Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet

Janssen Pharmaceutical Companies of Johnson & Johnson | April 11, 2019

MIAMI, April 11, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson unveiled new 48-week data for SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF) showing that a high proportion of HIV patients achieved an undetectable viral load through 48 weeks after rapidly starting SYMTUZA®. A secondary endpoint of the study also showed that 97% of patients reported they were satisfied with their treatment.1 The results from the DIAMOND study – the first prospective Phase 3 trial studying the rapid initiation of a single-tablet regimen (STR) – were presented at the 13th Annual American Conference for the Treatment of HIV (ACTHIV 2019) in Miami, Florida. The DIAMOND study evaluated the once-daily STR SYMTUZA® for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients who were enrolled within 14 days of receiving an HIV diagnosis and then started on SYMTUZA® before laboratory or baseline resistance test results were available.1 SYMTUZA® is approved by the U.S. Food & Drug Administration (FDA) for the treatment of HIV-1 infection in treatment-naïve and certain virologically suppressed adults.

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Artemisinin-based combination therapy (ACT) is the best available treatment to treat malaria Thanks to a successful partnership with Medicines for Malaria Venture (MMV), a dispersible version is now available for children.


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Qualigen Therapeutics Acquires Majority Stake in Infectious Disease Diagnostics Technology Company NanoSynex

Qualigen Therapeutics, Inc. | June 03, 2022

Qualigen Therapeutics, Inc. a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has completed the acquisition of a majority stake in NanoSynex Ltd., an Israeli-based developer of next generation diagnostics technology. NanoSynex’s award winning technology is an Antimicrobial Susceptibility Testing (AST) platform that aims to provide clinical laboratories worldwide with a rapid, accurate and personalized test for bacterial infections, especially difficult-to-treat drug resistant strains, with the goal of quickly matching the correct antibiotics at the correct concentration to treat a patient’s specific infection. Antibiotic misuse and overuse have given significant rise to more frequent and more deadly antibiotic resistant bacteria, such as Methicillin-resistant Staphylococcus aureus (MRSA). Multi-drug resistant pathogens such as these have been declared a substantial threat to U.S. public health and national security by the Institute of Medicine and a federal Interagency Task Force on Antimicrobial Resistance. According to some estimates, the global infectious disease diagnostics market is expected to reach ~$39.8 Billion by 2026 from ~$28.1 Billion in 2021. “Living through two and a half years of COVID-19 has taught us the critical role diagnostics plays in combating infectious disease, and the need to be prepared for the next wave. NanoSynex’s technology shows great promise in rapidly and accurately matching antibiotics to the target bacteria, and in doing so, quickly equipping healthcare providers with the data needed to treat their patients with the right antibiotic at the right dose at the right time. We strongly believe in the potential of this platform, and our ability to leverage our long-standing diagnostics development, regulatory and commercial expertise to help bring the NanoSynex diagnostics technology to market sooner.” Michael Poirier, Qualigen's Chairman and CEO “We are excited about beginning a new journey with Qualigen and joining forces in a common mission to develop innovative diagnostics. This partnership takes the NanoSynex AST platform to the next level," added NanoSynex Co-Founder and Chief Executive Officer, Diane Abensur Bessin. NanoSynex is led by a dynamic team of healthcare subject matter experts, microbiologists, and engineers, including its co-founders – Diane Abensur Bessin and Michelle Heymann, who were selected for Forbes’ 2020 Tech 30 Under 30 list. Qualigen’s diagnostics team, led by Shishir Sinha, Senior VP and Chief Operating Officer, will work closely alongside the Israeli-based NanoSynex team on technology development, regulatory path, and commercial preparedness. Qualigen also envisions potential synergies with its proprietary FastPack® diagnostics platform to further strengthen the Company’s diagnostics business which has seen a post-COVID-19 resurgence. Qualigen’s purchase of the controlling interest in NanoSynex was primarily accomplished via a stock-for-stock acquisition with a controlling shareholder of NanoSynex. Qualigen also provided an investment in NanoSynex at closing and will provide future milestone-based funding leading to the commercialization of this technology. NanoSynex’s Board will initially be comprised of two current NanoSynex directors – NanoSynex co-founders - and two Qualigen appointees – Mr. Poirier and Mr. Sinha. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions. About NanoSynex NanoSynex is a MedTech company that aims at providing new solutions to improve testing quality, patient outcomes, and reduce healthcare costs by speeding up diagnostic processes. NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST). The technology is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth. This disruptive development was born from exciting research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the Technion Institute of Technology – Biomedical Engineering Faculty.

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Vetsource Expands Its Solution Set to Include Data and Insights, Client Engagement

Vetsource | February 28, 2022

Vetsource®, a pet health company that provides innovative pharmacy, technology and business services designed to help customers provide products and services to those who care for pets, has added data and insights, and client engagement offerings to its portfolio of customer solutions. Previously focused primarily on the home delivery of prescription and nonprescription items on behalf of veterinary practices, Vetsource has expanded its services in order to build a world-class infrastructure to help its veterinary practice, industry and retail customers deliver a competitive and personalized experience for their clients. The portfolio expansion is the result of Vetsource's investment in two companies – VetSuccess and Vet2Pet – as part of a long-term strategy to continue to meet the needs of its customers, and ultimately pet owners. "As the veterinary market has evolved, we've recognized the need to expand our solution set to help our customers engage with their clients in meaningful ways and leverage data to improve compliance rates and revenue. These services are a natural complement to our prescription management solution," Kurt Green, Vetsource CEO As the industry's leading data experts, VetSuccess provides performance reports, dashboards, and data services to veterinary practices, as well as robust analytics and quantitative veterinary insights to industry partners. These intuitive and interactive solutions allow customers to gain a deeper understanding of business performance, uncover actionable insights and make confident decisions that improve day-to-day operations. "With our strong alignment on company culture and core values, VetSuccess is a natural fit to join forces with Vetsource," said Katie McClean, Managing Director of VetSuccess. "We're proud to apply our expertise to help Vetsource deliver a data-driven platform that simplifies workflows and fosters growth for veterinary practices, ultimately providing the solutions partners need to break barriers and build bridges that strengthen the human-animal bond." Vet2Pet offers veterinary medicine's only customizable, all-in-one client connection system and app. Features like appointment management, pharmacy refills, 2-way chatting and texting, reminders, and rewards programs make it easy for practices and pet owners to interact, increase practice revenue, and save staff an average of three hours of phone time each day. "Joining Vetsource will help us achieve the dream we've had for Vet2Pet since its inception. Veterinarians will now have access to sophisticated software that elevates the client experience, improves team efficiency, and helps practices retain their pharmacies. This is a win for everyone," said Dr. Stacee Santi, Managing Director of Vet2Pet. In addition to product development, Vetsource has made significant investments in its workforce, leadership, and pharmacy operations, including the addition of a new pharmacy on the East Coast in 2021. Over the last three years, Vetsource has focused on building the teams that will drive products forward by more than doubling its workforce, including a deep investment in engineering talent. Vetsource recently hired Chief Product Officer, Ami Murthy, who brings extensive experience in product management and consumer ecommerce from leadership roles at companies such as eBay and Amazon. "Our dedication to providing a powerful platform is demonstrated not only in the investments we have made in enhancing our products, but also in the expertise of our teams," added Green. "After more than a decade as a pioneer in this market we want to continue to lead the way and we're just getting started." About Vetsource Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and their caretakers. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement. Founded in 2008 to help veterinary practices compete in the online marketplace with a home delivery solution, Vetsource expanded with the acquisitions of VetSuccess and Vet2Pet. Comprising over 500 employees, Vetsource is headquartered in Portland, Ore., with additional offices in Colorado, Oklahoma, Pennsylvania and Toronto, as well as multiple pharmacy locations.

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BD TO ACQUIRE PARATA SYSTEMS TO ENTER NEW PHARMACY AUTOMATION SOLUTIONS MARKET

BD | June 07, 2022

BD a leading global medical technology company, and Frazier Healthcare Partners, a leading private equity firm focused exclusively on the health care sector, today announced a definitive agreement for BD to acquire Parata Systems, an innovative provider of pharmacy automation solutions, for $1.525 billion. Parata's portfolio of innovative pharmacy automation solutions power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience. Significant macro trends such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacists are driving demand for intelligent workflow solutions. Through the use of automation and advanced software, pharmacists can focus more of their time on higher value clinical work and patient interactions to help improve medication adherence, medication safety and patient outcomes. The transaction will be complementary to BD's solutions in medication management with a new set of technologies across the care continuum, including acute care health systems, retail pharmacies, long-term care and home settings. Parata provides BD access to a new $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. Together with BD, the company expects Parata's solutions to outpace market growth through BD's commercial footprint, global scale and innovation capabilities. "Parata expands BD's solutions to a new area of the high-growth pharmacy automation space and is a prime example of BD executing our disciplined M&A strategy. Parata has a highly attractive financial profile and compelling value proposition that meets all of our rigorous investment criteria on growth, profitability and returns. With the addition of Parata, BD further advances our 2025 growth strategy around smart, connected care and enabling new care settings. We look forward to welcoming the talented Parata team to BD." Tom Polen, chairman, chief executive officer and president of BD Rob Kill, chief executive officer of Parata added, "BD and Parata share a common purpose with closely aligned cultures. We are very proud of the company the team has built at Parata over the past 21 years and feel BD is a great home for our company, innovative solutions and technology, and Parata's team members. The combination with BD will further advance our purpose of powering pharmacies to help people lead healthier lives." About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. About Parata Systems Parata provides pharmacy technology solutions to reduce costs, enhance patient safety and improve the patient experience by offering a comprehensive pharmacy automation portfolio with medication adherence packaging, high-speed robotic dispensing technologies and pharmacy workflow solutions. About Frazier Healthcare Partners Founded in 1991, Frazier Healthcare Partners is a leading private equity firm focused exclusively on the healthcare sector. With over $7.1 billion in total capital raised, Frazier has invested in more than 200 companies with transaction types ranging from buyouts of profitable healthcare services companies to venture capital and company creation. Frazier has a philosophy of partnering with strong management teams while leveraging its internal operating resources and network to build exceptional companies. Frazier has offices in Seattle, WA, and Menlo Park, CA, and invests broadly across the U.S., Canada, and Europe.

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PHARMACY MARKET

Orbit Discovery and WuXi AppTec Sign Agreement to Access Peptide Discovery and Optimisation Technologies

Orbit Discovery | March 08, 2022

Orbit Discovery a ground-breaking peptide discovery company is pleased to announce the commencement of a partnership with WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry. Orbit will combine its leading peptide discovery platform and experience with WuXi AppTec’s downstream capabilities. Specifically, Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid timeframe. Orbit will also utilise other capabilities within WuXi AppTec, in particular their expertise in cell line and assay development and biophysical analysis. Incorporating these capabilities into the Orbit platform will enable functional assays to be developed against a wider range of targets, facilitating direct functional screens using novel bead-based technologies and microfluidics. This is the first strategic technology link Orbit has penned since its formation in 2016. The partnership underlines the commitment of the new management team to deliver ground-breaking technology and broader capabilities to the Partners engaged in applying the Company’s technology for the discovery of peptide therapeutic leads. “We aim to move Orbit to the forefront of peptide discovery, and relationships such as this help us leverage expertise that would take far longer to grow organically. We see the partnership with WuXi AppTec as being a key relationship and a great asset to our current Partners, and Partners of the future.” He added: “We see particular value in the development and manufacturing platform of WuXi AppTec, that will enable us to generate peptides at small or large scale that incorporate chemical modifications to facilitate peptide optimisations and the journey towards a therapeutic candidate.” Dr Neil Butt, Chief Executive Officer of Orbit Discovery

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Spotlight

Artemisinin-based combination therapy (ACT) is the best available treatment to treat malaria Thanks to a successful partnership with Medicines for Malaria Venture (MMV), a dispersible version is now available for children.

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