BUSINESS INSIGHTS, VIEWS AND ANALYSIS
HOVIONE | December 15, 2022
Hovione and GEA announced a strategic collaboration to advance Continuous Tableting. This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology.
The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance.
"Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all. We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption."
Jean-Luc Herbeaux, CEO of Hovione. He adds
Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology."
About Hovione
Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
About GEA
GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology.
The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance.
"Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all." Says Jean-Luc Herbeaux, CEO of Hovione. He adds "We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption."
Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology."
About Hovione
Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
About GEA
GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".
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BUSINESS INSIGHTS, PHARMA TECH
Arrowhead and Amgen | December 21, 2022
Arrowhead Pharmaceuticals Inc. announced a $25M milestone payment from Amgen. This milestone was triggered by the first subject enrolled in Amgen’s Phase 3 trial of olpasiran. Arrowhead is further eligible to receive up to an additional $535 million in aggregate development, regulatory, and sales milestone payments from Amgen and Royalty Pharma plc.
“We are pleased with the great progress on the clinical development of olpasiran, which was developed using Arrowhead’s proprietary TRiMTM technology. This is an important milestone for the program and for Arrowhead, as this is the second TRiMTM-enabled candidate to enter Phase 3 studies. Importantly, as our pipeline continues to advance expeditiously, we anticipate multiple Arrowhead therapies will also reach Phase 3 trials over the coming year.”
Christopher Anzalone, Ph.D., Arrowhead’s president and CEO
Olpasiran is a small interfering RNA originally developed by Arrowhead using its proprietary Targeted RNAi Molecule, or TRiM, platform and licensed to Amgen in 2016. It is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically determined risk factor for cardiovascular disease. Phase 2 study results from the OCEAN(a)-DOSE study were presented at the American Heart Association Scientific Sessions 2022, where olpasiran demonstrated a significant and sustained reduction in Lp(a) levels over 36 weeks. These data were simultaneously published in the New England Journal of Medicine on November 6, 2022.
About Lp(a)
Lp(a) is genetically determined1-3 and a presumed independent risk factor for cardiovascular disease. Although an agreed upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).1 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.3
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
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BUSINESS INSIGHTS
BC Platforms | November 25, 2022
BC Platforms a global leader in healthcare data management and analytics announced that it has been chosen as key partner in a European Commission project. Under the EC's Horizon Europe program*, Helsinki University Hospital has been awarded a contract to lead a EURO 7 million consortium project termed ONCOVALUE. BCP will work closely with HUS as a key delivery partner in this major EC project.
ONCOVALUE is an Artificial Intelligence-based framework which assesses, in real-time, real-life effectiveness of novel cancer therapies. It does this by standardising data processing in hospitals enabling them to efficiently measure the cost effectiveness of new cancer therapies for Health Technology Assessment (HTA) and regulatory purposes. BCP will aid in core aspects of the project, including creating the technical architecture and providing the data analysis, to ensure this technology can transform unstructured patient data from medical notes and images into structured data and real-world evidence (RWE) that clinicians can use in treatment management and with health regulatory and HTA bodies
"This latest partnership with ONCOVALUE is part of our rapidly expanding Trusted Collaborative Environment solution. I'm proud our sophisticated healthcare data management and analytics products have been recognised by this significant, four-year, Horizon Europe project. By opening the door to widespread regulatory and HTA integration of real-world data, ONCOVALUE should lead to better, more environmentally sustainable therapies, technologies, and digital solutions for cancer care."
Tero Silvola, CEO of BC Platforms
Johanna Mattson, HUS's Senior Medical Director in Oncology, said, "ONCOVALUE aims to develop novel AI-based tools to automate the collection and analytics of clinical data. This will contribute to the increased cost-effectiveness and sustainability of European cancer care. Systematic collection and evaluation of patient reported outcomes should lead to improved health and well-being and should reduce the growing global burden of cancer treatment."
The ONCOVALUE consortium is made up of eleven institutions and companies in Finland, The Netherlands, Denmark, Portugal, and Italy. Over the four-year project span, annually around 40,000 European patients will participate from hospitals in the consortium.
About BC Platforms
BC Platforms is a global leader in building data networks for the life sciences industry and provides versatile technology platforms for personalised medicine, accelerating the translation of innovations into clinical practice. We convert complex biological information collected in the healthcare setting into actionable insights. With our innovative technology we are creating a patient centric infinity loop between the life sciences and healthcare sectors. Data we generate, harmonise, and manage, from diverse biobanks and healthcare institutions, is made accessible for pharmaceutical and biotech companies to enhance their core strengths in research and development. In parallel, we enable stratification of patients towards targeted therapies, delivering on the promise of more personalized healthcare.
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