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Fails second Phase
Novavax’s RSV vaccine

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Pharmaceuticals

Following the news on 28 February 2019 that Novavax’s respiratory syncytial virus (RSV) disease vaccine for infants – ResVax – did not meet its primary Phase III endpoint, Paul Jeng, PhD, Pharma Analyst at GlobalData, a data and analytics company, offers his view on the future prospects for ResVax in RSV prevention:

“This is the second Phase III trial of ResVax to miss primary efficacy objectives, following disappointing results from a 2016 study to prevent RSV-associated lower respiratory tract infections (LRTI) in elderly adults. As a silver lining, ResVax did meet its secondary trial objectives, with 44% and 48% efficacy against RSV LRTI hospitalizations and severe hypoxemia, respectively. If the vaccine is ultimately cost-effective, it may find a commercial window as a preventative measure against the most serious consequences of RSV infection. Novavax can also continue its early-stage development of ResVax in young children as a pediatric vaccine.

A successful vaccine for prevention of serious RSV infections in infants has been elusive to drug developers due to issues with suboptimal neonatal immune response and challenges in vaccine antigen selection. However, the competition to establish a first-to-market advantage will grow stronger as other RSV vaccines, including Janssen’s Phase II vaccine (Ad26.RSV.preF) that encodes a pre-fusion F protein, advance through clinical trials. Moreover, AstraZeneca and Sanofi’s prophylactic monoclonal antibody, MEDI8897, recently received an FDA Breakthrough Therapy Designation and is positioned for a pivotal Phase III study, with potential to cut into future RSV market share. Novavax’s best case scenarios for ResVax now include a longer approval horizon or more restricted target patient population than initially anticipated.”

Conveying & Filling, Packaging, Labeling & Storage Fairs Pharmaceuticals Plant Construction, Engineering & Components

Feeder Design for the Pharmaceutical Industry
Feeding Solution for Demands of Processing

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Coperion K-Tron’s new QT20 and QT35 pharmaceutical feeders with redesigned trapezoid scale shape and significantly smaller footprint are optimized for multi-feeder clusters around a process inlet.
Coperion K-Tron’s new QT20 and QT35 pharmaceutical feeders with redesigned trapezoid scale shape and significantly smaller footprint are optimized for multi-feeder clusters around a process inlet. (Picture: Coperion K-Tron)

At this year’s Interphex as well as at Powtech Coperion K-Tron will display the next generation of its highly accurate, gravimetric K3-PH feeders for the pharmaceutical industry. These modular feeders have been specially designed to meet the growing demands of continuous processing. Thanks to the use of a smaller D4 platform scale incorporating the patented and highly accurate Smart Force Transducer (SFT) weighing technology, they require significantly less floor space compared to previous models. Depending on the process and requirements, several feeders can be grouped into a cluster, for example for continuous processes such as direct compression (CDC), extrusion, wet and dry granulation, and continuous coating as well as traditional batch processes.

Easy handling and better product quality

The modular design of this innovative feeder line simplifies cleaning and reduces changeover times. The “Quick Change” design, whereby the feeder bowl can be quickly decoupled from the feeder drive, also enables simple and fast product changes. By simply releasing two clamps, the used feeding unit can be removed and replaced with a clean one.

The three available Coperion K-Tron feeder types QT20, QT35 and QS60 (twin and single screw) can be used with the same scale and drive units. They are interchangeable, depending on the product to be fed, the required feed rates and the necessary scale resolution. For an optimal Wet-In-Place (WIP) result, every unit has an integral two degree pitch facilitating maximum drainage during the cleaning process. In addition, the feeder bowls and hoppers feature a new improved seal design for optimal product containment. The complete line of equipment is engineered to meet the rigid requirements of the pharmaceutical industry, including strict adherence to cGMP guidelines and standards as well as the use of FDA approved materials of construction. Initial industry reactions to the design include very positive comments on the use of a single gearbox for the complete speed ranges of all feeder models.

High-accuracy weighing with patented SFT technology

The new D4 platform scale features the same state-of-the-art sanitary design of the established Coperion K-Tron D5 scale. Smooth, crevice free surfaces prevent deposit of dust and product residue and enable easy cleaning. The redesign of the scale from a round design to a trapezoid design features a much smaller footprint and facilitates an optimized multi-feeder arrangement. This is especially useful in areas with limited space, where multiple ingredients must be fed into one process inlet. At the heart of the new D4 scale, Coperion K-Tron’s patented SFT single wire weighing technology provides a highly accurate weight signal with a resolution of 1:4,000,000 in 80 ms. The electronics include linearization, temperature compensation and a digital low-pass filter to reduce the effect of plant vibration. The 100% digital design eliminates the need for calibration.

Coperion at the Interphex 2019: Booth 2558

Coperion at the Powtech 2019: Hall 4, Booth 290

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Pharmaceuticals

Merck
All-Cash Proposal to Acquire Versum

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Merck, a science and technology company, today delivered a letter to the Board of Directors of Versum Materials, Inc. (“Versum”), outlining the terms of a superior proposal to acquire Versum for $ 48 per share in cash, representing a premium of 51.7% to the undisturbed trading price per Versum share on the trading day prior to announcement of the Entegris, Inc. (“Entegris”) transaction (January 25, 2019). Merck’s proposal is therefore substantially superior to the Entegris transaction.

“We truly believe in the power of a combined electronic materials portfolio of Merck and Versum. Our attractive cash proposal to Versum’s investors underlines that we are fully committed to completing this transaction successfully”, said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck. “It is our clear intention to further strengthen our operations in the U.S. We are proud of our nearly 130 years of U.S. market history and already more than 10,000 highly qualified employees today working at more than 50 sites coast-to-coast.”

The combination of Merck’s and Versum’s businesses would create a deep and complementary portfolio of electronic materials, equipment and services for the semiconductor and display industries. The combined R&D capabilities would enable faster innovation cycles and strengthen the product offering to customers. They would offer increased scale, product and service depth, an enhanced global presence and a strengthened supply chain, which would help drive leading innovation supported by long-term tailwinds in the industry. Moreover, they would provide an additional source for innovation through leading positions in attractive segments.

All-cash consideration offering attractive premium

Merck’s all-cash proposal represents an attractive premium across key benchmarks:

  • 51.7 % premium to Versum’s undisturbed share price, on January 25, 2019, the day prior to the Versum-Entegris merger announcement;
  • 15.9 % premium to Versum’s current share price as of February 26, 2019

Additionally, the all-cash proposal offers Versum’s shareholders certain value, and does not leave them exposed to integration or other post-merger risks. With Merck’s strong credit rating, the transaction will be fully financed and the transaction agreement will not have a financing contingency.

Commitment to strengthen U.S. operations

Merck has a strong reputation for innovation and has demonstrated a robust commitment to R&D spending and capital investment. As the long-term secular trends in science and technology continue to drive lasting demand for electronic materials, the leaders will be those willing to invest, innovate and adapt in this fast-developing environment. Merck believes this philosophy is consistent with Versum’s culture and strength of its employees, and as such intends to maintain Versum’s Tempe, AZ site as the major hub for the combined electronic materials business in the U.S., complementing Merck’s already strong commitment to this important market.

An opportunity for Versum employees

The firm is a long-term oriented, predominantly family-owned science & technology company. “Performance, People & Technology” are its three strategic priorities. In Merck’s more than 350-year history, people have always been and will continue to be at the center of everything it does.

Rge company already has a strong footprint in the U.S. and a track record as a top employer. Over the past decade, the company has invested some $24bn in the U.S. through acquisitions alone, including the successful acquisitions of Millipore in 2010 and Sigma-Aldrich in 2015.

Versum employees will become an integral part of a leading electronic materials business and will benefit from new and exciting development opportunities within a truly global science and technology company.

Timing

The company is confident it can close a transaction with Versum in the second half of 2019, assuming expedient engagement by the Versum Board of Directors. Merck’s long track record of completing acquisitions, its strong balance sheet and investment-grade credit rating position the combined company well for a future of investment and growth. Unlike the Entegris transaction, the only shareholder approval required by Merck’s proposal is that of Versum’s shareholders, and Merck fully expects to receive all customary regulatory clearances in a timely manner.

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Conveying & Filling, Packaging, Labeling & Storage Pharmaceuticals

Future of the pharmaceutical industry
Solid Dosage Packaging wins Pharmapack Award

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Huhtamaki’s Push Tab has been selected as the Best Innovation in the Solid Dosage Packaging category in 2019 Pharmapack Awards
Picture: Huhtamaki

The annual awards recognize new innovative products that are set to shape the future of the pharmaceutical industry. Push Tab is a flexible blister solution for tablet packaging. It presents a new child-safe way of opening a strip pack by pushing through the tablet.

The material provides the highest barrier properties with improved shelf life. The barrier properties are not affected in any way by pushing through the film and thus guarantee the highest levels of product safety. The risk of migration is also very low, as the laminate does not contain any solvents. Based on the typical market specification of PET-PE-Alu-PE/Surlyn, Push Tab is suitable for all climate zones.

The Push Tab packaging is available in unlimited forms and shapes for differentiation. The material is also easy to print on with different technologies, which provides new opportunities for design and product visibility.

It’s main benefit for many applications is to be PVC free, cost effective as well as with only one specification suitable for all different climate zones. Recyclable version are under development.

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