Your guide to the pharmaceutical world Volume 12 Issue 6 Depositors and filling Old problem, new solutions Process, control and automation Dealing with demand Outsourcing Outsourcing the problem Depositors and filling Old problem, new solutions Process, control and automation Dealing with demand Outsourcing Outsourcing the problem www.pbiforum.net NTERN NATION AL Fut pro Fut ture fi g coding bility ce g Labelling, c and traaceab Food scienc Environmen spotlight ntal agingkc aa P rld o our guide to the pharmaceutical wY Issue 4 1olume 1 V mpeeee T profitable Sustainable, ature er bl a Unyielding i contro em l ll a Handlingth handli M net www .pbiforum.ne SEPTEMBER 2023 EAST MIDLANDS LEA £3.50 EADING BUSINESS MAGA AZINE een going gr WW The business case eo DMS Comms, Collab WW the barriers Organisatio bs and ANDSBUSINE rstoexceence ning - onal lear ESSLNKCOU w UK .co.uk www EMPOWER Your Business T OCTOB £2.95 BER2023 BreastC Hair & B Cce Bty WithLou In Love Month Awaren B th BLM GROUP www.blmgroup.co.uk Heritage Lincolns hi WWW.LINCWWW.LINC OLNSHIRETOOLNSHIRETO ODAYNEODAYNE september 2023 yorkshire & lincolnsh £3.50 shire’s leading business ma magazine VOLUME38SSUE09 .blmgroup.co.ukwww organ c Over Automation driving adaption success Driving business ning isational lear comngbaeso V w Often Imitated - Never Equalled www.blmgroup.co.uk8 20 24 28 Steve Fisher (s.fisher@blmgroup.co.uk) Michael Fisher (m.fisher@blmgroup.co.uk) Tess Egginton (t.egginton@blmgroup.co.uk) Angie Cooper (a.cooper@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Angela Sharman (a.sharman@blmgroup.co.uk) Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 Armstrong House, Armstrong Street, Grimsby, North East Lincolnshire DN31 2QE England All rights reserved. No part of this publication may be reproduced, transmitted, photocopied, recorded or otherwise without express permission of the copyright holder, for which application should be addressed first to the publisher. While every reasonable care is taken, neither the publisher nor its participating agents accept liability for loss or damage to prints, colour transparencies, negatives or other material of whatever nature submitted to this publication. The views expressed in this publication are not necessarily the views of those held by the publisher. News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A round-up8 2024 has been a cautious year for many pharmaceutical businesses, with smaller but still significant acquisitions. End of year success stories12 2024 has certainly been another challenging year, but amidst the doom and gloom there have also been bright spots. Finance and investment16 The markets have been so erratic in the last few months that one has to wonder if the bubble won’t burst in a manner that will be looked back at in the history books. Depositors and filling20 Managing and controlling that flow is paramount to ensuring consistent flow and consistent filling of any pharma product. Process, control and automation24 The pharmaceutical industry is a high-demand one, not only at the consumer end but at every manufacturing and processing stage along the way. Attention to quality and cleanliness is crucial, from mixing and blending to preparing dosages, and all the way through to packing and transport. Outsourcing28 As a global shortage of skilled staff squeezes the industry, more and more companies are looking to outsource non-core operations to avoid the issue. Events 32 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy: stock.adobe.com/tilialucida4 Pharma Business International www.pbiforum.net Latest news Camida wins Pharma Supplier of the Year The much-coveted title, Pharma Supplier of the Year, was bestowed upon Camida at the 2024 Pharma Industry Awards. Camida was recognised by the expert judging panel for its commitment to quality, innovation, and reliability in the pharmaceutical supply chain and for its exceptional contribution to the industry. The prestigious award highlights Camida’s strong customer-focused approach and unwavering dedication to operational excellence, which has cemented its position as a trusted partner for leading pharmaceutical companies worldwide. “This award is a testament to the hard work and dedication of the entire Camida team,” said David Anchell, founder and managing director of Camida. “We are honoured to be recognised and celebrated among such an esteemed group of industry leaders, and we remain committed to supporting our clients with agile, sustainable, and innovative solutions that meet the highest standards in pharmaceutical manufacturing and development.” Process filter maker creates new global pharma and healthcare role A UK process filter manufacturer has appointed a top sales and procurement expert with extensive experience of biotech engineering to lead its strategy for global pharma and healthcare. Surrey-headquartered Amazon Filters has tasked Mafalda Silva with delivering a targeted international sales plan to accelerate growth while working closely with sales team colleagues, distributors, resale partners and customers. Mafalda takes up the new role of Market Manager – Pharmaceutical & Healthcare as the 39-year-old firm accelerates a dedicated push into the two target sectors, particularly in strategic sales territories such as Italy, Singapore and North America. Based in Cascais near Lisbon, Portugal, Mafalda has a background in biotechnological engineering that began in a public health laboratory specialising in water microbiology. After a decade in sales she spent the next eight years at an API manufacturer as a global procurement manager responsible for categories including process filtration. Cytomos secures £5m to scale up production of cell analysis technology Cytomos, an Edinburgh-based biotechnology company, has raised £5 million to scale up production of its unique cell analysis technology. The oversubscribed funding round was led by existing investors Archangels with participation from Old College Capital, Scottish Enterprise and British Business Bank. New investment will allow Cytomos to drive sales of its first commercial product, Celledonia™, built on its cell-analysis technology platform AuraCyt, which is already generating significant market traction. Celledonia™ is a benchtop cell analyser which aims to significantly enhance single-cell analysis, potentially transforming biological drug discovery, development processes, and biologics manufacturing, meeting a major unmet need for the biopharma industry. With its sights now set on establishing a foothold in North America, the company has a pipeline of trials planned with global partners and strong interest in co-development opportunities from high-profile technology developers and a top 10 pharma company. Pharma Business International 5 www.pbiforum.net Latest news Glox Therapeutics awarded £1m PACE grant to accelerate development of precision antibiotics against antimicrobial-resistant pathogens Glox Therapeutics, a company pioneering the development of precision antibiotic therapies based on naturally occurring bacteriocins, has secured £1 million in grant funding from PACE (Pathways to Antimicrobial Clinical Efficacy), one of the UK’s largest public-private initiatives targeting early-stage antimicrobial medicines and diagnostic discovery. The funding will help to accelerate the development of Glox Therapeutics’ novel antibiotics targeting drug-resistant pathogenic bacteria, Escherichia coli and Klebsiella pneumoniae. It will also enable the company to expand its team and foster further collaboration with industry experts. Glox Therapeutics is developing an entirely new class of antimicrobials based on proprietary protein bacteriocin engineering platforms. These potent therapeutics target specific pathogens, or a closely related group of pathogens, to selectively eradicate drug- resistant bacteria with unprecedented efficacy. Unlike conventional antibiotics, these do not harm the human microbiome, ensuring a more effective treatment strategy with reduced side-effects. © stock.adobe.com/OlekAdobe Dyno Therapeutics forms partnership with Roche to advance AAV gene therapy vectors for neurological diseases Dyno Therapeutics, a genetic technologies company applying artificial intelligence (AI) to enable in vivo gene delivery, has announced its second research collaboration with Roche to develop next-generation adeno-associated virus (AAV) vectors for gene therapies targeting neurological diseases. Dyno and Roche previously announced a research collaboration and license agreement for neurological diseases and liver-directed therapies in October 2020. Under the terms of this new collaboration, Dyno Therapeutics provides Roche further access to the company’s field-leading platform and sequence design technologies enabling in vivo gene delivery. Existing gene therapies have primarily used a small number of naturally occurring AAV vectors limited by low delivery efficiency as well as problems with pre-existing immunity and manufacturability. To overcome these challenges, Dyno has pioneered the application of AI and high-throughput in vivo data collection to engineering AAV capsids for improved tissue targeting, immune- evasion and manufacturability. © stock.adobe.com/K.A./peopleimages.com AbbVie and Gedeon Richter to discover and develop novel targets for neuropsychiatric conditions AbbVie and Gedeon Richter have announced a new discovery, co- development and license agreement to advance novel targets for the potential treatment of neuropsychiatric conditions. This collaboration expands upon the success of nearly two decades of partnership on central nervous system (CNS) projects, including globally launched products such as cariprazine (VRAYLAR® / REAGILA®) and the discovery of investigational drug candidate ABBV-932 for the treatment of bipolar depression and generalized anxiety disorder. “There remains a large unmet need for people living with neuropsychiatric disorders, making it imperative that we continue to innovate and pursue novel targets and approaches to discover and develop new therapies,” said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. “We are excited to expand our longstanding and successful partnership with Richter to help address the complex needs of these patients.” “This new agreement builds on years of successful partnership allowing Richter to further support AbbVie’s global ambition in neuropsychiatry and validates the quality of science behind our unique discovery platform,” said Gábor Orbán, chief executive officer of Gedeon Richter. © stock.adobe.com/ Farknot Architect6 Pharma Business International www.pbiforum.net Latest news Cancer Research UK and KisoJi Biotechnology collaborate to advance the first naked antibody against TROP2 into the clinic Cancer Research UK and KisoJi Biotechnology, a company focussed on the discovery and development of antibody therapeutics, have signed a landmark agreement to bring KisoJi’s lead asset, KJ-103, into a first-in-human clinical trial. KJ-103 is a naked anti-TROP2 antibody that has been created by KisoJi using its proprietary antibody technology. Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will sponsor, design and deliver a Phase 1/2a clinical trial of KJ-103, in selected TROP2 expressing solid tumours. KisoJi will supply the antibody for the clinical trial and work with CDD to complete the preclinical package. Cancer Research Horizons, Cancer Research UK’s innovation arm, will manage the commercial relationship. Unlike antibody drug conjugates (ADCs), KJ-103 does not require a cytotoxic payload but instead functions by recruiting immune cells to kill tumour cells. KJ-103 binds to TROP2 in a location distinct from where current TROP2 ADCs bind. It uses TROP2 as a way of directing macrophage activation and phagocytosis of the tumour cells expressing it, leading to tumour cell death. ViaNautis Bio signs agreement with Lilly to develop novel products delivering genetic medicines ViaNautis Bio, a biotechnology company at the forefront of delivering targeted genetic nanomedicines, has announced a collaboration with Eli Lilly and Company. Under the terms of the agreement, ViaNautis will receive an initial upfront payment from Lilly, with the short-term potential for additional payments including research-based milestones. Further milestones and royalties would be due should specific cargo-loaded polyNaut®-based products enter the clinic and reach commercialisation. This collaboration will leverage ViaNautis’ platform for precise delivery of genetic cargos to prioritised tissues to address significant unmet medical needs. ViaNautis’ proprietary polyNaut® nanovesicles are designed to deliver genetic materials with precise targeting of specific tissues and cell types. This technology aims to improve current genetic medicine delivery, potentially transforming treatment options for various diseases. Dr Francesca Crawford, co-founder of ViaNautis, said: “Combining our scientific know-how to precisely deliver genetic nanomedicines targeting difficult-to- reach sites, with Lilly’s extensive drug development and commercialization expertise will accelerate the creation of novel therapies to improve patient outcomes.” GSK to acquire CMG1A46 from Chimagen Biosciences, expanding immunology pipeline GSK and Chimagen Biosciences have announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen for $300 million upfront. GSK plans to develop and commercialise CMG1A46 with a focus on B cell- driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential to expand into related autoimmune diseases. For over a decade, GSK has been a pioneer in the treatment of lupus. This agreement underscores the importance of novel therapeutic approaches to address the heterogeneity of lupus manifestations and the continued burden, particularly in patients who suffer from severe disease and are refractory to current standard of care. Tony Wood, Chief Scientific Officer, GSK, said: “Through our work in systemic lupus erythematosus and lupus nephritis, we increasingly understand the underlying drivers of B cell-driven diseases. As a novel therapeutic option directed at deep B cell depletion, CMG1A46 offers exciting potential which we are pleased to take forward to address unmet need in lupus and related autoimmune conditions.” © stock.adobe.com /PRB ARTS © stock.adobe.com/Postmodern Studio © stock.adobe.com/ MagdaWygralak U.S. FDA approves IMKELDI oral solution for certain forms of leukemia and other cancers The U.S. Food and Drug Administration (FDA) has approved Shorla Oncology’s IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers. “We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” said Sharon Cunningham, Chief Executive Officer of Shorla. “Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.” Leveraging Shorla’s novel technology, IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy. IMKELDI can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST). Attruby approved by U.S. FDA to reduce cardiovascular death and cardiovascular- related hospitalization in ATTR-CM patients The U.S. Food and Drug Administration (FDA) has approved BridgeBio Pharma’s Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular- related hospitalization, and improved quality of life. “The need for more treatment options for patients living with ATTR-CM is crucial to achieving the goal of better outcomes and improved quality of life. Access to this new therapy means more hope and more opportunity to improve the lives of patients with amyloidosis,” said Muriel Finkel, President of Amyloidosis Support Groups, a non-profit organization dedicated to the support of amyloidosis patients and caregivers. Attruby is the first and only approved product with a label specifying near- complete stabilization of TTR. Attruby was designed to mimic a naturally occurring “rescue mutation” of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer. Through near- complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes. Arexvy approval expanded to adults aged 50-59 at increased risk of severe RSV disease in Japan Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a regulatory application to extend the indication of GSK’s Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV disease to include adults aged 50-59 at increased risk. Since September 2023, GSK’s RSV vaccine has been approved in Japan for adults aged 60 and over for the prevention of RSV disease. Tony Wood, Chief Scientific Officer at GSK, said: “This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection. Adults aged 50-59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time.” European Commission approves HYMPAVZI for adults and adolescents with severe hemophilia A or B without inhibitors The European Commission (EC) has granted marketing authorization for Pfizer’s HYMPAVZI (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors. HYMPAVZI is the first and only anti-tissue factor pathway inhibitor (anti- TFPI) approved in the European Union (EU) for the treatment of hemophilia A or B and the first hemophilia medicine approved in the EU to be administered via a pre-filled, auto-injector pen. HYMPAVZI offers a subcutaneous treatment option with a once-weekly dosing schedule and minimal preparation required for each individual administration. “There is a considerable treatment burden associated with the standard- of-care options for hemophilia A and B, including time-consuming preparation and administration of infusions and injections potentially causing missed doses and an increased risk of bleeding,” said Dr. Laurent Frenzel, Head of the Hemophilia Treatment and Research Center at the Necker-Enfants malades Hospital (Paris Cité). “HYMPAVZI is a significant advancement for eligible patients in that it may provide bleed prevention as well as once-weekly subcutaneous administration via a pre-filled pen.” U.S. FDA approves BIMZELX as first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa The U.S. Food and Drug Administration (FDA) has approved UCB’s BIMZELX (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), a chronic, recurring, painful and potentially debilitating inflammatory skin disease. Bimekizumab- bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). “We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate to severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people. This is the fifth patient population who may benefit from BIMZELX in the U.S., representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB. “This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines and raising standards of care.” www.pbiforum.netPharma Business International 7M&A ROUND-UP 8 Pharma Business International www.pbiforum.net © stock.adobe.com/ Александр ЛаневскийPharma Business International 9 www.pbiforum.net M&A ROUND-UP W ith geopolitical uncertainty, elections, and regulatory challenges, 2024 has been a year of caution and smaller deals, with this trend continuing as the year comes to an end. That doesn’t mean of course that there haven’t been significant transactions for pharmaceutical companies, especially with a wave of patent cliffs approaching and a need to acquire talent. Pharma Business International reflects on some of the deals revealed since our last issue. Novartis - Kate Therapeutics Novartis has swooped for Kate Therapeutics, a San Diego-based, preclinical stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies to treat genetically defined neuromuscular diseases. Under the terms of the agreement, Kate Therapeutics’ shareholders are entitled to receive up to $1.1bn, comprising a cash payment that was paid at closing of the transaction and additional amounts payable on achievement of specified milestones. Kate Therapeutics’ primary programs include preclinical candidates for Duchenne muscular dystrophy (DMD), facioscapulohumeral dystrophy (FSHD), and myotonic dystrophy type 1 (DM1). Kate’s Directed Evolution of AAV Capsid Leveraging In Vivo Expression of Transgene RNA (DELIVER) platform combines diverse capsid library generation with transcript-based in vivo selection and machine learning to evolve functional capsid variants. DELIVER has been used to evolve a novel class of liver de-targeted muscle-tropic capsids, which transduce both skeletal muscle and cardiac tissue with potency and selectivity in vivo, while avoiding the liver. Robert Baloh, Global Head of Neuroscience Research at Novartis, said: “This acquisition builds on our expertise and leadership in neuroscience drug discovery and brings to Novartis talent, expertise and capabilities that are highly complementary to our ongoing internal efforts. It reflects our commitment to addressing unmet medical needs in neuroscience and tackling the limitations of existing gene therapies for patients with inherited neuromuscular conditions.” Kate Therapeutics’ technology platforms integrate capsid and cargo technologies to deliver payloads to desired tissues, while potentially mitigating off-target effects to tissues such as the liver. This approach aims to improve both the efficacy and safety of gene therapies, opening potential possibilities for treating complex diseases previously difficult to address with current technologies, including inherited neuromuscular diseases. Keeping cautious 2024 has been a cautious year for many pharmaceutical businesses, with smaller but still significant acquisitions. 10 ÁNext >