – thanks to the significant increase in production capacity –ensure a continued of work on MabionHER2 and increase the intensity of clinical trials for other drugssaid Maciej Wieczorek, CEO of Mabion SA.

Modern biotechnology facility was built in the technology of ultra-high-quality walls of a “clean room”. It is equipped with high-end systems used in the operation of the building and the generation process fluids. Furthermore, it has inter alia:

  • an extensive ventilation system
  • an advanced compressed air generator
  • Own waste water treatment
  • a technical gases installation
  • advanced state-of-the-art process water system, so-called” water for injection”

The factory is equipped with the world’s only sterile filling lines for product based on robotic systems, which do not have contact with the product (only disposable materials are in contact with the drug) allowing the product to be dispensed to a great variety of packaging formats and changes in the format and size of the package during the dispersion process.

Mabion’s laboratories are one of the few places in Europe where you can carry out the whole process of new drug development biotechnology: from the design of a protein material – desired by the client, by the development of manufacturing technology, the development of analytical methods necessary for the characterization of the product, to producing the drug in the medium scale for clinical trials, or finished products for the pharmaceutical market.

 Mabion also has a Research and Development Center – a small-scale production plant – with a total area of approximately 650 sq. m, comprising 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. In Mabion SA’s Research & Development Center, a scale of production up to 500 liters of cultivation is possible. This scale is sufficient for the industrial production of certain biopharmaceuticals. Many biotech drugs, especially for use in oncology, require larger volumes of production, on a scale of several thousand liters. Biosimilar drugs, which develops Mabion:

  • MabionCD20 – oncological drug biosimilar to MabThera / Rituxan, widely used in the treatment of blood cancer (lymphomas, leukemias), and rheumatoid arthritis. Annual sales of MabThera / Rituxan exceeded 6 billion dollars in 2011;
  • MabionHER2 – oncological drug biosimilar to Herceptin, which is used in the treatment of breast cancer;
  • MabionEGFR – drug biosimilar to Erbitux, used to treat colorectal cancer and head and Neck;
  • MabionVEGF – drug biosimilar to Avastin, used in the treatment of tumors of the colon or rectum, lung, breast and kidney.

 Recombinant proteins / insulin analogues

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 in 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 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.

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

Consent of appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland

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.

Mabion has completed series of consultations with representatives of the American company Regulatory Compiliance Associates (RCA)

Mabion SA – biopharmaceutical, Polish company dedicated to development of therapeutic proteins, mostly monoclonal antibodies – has completed series of consultations with representatives of the American company Regulatory Compiliance Associates (RCA). The purpose of the meeting was to discuss the compatibility of the project Scientific Industrial Complex Medical Biotechnology in Konstantynów Łódz, as well as the manufacturing process of the drug-MabionCD20 in new complexes with the requirements of the US Agency for Food and Drug Administration (FDA). Conversations proceed as intended and ended up successful.