BUSINESS INSIGHTS

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

TriMas Closes on Acquisition of Omega
TriMas announced that it has closed the acquisition of Omega Plastics (“Omega”), a manufacturer of custom components and tooling for medical, as well as industrial applications, adding to TriMas’ Packaging group.

Omega leverages its core injection molding capabilities, ISO Class 8 clean room and advanced in-house tool making capabilities, to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega’s medical components are currently used in drug delivery, including consumable intravenous applications, as well as diagnostic testing and orthopedic applications.

As of September 30, 2021, TriMas’ Packaging group’s last twelve months sales were approximately $534 million, representing approximately 64% of TriMas’ total sales. TriMas plans to expand Omega’s production capacity, as required in order to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add to TriMas Packaging’s speed-to-market advantage on innovation and new product designs. Omega is expected to generate approximately $18 million in revenue in fiscal year 2021.

We welcome Omega to TriMas’ family of businesses and look forward to working with the Omega leadership team to unleash future growth opportunities. I’d like to thank all the teams from Omega, TriMas and our respective advisors that supported the work to complete this transaction.”

 Thomas Amato, TriMas President & CEO

The addition of Omega further expands TriMas Packaging’s Pharmaceutical & Nutraceutical product offering into supporting medical device contract development manufacturing customers.

Spotlight

When it comes to enlisting the cancer-fighting potential of the body’s immune defenses, Amgen believes versatility is a virtue. Dave Reese discusses Amgen’s growing cancer immunotherapy research capabilities. Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago.

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RESEARCH

eDeviation the Latest Protocol Deviations Cloud Software Solution

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance. Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams. "With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations." About Protocol Deviations A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity. About eDeviation eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.

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BUSINESS INSIGHTS

Karo Pharma acquires OTC brand portfolio from Teva Pharmaceuticals

Karo Pharma, Teva Pharmaceuticals | February 04, 2021

Karo Pharma Aktiebolag ("Karo") today reports the securing of an OTC brand portfolio containing Flux®, Decubal®, Lactocare®, Apobase®, Dailycare® and Fludent® from Teva Pharmaceuticals (Teva) for an absolute thought of EUR 84m. The exchange moves responsibility for brand portfolio, included Flux®, Decubal®, Lactocare®, Apobase®, Dailycare® and Fludent® from Teva to Karo. The brands created deals barely shy of EUR 35m in 2020 on a worldwide premise. The greater part is created in the Nordic business sectors, including Scandinavia, where the brands as of now are dispersed and showcased by Karo under a 7-year permit arrangement that was endorsed in the spring of 2019. The exchange adds around EUR 4m in net deals from new business sectors outside of Scandinavia of which approx. 80% is in Finland. The exchange disentangles the business set-up and gives Karo control of the resources, in this way preparing for long haul advancement of the brands and the worth chain. As far as monetary effect Karo will acknowledge direct investment funds in year 1 of simply under EUR 5m as expenses to Teva are disposed of. Karo as of now popularizes the items in Scandinavia and has dynamic associations with the agreement manufacturers that supply the brands. Subsequently, restricted added expenses and faculty are needed as an immediate aftereffect of the exchange. "The transaction is in full alignment with our strategy of owning and commercializing strong OTC brands within everyday healthcare. It gives us full global control of a very exciting brand portfolio that we will develop and optimize over the next years. It strengthens our position in the Nordic markets and notably it expands our business in Finland where we did not previously control these brands. Over the next years we shall expand life cycle management opportunities, drive activation across more channels and explore geographical market expansion", says Christoffer Lorenzen, CEO of Karo Pharma. The obtaining is an unadulterated resource bargain. No staff or assembling locales are incorporated, which limits business just as the innovation move chances. The exchange, which is financed with existing money and requires no extra credit facilities, is relied upon to close on April 1. About Karo Pharma Karo Pharma delivers smart choices for everyday healthcare. We own and commercialize branded, original over-the-counter products and prescription medicines. Our products are available in more than 60 countries, with Europe and the Nordic region as our core markets. Karo Pharma is headquartered in Stockholm, Sweden and listed on Nasdaq Stockholm Mid Cap.

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New AMR Action Fund steps in to save collapsing antibiotic pipeline with pharmaceutical industry investment of US$1 billion

AMR Action Fund | July 09, 2020

Today, more than 20 leading biopharmaceutical companies announced the launch of the AMR Action Fund, a ground-breaking partnership that aims to bring 2-4 new antibiotics to patients by 2030. These treatments are urgently needed to address the rapid rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR. The companies have raised so far nearly US$1 billion new funding to support clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections. Through the AMR Action Fund, pharmaceutical companies will join forces with philanthropies, development banks, and multilateral organizations to strengthen and accelerate antibiotic development. The Fund will focus on urgent public health needs. It will provide much needed financial resources, as well as important technical support to help biotech companies bring novel antibiotics to patients. The AMR Action Fund, an initiative of the international body representing the R&D pharmaceutical industry (International Federation of Pharmaceutical Manufacturers & Associations, IFPMA), was announced at simultaneous virtual launch events in Berlin, Germany, and Washington, D.C., USA, with a third event in Tokyo, Japan taking place on July 10.

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Spotlight

When it comes to enlisting the cancer-fighting potential of the body’s immune defenses, Amgen believes versatility is a virtue. Dave Reese discusses Amgen’s growing cancer immunotherapy research capabilities. Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago.