Novo Nordisk’s Victoza gets FDA okay for paediatric use

Pharmaphorum | June 18, 2019

Novo Nordisk’s GLP-1 agonist Victoza has become the first non-insulin drug to be approved in the US as a treatment for type 2 diabetes in children for almost two decades. The FDA says the okay to use Victoza (liraglutide) in paediatric patients aged 10 or over comes “at a time when an increasing number of children are being diagnosed with this disease.” The last drug to be approved for paediatric use in type 2 diabetes was metformin back in 2000. Type 2 diabetes is typically first diagnosed in people aged over 45, with the type 1, autoimmune form of the disease the most likely to be encountered in children. Latterly however, rising levels of overweight and obesity in even very young children has caused an uptick in type 2 cases in this age group. The US Centers for Disease Control and Prevention estimates that more than 5,000 new cases of type 2 diabetes are diagnosed each year among in people younger than age 20 in the US, out of around 1.4 million new cases across all age ranges. The Victoza approval comes after a priority review by the FDA, and shortly after Novo Nordisk reported the results of the phase 3 ELLIPSE trial which showed the drug was able to reduce haemoglobin A1c levels – a biomarker for blood glucose control – as effectively in children aged 10 to 17 as older patients. The GLP-1 agonist also had a similar safety profile regardless of the age of the patient. At the time the data was announced, ELLIPSE lead investigator William Tamborlane of Yale School of Medicine said that having a GLP-1 agonist available would be “transformational”, as currently insulin is the only approved rescue therapy for children who fail metformin monotherapy. Victoza offers a second option in these cases, he added.

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TherapeuticsMD and EW Healthcare Partners Announce Definitive Agreement for EW Healthcare Partners to acquire TherapeuticsMD

TherapeuticsMD, Inc | June 01, 2022

TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners, a private equity firm dedicated to making investments in rapidly growing healthcare companies. Under the terms of the transaction, which has been unanimously approved by TXMD’s board of directors, EW Healthcare Partners will commence a tender offer to acquire all outstanding shares of TXMD common stock for $10.00 per share in an all-cash transaction, followed immediately by a merger. The purchase price represents a premium of 367.3% over TherapeuticsMD’s closing share price on May 27, 2022. “We are very pleased to enter into this agreement with EW Healthcare Partners. Together, we will continue empowering women of all ages through a therapeutic focus in family planning, reproductive health, and menopause management. We have a deep appreciation for EW Healthcare Partners’s depth of expertise and track record and know they will bring an incredible value of knowledge and strategic guidance.” Hugh O’Dowd, Chief Executive Officer of TherapeuticsMD EW Healthcare Partners is one of the largest and oldest private healthcare investment firms with over $4B of capital raised since its inception. EW Healthcare Partners has made investments in over 150 rapidly growing healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. “We are pleased to welcome TherapeuticsMD to the EW Healthcare Partners portfolio and are deeply committed to the Company's mission of advancing women’s health. EW Healthcare Partners has already made a significant investment in women’s health through its acquisition of Majorelle. TherapeuticsMD represents a unique opportunity for Majorelle to enter the US market and is a perfect fit with our ambitious plans to create a fast-growing, premier trans-Atlantic women’s health platform. We bring an extensive network and capital to fund the further growth of the combined company,” said Evis Hursever, Managing Director at EW Healthcare Partners. “We look forward to working together with the company’s management team to enhance the patient experience, improve operational efficiency and create one of a very few trans-Atlantic specialty pharma companies dedicated to women’s health,” said Olivier Bohuon, Senior Adviser with EW Healthcare Partners and Chairman of Majorelle. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues. About EW Healthcare Partners (“EW”) With over $4 billion raised since inception, EW Healthcare Partners is one of the largest and oldest private healthcare investment firms and seeks to make growth equity investments in fast growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. Since its founding in 1985, EW Healthcare Partners has maintained its singular commitment to the healthcare industry and has been a long-term investor in over 150 healthcare companies, ranging across sectors, stages and geographies. The team is comprised of over 20 senior investment professionals with offices in New York, Houston and London.

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BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $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. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. 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.

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Simulations Plus Hosts 2nd Annual Pharmacometrics Workshop

Simulations Plus, Inc. | July 04, 2022

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced record-setting attendance and virtual content delivery for the 2022 Pharmacometrics Spring School using MonolixSuite™. New for 2022 was the introduction of the “NCA, bioequivalence, and beyond! Spring School” course using PKanalix™. Both workshops were held in March 2022. This year’s Spring Schools focused on population modeling for model-informed drug development and simulations of clinical trials using the MonolixSuite, and the analysis of PK data using non-compartmental analysis and bioequivalence calculations using the PKanalix platform. These courses, which were free to the pharmacometrics community, comprised both theoretical discussions and hands-on sessions. In total, there were 936 attendees from over 50 countries. The attendees were industry professionals from regulatory agencies, pharma companies, biotech, and CROs, as well as students and doctoral/postdoctoral researchers, with different backgrounds, who used the skills taught in these courses to make their modeling and simulation work more powerful and efficient. “The positive feedback and momentum from our first Spring School in 2021 carried forward to this year’s program, further substantiating the need to provide the pharmacometrics community with quality material and training. As a leader in providing modeling and simulation (M&S) software tools and services to support the industry and our clients in their efforts to leverage M&S for more efficient drug development, we were very pleased by the strong interest and support from the user community, and we look forward to offering our pharmacometrics workshops again in 2023.” Dr. Jonathan Chauvin, President of the Lixoft division at Simulations Plus About Simulations Plus Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. Environmental, Social, and Governance (ESG) We focus our Environmental, Social, and Governance efforts where we can have the most positive impact.

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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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