Your guide to the pharmaceutical world Volume 12 Issue 1 Microbiology and R&D Artificial microbiology Pumps and fluids Explosive growth Laboratories Adapting labs Microbiology and R&D Artificial microbiology Pumps and fluids Explosive growth Laboratories Adapting labs 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.uk4 12 16 20 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) Vicky Hunt (v.hunt@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 After a sluggish period, M&A activity in the pharmaceutical industry is picking up, with the end of 2023 and start of 2024 welcoming myriad deals. Laboratories12 Labs are changing with the times, and not only because of the lingering memory of COVID-19. Employee shortages and recruitment problems are forcing labs to reassess how they keep their talent, and artificial intelligence may soon become a gamechanger. Microbiology and R&D16 Artificial intelligence. Latest gimmick or the future of microbiology? Pumps and fluids20 The fluid handling market in pharma is growing explosively – driven in no small part by increased drug production and a growing adoption of single-use systems. Sorting and weighing24 When it comes to pharmaceutical products there can be no mistakes. Health, safety and hygiene28 Health and safety is neither fun nor glamorous, but in a world where pharma companies want to get the most out of their staff, they need to ensure those same staff are not in danger. 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/pingpao4 Pharma Business International www.pbiforum.net Latest news JIXING acquires investigational drug for acute ischemic stroke from Biogen Ji Xing Pharmaceuticals (JIXING) has acquired BIIB 131 from Biogen, for global clinical development. BIIB131 is an investigational drug for acute ischemic stroke (AIS). Its proposed mechanism of action includes both thrombolytic and anti- inflammatory activities. By restoring critical blood flow following acute stroke, it may benefit more patients over current standard of care by extending the otherwise short treatment window. In the prior Phase 2 clinical trial conducted in Japan, patients treated with BIIB 131 had significantly improved clinical outcomes (proportion of patients with no or minimal neurological deficits) at 90 days, compared to placebo. “Stroke is a serious threat to global health. BIIB 131 represents a potential breakthrough for a critical condition (AIS) that has not seen any meaningful pharmacologic innovation for almost 30 years. We hope to prove that BIIB 131 will significantly improve clinical outcomes for AIS patients around the world,” said Sandy Mou, board executive director and Chief Executive Officer of JIXING. JIXING will acquire the program for an undisclosed upfront with potential milestones and royalties on global sales. Cancer Research UK and Stitch strengthen partnership with two new studies Cancer Research UK and Stitch have expanded their partnership, focused on enhancing the patient experience within clinical trials. In their work together to date, Cancer Research UK and Stitch have worked to empower patients in managing their trial journey and capturing invaluable feedback. After a successful pilot study launched in January 2023 across two research sites in the Experimental Cancer Medicine Centres network, the charity’s Centre for Drug Development has decided to further integrate the Stitch platform into their clinical trial initiatives. The initial pilot demonstrates impressive participant engagement and survey response rates, providing Cancer Research UK with crucial insights to enhance the design of their trials. This positive outcome has prompted the charity to extend its collaboration with Stitch to two further studies set to go live in Spring 2024. In addition to these studies, Cancer Research UK will also be expanding the scope of the pilot study to provide more trial participants with the enhanced support offered by the Stitch platform. © stock.adobe.com/ chrisdorney Almirall and Microsoft partner for digital transformation to enable development of novel treatments for skin diseases Almirall, a global pharmaceutical company focused on medical dermatology, has formed a strategic partnership with Microsoft to drive innovation and digital transformation, advance the research of medical solutions for dermatological diseases, and accelerate the digital transformation of the company. During this three-year collaboration, Almirall and Microsoft Industry Solutions, in collaboration with some Microsoft partners, will create a joint Digital Office to build on Almirall’s unified data platform, and drive digital innovation in drug discovery and development by harnessing generative artificial intelligence and advanced analytics technologies. As part of this agreement, Almirall aims to apply its extensive R&D knowledge and expertise in drug discovery combined with Microsoft’s cutting-edge digital technologies to accelerate the development of innovative treatment options within medical dermatology. Within this partnership, Almirall plans to leverage generative AI for rapid analysis of extensive datasets creating a digital, agile, and patient-centric approach. Within Almirall R&D, the focus includes accelerating the discovery of new therapeutic targets, as well as using generative artificial intelligence and advanced analytics technologies. © stock.adobe.com/peterschreiber.media © stock.adobe.com/ ltyuanPharma Business International 5 www.pbiforum.net Latest news Axplora invests €8m in Le Mans to expand capacity for antibody drug conjugate manufacturing Axplora, a partner to Pharma companies and Biotechs for complex APIs, is investing €8 million to expand capacity for antibody drug conjugate payload manufacturing at its Le Mans site in France, to deliver life-changing cancer treatments for patients. This investment creates a new production suite for antibody drug conjugate payload manufacturing, to enable innovative pharmaceutical partners to develop the next generation of targeted therapies in oncology. This new suite will allow Axplora to produce various payloads at kilogram scale to secure the supply of API for customers. It has been designed to operate over a wide range of process conditions with best-in-class process equipment and containment technology. In addition, at least 15 new positions will be created to support the site. © stock.adobe.com/Alpha Tauri 3D © stock.adobe.com/ jetcityimage Takeda and Protagonist Therapeutics enter into worldwide license and collaboration agreement for late-stage rare hematology asset Takeda and Protagonist Therapeutics have signed a worldwide license and collaboration agreement for the development and commercialization of rusfertide, an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin, currently in a pivotal Phase 3 trial, VERIFY, for the treatment of Polycythemia Vera (PV). PV is a rare chronic blood disorder characterized by excessive production of red blood cells. The hallmark manifestations of PV are increased red blood cell count and iron deficiency, putting patients at higher risk of cardiovascular and thrombotic events, such as heart attack and stroke, often impacting quality-of- life with symptoms such as fatigue and confusion. Under the terms of the agreement, Protagonist will receive an upfront payment of $300 million and is eligible to receive additional worldwide development and regulatory milestone payments, as well as commercial milestones and tiered royalties on ex-U.S. net sales. Protagonist will remain responsible for research and development through the completion of the Phase 3 clinical trial and U.S. regulatory approval. Takeda has rights for ex-U.S. development and is responsible for leading global commercialization activities. © stock.adobe.com/ ctionGP LAVA Therapeutics collaborates with Merck & Co. to evaluate prostate cancer therapy LAVA Therapeutics has entered into a clinical trial collaboration and supply agreement with Merck & Co. to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207, a Gammabody® designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA- positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC). Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide pembrolizumab for the dose escalation and expansion phases of LAVA’s ongoing Phase 1/2a study of LAVA-1207, with the combination arm expected to be initiated in the first half of 2024. Enrollment and dose escalation will also continue in the LAVA-1207 monotherapy and interleukin-2 arms of the study. “We are excited to work with Merck & Co., Inc., Rahway, NJ, USA as we continue to unlock the therapeutic potential of LAVA-1207 and explore its potential capabilities in combination with KEYTRUDA®,” said Stephen Hurly, president and Chief Executive Officer, LAVA. 6 Pharma Business International www.pbiforum.net Latest news EraCal Therapeutics enters into collaboration and license agreement with Novo Nordisk for obesity treatment EraCal Therapeutics has entered into a collaboration and license agreement with Novo Nordisk to develop and commercialize EraCal’s oral, small molecule program. The asset was discovered with EraCal’s platform technology and is believed to target a novel mechanism of action controlling appetite and body weight to treat obesity. “This is an important agreement for EraCal Therapeutics as it showcases the team’s capabilities to identify new mechanisms of action and to discover and develop small molecules to target these biological pathways,” said Josua Jordi, CEO of EraCal Therapeutics. “We consider Novo Nordisk the ideal partner to bring this program to patients and are excited to join forces to lead innovation.” Novo Nordisk obtains the exclusive rights to develop and commercialize the program under the agreement, while EraCal is eligible to receive upfront, development, and commercial milestones of up to 235 million EURO and further royalties on sales of a marketed product. 4DMT receives Rare Pediatric Disease Designation from FDA for cystic fibrosis treatment The U.S. Food and Drug Administration (FDA) has granted 4D Molecular Therapeutics, a clinical-stage genetic medicines company, Rare Pediatric Disease Designation (RPDD) for the company’s product candidate aerosolized 4D-710 for treatment of cystic fibrosis (CF) lung disease. 4D-710 is being evaluated in the Phase 1/2 AEROW clinical trial in people with CF who are not eligible for, or cannot tolerate any of, the currently approved CFTR modulators. RPDD may be granted to investigational drugs and biologics designed to address serious or life-threatening diseases primarily affecting individuals 18 years of age and under, and meeting the definition of “rare disease or condition” (affects less than 200,000 individuals in the U.S.). If the drug or biologic is approved for marketing, 4DMT may qualify for a priority review voucher that may be transferred or sold to another sponsor © stock.adobe.com/high_resolution Orphan drug designation granted in US and EU for systemic sclerosis treatment AnaMar, a clinical-stage biotech company developing first in class anti-fibrotic 5- HT2B receptor antagonists, has been granted orphan drug designation (ODD) in the US and EU for its lead clinical candidate, AM1476 for the treatment of systemic sclerosis (SSc). AM1476 is a selective peripheral-acting 5-HT2B receptor small molecule antagonist that can be delivered orally. It has demonstrated efficacy in in vitro and in vivo models of fibrosis, as well as favourable safety and pharmacokinetic profiles in Phase I clinical studies. AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis. Systemic sclerosis is a chronic, progressive, autoimmune disease characterized by inflammation and fibrosis, i.e. uncontrolled scar tissue formation, in skin and various internal organs. Interstitial lung disease (ILD) is a common and early manifestation of SSc. ILD causes progressive lung scaring, known as fibrosis, which leads to increasing, chronic, breathing problems and organ dysfunction, and can lead to death. There are currently no treatments on the market that effectively stop or reverse scarring in both skin and lung tissue. © stock.adobe.com / Andrey Popov © stock.adobe.com / Kadmy GAMMAGARD LIQUID® approved by U.S. FDA for adults with CIDP The U.S. Food and Drug Administration (FDA) has approved Takeda’s GAMMAGARD LIQUID® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It can be used as induction therapy, which includes an induction dose followed by maintenance doses. For treatment of CIDP, GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients nor as maintenance therapy for periods longer than six months. “The approval of GAMMAGARD LIQUID for treatment of CIDP is an encouraging validation of our decades-long commitment to advancing plasma-derived therapies on behalf of people living with rare neuromuscular disorders and bringing our portfolio of differentiated IG therapies to these patients,” said Richard Ascroft, senior vice president and head of Takeda’s U.S. Plasma-Derived Therapies Business Unit. “Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.” VYVDURA® injection for subcutaneous use approved in Japan for generalized myasthenia gravis argenx has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) use for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use. “Today’s approval of VYVDURA marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, general manager, argenx Japan. “Bringing VYVDURA to Japan means there are now two formulations available for gMG patients, including the possibility to self-inject at home, allowing patients and their healthcare providers to choose the best option to meet their treatment needs.” AGAMREE approved to treat Duchenne muscular dystrophy in the UK Santhera Pharmaceuticals’ AGAMREE® (vamorolone) has been approved in the United Kingdom (UK) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status. The UK’s MHRA, adopting the view of the European Medicines Agency (EMA), acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy. “We are delighted to have secured a third approval for AGAMREE to treat Duchenne from a major regulatory agency, after the U.S. FDA and the EU EMA, within a couple months,” said Shabir Hasham, MD, chief medical officer of Santhera. “In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognize the benefits of treatment with AGAMREE for bone health and growth, underlining the favorable safety and tolerability profile of this novel medicine compared to conventional corticosteroids. We are working towards making AGAMREE available to patients in the UK in the second half-year 2024.” Europe’s first ustekinumab biosimilar to Stelara secures approval The European Commission has issued a marketing authorization for STADA and Alvotech’s Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein and Norway. This European marketing authorization for Uzpruvo paves the way for market entry as soon as possible following the expiry in July 2024 of a European Supplementary Protection Certificate (SPC) for Stelara. Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology and rheumatology. STADA’s global specialty head, Bryan Kim, said: “This first marketing authorization for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition. By adding to our current roster of six marketed biosimilars, STADA looks forward to offering Europe’s gastroenterologists, dermatologists and rheumatologists a further cost-effective treatment option.” Nucala approved in China for use in severe asthma with an eosinophilic phenotype The China National Medical Products Administration has approved GSK’s Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved for use in China for adult and adolescent patients with this condition. Asthma is a major health burden in China affecting an estimated 46 million adults. Of those, approximately 6% experience severe asthma, which confers the most substantial impact on daily living, is associated with an increased risk of exacerbations requiring hospitalisation, and higher likelihood of potentially fatal asthma attacks. Kaivan Khavandi, senior vice president, global head, Respiratory and Immunology, R&D, said: “We are delighted with this approval, supported by evidence in a Chinese population. Millions of people in China with severe eosinophilic asthma can now potentially benefit from the advance in management that Nucala could offer – a testament to GSK’s ongoing commitment to redefine respiratory disease management globally.” www.pbiforum.netPharma Business International 7M&A ROUND-UP 8 Pharma Business International W ith a flurry of deals since our last issue, expectations of a rise in M&A activity in the pharmaceutical industry seem to have been met, with 2024 looking set to be a busy year. Bristol Myers Squibb - Karuna Therapeutics & RayzeBio Bristol Myers Squibb closed out 2023 with a duo of acquisitions, firstly snapping up Karuna Therapeutics in a $14bn deal. Karuna is a biopharmaceutical company focusing on discovering, developing and delivering transformative medicines for people living with psychiatric and neurological conditions. The company’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024. KarXT is additionally in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb, said: “There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade. This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive, and have the potential to address areas of significant unmet medical need. We look forward to A flurry of deals After a sluggish period, M&A activity in the pharmaceutical industry is picking up, with the end of 2023 and start of 2024 welcoming myriad deals. Pharma Business International 9 M&A ROUND-UP welcoming the talented Karuna team to Bristol Myers Squibb.” This acquisition was quickly followed by that of RayzeBio, for $4.1bn. RayzeBio is a clinical-stage radiopharmaceutical therapeutics (RPT) company with an innovation-leading position in actinium-based RPTs and a pipeline of potentially first-in-class and best-in-class drug development programs. Current pipeline programs are targeting the treatment of solid tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs), small cell lung cancer, hepatocellular carcinoma and other cancers. AstraZeneca - Gracell & Icosavax AstraZeneca has also recently made a duo of acquisitions, including a $1.2bn deal for Gracell Biotechnologies, a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases. The proposed acquisition will enrich AstraZeneca’s growing pipeline of cell therapies with GC012F, a novel, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy, a potential new treatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases such as systemic lupus erythematosus (SLE). AstraZeneca’s second acquisition consists of a $1.1bn deal for Icosavax, a clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform. The proposed acquisition will build on AstraZeneca’s expertise in respiratory syncytial virus 10 Á © stock.adobe.com/volody10Next >