Merck announced that data from across its multiple sclerosis (MS) portfolio will be presented at the American Academy of Neurology (AAN) 2019 Annual Meeting, 4–10 May 2019 in Philadelphia, United States. Merck will present a total of 20 abstracts (18 posters and two platform presentations), including data on Mavenclad (cladribine tablets), the investigational therapy evobrutinib (an oral, selective Bruton’s Tyrosine Kinase (BTK) inhibitor) and Rebif (interferon beta-1a), as well as findings from the patient perceptions initiative by MS in the 21st Century.
“The wealth of data to be presented at AAN 2019 highlights our continued progress across our portfolio of marketed products and investigational agents in multiple sclerosis,” said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck. “We are very proud of our commitment to further the understanding of multiple sclerosis and enhance our clinical development program to meet the needs of patients.”
Key Mavenclad data will include:
- Post-hoc analysis of the Clarity Extension study to examine the durability of no evidence of disease activity-3 (NEDA-3) in relapsing MS (RMS) patients receiving cladribine tablets
- Integrated analysis of pooled long-term safety data of cladribine tablets in patients with MS collated from the Clarity, Clarity Extension, Oracle-MS studies and the Premiere registry
- A new analysis of the speed of onset of the MRI effect is presented. At 3 months the effect on new inflammatory lesions was apparent in the Oracle-MS study. In the same study consistency in clinical outcomes was observed across different patient subgroups defined by patient and disease characteristics at baseline
- Abstracts from the Oracle-MS study describe the effect of cladribine tablets on early MS
- Results from studies investigating the biological effects of cladribine tablets, including the effect on lymphocyte proliferation, and endothelial responsiveness to tumour necrosis factor and its effect on hematopoietic precursors and immune cells, to offer further insights on the potential mode of action of cladribine tablets
Key evobrutinib data will include:
- Results of analysis of the efficacy and safety of evobrutinib in patients with RMS over 48 Weeks: a randomized, placebo-controlled, phase 2 study
Key Rebif data will include:
- Investigation from the European Interferon Beta (IFNβ) pregnancy registry and Nordic health study into the prevalence of pregnancy outcomes in IFNβ-exposed women
- Results from the Improve study on the dynamics of pseudo-atrophy in RMS patients treated with interferon beta-1a as assessed by monthly brain MRI
Merck will also be announcing the launch of a new, collaborative MS research network called ‘MS-LINK’ (Leadership and Innovation Network), an initiative that brings together a community of multiple sclerosis stakeholders to form a scientific foundation for sustainable transformation of MS care, with the shared goal of improving patient outcomes.
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.
Turning the first spadeful
New Center of Excellence for meat portioning
As part of an official celebration, the first spadeful of earth was turned today for the construction of a new factory at TVI Entwicklung und Produktion GmbH in Bruckmühl. A state-of-the-art complex covering around 9,000 square metres of available space will be built there, and it will include an office building and Customer Center as well as the production hall. Completion is planned for May 2020, and the total investment amounts to approx. 17.5 million euros.
TVI is the market leader in meat-portioning machines and complete portioning lines. The product portfolio includes solutions for tempering, pressing, portioning and automating, as well as grill stick winders and equipment for producing kebab skewers. Since January 2017 Multivac has held a majority share in the company – and with the construction of the new building it is now creating the ideal conditions for further sustainable growth.
A large number of guests took part in the celebrations at Bruckmühl, among them Richard Richter, Mayor of Bruckmühl, Alois Allgaier and Thomas Völkl, the two CEOs of TVI, as well as Multivac Directors, Guido Spix (CTO/COO) and Christian Traumann (CFO).
Continuing to expand the position in precision meat portioning
“The Portioning Machinery Business Unit is developing in a very satisfactory manner. By investing in the new factory, we are facilitating the expansion of our product portfolio and at the same time enabling TVI’s leading position in precision meat portioning to be consolidated,” explained Guido Spix, CTO and COO of Multivac. “The number of employees is due to increase from the current 120 to around 250 in the coming years.”
The new Center of Excellence for meat portioning will include a production hall of around 5,600 square metres for the Pre-fabrication and Assembly areas as well as the Logistics, Warehouse and Development departments. The new factory will use a deep-well system to ensure that the building is cooled by ground water.
In addition to this, there will be a three-storey office building with a total area of 1,920 square metres, in which a modern canteen, high-quality offices and a recreation room will be housed. “When designing the new facility with its state-of-the-art working environment as well as its various functional areas and meeting places, it was very important for us to create an environment for our staff, in which they feel at ease and can find all the requirements for their work,” explained Alois Allgaier, CEO of TVI.
A two-storey Customer Center covering an area of around 1,400 square metres, including several demonstration rooms and a Customer Lounge, rounds off the new complex. “This will enable us in future to offer our customers the ideal conditions for discussing and demonstrating our high-performance portioning solutions under real conditions,” said Thomas Völkl, CEO of TVI. “It will also be possible to carry out individual trials with customers’ own products, as well as testing the solutions for feasibility, output, return on investment, give-away and other critical factors.”
Instant coffee in Vietnam
Freeze-dried coffee production plant for Tata Coffee
Gea has completed a new freeze-dried instant coffee plant on a green field site in Vietnam for Tata Coffee Vietnam Company Limited, a 100% subsidiary of Tata Coffee Limited, India.
According to the timetable for the contract project which was signed two years ago, the new plant was inaugurated on March 6, 2019 – just 19 months after the groundbreaking ceremony.
Vietnam is the world’s second largest producer of green coffee, after Brazil. The plant in the Binh Duong Province produces 5,000 metric tons/annum of freeze-dried coffee. Gea supplied the entire production line from roast bean treatment right through to the packing of the freeze-dried powder using its proven technology. This included: Carine extraction which operates at optimal conditions, using precisely developed extraction times to obtain the highest possible yields while respecting the final product quality; aroma recovery; mechanical vapor recovery (MVR) evaporation; and a Conrad 600 XL Eco freeze dryer for highly efficient continuous operation with minimal energy consumption. The company also supplied a complete pilot plant, providing Tata with facilities where it can develop exclusive blends for customers.
Previous work carried out for Tata Coffee includes a coffee extraction and evaporation plant that Gea built for the company in India in 2013. Gea also has extensive experience of building coffee plants in Vietnam and this local experience was extremely useful as Gea project managers were able to provide Tata with support in sourcing experienced and reliable local partners for managing, utilities, installation and workshop facilities. The factory required nearly one million man hours to build and maintain an exemplary safety record. The site has been certified for LEED (Leadership in Energy and Environmental Design) and is expecting BRC (British Retail Consortium) certification shortly.
Kim Knudsen, Head of Sales, Coffee and Freeze Drying at Gea said that the Tata factory in Vietnam had been a model project for the company. “This type of project is ideal for us at Gea because our expertise and scope of supply allows us to build the entire coffee line using our own resources,” he said. “This means we can maintain control and take responsibility for the entire project from start to finish.”