Sartorius Stedim Biotech Closes Acquisition of Slovenian Purification Specialist BIA Separations

Sartorius | November 03, 2020

Sartorius Stedim Biotech (SSB), a leading partner of the biopharma industry, successfully closed the acquisition of the Slovenian purification specialist BIA Separations. The transaction was completed on November 2, 2020, after receiving the required approvals. "BIA's portfolio is highly complementary to Sartorius Stedim Biotech. We are thus creating an excellent offering for the manufacturing of gene therapies and other advanced therapies, and are pleased to welcome 120 new employees," said Dr. Joachim Kreuzburg, Chairman of the Board and CEO of Sartorius Stedim Biotech. The total purchase price of the transaction is 360 million euros of which 240 million euros were paid in cash and 120 million euros in SSB shares. Both parties have further agreed on three tranches of earn-out payments based on performance over the next five financial years. SSB has been preparing to integrate BIA Separations so this can now be initiated despite the special conditions prevailing during the pandemic. BIA Separations develops and manufactures market-leading products for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are used in cell and gene therapies and other advanced therapies. BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics, and the company also has a strong presence with such novel drug candidates in the clinical pipeline. Expecting continued very strong double-digit sales growth over the next few years, BIA is forecasted to earn sales revenue of approx. 25 million euros in 2020 at profit margins that will be accretive to the underlying EBITDA margin of the Sartorius Stedim Biotech Group. The transaction is not expected to have any material impact on Sartorius Stedim Biotech's 2020 results.

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The infant gut microbiota has a high abundance of antibiotic resistance genes (ARGs) compared to adults, even in the absence of antibiotic exposure. Here we study potential sources of infant gut ARGs by performing metagenomic sequencing of breast milk, as well as infant and maternal gut microbiomes. We find that fecal ARG and mobile genetic element (MGE) profiles of infants are more similar to those of their own mothers than to those of unrelated mothers.

Spotlight

The infant gut microbiota has a high abundance of antibiotic resistance genes (ARGs) compared to adults, even in the absence of antibiotic exposure. Here we study potential sources of infant gut ARGs by performing metagenomic sequencing of breast milk, as well as infant and maternal gut microbiomes. We find that fecal ARG and mobile genetic element (MGE) profiles of infants are more similar to those of their own mothers than to those of unrelated mothers.

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Gilead and MacroGenics Announce Oncology Collaboration to Develop Bispecific Antibodies

Gilead and MacroGenics | October 18, 2022

Gilead Sciences, Inc. and MacroGenics announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART® platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes. A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics. MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing. “MacroGenics’ bispecific expertise naturally complements Gilead’s portfolio strengths in immuno-oncology and our growing hematology franchise. We believe MGD024, with its potential to reduce CRS and permit intermittent dosing through a longer half-life, could translate to more patient-friendly dosing and enhanced clinical outcomes for people living with AML and MDS. This partnership is the latest in our efforts to develop and advance transformative new cancer therapies as we deepen our portfolio across oncology indications.” Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Development, Gilead Sciences Scott Koenig, MD, PhD, President, and CEO, MacroGenics said, “Rapid advances over the last decade have made CD123 a very promising target in oncology research. Advancing our bispecific DART molecule, MGD024, through a strategic collaboration with the team at Gilead will accelerate our ability to drive further development of MGD024 to the potential benefit of people living with blood cancers.” MacroGenics will be responsible for the ongoing Phase 1 study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points. The Phase 1 study will include a dose escalation segment and an expansion segment that is intended to evaluate MGD024 as monotherapy and in combination with other therapies across multiple indications. About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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QIAGEN and Neuron23 Partner to Develop Next-Generation Sequencing Companion Diagnostic for Novel Parkinson’s Disease Drug

QIAGEN and Neuron23™ | September 15, 2022

QIAGEN and Neuron23 Inc., an early stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, announced the signing of an agreement to develop a companion diagnostic for Neuron23’s brain penetrant leucine-rich repeat kinase inhibitor for Parkinson’s disease. Under the new Master Collaboration Agreement, QIAGEN will develop and validate a clinical trial assay that will detect a combination of biomarkers discovered by Neuron23 that together predict the responsiveness of Parkinson’s disease to a LRRK2 inhibitor. The partnership will support the clinical development of Neuron23’s drug candidate that is currently in the late stages of preclinical development. Subject to further clinical development, the agreement also covers options for the future development of additional companion diagnostics. Neuron23 joins a group of more than 25 leading pharmaceutical and biotechnology companies who have reached master collaboration agreements with QIAGEN to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance precision medicine for the benefit of patients around the world. The assay for this collaboration will be integrated into a next-generation sequencing workflow that leverages QIAGEN’s Sample to Insight capabilities, including instrumentation, IVD sample preparation, library preparation and bioinformatics. The workflow is planned to be developed using the NextSeqTM 500 System as part of the NGS strategic collaboration between QIAGEN and Illumina. Based on Neuron23’s artificial intelligence (AI)-enabled drug discovery and biomarker platform, it will target a complex signature of 50 single nucleic polymorphisms for U.S. and European populations and eventually additional SNPs that are prevalent in Asian populations. “The collaboration with Neuron23 shows the rapid momentum precision medicine is gaining in disease areas outside oncology. Our expertise in blood- and NGS-based molecular testing from Sample to Insight will enable Neuron23 to run a clinical trial for a drug candidate that may have the potential to modify the course of an inexorable neurodegenerative disease in a genetically defined population.” Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics, at QIAGEN “This collaboration combines the leading expertise of Neuron23 in drug discovery, data science, and machine learning with QIAGEN’s long-standing experience and global leadership in companion diagnostic development. QIAGEN’s blood-based test will help to identify patients with Parkinson’s disease who are likely to respond to Neuron23’s LRRK2 inhibitor. The development of a companion diagnostic identifying this sub-population of Parkinson’s disease patients will de-risk the clinical development of Neuron23’s LRRK2 inhibitor and help identify individuals who may benefit from this disease-modifying therapy. We are excited to be working with an industry leader on the first companion diagnostic developed for Parkinson’s disease,” said Nancy Stagliano, Ph.D., CEO of Neuron23. No laboratory tests are currently available for the diagnosis of non-genetic cases for Parkinson’s disease. Usually, the disease is diagnosed based on medical history and neurological examination. Although no cure currently exists for Parkinson’s disease, therapies are used to alleviate some symptoms. LRRK2 is a complex, multidomain protein found in neurons and many tissues and cell types throughout the body. Mutations in the LRRK2 gene are one of the most common causes of familial Parkinson’s disease and individuals who inherit gain of function mutations in LRRK2 are clearly at higher risk to develop the disease in later life. Additionally, there is emerging evidence that LRRK2 may play a role in a subset of the larger population of patients with non-familial Parkinson’s disease. Recent investigations have shown that small-molecule LRRK2 inhibitors can be neuroprotective, suggesting that therapies targeting LRRK2 could be beneficial in a larger population of patients. QIAGEN is a pioneer in precision medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to polymerase chain reaction and digital PCR for companion diagnostic development. QIAGEN has ten PCR based companion diagnostic indications that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer and NSCLC, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer. About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics, Applied Testing, Pharma and Academia. As of June 30, 2022, QIAGEN employed more than 6,100 people in over 35 locations worldwide. About Neuron23™ Neuron23™ Inc. is an early stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases. Neuron23 combines recent advances in human genetics with a state-of-the-art artificial intelligence (AI)-enabled drug discovery and biomarker platform to advance therapeutics for devastating diseases. The Company’s focus areas are neurodegenerative diseases, neuroinflammatory diseases, and systemic autoimmune and inflammatory diseases. Founded in 2018, Neuron23 has assembled a world-class team of experts and entrepreneurs located in South San Francisco, CA.

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Heska to Acquire LightDeck Diagnostics to Invest in Manufacturing Capabilities and Accelerate Research and Development Efforts

LightDeck Diagnostics and Heska | September 13, 2022

Heska Corporation a leading global provider of advanced veterinary diagnostic and specialty solutions, announced today that the Company has entered a definitive agreement to acquire 100% of the share capital of MBio Diagnostics, Inc. d/b/a LightDeck Diagnostics a pioneer in innovative planar waveguide fluorescence immunoassay diagnostics with strong manufacturing and specialized production capabilities. Founded in 2009 and headquartered in Boulder, Colorado, LightDeck has developed a scalable and innovative platform for rapid and accurate point of care diagnostics. LightDeck's 80-member team includes industry veterans, engineers, and scientists, with deep technical expertise in assay development, manufacturing, and software development, who have collaborated with commercial, academic, and government partners worldwide to build an extensive intellectual property portfolio of 16 US patents and 15 international patents with broad applications, including in veterinary diagnostics, water testing, and human in-vitro diagnostics use. LightDeck's planar waveguide technology optimizes laser activated fluorescence and microfluidics to provide point of care cartridge-based testing without compromise, enabling reference lab-quality results in minutes with inexpensive, quantitative, and easy-to-use functionality. LightDeck's current Boulder location includes fully equipped laboratories for assay development and controlled manufacturing capabilities that support its new, state-of-the-art, highly automated facility in Longmont, Colorado, anticipated to go online in 2023 to dramatically scale-up capacity, production, and research and development. "We are thrilled to welcome the entire LightDeck team to Heska. We have known and closely followed their success for years and we are happy to fully join with them today as one team focused on supercharging their great work. LightDeck brings to Heska best-in-breed, highly scalable manufacturing and world-class assay development to help drive our strategies for winning at innovation and winning at scale," commented Kevin Wilson, Heska's Chief Executive Officer and President. "LightDeck was central in developing Heska's leading immunodiagnostic platform, Element i+®, including its current menu of Total T4, cTSH, Cortisol, and Progesterone. Having proven our capability, we now take this next important step as we aim to drive production of Element i+® analyzers and cartridges at scale and to accelerate key test menu expansion, such as our recently announced Nu.Q® Vet Cancer Screen, cCRP, SDMA, infectious diseases, and more, in single and multi-plex formats that are substantially better than the competition. We expect to drive gross margin improvement with new manufacturing capabilities and scaling across the business. The addition of LightDeck is a great strategic, financial, and cultural fit with Heska as we continue our march to the top of the innovation and manufacturing competition for the most valuable diagnostics," concluded Mr. Wilson. "This is a terrific outcome for LightDeck and Heska and their shareholders, employees and commercial partners. We have known and worked with Heska for years and we greatly admire the Heska organization. Since its founding in 2009, LightDeck has been dedicated to revolutionizing testing at the point of care- for faster, more accurate, less expensive, multi-plex testing of the most important diagnostic tests. We have developed one of the most innovative and technologically-advanced assay platforms in the world, which has led to our recent addition to Fast Company's Annual List of the World's 50 Most Innovative Companies for 2022. I am very proud of the work our team has accomplished over the last 13 years." LightDeck's Co-Founder and Chief Technology Officer, Mike Lochhead, went on to say, "We are excited to now enter this next phase with Heska to dramatically expand our reach and scale. What we do at LightDeck matters a great deal. With Heska, we go confidently into our next commercial, manufacturing, and development chapters, strongly engaged, highly supported, and clearly set-up for long-term success and growth." Nick Traggis, LightDeck's Chief Executive Officer About Heska Heska Corporation manufactures, develops and sells advanced veterinary diagnostics, informatics, and specialty healthcare solutions through its two business segments: North America and International. Both segments include Point of Care Lab testing instruments and consumables, digital imaging products, software and services, data services, allergy testing and immunotherapy, and single-use offerings such as in-clinic diagnostic tests and heartworm preventive products. The North America segment also includes private label vaccine and pharmaceutical production for third-parties, primarily for herd animal health. About LightDeck Diagnostics LightDeck Diagnostics believes in a new approach to healthcare, where quick and accurate diagnostic tests will be run wherever and whenever they are needed. The company's proprietary LightDeck® platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes. The LightDeck platform is achieving success in veterinary diagnostics and for environmental testing. LightDeck is also developing a portfolio of in vitro diagnostic panels. The company is based in Boulder, Colorado, and is recognized as Colorado BioScience Association's Company of the Year, 2021.

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