Darmstadt, Germany
Darmstadt, Germany

Merck KGaA is a German chemical and pharmaceutical company headquartered in Darmstadt, with around 40,000 employees in around 70 countries. Merck was founded in 1668 and is the world's oldest operating chemical and pharmaceutical company. The company was privately owned until going public in 1995. However, the Merck family still controls a majority of the company's shares.Following World War I, Merck lost possession of some of its foreign assets, including the Merck & Co. subsidiary in the United States. Merck & Co., which operates as Merck Sharp and Dohme outside the U.S. and Canada, is now an independent company. While Merck in Darmstadt is the legal successor of the original Merck and retains the rights to the name "Merck" in all countries except the U.S. and Canada, it is sometimes known as the "German Merck" or "Merck Darmstadt" in North America. The company was formerly also referred to as "E. Merck" .Merck KGaA operates mainly in Europe, Africa, Asia, Oceania and Latin America. Since Merck & Co. holds the rights to the Merck name in the U.S. and Canada, the company operated under the umbrella brand EMD Chemicals in North America, and since 2010 as EMD Millipore , formed from the initials of Emanuel Merck, Darmstadt. Wikipedia.


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An oral presentation includes an assessment of the duration of clinical outcome response to Cladribine Tablets from the CLARITY and CLARITY EXTENSION studies.1 The data demonstrate a statistically significant reduction in the annualized relapse rate at 96 weeks in both Cladribine Tablets groups, as compared with the placebo group (0.14 in the Cladribine Tablets 3.5-mg/kg group and 0.15 in the Cladribine Tablets 5.25-mg/kg group, vs 0.33 in the placebo group), for relative reductions of 57.6% and 54.5%, respectively (p<0.001 for both comparisons). Additionally, the proportion of patients with no new T1 Gd+ lesions was 73.0% to 89.9% respectively for the treatment groups (in CLARITY EXTENSION). In the 2-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. In CLARITY, patients were randomized to receive either Cladribine Tablets (3.5 or 5.25mg/kg) or placebo over two years. In the two-year extension, patients who received placebo in the double-blind phase, were re-randomized to receive Cladribine Tablets (3.5mg/kg). Patients who received Cladribine Tablets at either dose in the double-blind phase were re-randomized 2:1 to Cladribine Tablets 3.5mg/kg or placebo for years 3 and 4. "We compared the results from two 2-year studies to further understand the duration of efficacy of Cladribine Tablets," said Dr. Kottil Rammohan, an investigator in the CLARITY studies and Professor of Neurology – Clinical, and the Director of the Multiple Sclerosis Center at the University of Miami. "It's important that we saw similar results replicated in the CLARITY EXTENSION trial, which further supports the overall efficacy profile of Cladribine Tablets. Rates of clinical and MRI disease activity-free status were consistent with Cladribine Tablets across all subsets of MS patients for the duration in both trials." Additionally, a separate study, the ORACLE-MS study, investigated the effect of Cladribine Tablets 3.5 mg/kg of bodyweight or 5.25 mg/kg on conversion to clinically definite multiple sclerosis. Data showed that annualized relapse rates in the open-label period were lower in patients originally randomized to receive either dose of Cladribine Tablets compared with placebo (0.14 in the Cladribine Tablets 3.5-mg/kg group and 0.24 in the Cladribine Tablets 5.25-mg/kg group, vs. 0.42 in the placebo group.2 In the ORACLE-MS study, the most commonly reported AE in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 8.3% in patients previously exposed to Cladribine Tablets 5.25/mg/kg, 4.0% in patients previously exposed to Cladribine Tablets 3.5 mg/kg, and 3.3% in patients previously exposed to placebo. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada, Europe or elsewhere. I'm Facing MS: Interactive Booth EMD Serono has an interactive and innovative medical booth at CMSC. Attendees can learn more about EMD Serono's programs, pipeline and activities in neurology by visiting booth #701. EMD Serono has created an interactive experience for attendees, I'M Facing MS, which simulates changes in balance, fatigue, and vision that patients with MS experience. For every participant in the I'M Facing MS activity, EMD Serono will give a donation to the CMSC Foundation. On Thursday, May 25 at 5 p.m. CT we will present a $10,000 donation to the CMSC Foundation. Teamworks Program: A Virtual Team Addressing Patient Inquiries The CMSC, with support from EMD Serono, will launch an educational video series at this year's annual meeting. The videos are multi-purpose and are designed help the MS community prepare for doctor's appointments, gain knowledge when they are in between appointments, or aid physicians in providing education to their patients. The series will feature answers to patients' common questions and concerns, surrounding topics such as the symptoms that they are experiencing. The following abstracts were accepted for presentation at the CSMC 2017 Annual Meeting: About Cladribine Tablets Cladribine Tablets is an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of relapsing remitting multiple sclerosis. About Rebif® (interferon beta-1a) Rebif (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established. Important Safety Information Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation. Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif. Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury.  Monitor liver function tests and patients for signs and symptoms of hepatic injury.  Consider discontinuing Rebif if hepatic injury occurs. Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs. In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed. Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended. Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated. Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports. The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities. There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rebif full prescribing information is available at http://www.emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version= About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. About EMD Serono, Inc. EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. 1 Giovannoni G, et al. Benefits of Cladribine Tablets in patients with multiple sclerosis free from clinical and radiological indicators of disease activity in the CLARITY Extension study. Consortium of Multiple Sclerosis Centers. May 26, 2017; New Orleans, Louisiana. 2 Comi G, et al. Cladribine Tablets in the ORACLE-MS study open-label maintenance period: analysis of efficacy in patients after conversion to clinically definite multiple sclerosis (CDMS). Consortium of Multiple Sclerosis Centers. May 25, 2017; New Orleans, Louisiana. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/emd-serono-to-present-data-highlighting-investigational-cladribine-tablets-at-cmsc-2017-300463712.html


Under these agreements and upon delivery of pre-defined data packages, Merck KGaA, Darmstadt, Germany, has the option to acquire five of F-star's bispecific programs. This option includes exclusive development and commercialization rights to F-star's preclinical lead asset FS118, which is designed to block LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1), two pathways commonly used by cancer cells to evade the immune system. In addition, F-star will grant Merck KGaA, Darmstadt, Germany, exclusive development and commercial rights to four novel bispecific antibodies of Merck KGaA, Darmstadt, Germany's choosing from F-star's bispecific antibody platform. These bispecific antibodies target specific pathways to augment the anti-tumor immune response. In return, Merck KGaA, Darmstadt, Germany, will pay up to €115 million in upfront, R&D funding and milestone payments in the first 2 years, and may make further payments upon exercising its option and based on milestones. Merck KGaA Darmstadt, Germany, already has a bifunctional antibody in its pipeline, M7824. Currently in Phase I, M7824 is believed to combine two mechanisms in one molecule to fight cancer. The addition of assets from F-star's bispecific antibody platform enrich and complement Merck KGaA, Darmstadt, Germany's existing in-house technologies investigating molecules that offer the potential advantage of taking a dual approach to tackling cancer. Discovered in-house, M7824 is an investigational immunotherapy designed to simultaneously block two immuno-inhibitory pathways (PD-L1 and TGF-β) that are commonly used by cancer cells to evade the immune system. "This immuno-oncology collaboration expands our strong relationship with Merck KGaA, Darmstadt, Germany, and is a further validation of the potential of F-star's bispecific antibody platform," said John Haurum, CEO of F-star. "Our vision is to transform the treatment of cancer. This is the objective of partnering our lead asset FS118 and other next-generation immuno-oncology compounds with Merck KGaA, Darmstadt, Germany." Merck KGaA, Darmstadt, Germany, is committed to exploring an array of targets, and taking creative scientific approaches to developing novel therapies for hard-to-treat cancers. With the belief that rational combination is the key to the future of new and more efficacious treatment options, Merck KGaA, Darmstadt, Germany, has a particular focus on combination therapies, whether it be with chemotherapy/radiotherapy, other targeted therapies and/or immunotherapies from its own or external portfolios. The strength of Merck KGaA, Darmstadt, Germany's promising oncology development program and growing presence in the field of immuno-oncology demonstrates how the company is re-imagining the way cancer care is delivered. For further information and press materials on Merck KGaA, Darmstadt, Germany's activities in oncology, please visit http://www.emdgroup.com/emd/media/media_center_oncology.html All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany, generated sales of € 15.0 billion in 66 countries. Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the "Merck" name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/merck-kgaa-darmstadt-germany-strengthens-immuno-oncology-portfolio-through-expansion-of-f-star-collaboration-including-lag-3pd-l1-bispecific-antibody-300468333.html


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ENERGY.2009.3.3.1 | Award Amount: 36.65M | Year: 2010

The development and implementation of bio-refinery processes is an absolute necessity and the key to meet the vision towards bio-based economy. The EuroBioRef concept is an integrated, sustainable and diversified bio-refinery involving all biomass value chain stakeholders. The latter will allow large-scale research, testing, optimisation and demonstration of processes in the production of a wide range of products with the dual aim to use all fractions of various biomasses and exploit their potential to produce the highest value possible in an eco-efficient and sustainable way. Moreover, the project attempts to overcome the efforts fragmentation of the whole biomass value chain requiring greater networking, coordination and cooperation among a large variety of actors from biochemical and chemical industry, SMEs, scientific knowledge chain, and European organisations. The new concept will adopt a flexible and a modular process design adapted to large- but also small-scale production units easier to install in various European areas. The overall efficiency of this approach will clearly exceed existing pathways and will consider sustainable options in order to: - Produce and use a high diversity of sustainable biomasses adapted for European regions - Produce high specific energy bio-jet fuels (42 MJ/kg) - Produce multiple products (chemicals, polymers, materials) in a flexible and optimised way that take advantage of the differences in biomass components and intermediates - Improve cost-efficiency by 30% through improved reaction and separation effectiveness, reduced capital investments, improved plant and feedstock flexibility, reduction of production time and logistics - Reduce by 30% the energy - Produce zero waste and rationalise use of raw materials The impact of the project in terms of environment, social and economic benefits is important and could give a serious advantage for European bio-industry.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: HEALTH.2010.4.2-9-4 | Award Amount: 6.80M | Year: 2011

The COSMOS project will address the assessment needs of the cosmetics industry by delivering an integrated suite of computational tools to predict the effects of long-term exposure to cosmetic ingredients in humans, thus reducing the need for repeated dose toxicity testing in animals. To achieve this, individual modules comprising: (new) databases, thresholds of toxicological concern (TTC), in silico toxicology (grouping, read-across and QSAR), in vitro data and physiologically-based pharmacokinetic (PBPK) modelling, will be used to construct flexible workflows for assessing toxicity. The COSMOS project will be informed by the needs of industry through active stakeholder engagement, and will utilise innovative technologies from outside the cosmetics area. New databases for TTC and modelling studies will be created by harvesting US FDA legacy data for cosmetics. New and current databases will be combined to advance the state-of-the-art providing a transparent, freely-available public resource. Grouping and read-across will be achieved mechanistically and on the basis of structural similarity. The effective dose-response at the target organ will be estimated from in vitro effects and PBPK models, establishing an alternative (non-animal) basis for risk assessment. All models and Workflows developed will be transparent, fully documented and open access. The partners include world leaders committed to donating software and algorithms to support the open architecture. Data and models will be integratable with existing systems. Workflows will be automated through the KNIME software.


Rogov V.,Goethe University Frankfurt | Dotsch V.,Goethe University Frankfurt | Johansen T.,University of Tromsø | Kirkin V.,Merck KGaA
Molecular Cell | Year: 2014

Selective autophagy ensures recognition and removal of various cytosolic cargos. Hence, aggregated proteins, damaged organelles, or pathogens are enclosed into the double-membrane vesicle, the autophagosome, and delivered to the lysosome for degradation. This process is mediated by selective autophagy receptors, such as p62/SQSTM1. These proteins recognize autophagic cargo and, via binding to small ubiquitin-like modifiers (UBLs)-Atg8/LC3/GABARAPs and ATG5-mediate formation of selective autophagosomes. Recently, it was found that UBLs can directly engage the autophagosome nucleation machinery. Here, we review recent findings on selective autophagy and propose a model for selective autophagosome formation in close proximity to cargo. © 2014 Elsevier Inc.


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2011.3.6 | Award Amount: 4.98M | Year: 2011

SCOOP is focussed on OLED technology, microdisplays based on the combination of OLED with CMOS technology, and innovative visualisation systems. OLED microdisplays are based on Above-IC integration with the principal value chain being located in Europe. SCOOP intends to improve the competitiveness of European industry by helping the industrial partners to maintain and improve their technological advance and to extend their market share by enabling new products. The project will also contribute to strengthen Europes scientific and technology base in the field of OLED and thin film encapsulation, which can be leveraged for a variety of applications through the institutional partners and the material supplier involved in the project. The project will also provide system integrators with components with outstanding features enabling innovative products like informative eyewear or augmented reality glasses. Technical focus is on the development of OLED materials and devices with high brightness and high reliability as well as corresponding thin film encapsulation stacks, in order to overcome current limitations of OLED microdisplays, in particular for high end applications like electronic viewfinders, Head Mounted Displays for augmented reality, CAD, or professional applications. Moreover, by developing a new approach producing colour subpixels without colour filter in a simplified process, we will extend the field of application of OLED microdisplays to systems that require higher luminance for readability even in bright sunlight, like e.g. augmented reality glasses for medical, sports, or logistics. The partners cover the whole value chain, from research, materials, components to systems. All industrial partners have their main manufacturing sites located in Europe. The outcomes of the project are not limited to microdisplay applications but can apply to many OLAE devices like biosensors, small to large size direct view displays, lighting devices, or solar cells


Grant
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: ENERGY.2011.2.1-2;NMP.2011.1.2-1 | Award Amount: 10.02M | Year: 2012

This project will exploit the potential of chalcogenide based thin film photovoltaic technologies for the development and scale-up of new processes based on nanostructured materials for the production of high efficiency and low cost photovoltaic devices and modules compatible with mass production requirements. Cu(In,Ga)(S,Se)2 (CIGS) chalcogenide based devices have the highest efficiency of all thin film PV technologies, having recently achieved a record value of 20.3% at cell level. These technologies have already entered the stage of mass production, with commercial modules that provide stable efficiencies in the 11-12% range, and a predicted world-side production capacity over 2 GW/a for 2011. However, current production methods in CIGS industrial technologies typically rely on costly, difficult to control (over large surfaces) vacuum-based deposition processes that are known for low material utilisation of 30-50%. This compromises the potential reduction of material costs inherent to thin film technologies. At the forefront of this, the SCALENANO project proposes the development of alternative environmental friendly and vacuum free processes based on the electrodepositon of nanostructured precursors with the objective to achieve a much more efficient exploitation of the cost saving and efficiency potential of CIGS based PV. The project also includes the exploration and development of alternative new processes with very high potential throughput and process rate based in the use of printing techniques with novel nanoparticle ink formulations and new cost effective deposition techniques, that will allow proposing an industrial roadmap for the future generation of chalcogenide based cells and modules


Grant
Agency: European Commission | Branch: FP7 | Program: MC-ITN | Phase: FP7-PEOPLE-2012-ITN | Award Amount: 466.73K | Year: 2012

Electronic, label-free biosensors characterized by rapidity and detection proved to be very promising being able to directly detect biological recognition events without the need of markers. In this respect, organic bioelectronics has gained a huge interest among scientists coming from different disciplines and sectors due to its high impact on medical, clinical, food and environmental fields. Presently Europe holds a leading position in this research area, being almost all the world-leading research groups and industrial companies in this field located in Europe. Realizing the promise of Organic electronic sensors requires research and training in crossing disciplines, such as chemistry, biology, physics, materials science, and electrical engineering. The objective of this project is to strengthen the research in this new and fast developing strategic research field by teaching and training the next generation of scientists on OFET biosensors developments both in the academia and the private sectors. Innovative OFET biosensors for point-of-care application capable of sensitive, selective and reliable detection of analytes of clinical relevance will be developed. The novelty of the proposal is the development of OFET devices that fully integrate biological recognition elements, such as antibodies or other receptors to confer specificity. Specific reactions (i.e. antigen/antibody binding) will be then used for analyte detection. However, not only medical diagnostics but also a wide range of sensing applications (e.g. food monitoring, detection of chemical, biological poisoning agents, etc.) will benefit from these new OFET device configurations.


Harmonization of diagnostic nomenclature used in the pathology analysis of tissues from rodent toxicity studies will enhance the comparability and consistency of data sets from different laboratories worldwide. The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) is a joint initiative of four major societies of toxicologic pathology to develop a globally recognized nomenclature for proliferative and nonproliferative lesions in rodents. This article recommends standardized terms for classifying changes observed in tissues of the mouse and rat central (CNS) and peripheral (PNS) nervous systems. Sources of material include academic, government, and industrial histopathology databases from around the world. Covered lesions include frequent, spontaneous, and aging-related changes as well as principal toxicant-induced findings. Common artifacts that might be confused with genuine lesions are also illustrated. The neural nomenclature presented in this document is also available electronically on the Internet at the goRENI website (http://www.goreni.org/).


Czodrowski P.,Merck KGaA
Journal of Chemical Information and Modeling | Year: 2013

A detailed analysis of the hERG content inside the ChEMBL database is performed. The correlation between the outcome from binding assays and functional assays is probed. On the basis of descriptor distributions, design paradigms with respect to structural and physicochemical properties of hERG active and hERG inactive compounds are challenged. Finally, classification models with different data sets are trained. All source code is provided, which is based on the Python open source packages RDKit and scikit-learn to enable the community to rerun the experiments. The code is stored on github (https://github.com/pzc/herg-chembl-jcim). © 2013 American Chemical Society.

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