Your guide to the pharmaceutical world Volume 12 Issue 4 Packaging Packaged protection Temperature control Cold opportunities Materials handling In hand Packaging Packaged protection Temperature control Cold opportunities Materials handling In hand www.pbiforum.net4 12 20 24 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 The rebound of M&A in the pharmaceutical industry is continuing. Packaging12 Packaging's rather surprising role in combating counterfeit drugs remains an important facet for the industry. Temperature control16 The need for temperature-controlled logistics has caught the attention of mainstream transport companies looking to diversify their offering or expand their capabilities. Software and IT systems20 While AI has its many downsides, companies are desperately trying to make use of it for a competitive edge, and those that fail to adapt could be left in the dust. Materials handling24 Effective materials handling contributes to maintaining product quality throughout the supply chain. From the moment raw materials are received to the point of consumption, the careful handling of goods prevents physical damage and maintains a product’s viability. Marketing28 The consumption of video content is on the rise, with video sharing platforms forming the lion’s share of some companies’ marketing and digital strategy. 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/ StellaPattaya4 Pharma Business International www.pbiforum.net Latest news Streamlining success: Sodexo’s quest for operation efficiency Sodexo is revolutionising workplace efficiency by using approaches that redefine productivity, streamline operations and maximise organisational performance. Following the significant shift in the industry caused by the heightened practices of the Covid pandemic and the resulting recession, in combination with the impact of the patent lifeline on business, many pharmaceutical companies are turning to suppliers to provide innovative solutions that continue to support their progression and pharmaceutical prowess whilst also streamlining services to create effective, cost-efficient workplaces. Across facility management, food service, space solutions and strategic insight support, enabling pharmaceutical organisations to operate smoothly and efficiently is core to Sodexo’s role as the global leading workplace service partner. Drawing on extensive experience with the largest pharmaceutical organisations in the UK and globally, Sodexo has identified five key areas for optimising efficiency: data-driven space reconfiguration, multi-use areas and modular cleanrooms, cutting-edge workplace solutions, streamlined operations and regulatory compliance, and focus on core business and task optimisation. Sodexo’s depth of understanding and quality assurance ensures that labs and cleanrooms run at full capacity, meeting stringent regulatory requirements and quality standards in a cost-efficient way. Boston Scientific obtains CE Mark for image guided programming software for Deep Brain Stimulation Boston Scientific has obtained CE Mark on the Vercise™ Neural Navigator 5 Software with STIMVIEW™ XT technology, which when used as part of the Vercise Genus™ Deep Brain Stimulation (DBS) Systems, can provide clinicians with simple and actionable data for efficient programming in the treatment of people living with Parkinson’s disease, essential tremor and dystonia. “We are now using image guided programming tools to optimally define the site of stimulation while we clinically assess the patient,” said Francesca Morgante, professor of Neurology and Eleonor Peel Chair for the study of Ageing at St. George’s University of London. “This advancement in the technology has substantially cut down our programming time and allowed to improve the symptoms of our patients in a significant shorter time.” The Vercise Neural Navigator 5 Software, with STIMVIEW XT technology, is the latest addition to the fully integrated portfolio of image guided programming solutions for Boston Scientific DBS Systems. These tools have demonstrated a reduction in programming time by 56% and provide real- time visualization and stimulation of each person’s unique brain anatomy. ACG Packaging Materials wins prestigious Kepner-Tregoe (KT) Excellence Award ACG Packaging Materials, a division of ACG – the world’s only integrated pharmaceutical solutions and manufacturing company, has been honoured with a Kepner- Tregoe (KT) Excellence Award in the team category for problem-solving excellence. For the last 30 years, the KT Excellence Awards have recognised exceptional results, talent, and achievements in the application of KT’s methodologies. They honour global organisations, teams and individuals who have demonstrated mastery of rational process and provide a recognition for being “the best in the world.” Kepner-Tregoe, a leader in consulting and training for over 65 years, played a pivotal role in advancing ACG Packaging Materials’ capabilities. In June 2023, 18 ACG associates received problem-solving skills development and coaching from Matthieu Coupeau, Senior Consultant at Kepner-Tregoe. This training provided the team with a structured methodology for tackling complex issues and delivering impactful results. Leveraging these newly acquired skills, the ACG team excelled against over 100 competitors, ultimately securing the prestigious award. © stock.adobe.com/ GorodenkoffPharma Business International 5 www.pbiforum.net Latest news Beckman Coulter Diagnostics announces €10m investment in Mid-West Ireland Beckman Coulter Diagnostics, the largest employer in East Clare and among the largest in the county, has announced a €10 million investment that underscores its commitment to innovation and growth in the region. The investment will enhance Beckman Coulter’s world-class diagnostics production with the addition of two new fully automated reagent filling lines and upgrades to the site’s infrastructure, boosting both efficiency and capacity. The company is actively hiring for 50 open roles and also announced 30 additional jobs arising, to be recruited between 2025 and 2027 for highly-skilled professionals at its Co. Clare facility for key functions such as Production Operations, Quality & Regulatory Affairs, Research & Development, etc. One of the top 3 diagnostics companies worldwide, Beckman Coulter Diagnostics employs over 11,000 people all over the world and plays a major role in world health. Every hour around the world, more than 1 million samples – representing up to 1 million people – are analysed in hospitals using Beckman Coulter instruments. © stock.adobe.com/ JHVEPhoto Dren Bio and Novartis to develop novel targeted myeloid engagers for cancer Dren Bio, a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, has entered into a strategic collaboration with Novartis Pharma, a subsidiary of Novartis. The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. “Our agreement with Dren Bio is a promising opportunity to discover novel bispecific antibody therapies for cancer, building on our longstanding expertise in immuno-oncology science at Novartis,” said Shiva Malek, Ph.D., Global Head of Oncology for Biomedical Research at Novartis. “We’re excited to collaborate to bring forward new therapeutic options for patients living with cancer, complementing our strategic efforts across a wide range of modalities, including targeted therapies, biologics, radioligand therapies and CAR-Ts.” © stock.adobe.com/ SewcreamStudio Angelini Pharma launches new crowdsourcing challenge Angelini Pharma, part of the privately owned Angelini Industries, has launched a new crowdsourcing campaign to identify innovative new Drug Delivery Systems (DDS) and Treatment Approaches to significantly improve the lives of people with epilepsy, especially elderly and paediatric patients. The challenge – New Drug Delivery Systems and Treatments for Improved Adherence and Better Management of Epilepsy – is the second partnership between Angelini Pharma and innovation scale- up Wazoku to identify innovative Drug Delivery Systems and Treatments. The challenge will tap into Wazoku’s 700,000-strong network to identify how to improve already existing ASMs (Anti Seizures Medications), and to propose new DDS and treatment approaches that utilise novel technologies. Identifying new options to increase adherence is vital to the management of epilepsy, which affects 50 million people worldwide. While current epilepsy treatment options include approximately 30 antiseizure medications (ASMs) available in various pharmaceutical forms, there are limitations in terms of adherence and general management related to specific unmet needs such as age, comorbid conditions, and safety concerns. Photo courtesy of Arthur Ellis6 Pharma Business International www.pbiforum.net Latest news Triastek and BioNTech to advance 3D printed oral RNA therapeutics Triastek, a leader in 3D printing pharmaceuticals, has entered into a research collaboration and platform technology license agreement with BioNTech, a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Under the agreement, the companies will develop RNA therapeutics for oral delivery based on 3D printing technology. The collaboration aims to provide groundbreaking therapies to address unmet medical needs in an easy to administer oral formulation. Triastek will contribute to the collaboration its expertise in innovative oral tablet designs made possible by 3D printing aimed at optimizing delivery of RNA therapeutics across the gastrointestinal mucosa, minimizing degradation in the gastrointestinal tract, and delivering RNA therapeutics to the portion of the gastrointestinal tract where absorption will potentially be the greatest. Triastek’s ability to create tablet structures with unique external and internal tablet geometries, including multiple-layer and multi-compartment designs, will be leveraged, aiming to optimize delivery of novel RNA therapeutics. 4D Medicine raises £3.4m 4D Medicine – whose innovative biomaterial has potential to be used for a wide range of 3D printed implants and surgical devices – has raised £3.4m ($4.4m) in a Series A investment. The funding will enable the company to complete pre-clinical testing of its first product range and seek FDA clearance for entry into the US market. A spin-out from the Universities of Birmingham and Warwick, 4D has developed a resorbable biomaterial, 4Degra, that is being used to develop implants such as orthopaedic devices or soft tissue scaffolds to help patients recovering from surgery or injuries. Preliminary testing has shown that as healing progresses, the biomaterial gradually erodes and is resorbed by normal metabolic processes as natural tissue grows back in its place. 4Degra promises some key advantages over existing resorbable biomaterials used for implants. With some materials, the entire product breaks down rapidly, creating acidic by- products that can cause pain, inflammation and cysts. By contrast 4Degra degrades gradually, starting from the surface, and does not release harmful acidic by-products. Beckman Coulter introduces new integrated chemistry and immunoassay analyzer Beckman Coulter Diagnostics has introduced the new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer. As healthcare systems around the world strategically adopt networked laboratory operational models for better efficiency and patient access, Beckman Coulter continues to introduce new innovations to address the needs of the entire network with specific solutions for satellite or independent laboratories, as well as core laboratories. Utilizing Beckman Coulter’s common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio, the DxC 500i Analyzer enables commutable patient results, offering hospitals and healthcare networks strategic benefits in patient care and inventory management. Kathleen Orland, Senior Vice President, Business Unit, General Manager, Chemistry and Immunoassay for Beckman Coulter Diagnostics, said: “The DxC 500i Clinical Analyzer powers both clinical chemistry and immunoassay testing in one space-saving package. With steadfast performance, practical simplicity, and trusted clinical quality, this analyzer meets the specific demands of the low-volume laboratory customer, standalone laboratories and community hospitals.” © stock.adobe.com / adragan Philip Smith, 4D Medicine CEO U.S. FDA approves ERZOFRI for schizophrenia and schizoaffective disorder The U.S. Food and Drug Administration (FDA) has approved Luye Pharma Group’s ERZOFRI (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurring relapses. Antipsychotic medications play an important role in treating and controlling symptoms of schizophrenia and schizoaffective disorder, but patient adherence to antipsychotics is generally poor. Using long-acting injectable (LAI) antipsychotics is effective in improving patient adherence, as they can reduce the dosing frequency and can also reduce the risk of patients not adhering to their dosing regimen without the knowledge of their healthcare providers. ERZOFRI, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S. MHRA approves first generic raltegravir medicines to treat adult and paediatric patients infected by HIV The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first generic raltegravir medicines to treat adult and paediatric HIV patients who weigh at least 40kg. The Human Immunodeficiency Virus (HIV) causes Acquired Immune Deficiency Syndrome (AIDS). HIV produces an enzyme called HIV integrase which enables multiplication of the virus in cells within the body. Raltegravir stops this enzyme from working, and when used with other medicines it may reduce the amount of HIV in the patient’s blood and increase the patient’s CD4-cell count (a type of white blood cell that plays an important role in maintaining a healthy immune system). Reducing the amount of HIV in the blood may improve the functioning of the immune system, meaning the body may fight infection better. Raltegravir must be used in combination with other medicines for HIV. The new marketing authorisation was granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited. Tagrisso with chemotherapy approved in EU as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy. This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.” Tagrisso is approved as monotherapy in more than 110 countries including in the US, EU, China and Japan. Tagrisso with the addition of chemotherapy is also approved in the US, China, Japan and several other countries for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC. FDA approves Vabysmo prefilled syringe for three leading causes of vision loss The United States Food and Drug Administration (FDA) has approved Roche’s Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally. “We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, which are some of the leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.” Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in nAMD, DME and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision. Omjjara approved in Japan for treatment of myelofibrosis Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved GSK’s Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. This is the fourth major regulatory approval for GSK’s momelotinib in the treatment of myelofibrosis, following approval under the brand name Ojjaara from the US Food and Drug Administration and authorisations under the brand name Omjjara from the European Commission and the Medicines and Healthcare products Regulatory Agency in the UK. Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: “Myelofibrosis has a heavy disease burden, with symptomatic patients experiencing spleen enlargement, fatigue, night sweats and bone pain, along with anaemia which can lead to treatment discontinuation and dependence on regular blood transfusions. With the approval of Omjjara, myelofibrosis patients in Japan will have a new treatment option for this complex blood cancer.” www.pbiforum.netPharma Business International 7M&A ROUND-UP T he pharma industry’s busy dealmaking landscape is anticipated to continue for the remainder of 2024 as M&A acts as a critical tool to unlock value and drive innovation, as highlighted in PwC’s 2024 Mid-Year Outlook for Global M&A Trends in Health Industries. Though megadeals combining large conglomerates are less expected this year, dealmakers are keen to seal deals as they become used to navigating an environment of heightened interest rates and regulatory pressure and prepare for patent cliffs. Here, Pharma Business International shares fresh acquisitions since our last issue. Lilly - Morphic Eli Lilly and Company is set to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for treatment of serious chronic diseases, in a $3.2 billion deal. Morphic’s lead program is a selective oral small molecule inhibitor of ?4?7 integrin for the treatment of inflammatory bowel disease (IBD) that has the potential to improve outcomes and expand treatment options for patients. This molecule (known as MORF-057) is being evaluated in two Phase 2 studies in ulcerative colitis and one Phase 2 study in Crohn’s disease. Additionally, Morphic is developing a preclinical pipeline of other molecules for the treatment of autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases and cancer. “Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease,” said Daniel Skovronsky, M.D., Ph.D., Chief Scientific Officer of Lilly and President, Lilly Research Laboratories, President, Lilly Immunology. “We are eager to welcome Morphic colleagues to Lilly as this strategic transaction reinforces our commitment to developing new therapies in the field of gastroenterology, where Lilly has made significant investments to deliver first-in- class molecules for the benefit of patients.” “Morphic has always believed that the immense potential of MORF-057 to benefit patients suffering from IBD could be optimized by the ideal strategic partner. Lilly brings unparalleled resources and commitment to the inflammation and immunology field,” said A busy dealmaking landscape The rebound of M&A in the pharmaceutical industry is continuing. 8 Pharma Business International www.pbiforum.netM&A ROUND-UP Praveen Tipirneni, M.D., CEO of Morphic Therapeutic. “We built the Morphic Integrin Technology platform to realize the vast opportunity of integrin therapeutics. MORF-057 is a tremendous example of those efforts, an oral small molecule ?4?7 inhibitor with the potential to be well tolerated and efficacious, attributes that could unlock new possibilities in IBD treatment. My deepest thanks go to the entire Morphic Team for their expertise, creativity and tenacity. We are also grateful to the investigators and patients who have contributed to the success of MORF-057 thus far, and we eagerly anticipate the path forward for MORF-057 and other integrin medicines under Lilly’s stewardship.” Boehringer Ingelheim - Nerio Therapeutics Boehringer Ingelheim, meanwhile, has expanded its immuno-oncology pipeline, as the company is adding an innovative preclinical program with the acquisition of Nerio Therapeutics for a total of up to $1.3 billion. Nerio’s small molecules inhibit the protein tyrosine phosphatases N1 and N2 (PTPN1 and PTPN2), which act as immune checkpoints. Through this mechanism, PTPN1/2 inhibition can activate the immune system to fight cancer cells. Immune checkpoint blockade with current checkpoint inhibitors has transformed the cancer treatment landscape. However, while this approach works for some patients, it does not provide a therapeutic benefit for all. Boehringer Ingelheim aims to change this paradigm and extend the benefits of immuno-oncology to more cancer patients with a comprehensive portfolio of therapies based on immune checkpoint blockade to boost the 10 Á © stock.adobe.com/ Oleg www.pbiforum.net Pharma Business International 9 Next >