Gilead Sciences, Inc. | August 05, 2022
Gilead Sciences, Inc. and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.
The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.
MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.
“The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.”
“We are excited to be joining Gilead. MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.”
Eliot Charles, Chairman of MiroBio
Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.
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, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California
Sartorius Stedim Biotech | August 09, 2022
Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has agreed to acquire 100 percent of Albumedix Ltd. from private investors. The Nottingham, UK-based company provides best-in-class recombinant albumin-based solutions. Recombinant human albumin is an important component for the biopharmaceutical industry required for various applications, for example as an animal-free additive to cell culture media and for the stabilization of vaccines and viral therapies. The business, founded in 1984, has more than 100 employees and is expected to generate revenue of approximately £33 million in 2022 with a significant double-digit EBITDA margin. The agreed purchase price amounts to approximately £415 million. The transaction is subject to regulatory approval and is expected to close before the end of the third quarter of 2022.
"Albumedix will be an important addition to Sartorius Stedim Biotech's advanced therapy solutions, particularly regarding our cell culture media business, as it will enable us to strengthen our position as a relevant supplier of innovative chemically defined media and critical ancillary materials. This market offers high growth potential due to the increasing regulatory requirements as well as rising demand for the use of recombinant human albumin in near-patient applications. Albumedix will also add important formulation excipients to our vaccine production solutions, allowing us to expand our existing customer relationships and forge new ones,"
René Fáber, member of the Board of Directors and Deputy CEO of Sartorius Stedim Biotech
"We are delighted to be joining forces with Sartorius Stedim Biotech and look forward to accelerating our ambitious growth plans in delivering critical solutions to our global customers. We have been highly impressed with Sartorius Stedim Biotech's knowledge and capabilities in the bioprocessing markets, and we are excited to join this purposeful journey. We believe Sartorius Stedim Biotech will bring tremendous value in strengthening our market reach and broadening our innovation capacity, as well as significantly scaling up our existing platform. We remain focused on our promise of empowering excellence in the life science industry," said Jonas S. Møller, CEO of Albumedix.
The existing 72,000-square-foot Albumedix site in Nottingham will be established as a center of excellence for innovation and GMP-compliant production of critical raw materials in Sartorius Stedim Biotech.
Milbank LLP provided legal counsel to Sartorius Stedim Biotech in this transaction. William Blair acted as financial advisor to Albumedix, and Eversheds Sutherland provided legal counsel.
This press release contains forward-looking statements about the future development of the Sartorius Stedim Biotech Group. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such statements. Sartorius Stedim Biotech assumes no liability for updating such statements in light of new information or future events. This is a translation of the original French-language press release. Sartorius Stedim Biotech shall not assume any liability for the correctness of this translation. The original French press release is the legally binding version.
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a total solutions provider, the company helps its customers to manufacture biotech medications safely, rapidly and economically. Headquartered in Aubagne, France, the shares of Sartorius Stedim Biotech S.A. are quoted on the Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In 2021, the company employed more than 10,400 people, and earned sales revenue of around 2.89 billion euros.
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.
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.
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.