BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | April 24, 2023
PCI Pharma Services a leading global contract development and manufacturing organization announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational. The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs. The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution.
“As the capacity for CDMOs worldwide to take on new projects shrinks, we’re excited to be able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to new and existing clients in Melbourne and San Diego,” said Brad Payne, Chief Operating Officer, PCI Pharma Services. “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.”
The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. Additionally, a Microcell Vial Filler at Melbourne further enhances the early-stage services offered and brings additional capacity to Australia—the world’s leading phase I environment. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment.
“There are less barriers to entry to start a clinical trial in Australia, as well as significant cost benefits, and with Melbourne being an especially popular place to conduct phase I trials, we knew we needed to bring this capability and added capacity to the local market,” said Tim Roberts, Chief Commercial Officer, PCI Pharma Services. “In addition, we are then able to take our clients through their lifecycle journeys with the expansions and advanced capabilities in our New Hampshire and Madison campuses. With successful recent inspections at our Bedford facility by the Brazilian (ANVISA) and Japanese (PDMA) regulatory authorities, our global reach to supply life-changing therapies to patients quickly and safely is wider than before.”
To better support its clients throughout the world, PCI has also recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Bridgewater, MA.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.
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BUSINESS INSIGHTS
Businesswire | May 22, 2023
Closed Loop Medicine Ltd, a leading TechBio company, developing combination prescription drug plus software therapy products that enable personalized dose optimization, and Pharmanovia, a global pharmaceutical company that commercializes novel medicines and revitalizes, extends and expands the lifecycle of established medicines, today announced that they have entered a global co-development partnership.
The partnership will initially focus on the development and launch of a drug + software combination version of a first-line anti-hypertensive in the UK, before phased global roll-out and additional therapies are added.
Hypertension is the leading preventable cause of morbidity and premature death worldwide, impacting over 1 in 4 men and 1 in 5 women, and costing the NHS alone over £2.1 billion/year (1, 2). Managing high-blood pressure through medication and lifestyle modifications significantly reduces associated health risks and improves quality of life; research in the US demonstrating improved standards of care could prevent 91,900 heart attacks, 139,000 strokes and 115,400 cardiovascular deaths within just 5 years (3). However, poor drug tolerability and treatment-related side effects significantly impact adherence, with less than 50% of patients maintaining their treatment regimen after a year, ultimately hindering treatment effectiveness, patient outcomes and overall disease management (4).
As part of this partnership, Closed Loop Medicine’s proprietary Software-as-a-Medical Device (SaMD) dosing optimization technology will be combined with Pharmanovia’s established anti-hypertensive medicines, under a single prescription. Recent preliminary clinical trial results have demonstrated that Closed Loop Medicine’s technology may provide the ability to dose optimize drug therapy, improve blood pressure control, and minimize side effects (5). By developing a new class of combination products for the treatment of hypertension, both companies aim to support patients and healthcare professionals to better manage high blood pressure.
Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, commented: “This pioneering partnership is a great example of where the power of software integration can add value to iconic medicines to make them more effective for patients. Through this co-development agreement, we will bring our IP, insight and technical know-how of dose optimized drug plus software integration alongside Pharmanovia’s innovative business model, to enable well-known and trusted brands to be positioned as value-driven precision medicine product solutions globally.”
Dr. James Burt, CEO of Pharmanovia, said: “Combining our experience in lifecycle management with Closed Loop Medicine’s unique approach and technology is an exciting next step in our strategy. It enables us to use innovative technology to enhance established medicines and bring much needed innovation to an area of large-scale unmet need. Together we aim to deliver a first in class combination regulated software and medicine – with the aim of delivering better patient outcomes, while enabling healthcare systems to reduce costly hospital procedures through better adherence and patient engagement.”
AboutPharmanovia
Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by enhancing established medicines either by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and through strategic partnerships.
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VIEWS AND ANALYSIS, PHARMACY MARKET
prnewswire | May 08, 2023
Telix Pharmaceuticals Limited announces that it has entered into an agreement with Bayer AG to supply Illuccix® kit for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer's androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline.
The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.
Telix Chief Medical Officer, Dr Colin Hayward stated, "We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix's unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool."
022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
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