Mutant monkey clones could aid study of autism

March 8, 2019 | 59 views

Scientists have created five monkey clones, all carrying the edited version of a specific gene. The monkeys’ birth shows that it is possible to make genetically identical primates that can serve as models of specific conditions. Genetically identical animals are useful for studying the genes underlying conditions such as autism: Scientists can alter a certain autism gene in one animal, for example, and compare it with another animal, making the effects of the mutation obvious. Monkeys are ideal models because their genetics and behavior are similar to those of people.

Spotlight

Harvest Healthcare Ltd

Harvest Healthcare Ltd is the leading manufacturer and distributor of quality healthcare equipment to the NHS, Care Home and Community markets, throughout the UK and internationally. We are continually developing our range of products to deliver a complete solution for all modern care environments. Focused on meeting the ever-evolving needs of patients, Harvest deliver quality and value for money.

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RESEARCH

Expansion of BioPharma: Opportunities and Investments

Article | July 11, 2022

Biopharmaceutical innovations are among the most ingenious and refined achievements of modern medical science. New concepts, techniques, and therapies are emerging, such as the cell therapy Provenge, which can be used to treat cancer, and gene therapies, which provide even more amazing promises of disease remission and regenerative medicine. In addition, the COVID-19 pandemic has caused a huge boom in the pharmaceutical industry. This is because more and more attention is being paid to increasing manufacturing capacity and starting new research on drug development. Biopharma: Leading the Way in the Pharma Sector In the past couple of years, the biopharmaceutical sector has deepened its roots across the medical and pharmaceutical industries, on account of the transformation of pharmaceutical companies towards biotechnology, creating opportunities for growth. Also, growing advancements in technologies such as 3D bioprinting, biosensors, and gene editing, along with the integration of advanced artificial intelligence and virtual and augmented reality are estimated to further create prospects for growth. According to a study, the biopharmaceutical sector makes nearly $163 billion around the world and grows by more than 8% each year, which is twice as fast as the traditional pharma sector. Massive Investments Directed Towards Biopharma Investing in biotech research and development (R&D) has yielded better returns than the pharma industry average. Hence, a number of pharmaceutical companies are shifting their presence toward biopharma to capitalize on the upcoming opportunities by investing in and expanding their biotechnology infrastructure. For instance, Thermo Fisher Scientific Inc., an American manufacturer of scientific instrumentation, reagents and consumables, and software services, announced an investment of $97 million to expand its bioanalytical laboratory operations into three new locations in the U.S. With this investment, the company will add 150,000 square feet of scientific workspace and install the most advanced drug development technologies to produce life-changing medicines for patients in need.

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MEDTECH

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | July 13, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MEDICAL

Biotech in 2022

Article | August 16, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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MEDTECH

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | July 5, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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Spotlight

Harvest Healthcare Ltd

Harvest Healthcare Ltd is the leading manufacturer and distributor of quality healthcare equipment to the NHS, Care Home and Community markets, throughout the UK and internationally. We are continually developing our range of products to deliver a complete solution for all modern care environments. Focused on meeting the ever-evolving needs of patients, Harvest deliver quality and value for money.

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INDUSTRIAL IMPACT

Ordaōs and NonExomics Announce Research Collaboration

Ordaōs and NonExomics | September 29, 2022

Ordaōs, a biotechnology company designing novel miniPROTM mini-proteins to help drug hunters deliver life-saving treatments, and NonExomics, a company specializing in the identification of novel targets from non-conventional protein-coding regions, announced a proof-of-concept research collaboration. As part of this endeavor, Ordaōs will use its proprietary design engine to generate and rank novel miniPRO™ candidates that meet specific target product profiles, beginning with three targets. NonExomics will conduct pre-clinical certification of these identified MinPRO™ proteins to demonstrate their promising commercial value. "This partnership allows us to spotlight the power of our Design Engine to create customized miniPRO™ proteins that are more configurable, penetrable and stable, and easier to manufacture. Our collaboration with NonExomics also allows us the mutual opportunity to underscore the potential of our specialties utilizing machine-driven technology." David Longo, CEO of Ordaōs NonExomics identifies whether novel proteins can function as drug targets for therapeutic purposes or can be used for diagnostic processes. The company has developed a technology that effectively combines artificial intelligence, proteomics, transcriptomics, and genomics to identify novel targets for quicker diagnosis and treatment of diseases that are currently considered to be incurable or difficult to manage. NonExomics plans to develop new therapies and diagnostics based on its proprietary nonexomic targets. "We at NonExomics are thrilled to be embarking on this exciting collaboration between our companies to fuel our shared goal of pursuing and developing new therapies for poorly treated or currently deemed incurable diseases," said Sudhakaran Prabakaran, PhD, CEO and Co-Founder of NonExomics. To select miniPRO™ candidates, Ordaōs will use its multitask meta-learning Ordaōs Design Engine to generate, appraise, and rank hundreds of thousands of proteins on their structures and drug-like properties for novel miniPRO™ candidates that meet the requirements of the desired specifications of NonExomics' product profile. NonExomics will then conduct a series of pre-clinical demonstrations of the selected Ordaōs miniPRO™ designs to prove they meet the specified product profiles. More About The Ordaōs Design Engine Ordaōs uses The Ordaōs Design Engine, to deliver true protein property design - leveraging continuous learning loops and proprietary data sets to translate human-targeted product criteria into machine-designed mini-proteins. Starting with amino acids, the Design Engine generates, appraises, and ranks billions of protein sequences and hundreds of thousands of protein structures and properties to create customized miniPRO™ proteins. These proteins are then rapidly evaluated in vitro to provide intelligent feedback on multiple design objectives including protein structure, binding specificity and affinity, solubility, stability, immunogenicity, and developability. This iterative process delivers optimized mini-proteins to meet the client's specific molecular target product profile (mTPP). They are also less likely to cause adverse side effects and are easier and less expensive to test, develop, and manufacture than traditional proteins. Using this approach, the Ordaōs Design Engine creates more ideal, unseen protein leads than others and can accelerate drug candidate development, increasing the probability of more therapeutically effective candidates. All of this provides clients with a high level of confidence in their investigational new drug (IND) applications. About Ordaōs Ordaōs is a human-enabled, machine-driven drug design company that helps birth novel therapies to reduce patient suffering, improve health, and extend life. Our flagship solution, miniPRO™ mini-proteins, enable drug hunters to deliver safer and more effective treatments in a fraction of the time of traditional discovery methods. About NonExomics NonExomics science and platform developed over eight years of rigorous academic and industry research, mines novel disease-associated proteins using the dark genome. NonExomics has opened up a new area of science with unlimited possibilities to cure diseases.

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CELL AND GENE THERAPY

Hamilton and BioFluidica Pen Next Generation Liquid Biopsy Platform Co-Marketing Agreement

BioFluidica, Inc. | September 28, 2022

Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips. This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy. "LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system." Rolf Muller, BioFluidica CEO About Hamilton Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions. Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world. About BioFluidica BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.

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CELL AND GENE THERAPY

Emergent BioSolutions Completes Acquisition of Exclusive Worldwide Rights to TEMBEXA® First FDA-Approved Smallpox Oral Antiviral for All Ages

TEMBEXA and Smallpox | September 27, 2022

Emergent BioSolutions Inc. announced that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® the first oral antiviral approved by the U.S. Food and Drug Administration for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent. “The addition of TEMBEXA to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat. We look forward to supporting the U.S. government’s smallpox preparedness strategy on a broader scale by executing on this BARDA contract.” Paul Williams, SVP government/MCM business at Emergent The 10-year contract valued at up to $680 million, to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government, was awarded to Chimerix on August 29, 2022. The contract includes an initial product procurement valued at approximately $115 million, with optional future procurement, valued at up to approximately $551 million, exercisable at the sole discretion of BARDA. In addition to product procurement, the contract includes reimbursed post marketing activities of approximately $12 million. Financial Terms Based on the terms of the final BARDA agreement, Emergent is expected to pay Chimerix An upfront payment of $238 million; Potential milestone payments of up to $124 million contingent on the potential exercise by the U.S. government of procurement options following the base period; 15% royalty on gross profit from sales of TEMBEXA outside the U.S.; 20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of the 1.7 million treatment courses as contemplated in the existing BARDA contract; and Up to an additional $12.5 million upon achievement of certain development-based milestones. ABOUT TEMBEXA TEMBEXA is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA has a BOXED WARNING for increased risk for mortality when used for longer duration. About Smallpox Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention variola virus is ranked in the highest risk category for bioterrorism agents due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community. About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

Read More

INDUSTRIAL IMPACT

Ordaōs and NonExomics Announce Research Collaboration

Ordaōs and NonExomics | September 29, 2022

Ordaōs, a biotechnology company designing novel miniPROTM mini-proteins to help drug hunters deliver life-saving treatments, and NonExomics, a company specializing in the identification of novel targets from non-conventional protein-coding regions, announced a proof-of-concept research collaboration. As part of this endeavor, Ordaōs will use its proprietary design engine to generate and rank novel miniPRO™ candidates that meet specific target product profiles, beginning with three targets. NonExomics will conduct pre-clinical certification of these identified MinPRO™ proteins to demonstrate their promising commercial value. "This partnership allows us to spotlight the power of our Design Engine to create customized miniPRO™ proteins that are more configurable, penetrable and stable, and easier to manufacture. Our collaboration with NonExomics also allows us the mutual opportunity to underscore the potential of our specialties utilizing machine-driven technology." David Longo, CEO of Ordaōs NonExomics identifies whether novel proteins can function as drug targets for therapeutic purposes or can be used for diagnostic processes. The company has developed a technology that effectively combines artificial intelligence, proteomics, transcriptomics, and genomics to identify novel targets for quicker diagnosis and treatment of diseases that are currently considered to be incurable or difficult to manage. NonExomics plans to develop new therapies and diagnostics based on its proprietary nonexomic targets. "We at NonExomics are thrilled to be embarking on this exciting collaboration between our companies to fuel our shared goal of pursuing and developing new therapies for poorly treated or currently deemed incurable diseases," said Sudhakaran Prabakaran, PhD, CEO and Co-Founder of NonExomics. To select miniPRO™ candidates, Ordaōs will use its multitask meta-learning Ordaōs Design Engine to generate, appraise, and rank hundreds of thousands of proteins on their structures and drug-like properties for novel miniPRO™ candidates that meet the requirements of the desired specifications of NonExomics' product profile. NonExomics will then conduct a series of pre-clinical demonstrations of the selected Ordaōs miniPRO™ designs to prove they meet the specified product profiles. More About The Ordaōs Design Engine Ordaōs uses The Ordaōs Design Engine, to deliver true protein property design - leveraging continuous learning loops and proprietary data sets to translate human-targeted product criteria into machine-designed mini-proteins. Starting with amino acids, the Design Engine generates, appraises, and ranks billions of protein sequences and hundreds of thousands of protein structures and properties to create customized miniPRO™ proteins. These proteins are then rapidly evaluated in vitro to provide intelligent feedback on multiple design objectives including protein structure, binding specificity and affinity, solubility, stability, immunogenicity, and developability. This iterative process delivers optimized mini-proteins to meet the client's specific molecular target product profile (mTPP). They are also less likely to cause adverse side effects and are easier and less expensive to test, develop, and manufacture than traditional proteins. Using this approach, the Ordaōs Design Engine creates more ideal, unseen protein leads than others and can accelerate drug candidate development, increasing the probability of more therapeutically effective candidates. All of this provides clients with a high level of confidence in their investigational new drug (IND) applications. About Ordaōs Ordaōs is a human-enabled, machine-driven drug design company that helps birth novel therapies to reduce patient suffering, improve health, and extend life. Our flagship solution, miniPRO™ mini-proteins, enable drug hunters to deliver safer and more effective treatments in a fraction of the time of traditional discovery methods. About NonExomics NonExomics science and platform developed over eight years of rigorous academic and industry research, mines novel disease-associated proteins using the dark genome. NonExomics has opened up a new area of science with unlimited possibilities to cure diseases.

Read More

CELL AND GENE THERAPY

Hamilton and BioFluidica Pen Next Generation Liquid Biopsy Platform Co-Marketing Agreement

BioFluidica, Inc. | September 28, 2022

Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips. This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy. "LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system." Rolf Muller, BioFluidica CEO About Hamilton Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions. Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world. About BioFluidica BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.

Read More

CELL AND GENE THERAPY

Emergent BioSolutions Completes Acquisition of Exclusive Worldwide Rights to TEMBEXA® First FDA-Approved Smallpox Oral Antiviral for All Ages

TEMBEXA and Smallpox | September 27, 2022

Emergent BioSolutions Inc. announced that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® the first oral antiviral approved by the U.S. Food and Drug Administration for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent. “The addition of TEMBEXA to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat. We look forward to supporting the U.S. government’s smallpox preparedness strategy on a broader scale by executing on this BARDA contract.” Paul Williams, SVP government/MCM business at Emergent The 10-year contract valued at up to $680 million, to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government, was awarded to Chimerix on August 29, 2022. The contract includes an initial product procurement valued at approximately $115 million, with optional future procurement, valued at up to approximately $551 million, exercisable at the sole discretion of BARDA. In addition to product procurement, the contract includes reimbursed post marketing activities of approximately $12 million. Financial Terms Based on the terms of the final BARDA agreement, Emergent is expected to pay Chimerix An upfront payment of $238 million; Potential milestone payments of up to $124 million contingent on the potential exercise by the U.S. government of procurement options following the base period; 15% royalty on gross profit from sales of TEMBEXA outside the U.S.; 20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of the 1.7 million treatment courses as contemplated in the existing BARDA contract; and Up to an additional $12.5 million upon achievement of certain development-based milestones. ABOUT TEMBEXA TEMBEXA is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA has a BOXED WARNING for increased risk for mortality when used for longer duration. About Smallpox Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention variola virus is ranked in the highest risk category for bioterrorism agents due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community. About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

Read More

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