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Infectious diseases
Commercial opportunities for vaccine developers

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Although development of interventions for emerging infectious diseases (EIDs) has traditionally been limited by a lack of market incentives, novel funding mechanisms and global partnerships for outbreak preparedness are expanding the commercial prospects for vaccine developers, according to GlobalData, a leading data and analytics company.

The company’s latest report: Vaccines for Emerging Infectious Diseases: Funding, R&D, and Global Partnership Strategies, finds that philanthropic organizations and public-private partnerships like the Coalition for Epidemic Preparedness Innovations (CEPI) are filling a niche for funding translational and clinical vaccine research, allowing development of vaccines for diseases such as Lassa fever to occur even in the absence of an ongoing epidemic. As of November 2018, there were 235 vaccines in preclinical investigation, clinical development, or marketed for twelve major EIDs.

“EIDs are uniquely challenging for vaccine development due to unpredictable clinical incidence or geographical patterns. In response to recent global outbreaks, such as the 2013-2016 West African Ebola epidemic, global partnerships have been formed to stimulate vaccine development with a blend of push and pull market incentives. Chief among these are advanced market commitments (AMCs) from health organizations to subsidize vaccine development by purchasing a vaccine before licensure.”

Paul Jeng, PhD, Infectious Diseases Analyst at GlobalData

GlobalData’s report also finds that 90.2% of marketed or experimental vaccines for major EIDs are still in preclinical or clinical development, leaving significant opportunity for drug developers to enter relatively open disease landscapes for numerous indications.

Jeng continues, “There is a wide gap in the stage of vaccine development for different EIDs. For instance, there have been 57 planned, ongoing, or completed clinical trials for vaccines to prevent Ebola virus disease, and Merck’s Phase III product, V920, is expected to receive FDA approval in 2019. However, the majority of EIDs do not have any licensed vaccine products. Some EIDs including Middle East Respiratory Syndrome (MERS) and Crimean-Congo Hemorrhagic Fever (CCHF) have had experimental vaccines tested in fewer than six clinical trials.”

“KOLs interviewed by GlobalData believed that regulators and vaccine developers are moving towards adaptive clinical trials that factor in rapid surges and declines in disease incidence. Instead of requiring a single large, randomized Phase III trial for vaccine approval, new strategies include collecting and combining data across multiple outbreaks, and expanding avenues for post-marketing studies to evaluate safety and clinical benefit,” concludes Jeng.

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Participation in a collaboration
Advance Vaccine Development and Manufacturing

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Merck and genOway Form CRISPR/Cas9 Strategic Alliance to Develop Rodent Models

Merck, a science and technology company, announced its participation in a collaboration with the Vaccine Formulation Institute and the European Vaccine Initiative. The effort will provide vaccine process development training courses within Transvac2, a collaborative infrastructure project under Horizon 2020.

“Involvement in this project is a natural extension to our longtime focus on accelerating vaccine development and manufacturing,” Udit Batra, member of the Merck Executive Board and CEO, Life Science. “Through the Transvac2 initiative, we are able to lend our expertise in vaccine research and development in this critically important field.”

Funded by the European Commission (EC), Transvac2 exists in part to accelerate vaccine development by enhancing European vaccine research and training and increase sustainability of EC vaccine projects by implementing a permanent research infrastructure for early vaccine development. Merck is among a list of collaborators joining the Transvac2 program.

As part of the program, Merck will hold a two-day training module in 2019 and in 2021 and will host applicants, selected by the Transvac2 Course Selection Panel, at Merck’s recently inaugurated M Lab Collaboration Center in Molsheim, France.

Participants will experience simulated lab processes, which will help them acquire fundamental skills needed for process development and will acquaint them with a single-use environment.

Merck’s focus, to find effective ways to accelerate vaccine development and manufacturing, includes collaborative work with leading research institutes and industries to introduce new technologies that advance the global vaccine industry. For this initiative, Merck is tapping its internal manufacturing expertise and process knowledge in viral vaccines and vectors.

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Collaboration extended by a further two years
European Space Agency and Merck Expand Cooperation

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Merck, a science and technology company, and the European Space Agency (ESA) signed a Letter of Intent to extend by a further two years their cooperation agreement from 2016. The two partners will continue to cooperate intensively in the fields of innovation, digitalization and materials research. With respect to innovation, the focus will be on the fields of Biosensing and Biointerfaces, Clean Meat and Liquid Biopsy technologies.

“It is our goal to continue and intensify the exchange between ESA and Merck in a targeted manner. Scientific progress is the key to improving the lives of millions of people. Partnerships, such as this one with ESA, help to accelerate this progress and thus to achieve objectives faster.”

Kai Beckmann, CEO Performance Materials and member of the Executive Board of Merck

“The profile and strategic interests of both organizations complement each other superbly,” said Rolf Densing, Director of Operations and Head of the European Space Operations Center (ESOC) at ESA. “This allows both partners to openly share and make use of synergies in terms of competences, methods and tools.”

Merck and ESA began cooperating in 2011 and had most recently extended their partnership in 2016. The focus of the agreement signed today is on the following topics:

Innovation: Future projects will be derived from the three strategic innovation fields of the Merck Innovation Center (Biosensing and Biointerfaces, Clean Meat and Liquid Biopsy technologies). The aim is to make contributions that will further the development of human space exploration.

Moreover, both partners will further share their experience and competence in the area of innovation processes, for instance, in stimulating innovation in both organizations in the context of the Merck Innovation Center or via the newly established managerial position of Innovation Officer on the ESA side.

The topic of Biosensing and Biointerfaces focuses mainly on the interface between biology and digitalization. By applying data analysis tools, faster and more precise (remote) monitoring and treatment will be enabled  in numerous disease areas. The focus of Clean Meat is on the biotechnology required to produce genuine meat grown in vitro. The third innovation field targets technological solutions to overcome unresolved challenges in the liquid biopsy workflow to detect diseases sooner and more readily.

Digitalization: Digitalization offers significant potential for ESA and Merck. Both organizations therefore aim to continue the exchange between their scientists and engineers on new and innovative technologies such as automation and autonomy concepts, artificial intelligence, cloud computing, simulation, and Big Data, and virtual reality methods for laboratory and exploration activities on both sides.

Materials Research: The development of new, high-performance materials is a core activity of ESA and Merck. Potential collaboration fields include liquid crystal technologies, coatings, and semiconductors.

Beyond the specific development of innovations, an intensive dialogue on future topics is also part of the collaboration. For example, in recent years, a series of events and activities have taken place. These include a co-hosted hackathon as well as a presentation by German ESA astronaut Thomas Reiter for selected scientists at Merck in Darmstadt. At the Innovation and Leadership in Aerospace Conference in 2018 in Berlin, Kai Beckmann and Rolf Densing were members of a panel discussion entitled “Space meets Non-Space”. As the only non-space industry partner, Merck participated for the second time in a cross-industry challenge at ESA’s second Space Exploration Masters last year. The topic of the winning team was use of bioreactors in space to solve the problem of having an autonomous food and oxygen supply at a lunar base.

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Merck
Chairman of the Supervisory Board re-elected

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The newly appointed Supervisory Board of Merck KGaA re-elected Wolfgang Büchele as its Chairman at its constitutive meeting directly following the 24th Annual General Meeting. Michael Fletterich was also confirmed as Vice Chairman, representing the employee side. Apart from Büchele and Fletterich, four further shareholder representatives were elected by shareholders at the Annual General Meeting in Frankfurt am Main. Moreover, two shareholder representatives were directly appointed by E. Merck KG. The eight employee representative members had already been elected on April 11. The Supervisory Board members are appointed for the period until the end of the Annual General Meeting 2024, which is to resolve on the approval of actions for fiscal 2023.

The new Supervisory Board of Merck KGaA consists of the following members: Dr. Wolfgang Büchele (Chairman), Michael Fletterich (Vice Chairman), Dr. Gabriele Eismann, Edeltraud Glänzer, Jürgen Glaser, Sascha Held, Michael Kleinemeier, Renate Koehler, Anne Lange, Peter Emanuel Merck, Dr. Dietmar Oeter, Dr. Christian Raabe, Helene von Roeder, Prof. Dr. Helga Rübsamen-Schaeff, Dr. Daniel Thelen, and Dr. Simon Thelen.

The term of office of the previous Supervisory Board members expired upon conclusion of the 2019 Annual General Meeting. In addition, the Annual General Meeting approved the actions of the Executive Board and the Supervisory Board of Merck KGaA for fiscal 2018 by a large majority and approved all of the resolutions on the agenda, including the proposed dividend of € 1.25 per share. Merck is thus maintaining the dividend at a stable level although earnings per share pre (EPS pre), which is decisive for the dividend to be paid, declined in 2018.

Around 1,000 shareholders took part in the Annual General Meeting. When the resolutions were voted on, around 86.5 million shares were represented, corresponding to 66.96 % of the approximately 129.2 million shares issued.

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