News Article | May 25, 2017
Under the terms of the agreement, PharmaMar will receive an upfront payment as well as development milestones related to the health approval procedure of Aplidin® in this country. PharmaMar will retain exclusive production rights and will supply the finished product to Eczasibasi for commercial use. Aplidin® is PharmaMar´s second most advanced anticancer drug currently under development for the treatment of multiple myeloma and angioimmunoblastic T-cell lymphoma. The Company announced in March 2016 that plitidepsin has shown positive results in a pivotal Phase III clinical trial (ADMYRE) for multiple myeloma and in September 2016, PharmaMar presented to the European Medicines Agency (EMA) the submission of the Marketing Authorization Application (MAA) for this drug in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM) . "The partnership with Eczasibasi will help in the commercialization in Turkey of plitidepsin, developed to tackle hematologic cancer. We are looking forward to working with one of the leading Health Care companies in this country", said Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit. "We are firmly committed to advancing in the development of innovative oncology therapies", he added. Atalay, CEO and President of the Eczasibasi Group, stated that "the agreement between PharmaMar and Eczac?ba?? Pharmaceuticals Marketing (EIP) offered a major advance for healthcare in Turkey, as Aplidin® represented the latest innovation in cancer treatment". Elif Çelik, Executive Vice President of the Eczasibasi Healthcare Division, noted that "the agreement ensured that multiple myeloma patients in Turkey would have access to the most innovative treatment at the same time as patients in other EU countries". She added that "the two parties hoped to extend the partnership to innovative products in other treatment areas as well". Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. A Phase III trial in multiple myeloma relapsed or refractory has been completed. Plitidepsin has received orphan drug designation in the European Union and the United States of America. Founded in 1942, Eczasibasi is a prominent Turkish industrial group, over 12,750 employees and a combined net turnover of TL 9.6 billion in 2016. Eczasibasi's core sectors are healthcare, consumer products and building products. Additionally, the Group is active in finance, welding technology and mining. The pioneer of Turkey's pharmaceutical industry, the Eczasibasi Healthcare Division is unique in the breadth of its activities, which range from preventive care to early diagnosis and from innovative treatment to close patient follow-up and home care. Through this holistic approach, the Division contributes to wellbeing at every phase of human life. EIP is a wholly-owned Eczasibasi Group company with an expertise in the marketing, sales and distribution of imported and locally manufactured pharmaceutical and health-based personal care products. EIP's diverse portfolio has a special focus on specialty care and rare diseases, and the company is now preparing to launch biosimilar products for cancer treatments not currently available in Turkey. EIP has four strategic business units, with a sizeable sales force covering 25,000 physicians and 5,000 pharmacies all around Turkey. One of the fastest growing pharmaceutical companies in Turkey, EIP has numerous licensing agreements with multinational partners, among them Galderma, Procter&Gamble Health, Chugai Pharmaceutical, Cadila Healthcare, Astellas, and Tillots Pharma. Aplidin® is expected to be marketed in Turkey no later than 2020. Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www. .
News Article | April 24, 2017
MADRID, April 24, 2017 /PRNewswire/ -- PharmaMar (MCE: PHM), a leading biopharmaceutical company focused on the discovery and development of innovative marine-derived anticancer drugs, will host today a Research and Development Event in New York from 10:30 am - 1:30 pm ET. ...
News Article | May 4, 2017
This decision has been based, on the one hand, for the recognition as an orphan drug granted by the European Commission, as by the Food and Drug Administration (FDA) in 2004, and, on the other hand, by the data provided to the agency relating to efficacy, safety, quality of the drug and prevalence of the disease. "This authorisation is an important milestone in the treatment of multiple myeloma, recognizing that Aplidin®, with its novel mechanism of action, could become a therapeutic alternative," explains Luis Mora, Managing Director of the Oncology Business Unit at PharmaMar. Orphan drug designation in the European Union and Switzerland is given to compounds that are developed for the treatment of diseases that affect 5 out of every 100,000 inhabitants. This designation provides the sponsor with a series of incentives, amongst which are included the possibility of a priority review by Swissmedic, the competent authority in Switzerland. Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. A Phase III trial in multiple myeloma relapsed or refractory has been completed. Plitidepsin has received orphan drug designation in the European Union and the United States of America.
News Article | April 27, 2017
In addition, Sue Friedman represented the patients' association Facing Our Risks of Cancer Empowered (FORCE), of which she is the Executive Director, with the aim of highlighting the importance of joint investigation and innovation in oncology by oncological centres, opinion leaders and patients. Representing the company's management team, José María Fernández, President of PharmaMar, presented the company's five-year growth plan following on from the basis of the progress that has been delivered to date. "Today, PharmaMar has a treatment option that is accessible for oncological patients, but our project is to keep growing". In addition, Luis Mora, Managing Director of PharmaMar's Oncology Business Unit, added that the company's aims are directed at "being able to deliver three valid products for a minimum of five indications to the medical community in the near future, following the successful example of Yondelis®". The presentation by Arturo Soto, director of Clinical Development of PharmaMar´s Oncology Business Unit, included the earlier clinical data for Lurbinectedin in ovarian, small cell lung, breast and endometrial cancers, which preceded the current CORAIL and ATLANTIS Phase III studies with lurbinectedin which assess the efficacy in platinum-resistant ovarian cancer and in small-cell lung cancer, respectively. Information was also offered about several clinical trials in progress as well as a general vision of the company's strategy. Jose Luis Moreno, Director of Capital Markets also presented the company financials, balance sheet and income statement as of year-end 2016 and updated certain expectations for 2017. Finally, Pascal Besman, PharmaMar's Chief Operations Officer in the United States , told the attendees about the company's development plan in the country. This involves establishing a solid communication structure with key groups within the health system, patient and care giver associations, oncologists and the media. The meeting was recorded and the content will be available for viewing in the Events Calendar section of the website https://www.pharmamar.com.
Agency: European Commission | Branch: FP7 | Program: MC-ITN | Phase: FP7-PEOPLE-2013-ITN | Award Amount: 3.90M | Year: 2013
Marine sponges harbour extremely diverse populations of microbes, and are world record holders for the production of a plethora of bioactive molecules. Previous studies, however, aiming at the growth of sponges or their associated microbes for the production of bioactive compounds to supply biological material for clinical trials, have been largely unsuccessful. BLUEPHARMTRAIN is a multi-disciplinary alliance of 20 academic and industrial partners that will excel in research and training through integration of complementary expertise in cell biology, microbiology, natural product chemistry, genomics & transcriptomics (omics) and socio-economics. We will adopt cutting-edge omics technologies to give a new boost to the more traditional disciplines: microbial isolation, cell culture and natural product chemistry to go beyond the current scientific frontiers. For example, metagenomic and transcriptomic data will be applied to identify the metabolic potential and restrictions of -yet- uncultured microbes and will serve for the design of tailor-made cultivation conditions. In addition, heterologous expression of bioactive gene clusters and enzymes able to perform unusual modifications will serve as an alternative strategy to unlock the bioactive potential of sponges. Thus we aim to develop an extensive technology platform that is applicable for obtaining a wide variety of bioactive compounds from distinct sponges and their microbes. BLUEPHARMTRAIN will provide a complementary set of experimental and conceptual local and network-wide training modules and workshops to 15 young researchers. The recruited fellows will work towards personalized training plans to meet individual needs and interests, generating a critical mass of young researchers in the emerging field of blue biotechnology. The presence of a large consortium of versatile biotechnology, pharmaceutical and consultancy firms ensures a good balance between academic and transferable skills acquired by the fellows.
Agency: European Commission | Branch: FP7 | Program: CP-TP | Phase: KBBE.2012.3.2-02 | Award Amount: 11.97M | Year: 2012
Marine microorganisms form an almost untapped resource of biotechnological potential. However, its use is hindered by the low success rate of isolation of novel microorganisms and often by poor growth efficiency. Hence, the vast majority of marine microorganisms has not been cultivated and is often considered as unculturable. MaCuMBA aims at improving the isolation rate and growth efficiency of marine microorganisms from conventional and extreme habitats, by applying innovative methods, and the use of automated high throughput procedures. The approaches include the co-cultivation of interdependent microorganisms, as well as gradient cultures and other methods mimicking the natural environment, and the exploitation of cell-to-cell communication. Signaling molecules produced by microorganisms may be necessary for stimulating growth of the same or other species, or may prevent their growth. Signaling molecules also represent an interesting and marketable product. MaCuMBA will make use of high throughput platforms such Cocagne, using gel micro-droplet technology, or MicroDish in which many thousands of cultures are grown simultaneously. Various single-cell isolation methods, such as optical tweezers, will aid the isolation of specific target cells. Isolated microorganisms as well as their genomes will be screened for a wide range of bioactive products and other properties of biotechnological interest, such as genetic transformability. Growth efficiency and expression of silent genes of selected strains will be increased also by using the clues obtained from genomic information. MaCuMBA is targeted to SMEs and industry and they make a significant part of the consortium, ensuring that the project focuses on the interests of these partners. Moreover, MaCuMBA has adopted a comprehensive and professional exploitation, dissemination, implementation, and education strategy, ensuring that MaCuMBAs results and products will be directed to end-users and stakeholders.
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: NMP-2010-4.0-1 | Award Amount: 13.15M | Year: 2011
The aim of the MultiFun consortium is to develop and validate a novel and minimally-invasive nanotechnology system to improve cancer diagnosis and treatment. MultiFun nanotechnology is based on multifunctionalised magnetic nanoparticles to selectively target and eliminate breast and pancreatic cancer (stem) cells. The improved magnetic features of the MultiFun magnetic nanoparticles will lead to potential medical applications such as contrast agents and magnetic heating inductors. Moreover, magnetic nanoparticles can be functionalised with ligands to increase their affinity towards cancer cells in order to facilitate diagnosis of tumours by MRI. Targeting peptides and antibodies will be employed, including antibodies against cancer stem cells leading to early cancer detection by MRI means. The same nanoparticles will be used simultaneously as functional nanocarriers and heating inductors in order to provide a combined therapeutic modality. The synergistic effects of drugs, peptides, small RNAs and heat will be evaluated to determine the effectiveness of different therapeutic combinations. Interestingly, the use of ligands will favour the specific application of the therapeutic modalities to cancer (stem) cells, increasing the effectiveness and reducing side effects. Thus, MultiFun multimodal therapeutic approach is designed to efficiently remove cancer cells, including cancer stem cells, from the tumour site. The toxicity of functionalised magnetic nanoparticles will be assessed in vitro and in vivo to warrant a safe use and shed some light on the risks. The distribution and activity evaluation of functionalised nanoparticles will be performed in human breast and pancreatic cancer xenograft models. The use of novel magnetic nanoparticles for biomedical applications provides opportunities for new instrumentation: 1) detection and quantification of magnetic nanoparticles in blood, urine and tissues, and 2) magnetic heating induction for raising cell temperature.
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: OCEAN.2011-2 | Award Amount: 11.51M | Year: 2012
Micro B3 will develop innovative bioinformatic approaches and a legal framework to make large-scale data on marine viral, bacteria; archaeal and protists genomes and metagenomes accessible for marine ecosystems biology and to define new targets for biotechnological applications. Micro B3 will build upon a highly interdisciplinary consortium of 32 academic and industrial partners comprising world-leading experts in bioinformatics, computer science, biology, ecology, oceanography, bioprospecting and biotechnology, as well as legal aspects. Micro B3 is based on a strong user- and data basis from ongoing European sampling campaigns to long-term ecological research sites. For the first time a strong link between oceanographic and molecular microbial research will be established to integrate global marine data with research on microbial biodiversity and functions. The Micro B3 Information System will provide innovative open source software for data-processing, -integration, -visualisation, and -accessibility. Interoperability will be the key for seamless data transfer of sequence and contextual data to public repositories. Micro B3 will allow taking full advantage of current sequencing technologies to efficiently exploit large-scale sequence data in an environmental context. Micro B3 will create integrated knowledge to inform marine ecosystems biology and modelling. Moreover, it will facilitate detecting candidate genes to be explored by targeted laboratory experiments for biotechnology and for assigning potential functions to unknown genes. Micro B3 will develop clear IP agreements for the protection and sustainable use of pre-competitive microbial genetic resources and their exploitation in high potential commercial applications. To underline the translational character of Micro B3, outreach and training activities for diverse stakeholders are planned as well as an Ocean Sampling Day to transparently make project results accessible and gain valuable user feedback.
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: KBBE-2008-3-2-07 | Award Amount: 4.98M | Year: 2009
The Project aims at the mining of individual enzymes and metabolic pathways from extremophilic marine organisms and the metagenomes from microbial communities from peculiar marine environments and consequent funnelling the new enzymatic reactions and processes towards the new biotechnological applications. Project builds up on the scientific and technological excellence of individual academic and industrial partners, and beyond that, on application of the state-of-the-art technologies for archiving, molecular screening for the activities (using a unique Surface Plasmon Resonance screening platform), protein structure elucidation, enzyme engineering and directed evolution and establishing new biotechnological processes (biocatalysis, synthesis of fine chemicals, etc.). Marine sampling hotspots to produce the metagenomic resources for their further exploration will cover the whole diversity of marine microbial life at its limits (hypersaline, low and high temperature, high pressure and low water activity conditions, etc.). Individual enzymes interacting with the substrates will be identified, and in case they are new, hyperexpressed and crystallized and their structures will be elucidated. Consequently, the most promising candidates will be scored against the chiral substrates of relevance for biocatalysis and their ability to perform in water-free systems will be evaluated, the directed evolution will be implemented to improve the performance, and specificity of the enzymes. A comprehensive bioinformatic survey throughout the whole tree of cellular life will reveal and suggest the new candidates homologous to the discovered new proteins, from other organisms to be cloned and assayed. The implementation of the set of new enzymes in the biotechnological processes for fine chemical synthesis and drug discovery will be conducted in a strong alliance with competent industrial partners.
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.4.1-2 | Award Amount: 4.28M | Year: 2012
Multiple Myeloma (MM) is an incurable disease with rapidly growing prevalence and poor prognosis. Consequently, it is the goal of the OPTATIO consortium to seek out novel strategies for the development of novel diagnostic and therapeutic options. The MM pathogenesis involves not only genetic changes within the tumour cells but also the emergence of supportive conditions by the bone marrow microenvironment (BMM). To target the essential components of this support system, it is the goal of the project to establish preclinical in vitro and in vivo models of MM that include functionally relevant elements of the BMM. The OPTATIO consortium will therefore analyse clinical data to correlate the presence of particular MM-BMM interactions with the pathogenesis of MM, with its intrinsic therapy resistance as well as with disease relapse due to the development of acquired drug resistance. These correlative data will be validated using autologous MM-BMM co-culture assays and reverse translated into in vitro screening and in vivo models, which will be subsequently used to develop lead compounds that target myeloma cells within their microenvironment. The clinical expertise of several oncological divisions, the research experience of academic laboratories and the pharmaceutical know-how of small and medium sized enterprises as well as biotech industry joined their efforts within the OPTATIO consortium to drive this important development and to ensure translation towards clinical trials. Expected impacts of the project include establishment of better diagnostics, new drug screening approaches for MM and novel personalised therapies based on individual ex vivo phenotyping leading to reduced patient mortality. Since envisaged drug screening methods are applicable to other areas of research and development, the project results will open new markets for industry partners in the fields of drug discovery and pharmaceutical development of products and services for personalized medicine.