Your guide to the pharmaceutical world Volume 11 Issue 4 Packaging Sustainable, traceable, profitable Temperature control Unyielding integrity Materials handling Handling the issue Packaging Sustainable, traceable, profitable Temperature control Unyielding integrity Materials handling Handling the issue www.pbiforum.net26-28 SEPT HALL 5 • NEC PPMASHOW.CO.UK10 18 22 30 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. Beckman Coulter9 Beckman Coulter Connects Scopio Labs Digital Cell Morphology with Hematology Workcell Extending Automated Workflow. M&A round-up10 Huge cash reserves and a looming patent cliff are expected to see a surge in dealmaking for Big Pharma. Materials handling14 Materials handling is more important in pharma than any other industry and the explosive growth expected for the sector proves it. Packaging18 There’s no easy means of defining end of line packaging given the depth of its capabilities and requirements. It’s an industry constantly in flux, moving quickly to try and keep up with legislation and trends, while remaining efficient enough to keep the pharmaceutical industry turning a profit. Yet it’s also doing this while meeting the growing requirement for energy efficiency in the supply chain. Marketing22 Social media and digital channels aren’t only changing the way in which pharmaceutical and medical products are marketed but are changing how companies conduct their market research. Software and IT systems26 AI is the new kid on the block, and every industry is looking at ways to incorporate it. The pharma industry is no exception. Temperature control30 Maintaining the cold chain is vital to ensure the efficacy of vaccines and vital medical products. As well as an upsurge in growth over the last decade, the sector needs to remain robust in the face of any future pandemics. Events 34 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy:stock.adobe.com/ Anusorn4 Pharma Business International www.pbiforum.net Latest news Sygnature Discovery accelerates global growth with North American acquisition Integrated drug discovery partner, Sygnature Discovery has acquired one of North America’s largest discovery Contract Research Organisations, Canada-based NuChem Sciences. This acquisition cements Sygnature as one of the world’s largest players in integrated drug discovery phase solutions and advances their vision to become the global market leader. Marc Lebel, Pharm. D., president and chairman at NuChem Sciences, said: “Our company goals and values fit perfectly with those of Sygnature in becoming a global leader in drug discovery services. We are delighted to become an integral part of the Sygnature Group, allowing us to leverage our deep scientific expertise and presence across North America and Europe, to the benefit of customers and employees.” Following this acquisition, Sygnature Discovery will have more than 1,000 staff across 53 nationalities, including over 900 scientists who work on standalone and integrated drug discovery programmes for pharma, biotech, VCs, and NFPs. Dr Simon Hirst, CEO at Sygnature Discovery, said: “This acquisition represents a pivotal milestone in the Sygnature growth plan, allowing us to deliver better discovery solutions to customers around the world.” NorthX Biologics acquires biologics manufacturing unit from Valneva NorthX Biologics, a Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, has acquired the Stockholm-based Clinical Trial Manufacturing unit from Valneva Sweden. The acquisition includes the transfer of a multi-purpose facility, situated in the Stockholm life science cluster, close to Karolinska University Hospital. In addition, 30 staff members who currently operate the facility will also join NorthX. The site and staff have a long history with extensive experience of serving both Valneva internally and also working with external customers on a contract development and manufacturing basis. With expertise in mammalian expression systems and viral vectors, the capabilities complement those of NorthX’s existing business of advanced microbial based manufacturing of proteins and plasmid DNA. The acquired unit excels in process development, scale up, GMP production, quality control analytics, and quality assurance/release and is capable of working with Biosafety Level (BSL) 2/2+ and BSL 3 organisms. With this expansion, NorthX enhances its capabilities and can offer comprehensive services to a wider range of clients globally. © stock.adobe.com/ aicandy Biography: Alf Goebel, CEO, advanco. Alf Goebel has been the CEO of advanco since 2019. He has overseen a significant period of expansion in advanco’s evolution, firmly establishing it as one of the globe’s leading providers of levels 2 to 5 item level serialization for the pharmaceutical sector. Alf is a senior enterprise software sales, marketing & product executive, with over 25 years‘ enterprise software industry experience. He has strong operational experience, specializing in high growth businesses in Europe and the US. He has extensive experience with global partnerships in the SAP eco system. He also was a partner at Lupo Ventures and has held senior executive positions at several leading technology companies, including Snow Software, MSC Software and Software AG. An internationally-recognized expert on regulated track and trace, Alf is an established industry commentator and speaks at pharmaceutical and serialization events across the world. He is also a board member of OPEN- SCS, the industry body responsible for promoting common standards across the pharmaceutical serialization sector. Alf is resident in Silicon Valley and divides his time between Silicon Valley and Europe. Advanco is a portfolio company of Parabellum Investments which is led by founder and CEO, Rami Cassis. © stock.adobe.com/ motorolkaPharma Business International 5 www.pbiforum.net Latest news Roquette, a global leader in plant-based ingredients and pharmaceutical excipients, has agreed to acquire Qualicaps and reinforce its position as a major supplier to the pharmaceutical industry. The combination of the two businesses will contribute to Roquette’s strategic growth plan and will create new opportunities for Roquette and Qualicaps’ customers and employees. Qualicaps is headquartered in Nara, Japan, and is the third largest producer of hard capsules for oral dosage solutions. With an attractive client base that includes major pharmaceutical and food companies around the world, and a workforce of 1,400 employees located in different sites in Asia, Europe and the Americas, Qualicaps is a renowned global player, relying on high-quality products and a strong innovation pipeline. This strategic investment offers Roquette the ability to expand the global footprint of its pharmaceutical business, as well as enrich its offerings of oral dosage solutions. Roquette’s deep knowledge and expertise in the development of pharmaceutical excipients will be further enhanced by Qualicaps’ expertise in capsules, as well as by their assets and infrastructure. © stock.adobe.com/James Thew © stock.adobe.com/cbies Alexion enters agreement with Pfizer for portfolio of preclinical rare disease gene therapies Alexion, AstraZeneca Rare Disease, has entered a definitive purchase and licence agreement for a portfolio of preclinical gene therapy programmes and enabling technologies from Pfizer. The agreement furthers Alexion and AstraZeneca’s commitment to advancing next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies. As part of the agreement, the transaction will bring to Alexion a number of novel adeno-associated virus (AAV) capsids. AAV capsids have been shown to be an effective mechanism for delivering therapeutic gene cargos for gene therapy and gene editing. These new resources build on Alexion and AstraZeneca’s combined capabilities in genomic medicine, recently strengthened with the acquisition of LogicBio, with the objective to develop new genetic therapies with improved safety and efficacy profiles. Additionally, Alexion will seek to welcome talent from Pfizer associated with the portfolio. Under the agreement, Alexion will purchase and licence the assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales. © stock.adobe.com/ Africa Studio STADA grows European Consumer Healthcare portfolio by acquiring additional brands from Sanofi STADA is expanding its European Consumer Healthcare portfolio by acquiring another range of well-established local and regional consumer healthcare brands from Sanofi in European countries, including Belgium, Germany, Hungary, Spain and the United Kingdom, as well as Nordic countries. The transaction covers several brands, including: Antistax for pain relief and tiredness in legs; the allergy eye drops Lomudal; Omnivit vitamins; and Opticrom allergy eye drops. In addition, the two painkillers AAS and Dolalgial, as well as Bila-Git for gallbladder complaints, are part of the acquired portfolio. “We are pleased to continue our collaboration with Sanofi. This acquisition further strengthens STADA as a top-four player in Europe’s consumer healthcare market and supports our growth acceleration along our purpose of ‘Caring for People’s Health as a Trusted Partner’,” said STADA’s CEO, Peter Goldschmidt. “As a broad-based European player with a strong presence in local markets, STADA is a go-to partner in consumer healthcare,” Goldschmidt highlighted. “The brands being acquired, and their geographic presence, are well aligned and synergistic with the organic activities in STADA’s core countries.” Roquette to snap up Qualicaps 6 Pharma Business International www.pbiforum.net Latest news Menarini becomes exclusive distributor for INVOKANA® (canagliflozin) and VOKANAMET® (fixed-dose combination of canagliflozin and metformin) in the UK A. Menarini Farmaceutica Internazionale SRL (Menarini) has become the exclusive distributor for INVOKANA® (canagliflozin) and VOKANAMET® (a fixed-dose combination of canagliflozin and metformin) in the United Kingdom, including Northern Ireland, where the products have obtained Pricing and Reimbursement Approvals. Menarini entered into an exclusive distribution agreement with manufacturer Janssen Pharmaceutica NV (Janssen) effective from January 2, 2023. Menarini has taken up the physical distribution as of July 1, 2023. As a result of this agreement, Menarini becomes the exclusive distributor for the products in the concerned countries, with exclusive rights to promote, distribute, and sell the products through its network of independent associated companies. Janssen’s affiliate, Janssen-Cilag Ltd, remains Marketing Authorisation Holder (MAH) in the concerned countries. Under the agreement, Janssen maintains manufacturing responsibilities and will continue to be responsible for certain regulatory activities, including Marketing Authorisation updates and pharmacovigilance in close collaboration with Menarini and its associated companies. Lupin Healthcare launches Beclu® (beclometasone dipropionate) certified carbon neutral inhalers for the treatment of asthma in the UK Lupin Healthcare, the UK-based wholly owned subsidiary of Lupin Limited (Lupin) has announced the UK launch of Beclu® (beclometasone dipropionate) 100 micrograms (mcg) and 200 mcg pressurised metered dose inhalers (pMDI) for the treatment of mild, moderate or severe asthma. Beclu 100 is indicated for both adults and children, while Beclu 200mcg is indicated for adult use only. The availability of Beclu pMDIs has the potential to provide cost savings for the NHS whilst being a certified carbon neutral inhaler as a result of carbon offsetting. Beclu 100 and 200 have the same active ingredients and licensed indications as the respective strengths of Clenil® Modulite® and Soprobec®. Approximately 5.4 million people are currently receiving treatment for asthma in the UK. The annual asthma cost burden on the NHS is estimated at £3bn per year. Over the past 12 months, to February 2023, the NHS spent over £43m on Clenil® Modulite® 100 and 200mcg. Beclu pMDIs offer a 30% NHS list price saving vs Clenil® Modulite® 100 and 200mcg, equating to approximately £13m per annum for the NHS. © stock.adobe.com joyfotoliakid ACG acquires Technical Aluminium Foil Company ACG has announced full shareholding ownership of Technical Aluminium Foil Company (TAFC). This strategic move further solidifies ACG’s growth trajectory across the Middle Eastern and African markets. As the world’s only integrated pharma manufacturing solutions company, ACG offers a diverse range of products including capsules, films, foils, engineering equipment and inspection systems. The addition of TAFC, a prominent aluminium foil packaging company based in the UAE, strengthens ACG’s position as a leading provider of comprehensive packaging solutions. TAFC boasts over a decade of experience serving the pharmaceutical and food industries with its extensive range of aluminium and specialty packaging foils renowned for their exceptional high barrier properties. The company’s expertise in lacquering, lamination, printing and slitting further enhances ACG’s capabilities in meeting the diverse packaging needs of its clients. This acquisition represents ACG Group’s inaugural venture in the Middle East, following recent successful acquisitions of ComboCap and AquaCap in the Americas. TAFC seamlessly aligns with ACG Films and Foils’ existing business operations, enabling both entities to harness their collective strengths and expertise for accelerated growth. Shivshankar S.R., CEO at ACG Films & Foils FDA approves first nonprescription daily oral contraceptive The U.S. Food and Drug Administration (FDA) has approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy — the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online. “Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.” The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc. UK MHRA authorises GSK’s respiratory syncytial virus vaccine for older adults The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised for use in Great Britain by the MHRA. Neale Belson, senior vice president and general manager UK at GSK, said: “We are very excited by today’s announcement. Our ambition is to help protect adults 60 years of age and older in the UK who are at risk from RSV disease, including those with underlying medical conditions, who drive the majority of RSV hospitalisations. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation.” Enhertu approved in China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, said: “Patients with HR-positive or HR-negative, HER2-low metastatic breast cancer previously had few effective treatment options beyond chemotherapy. The results from the DESTINY-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2-low via routine testing. This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide.” Mirum’s LIVMARLI authorized in Canada for cholestatic pruritus in patients with Alagille syndrome Mirum Pharmaceuticals’ LIVMARLI (maralixibat oral solution) has been authorized by Health Canada for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). ALGS is a rare genetic disorder caused by abnormalities in bile ducts that can lead to progressive liver disease. Malformed or reduced bile ducts cause cholestasis, the accumulation of bile acids in the liver, which leads to inflammation and liver injury, and prevents the liver from working properly. Cholestasis in ALGS is associated with pruritus which is among the most common indications for liver transplant in ALGS. “Today’s approval in Canada furthers our commitment to ensuring patients globally have a meaningful and effective treatment option for the unrelenting burden of cholestatic pruritus impacting patients and their families living with ALGS,” said Chris Peetz, president and Chief Executive Officer at Mirum. “We are grateful to the patients, families, clinicians and ALGS community who made this approval possible.” FDA approves XDEMVY 0.25% for the treatment of Demodex blepharitis The U.S. Food and Drug Administration (FDA) has approved Tarsus Pharmaceuticals’ XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. XDEMVY, formerly known as TP-03, is the first and only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. “We are thrilled to announce the FDA approval of XDEMVY for the treatment of Demodex blepharitis and look forward to making this product broadly available to the millions of patients who have not had any FDA approved therapeutics for this disease,” said Bobak Azamian, MD, PhD, Chief Executive Officer and chairman of Tarsus. “This tremendous milestone was achieved through a successful collaboration of our talented Tarsus team, countless eye care providers and the hundreds of patients who participated in our trials. We are grateful and honored for the opportunity to introduce the first and only approved therapeutic for this disease to the eye care community.” www.pbiforum.netPharma Business International 7Pharma Business International 9 www.pbiforum.net BECKMAN COULTER DIAGNOSTICS Beckman Coulter Connects Scopio Labs Digital Cell Morphology with Hematology Workcell Extending Automated Workflow Beckman Coulter debuted its hematology analyzer and slidemaker stainer connected to Scopio Labs’ digital morphology platform for end-to-end digitization with artificial intelligence- assisted peripheral blood smear analysis at the 2023 American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Lab Expo. The solution features the Beckman Coulter DxH 900 Workcell and DxH Slidemaker Stainer II connected with the Scopio X100HT digital morphology platform capable of continuous loading, scanning and analysis. “With the increasing attention of hematological disorders and malignancies, the accuracy and timeliness of peripheral blood smears results are critically important for timely diagnosis and effective treatment initiation,” said Dan Xu, Vice President/GM, Hematology and Urinalysis Business Units for Beckman Coulter. “The peripheral blood smear (PBS) review is a powerful diagnostic tool that provides clinicians with information about a variety of disorders such as blood-related cancers, anemia, infections, and many other life- threatening medical conditions. Often, performing PBS analysis forces medical technicians to compromise on either field of view or resolution and requires physically transferring PBS slides to a microscope for manual review. Our new capability to automatically transfer PBS slides from Beckman Coulter’s DxH Slidemaker Stainer II to the Scopio X100HT platform removes the need for a technician to manually transfer the slides, resulting in lab efficiency for medical technicians, while Scopio’s Full- Field technology removes the need to revert to the microscope for manual review.” “Connecting the Scopio X100HT with the DxH 900 Workcell is a tremendous step forward in advancing our global partnership with Beckman Coulter, which we initiated one year ago,” said Itai Hayut, CEO and Co-Founder of Scopio Labs. “A fully integrated hematology workflow from the complete blood count (CBC) test to slide staining (SMS) to peripheral blood smears (PBS) will empower qualified experts in detecting blood-related medical conditions.” In manual microscopy, users must choose between a large field of view or high resolution. Scopio solves that trade- off, capturing large scan areas at 100X magnification, and virtually eliminates the need for additional manual microscopic examination. With this newly connected capability, the X100HT is able to process up to 30 samples an hour, meeting the high-throughput requirements of large hospitals and labs, and fully supports remote review capabilities. Scopio X100 HT is CE marked and has received U.S. Food and Drug Administration 510(k) clearance with its PBS Application coupling high- throughput capabilities with high- resolution scanning for hematological analysis. Catering to large medical facilities and labs across the world, the X100HT complements the previously- cleared X100 instrument designed with a 3-slide tray and a throughput of up to 15 slides an hour for a 200 WBC Diff, making it an optimal solution for small to medium size laboratories. Next >