All power of the sea. now against. cancer.

Transcription

1 All power of the sea now against cancer.

2 All power of the sea, now against cancer 1 PharmaMar is the first company in the world to research, develop and market a marine-based drug to fight cancer.

3 2 PharmaMar All power of the sea, now against cancer 3 PharmaMar, founded in 1986 and part of Zeltia Group, is a biopharmaceutical company which explores the seas to find innovative cancer treatments. Proof-of-concept of the sea as a source of pharmaceuticals came in 2007 with the approval of Spain s first antitumour drug by European Comission. PharmaMar is committed to an integrated business model ranging from drug discovery through to commercialisation. Leaders in marine biotechnology

4 4 PharmaMar All power of the sea, now against cancer 5 Over millions of years, innumerable forms of marine life have evolved to produce an extraordinary variety of highly sophisticated chemical compounds. They include molecules with strong biological activity, developed as a biochemical defence to survive in an extremely competitive environment. In the relatively near future, the marine environment in all of its manifestations will be producing leads to novel treatments against cancer and other diseases. Chabner, Bruce: Marine anticancer compounds in the era of targeted therapies. Publicaciones Permanyer. Colección: International Oncology Updates, p. PharmaMar is conducting a pioneering marine biotechnology programme in search of new anti-cancer drugs. The company s research taps the sea, whose enormous biodiversity makes it a vital source of new antitumour drugs. The sea as a source of inspiration

5 6 PharmaMar All power of the sea, now against cancer 7 The oceans are brimming with more than 3 x bacteria that s about 100 million times more cells than there are stars in the visible Universe. Although the exploration of marine ecosystems is only recent, PharmaMar has already begun to commercialise the first anti-cancer drug of marine origin. Jon Copley, Nature 415, (7 February 2002) Evolution has defined and selected a range of strategies for survival, defence, attack, adaptation and communication among marine organisms, which comprise a veritable arsenal of molecules (metabolites) which we can use to improve human health. We know now that there is much more biodiversity in the oceans than on land. The exploration of the seas in search of chemical compounds has only just begun, as only about 20,000* natural marine products with biological activity are currently known. Pioneers in the exploration of marine biodiversity *MARINLIT database.

6 8 PharmaMar All power of the sea, now against cancer 9 PharmaMar employs experts in marine biology who explore the oceans in search of small marine samples in select locations. The search for new molecules Using chromatography, PharmaMar isolates molecules of interest from the marine samples and quickly elucidates their chemical structure. Innovative antitumour molecules hitherto undocumented in the scientific literature are designed and synthesized in the laboratory by chemical processes. Chemical synthesis avoids the need to deplete the natural source by producing the compounds in sufficient quantities for development and future commercialisation.

7 10 PharmaMar All power of the sea, now against cancer 11 PharmaMar collaborates with several patient organizations which are involved in international projects, meetings and training plans. PharmaMar is committed to the search for new drugs to treat common cancers, such as breast, lung and prostate. It also researches and develops drugs for rare diseases (those affecting less than 5 out of every 10,000 people, according to the EU s definition). PharmaMar is also committed to developing compounds for treating paediatric tumours. PharmaMar is also committed to developing compounds for treating paediatric tumours. The company has obtained several orphan drug designations from both the European Commission (EC) and the US Food and Drug Administration (FDA). Through this commitment to excellence and innovation, PharmaMar aims to provide both patients and their doctors with new treatment options that offer significant clinical benefits and help combat rare illnesses. Commitment to patients

8 12 PharmaMar All power of the sea, now against cancer 13 lvaro uan aria Personalised medicine zucena ngel oe arlos ulio ateo elena Different individuals respond differently to a given drug, in terms of both efficacy and toxicity. Therefore, predicting sensitivity to our marinederived antitumour molecules is one of the principal goals behind PharmaMar s research with a view to optimising cancer treatments. Our Molecular Medicine department goes to great lengths to determine the molecular signatures of sensitivity to our compounds. We have very powerful genetic and molecular techniques that enable us to understand the complex mechanisms which determine a drug s activity against a certain type of tumour. Many studies suggest that genetic stratification of patients makes it possible to identify subgroups with greater probability of responding to a given treatment, thereby enhancing the selection of therapies most likely to be of clinical benefit to patients.

9 14 PharmaMar Todo All el power poder of del the mar sea, ahora now against contra el cancer cáncer 15

10 16 PharmaMar All power of the sea, now against cancer 17 At PharmaMar, we have established an effective and efficient international supply chain for clinical and commercial use. At our facilities in Colmenar Viejo, we synthesize intermediate products and active principles (APIs) for the manufacture of our drugs, and undertake secondary conditioning to meet commercial needs and cover ongoing clinical trials and compassionate use programmes. We do this with the levels of service, agility and rigour that these activities require to guarantee industrialscale manufacture and supply of our products, always in strict compliance with Good Manufacturing Practices (GMP) and the regulations on protecting our workers and the environment. Clinical development advances in parallel with the development of products, processes and analytical methods. This allows for continuous improvement and ensures the quality of our products, while complying with the regulatory requirements for the authorisation of our clinical trials. This arduous systematic work enables us to define a solid validated industrial process, culminating with the chemical and pharmaceutical documentation required by the authorities to authorise our products for commercialisation. We produce in Spain for the rest of the world

11 18 PharmaMar All power of the sea, now against cancer 19 Our spirit, tenacity and desire to meet the needs of patients and health professionals has led us to take on the European market, i.e. over 450 million people with varied national legislation and more than 20 official languages. PharmaMar has a specialised product sales organisation in Europe. We have our own sales network as well as three sales offices in the main markets in Europe: Germany (Berlin), Italy (Milan) and Spain (Madrid). As part of our sales strategy, structured in nine regions, we also work with Quintiles. In the rest of Europe, promotional and sales distribution agreements have been signed with Swedish Orphan Biovitrum for the Nordic countries and Eastern Europe, and with Genesis Pharma for Greece, Cyprus and the Balkan region. PharmaMar s European sales activities are coordinated from Colmenar Viejo (Madrid). Specialised multinational sales network

12 20 PharmaMar All power of the sea, now against cancer 21 Excellent alliances, the basis for our sales strategy We maintain a solid pipeline of compounds which are under ongoing development through a network of first-class partners, alliances and associations. Our satisfactory alliances with other companies and countless partnerships with universities, hospitals and scientific institutions worldwide are a testament to our commitment to this synergistic strategy. PharmaMar has established licensing agreements with Johnson & Johnson (US), Taiho Pharmaceutical (Japan) and other leading companies to guarantee that patients worldwide have access to the innovative drugs developed by PharmaMar. PharmaMar has an agreement with Marinomed, a company specialised in marine organism research, to license analogues for use outside of oncology. We are looking for partners in Europe, the US and Japan who can contribute to the success of our portfolio of marine-based products.

13 22 PharmaMar All power of the sea, now against cancer 23 PharmaMar is involved in numerous innovative projects in Spain and around the world which aim to advance scientific knowledge our greatest asset and place it at the service of novel drug development to improve patients lives. National cooperation projects INNPACTO PROJECTS The INNPACTO programme under the Spanish Ministry of the Economy and Competitiveness s National Programme for Public-Private Cooperation, is a programme of government assistance for cooperation projects. Its purpose is to support projects involving cooperation between public or private research centres and companies to perform R&D and innovation projects. This programme is co-financed by the European Union through the European Regional Development Fund (ERDF). POLYSFERA (INNPACTO ) POLYSFERA: Polymer nanocapsules for controlled release of antitumour drugs. Search for new controlled and directed mechanisms for releasing PharmaMar s antitumour drugs based on polymer particles developed using nanotechnology. BIOKÉTIDO (INNPACTO ) BIOKETIDO: Marine polyketides in oncology. This project uses biotechnology to develop bioprocesses for supplying marine-derived antitumour compounds. Application of molecular biology techniques to produce the antitumour molecules isolated by PharmaMar with a view to defining a process that ensures the supply and research into them. ORALBEADS (INNPACTO ) ORALBEADS: Development of micro/ nanostructured dispersions of solids for the oral administration of marine antitumour compounds. Development of an effective formula for the oral administration of one of PharmaMar s marine antitumour molecules, using solid dispersions with highly innovative technologies. MARINMAB (INNPACTO ) MARINMAB: Development of a new generation of anti-cancer therapies: Antibody conjugates for marine-based drugs. Research and development of antibody-drug conjugates in order to enhance the therapeutical efficiency of PharmaMar s compounds and produce new enhanced molecules. TORRES QUEVEDO SUBPROGRAMME The Torres Quevedo Subprogramme of the Ministry of Economy and Competitiveness provides three-year grants for hiring R&D personnel (PhDs and technologists), co-financed by the European Social Fund. International cooperation projects SEVENTH FRAMEWORK PROGRAMME (FP7) The framework programmes are the principal funding mechanism through which the European Union supports research and development in practically all scientific disciplines. The Seventh Framework Programme (FP7) concludes in 2013, when the next programme will commence. MULTIFUN (FP7 NMP ) MULTIFUN: Multifunctional Nanotechnology for selective Detection and Treatment of Cancer (Collaborative Project). Development and validation of novel, minimallyinvasive nanotechnology systems to enhance cancer diagnosis and treatment using magnetic nanoparticles. MAMBA (FP7 KBBE ) MAMBA: Marine Metagenomics for new Biotechnological Applications (Collaborative Project). Discovery and use of new microbial activities using enzymatic reactions and processes for new biotechnology applications. OPTATIO (FP7 HEALTH ) OPTATIO: OPtimizing TArgets and Therapeutics In high risk and refractory Multiple Myeloma (Collaborative Project). Search for predictive and prognostic markers of the malignisation process in multiple myeloma. Pre-clinical trials required to develop a treatment for this disease. Innovation and internationalisation at companies such as PharmaMar ensure our country s competitiveness and future development in the highly-specialised field of biopharmaceutical research. MICRO B3 (FP7 OCEAN ) MICRO B3: Marine Microbial Biodiversity, Bioinformatics and Biotechnology (Collaborative Project). Development of innovative bioinformatic methods and a legal framework which allows for greater integration of the data available on the biology of marine ecosystems. MACUMBA (FP7 KBBE ) MACUMBA: Marine Microorganisms: Cultivation Methods for Improving their Biotechnological Applications (Collaborative Project). Improve the isolation rate and growth efficiency of marine micro-organisms using innovative methods and high-performance automated procedures. Value-added synergy

14 24 PharmaMar All power of the sea, now against cancer 25 PharmaMar supports the responsible protection, conservation and sustainable use of valuable resources, in coherence with Article 1 of the Rio de Janeiro Convention on Biodiversity, which refers to the sustainable use of natural resources and the balance between ecosystems, society and the world economy. PharmaMar uses an underwater robot with an umbilical cord which is operated from the surface and provides a real-time view of the seabed, allowing for the selection of sample zones and minimising human interaction with the ecosystem. From an environmental protection standpoint, sample collection conforms to the two leading world standards in this area: the International Union for the Conservation of Nature (IUCN) Red List, which is revised annually and includes more than 15,000 endangered species, andcites (the Convention on International Trade in Endangered Species of Wild Fauna and Flora), to which participating governments adhere voluntarily. We collect samples of marine invertebrates manually and selectively via scuba diving; we avoid mechanical systems, such as drag nets or dredging, thereby eliminating the impact on the natural environment. Ecosystem conservation, the future of our research

15 26 PharmaMar All power of the sea, now against cancer 27 We research to provide solutions which improve the quality of life for cancer patients and their families. PharmaMar is firmly committed to researching innovative therapies for the betterment of society and to creating value for our shareholders. PharmaMar contributes to greater understanding of local marine ecosystems and their conservation through a bio-exploration programme which includes a very wide range of marine organisms. The information obtained by PharmaMar s expeditions is shared with local communities and teaching institutions in the areas where we engage in prospection, providing them with new knowledge about their marine ecosystems. With this goal in mind, we increasingly invest resources in research, using cutting-edge technology to develop innovative therapies for diseases for which there is no effective remedy, such as cancer. As part of our commitment to the advancement and the future of science, we support training for young scientists through agreements with Spanish and foreign universities. We believe in the importance of collaboration and the transfer of technical knowledge as a means of promoting science and research and of working for the future of society. Our employees are our most important asset and we are at the forefront in integrating women into our workforce; they currently account for 60% of the total. As for educational level, 70% of our employees are university graduates or PhDs. We conduct ethical research, working actively to improve alternative methods so as to reduce the use of animal trials. Corporate Social Responsibility (CSR): We contribute to social progress

16 «Nature distributed medicine everywhere.» Pliny the Elder. 74 AD

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