Phase 1 Clinical Trial for Coronavirus Vaccine Begins in Seattle

PharmaNewsIntelligence | March 17, 2020

Phase 1 clinical trials for a coronavirus vaccine have begun at Kaiser Permanente Washington Health Research Institute (KPWHR) has begun, according to a statement from the National Institutes of Health. The investigational vaccination, funded in part by the National Institute of Allergy and Infectious Disease, began today by administering the first immunization to a healthy adult between ages 18 and 55 years old. In total, the phase 1 clinical trial will enroll 45 adults who fit this criteria and investigate outcomes over a six-week test period.

Spotlight

To finish off our marketing excellence focus month, we speak with David Richardson from Cutting Edge Information about the importance for pharma to have a successful marketing strategy.

Spotlight

To finish off our marketing excellence focus month, we speak with David Richardson from Cutting Edge Information about the importance for pharma to have a successful marketing strategy.

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PHARMACY MARKET

Cardurion Pharmaceuticals Announces Investment of up to $300 Million From Bain Capital

Cardurion Pharmaceuticals | October 28, 2021

Cardurion Pharmaceuticals, Inc a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases, today announced it has received a private investment of up to $300 million from Bain Capital Life Sciences and Bain Capital Private Equity. Bain Capital joins existing investors, Takeda Pharmaceuticals and Polaris Partners, in supporting the evolution of Cardurion into a leading cardiovascular biotechnology company. Based in Boston, Massachusetts and with facilities there and in Shonan, Japan, Cardurion’s mission is to transform the treatment of cardiovascular diseases by translating the science of cardiovascular signaling pathways into groundbreaking therapeutics. The Company’s innovative pipeline of cardiovascular drug candidates includes a PDE9 inhibitor and a CaMKII inhibitor program. The investment will support the thoughtful advancement of Cardurion’s pipeline, enable the Company to scale its team, and create an industry-leading platform. “We could not be more excited to welcome Bain Capital as investors in this transformational milestone for Cardurion We have a shared vision to continue to build a world-class cardiovascular company pursuing treatments for a broad range of debilitating diseases. This funding will allow us to advance our first-in-class PDE9 inhibitor into a major Phase 2 trial in heart failure and to support the initiation of first-in-human studies with our CaMKII inhibitor program in several cardiovascular indications. We look forward to leveraging the experience and resources of our investors to build and scale Cardurion as a leading cardiovascular biotechnology company.” Peter Lawrence, Chief Executive Officer of Cardurion “This is an impressive team laser-focused on deep science, innovation, and collaboration in a strategically important therapeutic area where there is high unmet need for patients,” said Adam Koppel, M.D., PhD, a Managing Director at Bain Capital Life Sciences. “We look forward to a lasting partnership with Mike and Peter and their team, supporting the efforts to identify and develop novel therapies while building out a scale platform that can serve as a champion for cardiovascular drug development.” “This investment will accelerate our progress as we work to create transformative new medicines that deliver value for patients and other key stakeholders,” said Michael E. Mendelsohn, M.D., Founder and Chairman of Cardurion. “Cardurion is dedicated to advancing novel mechanisms that yield new treatments for cardiovascular disease, which remains the greatest cause of morbidity and mortality in our society.” In conjunction with Bain Capital’s investment, Koppel and Nicholas Downing, MD, a Principal at Bain Capital Life Sciences, will join the Cardurion Board of Directors. About Cardurion Pharmaceuticals Cardurion Pharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases. Founded by physician-scientist Michael E. Mendelsohn, M.D., and built by a team of physician-scientists and industry leaders with extensive experience in cardiovascular science, drug development and business development, Cardurion Pharmaceuticals is pursuing unique drug discovery and development programs to target major unmet needs in cardiovascular medicine. Cardurion Pharmaceuticals has facilities in Boston, Massachusetts and Shonan, Japan. About Bain Capital Founded in 1984, Bain Capital, LP is one of the world’s leading private multi-asset alternative investment firms with offices on four continents and deep experience in healthcare. Bain Capital manages approximately $150 billion across asset classes and leverages the firm’s shared platform to capture opportunities in strategic areas of focus. Bain Capital Private Equity has partnered closely with management teams to provide the strategic resources that build great companies and help them thrive. A team of more than 275 investment professionals creates value for portfolio companies through its global platform and depth of expertise in key vertical industries including healthcare. Bain Capital Life Sciences pursues investments in biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and enabling life science technology companies globally. The team focuses on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs.

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PHARMA TECH

Fareva and ApiJect sign a licensing agreement to create a France-based 500M unit annual capacity for single-dose prefilled vaccine injections

ApiJect Systems Corp. | December 10, 2021

Fareva and ApiJect Systems, Corp. announced a 10-year licensing agreement to install three Blow-Fill-Seal production lines that when operational will be able to fill-finish more than 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect's innovative prefilled injector technology. Fareva intends to invest more than €50M for these three manufacturing lines, with support from the Government of France, through the "France Relance" industry initiative and the Investments for the Future Program. The three manufacturing lines and ApiJect's technology utilize the Blow-Fill-Seal aseptic packaging process. BFS has demonstrated its ability to package certain vaccines and large molecule formulations, and ApiJect is helping to expand BFS's capabilities to additional drug products, including temperature sensitive pharmaceuticals. When cleared by regulators, ApiJect will provide the necessary needle hub and other attachable components to convert finished BFS single-dose containers from these lines into easy-to-assemble, ready-to-use prefilled injectors. COVID-19 has demonstrated the strategic importance of regional pharmaceutical manufacturing to ensure strong and reliable medical supply chains. By investing in these three BFS lines and installing ApiJect technology, Fareva is helping to increase Europe's high-speed, high-volume fill and finish capacity by potentially more than 500 million doses per year. And, the compact polyethylene-based supply chain of BFS helps establish and maintain dependable and resilient fill-finish capacity, even in the face of additional COVID-19 pandemic waves and their supply chain repercussions. "This commitment by Fareva, with the support of the French Government, to expand fill-finish capacity is the right step at the right time. We are proud to partner with Fareva in bringing the next generation of injection technology to global health." ApiJect CEO and Chair Jay Walker commented Mr. Walker continued: "Our mission at ApiJect is to support and execute a strategy of expanded distributed fill-finish capacity in the U.S. and regionally around the world. This is desperately needed in the battle against COVID, particularly as we continue to face emerging variants. Distributed fill-finish capacity will also yield huge dividends when future pandemics and other possible bio-emergencies threaten our populations. Fareva, along with its support from the French Government, is showing itself to be a vital leader in confronting and defeating the COVID threat." The new lines will be situated in Fareva Excelvision, located in Annonay, France, which has more than 50 years of experience manufacturing BFS containers and exporting products around the world. The BFS machines will be purchased from Rommelag in Germany. Clean rooms for these new lines will be operated in a Biosafety Level 2 (BSL2) environment, allowing them to handle most vaccines. The objective is to start the first validation batches in June 2022. In addition, this capacity expands ApiJect licensing of its BFS manufacturing and device technology to the USA and Europe. Olivier Dussopt. Minister Delegate for Public Accounts said: "I am very happy that Fareva, and their manufacturing site of Annonay in Ardeche, invests in such a development project, concerning 3 production lines for an amount of 50 million euros. The government will support those investments with a program of 36,9 million euros. This is an excellent news for the local territory as it will create 150 jobs and this is also an excellent news for France and Europe that will benefit from this high technology for the manufacturing of pharmaceutical drugs and more precisely of vaccines. " Agnès Pannier-Runacher, Minister Delegate for the Industry declared: "I welcome the project implemented by Fareva in collaboration with ApiJect, a world premiere that will enable the production up to 500 million of injectable pharmaceutical products from 2022. This ambitious 50 million euros project will strengthen our healthcare industry in France and shows that innovation is not only in the vaccines but also stands in the injection devices. It is also the reason why we have agreed to support it with the France Relance program." ABOUT APIJECT SYSTEMS, CORP. ApiJect Systems, Corp. is a public-benefit medical technology company working to bring prefilled, single-dose injections to more people in every market. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own ApiJect-licensed Blow-Fill-Seal packaging lines or at one of our world-class manufacturing partners. ABOUT FAREVA Fareva, a family-owned company, whose strength lies in its financial independence, is one of the world's leading CDMOs in the pharmaceuticals, cosmetics, make-up, and industrial and homecare fields. Fareva operates in 12 countries with 42 factories and employs more than 13 000 employees with annual revenues reaching € 1.8 billion in 2020. ABOUT "FRANCE RELANCE" France Relance is a €100 billion investment plan designed to support economic recovery in France in the wake of the COVID-19 pandemic. The program supports businesses, new production models, transformation of infrastructure, and training investment.

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ConcertAI Names Claudio D'Ambrosio, PhD, as Head of Biopharma Partnerships and RWE Solutions

Prnewswire | September 10, 2020

ConcertAI has hired Claudio D'Ambrosio, PhD, as head of biopharma partnerships and real-world evidence Solutions. Claudio brings over 15 years of experience as a cancer researcher, commercial leader, and strategic scientific partner to the life sciences industry to help advance the goals of ConcertAI of bringing rapid innovation and precision real-world evidence oncology to the world's top global pharmaceutical companies. ConcertAI is a fast-growing company with the leading technology for integrated Real-World Data (RWD), AI cloud solutions, and advanced outcomes, and data science services for oncology RWE). The mission of ConcertAI is to advance the regulatory and market access applications of precision RWE through a unique set of validated RWD solutions and complementary eurekaHealth technologies.

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