Mallinckrodt, Silence Theraputics to commercialise RNAi therapeutics

Pharmatimes | July 22, 2019

Silence Theraputics and Mallinckrodt have announced a collaboration that will allow the companies to develop and commercialise RNAi drug targets designed to inhibit or silence the complement cascade, a group of proteins that are involved in the immune system and that play a role in the development of inflammation. The agreement provides Mallinckrodt with an exclusive worldwide license for C3 (SLN500) - a preclinical asset that targets a specific protein in the complement pathway - and an option for up to two additional assets with different complement protein targets. Under the terms of the deal Mallinckrodt has agreed to provide Silence with an upfront payment of $20 million. Silence is also eligible to receive up to $10 million in research milestones for SLN500 and for each optioned asset, in addition to funding for Phase I clinical development including GMP manufacturing. The company is “very excited by the significant potential offered by Silence’s RNAi technology to meet the needs of underserved patients in a number of serious and critical conditions,” said Steven Romano, chief scientific officer and executive vice president of Mallinckrodt, continuing to say that they “look forward to collaborating with them to advance development of complement-targeted assets as new therapeutic options.”

Spotlight

Since the time of blockbuster drugs and mirrored sales teams a decade ago, pharmaceutical reps’ access to physicians continues to decline each year. Studies indicate that between 36.5% - 44% of physicians are now being designated as “no access.”1 Despite this declining access trend, the industry continues to allocate most of its total sales and marketing budgets to its sales forces, reaching estimates of $12 billion in 2016. With so much at stake, the industry can ill afford to arm its sales force with inadequate sales reports. Yet, the reporting function continues to fall short.


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Pneuma Systems collaborates with West Pharmaceutical Services, Inc. to improve the patient experience

Pneuma Systems Corporation | April 08, 2022

Medical technology company, Pneuma Systems Corporation, has entered a multi-faceted business collaboration with West Pharmaceutical Services, Inc. with the goal of improving the patient's experience with drug therapy. West is a leading global manufacturer in the design and production of technologically advanced, high-quality, integrated containment and delivery systems for injectable medicines. Pneuma Systems Corporation has developed a family of fluid flow technologies that are aimed at scientific and medical applications. The global intravenous pump market segment is expected to reach USD 20.5 billion over the next five years. Pneuma will provide a novel closed-loop fluid flow control platform that West will use to develop drug delivery solutions for pharmaceutical companies and clinical end users. West will provide technical and financial support to Pneuma and access to the emerging West Digital Platform, designed to improve transmission of data and other information. "West's almost century-long commitment to the development of drug delivery systems dovetails with our cutting-edge flow control technology. West's latest foray into a broad digital architecture is very important to us. When you improve both fluid flow and information flow, the result is an improvement in workflow, which results in higher levels of patient safety and lower costs," said Pneuma CEO Jeffrey Carlisle. "We are aiming at disruptive improvements in workflow." "We are excited about our collaboration with Pneuma and the potential of their technologies to address a variety of flow control challenges to drive improvements in healthcare. At West our mission is to improve patient lives not only through our products and services but also by investing in small innovative companies and offering our deep technical and commercial expertise to help them bring their transformation technologies to the market," Scott Young, VP Venture & External Collaboration at West Pneuma Systems, together with its strategic partners, plans to install PneumaDrive™ technology-based infusion devices in infusion centers, home care, and acute care settings around the world. The low cost PneumaDrive™ technology can replace existing infusion pumps and automate "gravity drip" infusions, providing patients with a safer and easier experience. About Pneuma Pneuma Systems is a New Hampshire based company founded by Jeffrey Carlisle, also Founder of the recently acquired Ivenix. Pneuma is dedicated to improving fluid flow, information flow, and workflow for the IV therapy process. About West West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With approximately 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 45 billion components and devices each year.

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Integrity Bio and LakePharma Become Curia

Curia | February 15, 2022

Curia, formerly AMRI, a leading contract research, development and manufacturing organization, announced that Integrity Bio and LakePharma, two companies that it acquired last year, have fully transitioned to the Curia brand. This change reflects the accelerated organizational integration of the acquired companies into Curia and its provision of comprehensive biologics discovery, development and manufacturing solutions to customers. Curia completed the acquisition of Integrity Bio in August 2021 and closed the LakePharma transaction in September 2021. “The addition of LakePharma and Integrity Bio demonstrate our commitment to expanding and deepening our biologics capabilities. We have moved quickly to integrate our expanded organization so we can provide comprehensive technology and scientific solutions that enable customers to advance their biologics candidates from R&D through manufacturing. More than a name change, the combined Curia organization brings a singular focus on creating a distinctive customer experience designed to accelerate projects and navigate complexity, all driven by a shared commitment to the mission of improving patients’ lives." Curia Chairman and CEO John Ratliff About Curia Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure.

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BUSINESS INSIGHTS

CCT Research Announces New Partnership with BEKHealth

CCT Research | February 18, 2022

CCT Research has announced an exciting partnership with BEKHealth. The collaboration streamlines access to electronic medical records (EMR) data, across CCT sites and drives a data-driven approach to trial execution and management. CCT has established itself as an innovator in conducting clinical trials. Using BEKHealth, a provider of software solutions for enhancing clinical research processes, will enable CCT to more accurately identify and fit studies to its sites. The deep commitment by both companies to improving the outcomes of clinical trials made the relationship a natural fit. “One of CCT’s driving forces is to promote an environment of innovation and continuous improvement. Our partnership with BEKHealth strengthens our ability to identify potential research participants, ultimately creating greater accessibility to clinical trials.” Jennifer Kocour, President, CCT Research More than just a “technology” partnership, this collaboration with BEKHealth is also patient-centric– which remains a top priority for CCT. Once studies are awarded, it will power onsite research by identifying patients who fit studies best, saving sites, patients, and staff time and hassle. “At the individual site level, our goal is to optimize research to be as beneficial to the practice and its patients as possible with minimal disruption to the clinics day-to-day operations. We view data and technology as central to that strategy and couldn’t be more excited to work with BEKHealth,” said Kyle McAllister, Vice President, Data & Analytics, CCT Research. “The breadth and depth of CCTs network was an exciting opportunity. The ability to leverage technology to centralize key drivers of success such as feasibility, site selection, patient recruitment and analytics drives a new paradigm in clinical research,” said Jason Baumgartner, CEO and Founder, BEKHealth. “Our platform is secure and activation creates a minimal burden on IT teams. What this means for the provider and patient is our collaboration will have a major impact quickly.” “We provide an integrated clinical operating platform that enables companies to streamline research across multiple key processes,” said Josh Ransom, PhD, Vice President, Customer Experience, BEKHealth. “Ultimately this means our partners can scale their businesses faster by improving operational efficiency while taking out manual and inefficient steps.” About CCT Research CCT Research is a network of clinical research sites embedded in the offices of skilled physicians conducting clinical trials to offer patients with innovative medical treatments and safe, effective care options. CCT Research was founded in 2017 and has more than 20 locations across Arizona, Georgia, Kentucky, Nebraska, Nevada, and Utah. The sites are located within physicians’ offices, within ACO networks, and several dedicated research centers. CCT supports research in Neurology, Family Practice, and Dermatology, with plans to include additional therapy areas soon. The company's unique model simplifies the process for trial participants and provides pharmaceutical sponsors with high-quality data.

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BUSINESS INSIGHTS

ApiJect Announces Investment by Royalty Pharma and Jefferies

ApiJect Systems Corp. | May 19, 2022

ApiJect Holdings, Inc., the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, announced today that it had completed a $111 million private round of investment. This investment round values ApiJect at approximately $300 million. The new round was led by Royalty Pharma and Jefferies Financial Group (NYSE: JEF), which acquired a revenue interest in addition to equity. Jefferies and ApiJect's other lenders also converted all of their debt into ApiJect equity, such that following this transaction, ApiJect has no debt on its balance sheet. The funds will be used for continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system, to deploy its equipment and proprietary technologies to licensees, and for general working capital purposes. Royalty Pharma and Jefferies are represented on ApiJect's Board of Directors, along with ApiJect co-founders Jay Walker and Marc Koska, and Hanjin In, the CEO of Tae-Chang Industrial Co., Ltd., ApiJect's South Korean cannula supplier. ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step. BFS technology greatly reduces the risk of contamination and error during one of the most critical steps of drug production. BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand such as for a rapid response to population-scale health emergencies. Advancements developed by ApiJect for temperature management now enable BFS manufacturing of a vast array of sterile injectable drugs, including ultra-cold mRNA vaccines. "This is an important day for injection device innovation, and, with that, the future health of billions of people throughout the world. The investment provided by Royalty Pharma and Jefferies supports further development of an injection technology that can scale rapidly and efficiently to meet global demand for injectable medicines." ApiJect Chief Executive Officer Jay Walker Mr. Walker further said: "We welcome Royalty Pharma's commitment to the ApiJect mission. Royalty Pharma has a proven track record in selecting successful partners and in assisting in advancing its partners' goals. We could not ask for a better strategic partner from within the pharma industry. In Jefferies, we have a partner that has been with us from virtually the beginning of ApiJect." "We are delighted to form this win-win partnership with ApiJect," said Pablo Legorreta, Royalty Pharma's Founder and Chief Executive Officer. "The global pandemic highlighted the clear unmet need for a new kind of prefilled syringe that can be rapidly produced to respond to public health threats, and at massive scale that would be capable of delivering hundreds of millions, potentially billions, of doses to people in the U.S. as well as globally. ApiJect is developing a truly innovative technology, that could transform the manufacturing and delivery of life-saving injectable drugs in a way that would also make these medicines safer and more readily accessible for patients around the world." "We are proud of our association with ApiJect and believe strongly that their solutions will be a positive gamechanger in many of the most critical aspects of improving health globally," said Rich Handler, CEO of Jefferies. The first potential device made on the ApiJect Platform is the Prefilled ApiJect Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5mL dose into a patient with a simple squeeze of the BFS container by the healthcare professional. This new type of prefilled injector will be ApiJect's first product submitted for regulatory review and approval. The Prefilled ApiJect Injector and its manufacturing process include An aseptically filled single-dose container, designed to enable efficient and intuitive injection administration. A pen-needle-style hub that turns the BFS container into an injection device. Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging. ApiJect recently launched its Technology Development Center in the greater Orlando area to bring to the U.S. critical capabilities for device design and engineering, and BFS mold development, as well as for small-scale manufacturing of single-dose, prefilled injectors and other injectable devices. Its purpose is to dramatically reduce the time and processes necessary for product development. ApiJect's Technology Development Center supports the company's existing fill-finish lines at its manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million single-dose prefilled injectors annually. About ApiJect Systems ApiJect Systems, Corp., is a public-benefit medical technology company working to use our platform to bring more prefilled, single-dose injections to patients everywhere. 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 Blow-Fill-Seal packaging lines with ApiJect-licensed technology, or at one of ApiJect's world-class manufacturing partners.

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Spotlight

Since the time of blockbuster drugs and mirrored sales teams a decade ago, pharmaceutical reps’ access to physicians continues to decline each year. Studies indicate that between 36.5% - 44% of physicians are now being designated as “no access.”1 Despite this declining access trend, the industry continues to allocate most of its total sales and marketing budgets to its sales forces, reaching estimates of $12 billion in 2016. With so much at stake, the industry can ill afford to arm its sales force with inadequate sales reports. Yet, the reporting function continues to fall short.

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