Your guide to the pharmaceutical world Volume 11 Issue 5 Machinery and equipment Industry 4.0 Environmental Pharma’s environmental problem Vision, inspection and detection Machine vision Machinery and equipment Industry 4.0 Environmental Pharma’s environmental problem Vision, inspection and detection Machine vision 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 Pharma Business International reflects on a handful of new deals that have sprung up since our last issue. Machinery and equipment12 The future of machinery is now and, in all honesty, it should have been years ago. Vision, inspection and detection16 Quality assurance and health and safety both rely on good inspection, and we are long past the point where the human eye can be of any practical use in a factory setting. As demand for machine vision systems increases however, the complexity of the task rises in tandem. Environmental20 Consumers and governments are pushing toward more sustainability, and the pharma industry may be in trouble if it doesn’t take drastic steps. Logistics24 With the environment being ever more in the spotlight, logistics becomes an ever more thorny subject. Traceability28 Counterfeit drugs are on the rise globally, and it’s not just in poorer, developing nations. 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/ Malik E/peopleimages.com4 Pharma Business International www.pbiforum.net Latest news Astellas to invest over €330m in new Irish facility Astellas Pharma has revealed plans to submit an application to build a new state-of-the-art facility, at an approximate cost of €330 million, in Tralee, Co. Kerry. This investment by Astellas in Ireland will expand its capacity and capabilities for aseptic drug products, reinforce stable production for global supply and accelerate the development and commercialization of innovative antibody drugs and other new products. The facility will be based on the Industrial Development Authority’s (IDA) greenfield site in Kerry Technology Park, Tralee, bringing highly specialized engineering, science and technology roles to the region and helping to further the Astellas VISION to “be on the forefront of healthcare change to turn innovative science into VALUE for patients.” Hideki Shima, chief manufacturing officer at Astellas, said: “Astellas is developing innovative drugs and technologies based on our Focus Area research and development approach, placing patients at the forefront of everything we do. With the new facility, Astellas will aim to strengthen our in-house production capacity and capabilities and ensure a stable supply of high-quality Astellas medicines to patients around the world.” AbCellera collaborates with Incyte to accelerate discovery and development of therapeutic antibodies in oncology AbCellera has entered into a strategic collaboration with Incyte to discover and develop therapeutic antibodies in oncology. “We are excited to partner with Incyte, which has a track record of developing first-in-class medicines and bringing them to patients in need,” said Murray McCutcheon, Ph.D., senior vice president of partnering at AbCellera. “We look forward to working as an extension of Incyte’s team to address complex antibody discovery challenges and accelerate the development of Incyte’s preclinical pipeline of oncology medicines.” “This collaboration supports our continued commitment to developing new therapeutics that may improve and expand treatment options for patients with cancer,” said Patrick Mayes, Ph.D., vice president, BioTherapeutics at Incyte. “We are excited to partner with AbCellera to initiate this research and look forward to collaborating with them to identify new antibody therapeutics that may address unmet needs in oncology.” Under the financial terms of the agreement, Incyte has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive downstream clinical and regulatory milestone payments and royalties on net sales of products. © stock.adobe.com/ Gorodenkoff Evaxion partners with Afrigen Biologics to develop mRNA vaccine against gonorrhea Evaxion, a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, is collaborating with Afrigen Biologics (Afrigen) to develop a prophylactic vaccine based on Evaxion’s EDEN™-discovered gonorrhea targets. Evaxion’s chief scientific officer, Birgitte Rønø, expressed enthusiasm about the collaboration, stating: “We are thrilled about this partnership. It offers a unique opportunity to deliver our EDEN™-identified antigens using mRNA and it accelerates clinical validation of the EDEN™ platform. This partnership has the potential to address a serious unmet global medical need against the pathogen for which no vaccine currently exists.” The EDEN™-discovered antigens have demonstrated high levels of protection in preclinical studies. This partnership will explore the expression and biological activity of the antigens in mRNA format. Following the validation phase, the partners will negotiate a subsequent agreement for clinical development and commercialization, with the opportunity to bring in additional partners. © stock.adobe.com/ Nakron © stock.adobe.com/ Arif BiswasPharma Business International 5 www.pbiforum.net Latest news UK Health Security Agency agrees vaccine deal The UK Health Security Agency (UKHSA) has agreed a deal for millions of life-saving vaccines to be produced in the UK if a future influenza pandemic is ever declared. The advance purchase agreement (APA) means healthcare company CSL Seqirus will be on standby to produce over 100 million influenza pandemic vaccines if or when they are needed. UKHSA and its predecessor organisations have had similar agreements in the past, but this is the first time the manufacturing process will be based entirely in the UK, giving better security of access if global demand ever outweighs supply. The vaccines will be tested, licensed, and approved and tailored to combat the specific pandemic flu strain identified at the time. They will be produced at CSL Seqirus’s existing manufacturing plant in Liverpool in the event a pandemic is declared by the World Health Organization (WHO). © stock.adobe.com/weyo © stock.adobe.com/Keitma Pharmanovia acquires global central nervous system (CNS) portfolio from Sanofi Pharmanovia has expanded its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from global healthcare company, Sanofi. The brands span four therapy areas of ongoing unmet need associated with CNS disorders – psycholeptic, anxiolytic, anti-epileptic and anti-psychotic. Clobazam is from a class of drug called benzodiazepines and can be used to treat anxiety, with or without insomnia or certain psychiatric conditions, in certain patients. The acquired brands include Frisium®, Sentil®, Urbanyl®, Urbanil®, Urbanol®, Urbadan®, Noiafren® and Castilium®. Frisium® may also be used as adjunctive therapy in epilepsy. Phenobarbital (brand: Gardenal®) is used as an anti-convulsant to treat all forms of epilepsy except absence seizures. Cyamemazine (brand: Tercian®) is used to treat certain types of psychotic conditions, anxiety in patients where other treatments have failed and also some types of depression in combination with another anti-depressant. Prochlorperazine (brand: Stemetil®) is used to treat vertigo, and nausea and vomiting due to various causes. It may also be used for other conditions such as schizophrenia, acute mania and as an adjunct to the short-term management of anxiety. © stock.adobe.com/ TuMeggy BioNTech and CEPI to advance mRNA mpox vaccine development BioNTech SE and the Coalition for Epidemic Preparedness Innovations (CEPI) have formed a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox (formerly monkeypox, caused by a member of the Orthopoxvirus viral family), an infectious disease that can lead to severe, life-threatening complications. Mpox gained global attention in May 2022 with an increasing number of cases that then developed into an international outbreak. CEPI will provide funding of up to $90 million to support the development of mRNA-based vaccine candidates. The mpox vaccine program BNT166 is part of BioNTech’s efforts to develop novel prophylactic vaccines for a range of infectious diseases with a high medical need, including indications that are disproportionally prevalent in lower-income countries. Since the eradication of smallpox in 1980, the global population-level immunity against the Orthopoxvirus viral family, including mpox, has been waning. BioNTech is aiming to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale. 6 Pharma Business International www.pbiforum.net Latest news Mendus receives U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia Mendus, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the company’s lead program, vididencel, for the treatment of Acute Myeloid Leukemia (AML) in complete remission with residual disease. Advantages of the Fast Track Designation include close and early interactions with the FDA to support accelerated approval, as well as the possibility of a “rolling review” for a subsequent market application. The FDA’s decision was based on results from the ADVANCE II clinical trial, which delivered promising survival read-outs and underpinned the safety of vididencel as a monotherapy in AML. Vididencel had already been assigned Orphan Drug Designation for treatment of AML in the US and Europe. Additionally, Mendus had recently been granted an Advanced Therapy Medicinal Product (ATMP) certificate by the European Medicines Agency (EMA) following a review of manufacturing quality and non-clinical data for its lead pipeline program vididencel. Orakl Oncology raises €3m to develop techbio platform for precision oncology Orakl Oncology, a precision oncology start-up, has raised €3 million to develop its techbio platform that integrates best-in-class biology with real-world patient data at scale to accurately model tumors and accelerate oncology drug development. A major challenge in oncology is that drug candidates meet patients too late in the development process. This leads to a 96% failure rate in clinical trials and missed treatment opportunities for cancer patients. The future of cancer treatment and drug development relies on recognizing that each tumor is different. In response to this unmet need, Orakl Oncology is combining cell biology, engineering and machine learning to build unique tumor avatars for each individual cancer patient that can mimic real-life responses to drugs. Orakl Oncology’s growing collection of avatars captures the complexity and heterogeneity of cancer at the population scale, helping pharma and biotech companies to identify new therapeutic targets or predictive biomarkers and increase clinical trial success rates. © stock.adobe.com/LASZLO First Wave BioPharma to repurpose Sanofi’s Capeserod for gastrointestinal indications First Wave BioPharma, a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, has announced an agreement with Sanofi to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will repurpose and develop for gastrointestinal (GI) indications. Under the terms of the agreement, First Wave will receive from Sanofi an exclusive, global license for Capeserod and will assume responsibility for all future clinical development. The licensing agreement, which includes a modest upfront payment, backend milestone payments and single digit royalties on net sales, provides a right of first refusal for Sanofi to reacquire Capeserod following certain stages of clinical development and to commercialize the product. Sanofi’s research on Capeserod and the subsequent artificial intelligence (AI)- empowered analyses suggest that the drug’s mechanism of action has potential applications for several gastrointestinal disorders in multibillion-dollar markets where there are significant unmet clinical needs. © stock.adobe.com / valiantsin © stock.adobe.com / Vitalii FDA approves Biogen’s TOFIDENCE, a biosimilar referencing ACTEMRA The U.S. Food and Drug Administration (FDA) has approved Biogen’s TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. TOFIDENCE is the first tocilizumab biosimilar approved in the United States. “The approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, global head of biosimilars at Biogen. Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Japan approves GSK’s Arexvy, the country’s first RSV vaccine for older adults Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved GSK’s Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV (respiratory syncytial virus) disease for adults 60 years of age and above. This is the first time an RSV vaccine for older adults has been approved in Japan. Tony Wood, chief scientific officer at GSK, said: “Arexvy is Japan’s first approved RSV older adult vaccine, and is a major advance for public health with the potential to help protect around 43.5 million Japanese people aged 60 and older. Following key approvals in the US, EU, UK and Canada earlier this year, today’s authorisation reinforces GSK’s industry-leading vaccine portfolio.” RSV is a common, contagious respiratory virus that causes an estimated 470,000 hospitalisations and 33,000 deaths each year in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in Japan. Its impact on healthcare systems may further increase as the population ages. Amicus Therapeutics receives FDA approval for new Pompe disease treatment The U.S. Food and Drug Administration (FDA) has approved Amicus Therapeutics’ Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) 65mg capsules. This two-component therapy is indicated for adults living with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). Late-onset Pompe disease is a rare, debilitating, and life- threatening lysosomal disorder caused by a deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced levels of GAA lead to the accumulation of the substrate glycogen in the lysosomes of muscle cells and glycogen buildup causes muscle damage. Disease severity ranges across a spectrum, with predominant manifestations such as skeletal muscle weakness and progressive respiratory involvement. Pombiliti + Opfolda is a unique two-component therapy. Pombiliti is a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), designed for increased uptake into muscle cells. Once in the cell, Pombiliti can be properly processed into its most active and mature form to break down glycogen. Opfolda is an enzyme stabilizer designed to stabilize the enzyme in the blood. Sandoz receives European Commission approval for Tyruko, a biosimilar for multiple sclerosis Sandoz has been granted marketing authorization by the European Commission (EC) for the biosimilar Tyruko (natalizumab), developed by Polpharma Biologics. The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing- remitting multiple sclerosis (RRMS), the same indication as approved by the EC for the reference medicine Tysabri (natalizumab). Rebecca Guntern, president Europe, Sandoz, said: “Multiple sclerosis (MS) is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential. Today’s approval brings us one step closer to reducing the burden of this disease for those living with multiple sclerosis in Europe by making the life- enhancing treatments they need more accessible.” Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets. Fabre-Kramer Pharmaceuticals gains FDA approval for Exxua for major depressive disorder The U.S. Food and Drug Administration (FDA) has approved Fabre- Kramer Pharmaceuticals’ Exxua (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults. Exxua represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. Exxua has been shown to effectively relieve depressive symptoms, and its approved labeling does not contain Warnings or Adverse Reactions regarding causing sexual dysfunction or weight gain vs. placebo. “Exxua represents an important milestone in the treatment of MDD, a serious and debilitating condition that affects millions of people worldwide,” said Stephen Kramer, M.D., CEO of Fabre-Kramer. “There is value in providing prescribers and patients with a wide range of effective options for use in clinical practice. We are proud to bring this innovative therapy to patients who need a new option to manage their depression and improve their quality of life.” www.pbiforum.netPharma Business International 7M&A ROUND-UP 8 Pharma Business International www.pbiforum.net Dealmaking returns Dealmaking returns Pharma Business International 9 www.pbiforum.net M&A ROUND-UP © stock.adobe.com/juliasudnitskaya T he dampening effect of the COVID-19 pandemic on M&A in the pharmaceutical industry is starting to subside, with life returning to dealmaking in the sector. Here we cover some recent transactions. Eli Lilly and Company - POINT Biopharma Global Eli Lilly and Company recently announced a definitive agreement to acquire POINT, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer, in a $1.4 billion deal. POINT’s lead programs are in late- phase development. PNT2002 is a prostate-specific membrane antigen (PSMA) targeted radioligand therapy for patients with metastatic castration- resistant prostate cancer (mCRPC) after progression on hormonal treatment. PNT2003 is a somatostatin receptor (SSTR) targeted radioligand therapy for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Beyond the late- stage clinical pipeline, POINT has a number of additional programs in earlier stages of clinical and preclinical development. Radioligand therapy can facilitate the precise targeting of cancer by linking a radioisotope to a targeting molecule that delivers radiation directly to cancer cells, enabling significant anti-tumor efficacy while limiting the impact to healthy tissue. Jacob Van Naarden, president of Loxo@Lilly, the oncology unit of Eli Lilly and Company, said: “Over the past few years, we have seen how well-designed radiopharmaceuticals can demonstrate meaningful results for patients with cancer and rapidly integrate into standards of care, yet the field remains in the early days of the impact it may ultimately deliver. We are excited by the potential of this emerging modality and see the acquisition of POINT as the beginning of our investment in developing multiple meaningful radioligand medicines for hard-to-treat cancers, as we have done in small molecule and biologic oncology drug discovery and development. We look forward to welcoming POINT colleagues to Lilly and working together to build upon their achievements as we develop a pipeline of meaningful new radioligand treatments for patients.” POINT operates a 180,000-square-foot radiopharmaceutical manufacturing campus in Indianapolis and a radiopharmaceutical research and development center in Toronto. These facilities will be utilised alongside POINT’s network of supply chain partners for sourcing radioisotopes and their precursors. Joe McCann, Ph.D., CEO of POINT, said: “The combination of POINT’s team, infrastructure and capabilities with Lilly’s global resources and experience could significantly accelerate the discovery, development and global access to radiopharmaceuticals. I look forward to a future where patients all over the world can benefit from the new cancer treatment options made possible by the joining of our two companies.” Danaher - Abcam Meanwhile global science and Pharma Business International reflects on a handful of new deals that have sprung up since our last issue. 10 ÁNext >