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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The logo of Swiss pharmaceutical company Roche is seen outside their headquarters in Basel, January 30, 2014. REUTERS/Ruben Sprich/File Photo ZURICH (Reuters) - Roche's Tecentriq immuno-oncology drug failed a late-stage follow-up trial against advanced bladder cancer, the Swiss drugmaker said on Wednesday, raising questions about whether regulators could scale back their approval of the medicine. Roche, the world's biggest maker of cancer drugs, had won fast-track approval last May in the United States for Tecentriq against bladder cancer but full approval hinged on further trials. Roche said a phase III IMvigor211 study that evaluated the drug in people with locally advanced or metastatic urothelial cancer whose disease progressed during or after treatment with chemotherapy "did not meet its primary endpoint of overall survival compared to chemotherapy." Roche said it was sticking by Tecentriq. "We believe that Tecentriq will continue to play an important role in the treatment for people with advanced bladder cancer, and will discuss these data with health authorities," a company spokesman said on Wednesday. The drug, also already approved for lung cancer, is a pillar of Roche's cancer drug strategy and is seen by its scientists as a backbone for multiple combinations with other drugs to fight various forms of the disease. The company has more than 30 trials ongoing with Tecentriq. In the first quarter, sales of Tecentriq, also known as atezolizumab, hit 113 million Swiss francs ($112.45 million), more than the 103 million estimate in a Reuters poll. "This puts the existing U.S. bladder cancer approval in serious doubt, and will also, of course, raise market concerns about Tecentriq's efficacy in other cancer types," Kepler Cheuvreux analyst David Evans wrote in a note to investors. Deutsche Bank analysts said the failure placed up to $1 billion in peak sales at risk, though they also said more important would be late-stage trial data, expected after July, about Tecentriq's performance in the larger, more-lucrative lung cancer setting. The failure also comes as more of Roche's rivals enter the market for treating bladder cancer. U.S. health regulators on Tuesday granted accelerated approval for Pfizer Inc's immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany's Merck KGaA. The IMvigor211 study had been meant to confirm a previous trial, called IMvigor210, that was central to the U.S. Food and Drug Administration's accelerated approval last year of Tecentriq against bladder cancer. While Tecentriq's results in Imvigor211 were consistent with its previous study, Roche said, patients getting chemotherapy in the latest trial survived longer than anticipated. "We will apply insights to the continued development of Tecentriq," Roche said. The failure of Tecentriq is the latest instance where cancer immunotherapies have not lived up to their promise of revolutionizing treatment. Tecentriq belongs to a class of drugs called PD-1 inhibitors, which help the immune system to fight cancer by blocking a mechanism that tumors use to evade attack. Last year, Bristol Myers-Squibb's Opdivo failed to do better than older chemotherapies.


"We hebben een positieve start van het jaar gekend. De indiening van de aanvraag voor regelgevende goedkeuring voor caplacizumab in Europa om aTTP te behandelen was een zeer belangrijke mijlpaal voor de Vennootschap, evenals de voltooiing van de patiëntenrecrutering in de Fase III HERCULES studie. We zijn nu een commerciële infrastructuur aan het opzetten om caplacizumab naar de markt te brengen en we zijn toegewijd om het zo snel mogelijk toegankelijk te maken voor patiënten. Initiële recrutering voor de Fase IIb studie met ons anti-RSV Nanobody in baby's loopt volgens plan en we gaan verder met de voorbereidingen voor een studie met dit Nanobody in patiënten die een stamceltransplantatie hebben ondergaan en die een RSV infectie hebben. Gesprekken met regelgevende instanties over onze Fase IIb data in RA met vobarilizumab en over een potentieel Fase III studieprogramma waren informatief in onze evaluatie rond het verderzetten van de molecule in deze indicatie. We verwachten nog steeds om data over onze SLE studie met vobarilizumab in 300 patiënten te rapporteren in H1 2018. Onze partners hebben ook goede vooruitgang geboekt in de ontwikkeling van Nanobodies die we samen hebben ontdekt. In het bijzonder in deze periode, waren Merck KGaA's resultaten van een Fase Ib studie in psoriasis met ons anti-IL-17A/F bispecifiek Nanobody uiterst boeiend. Met vandaag meer dan 45 O&O programma's in eigen ontwikkeling en met partners, waarvan 8 in klinische ontwikkeling, kijken we uit naar belangrijke vooruitgang in 2017." De inkomsten daalden tot €9,1 miljoen (2016: €27,4 miljoen), hoofdzakelijk door lagere erkende inkomsten van vooruitbetalingen uit de lopende samenwerkingsovereenkomst met AbbVie en door mijlpaalbetalingen ontvangen in het eerste kwartaal van 2016. Gezien de productportefeuille nu meer producten bevat die zich in een later stadium van ontwikkeling bevinden, stegen de operationele kosten tot €29,3 miljoen (2016: €28,1 miljoen), hoofdzakelijk door hogere externe O&O kosten. Het netto financiële resultaat was -€1,9 miljoen (2016: €17,5 miljoen), hoofdzakelijk als gevolg van het effect van de berekening van de reële waarde van de Converteerbare Obligatie. Als gevolg van het voorgaande, sloot de Vennootschap de periode af met een netto verlies van €22,1 miljoen (2016: netto winst van €16,8 miljoen). Per 31 maart 2017 had de Vennootschap €209,2 miljoen aan liquide middelen, kasequivalenten, in pand gegeven geldmiddelen en beleggingen op korte termijn. De cash burn van €26,2 miljoen ligt hoger dan vorig jaar door een vertraging in een betaling van €5,5 miljoen, die pas in het begin van Q2 2017 werd ontvangen en ook als gevolg van het groter aantal mijlpaal- en vooruitbetalingen die in Q1 2016 werden ontvangen. Ablynx verwacht om topline resultaten van de Fase III HERCULES studie met caplacizumab in aTTP patiënten te rapporteren in de tweede helft van 2017. Deze data zullen naar verwachting de recent ingediende aanvraag tot markttoelating (MAA) bij het Europees Geneesmiddelenbureau (EMA) en de geplande indiening van de vergunningsaanvraag voor biologische middelen (Biologics License Application - BLA) in de Verenigde Staten in 2018 ondersteunen. Ablynx is een biofarmaceutische onderneming actief in de ontwikkeling van Nanobodies®, gepatenteerde therapeutische eiwitten gebaseerd op enkel-keten antilichaamfragmenten die de voordelen combineren van medicijnen gebaseerd op conventionele antilichamen en kleine chemische moleculen. Ablynx is toegewijd om nieuwe medicijnen te ontwikkelen die een duidelijk verschil kunnen maken voor de samenleving. De Vennootschap heeft vandaag meer dan 45 programma's in eigen ontwikkeling en met partners in diverse therapeutische indicaties zoals inflammatie, hematologie, immuno-oncologie, oncologie en ademhalingsziekten. Ablynx heeft overeenkomsten met verscheidene farmaceutische bedrijven waaronder AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk en Taisho Pharmaceutical. De onderneming is gevestigd in Gent, België. Meer informatie is te vinden op www.ablynx.com.


Novac N.,Merck KGaA
Trends in Pharmacological Sciences | Year: 2013

Drug repositioning is an innovation stream of pharmaceutical development that offers advantages for drug developers along with safer medicines for patients. Several drugs have been successfully repositioned to a new indication, with the most prominent of them being viagra and thalidomide, which have generated historically high revenues. In line with these developments, most of the recent articles and reviews on repositioning are focused on success stories, leaving behind the challenges that repositioned compounds have on the way to the clinic. Here, I analyze repositioning as a business opportunity for pharmaceutical companies, weighing both challenges and opportunities of repositioning. In addition, I suggest extended profiling as a lower-risk cost-effective repositioning model for pharmaceutical companies and elucidate the novel collaborative business opportunities that help to realize repositioning of shelved and marketed compounds. © 2013 Elsevier Ltd.


Goodman S.L.,Merck KGaA | Picard M.,Merck KGaA
Trends in Pharmacological Sciences | Year: 2012

Integrins are a large family of molecules that are central regulators in multicellular biology. They orchestrate cell-cell and cell-extracellular matrix (ECM) adhesive interactions from embryonic development to mature tissue function. Diverse human pathologies involve integrin adhesion, including thrombotic diseases, inflammation, cancer, fibrosis and infectious diseases. Integrins are exciting pharmacological targets because they are exposed on the cell surface and are sensitive to pharmacological blockade, but the scale of current efforts involving integrin therapeutics continues to surprise. Several therapeutics targeting integrins are effective drugs: five have been approved for use in clinic, with combined sales of over $1.5 billion in 2010 (based on company reports from that year). We gathered information from three major drug-trial databases and found that ∼260 anti-integrin drugs have entered clinical trials. Here we overview integrins as drug targets and focus on cancer. © 2012 Elsevier Ltd. All rights reserved.


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


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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