Your guide to the pharmaceutical world Volume 10 Issue 6 End of year success stories Looking back on 2022 Depositors and filling Accurate measurements Outsourcing Someone else’s business End of year success stories Looking back on 2022 Depositors and filling Accurate measurements Outsourcing Someone else’s business www.pbiforum.net 01.qxp_Layout 1 08/12/2022 11:04 Page 1 NTERN NATION AL an on nt d export Import and oading baLay doors spotlight sy and ackPaging doors ARY2022 T FEBRUA£2.95 hthearts Healing inspiti Valentin you’ll lov Fashion on ’ workout Winter i t WWW.LINCWWW.LINC COLNSHIRETOCOLNSHIRETO ODAY.NETODAY.NET BLM G FEBRUARY 2022 EAST MIDLANDS LEA £3.50 EADING BUSINESS MAGA AZINE UK www.blmgroup.co.uk The power of print Investing in the Indus e e futur ANDSBUSINE stry level up ESSLINKCOU w EMPOWER Your Business y erstor v Co rld o our guide to the pharmaceutical wY olume 9 Issue 6V Globa w varia A ne e C l Mk educing theR ade tr t hdt The digital resear e M l h rc t e www .pbiforum.net y 2022 februar yorkshire & lincolnsh £3.50 shire’s leading business ma magazine VOLUME 37 ISSUE 2 .blmgroup.co.ukwww s all ab It’ ow Let your business gr Levelling up bout the print V w Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 08/12/2022 11:05 Page 114 22 26 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. CXV Global Q&A8 The pharmaceutical industry is put under increased pressure to get more out of their existing assets, particularly with regard to factory and line automation. We speak to Frank Madden, Founder and CEO of automation and digitalisation specialists CXV Global to learn more about how they’re helping clients optimise their processing lines. M&A round-up10 While 2022 has been a quieter year for M&A, significant deals continue to be made. End of year success stories14 The year has been a challenging one for sure, but as we look back on 2022 we see it’s also been a time for growth – and that 2023 may continue the same trend. Finance and investment18 2021 was a record year when it came to many parts of the pharma industry, and this led some investors to have unrealistic expectations. With 2022 being more on par with normal, and thus disappointing many, we may be looking at a cautious outlook for 2023. Depositors and filling22 Accurate measurement, efficient filling and maximum hygiene all add pressure to the depositors and filling sector, and there are plenty of options available to suit any size of operation. Process control and automation26 Automation is about more than replacing human workers with machines – it is about achieving more than humans ever could and creating new opportunities for the company because of it. Outsourcing 30 Outsourcing can be risky business, but it can also be good business – we explore why, and what to keep in mind. 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/motorolka 03.qxp_Layout 1 12/12/2022 09:33 Page 14 Pharma Business International www.pbiforum.net Latest news Biovac signs deal with IVI to develop and manufacture oral cholera vaccine South African bio-pharmaceutical company, Biovac, has concluded a ground-breaking licensing and technology transfer agreement with the International Vaccine Institute (IVI), a non-profit international organisation headquartered in South Korea, for the manufacture of an oral cholera vaccine (OCV). The project is significant for Biovac as it enables drug substance manufacturing capability to be built, that is, production of the antigen/raw material needed to manufacture actual vaccines. This is one of the remaining steps in the vaccine manufacturing value chain that is currently missing not only at Biovac but across the African vaccine manufacturing landscape. The partnership with IVI aims to license and transfer technology with the ultimate aim of increasing production volumes in order to reduce the critical shortage of vaccines needed to prevent cholera globally. This transfer of technology will also establish and demonstrate capacity for Good Manufacturing Process (GMP) scale-up, local manufacture of clinical trial product, and end-to-end production of vaccines in Africa for African and worldwide usage. Regeneron and CytomX collaborate for conditional bispecific cancer therapies Regeneron Pharmaceuticals and CytomX Therapeutics have announced a collaboration and licensing agreement to create conditionally-activated investigational bispecific cancer therapies utilizing CytomX’s Probody therapeutic platform and Regeneron’s Veloci- Bi bispecific antibody development platform. The collaboration is strategically focused on applying CytomX’s biologic masking strategies to develop investigational Regeneron bispecifics that remain inactive until activated by proteases in the tumor microenvironment. This technology has the potential to widen the therapeutic window and help minimize off-target effects for these next-generation T-cell engaging therapies, potentially addressing tumor types that have historically been unresponsive to immunotherapy. Under the agreement, Regeneron and CytomX will collaborate on the discovery activities to identify and validate conditionally active bispecific antibodies. Regeneron will be responsible for funding preclinical and clinical development and commercialization activities. CytomX will receive an upfront payment of $30 million and will be eligible to receive future target nomination payments and preclinical, clinical, and commercial milestones of up to $2 billion. CytomX is also eligible to receive tiered global net sales royalties. © stock.adobe.com/ Arnéll Koegelenberg/peopleimages.com © stock.adobe.com/Christoph Burgstedt Medicines Discovery Catapult and Xerion Healthcare secure funding for innovative brain tumour treatment Medicines Discovery Catapult (MDC) and Xerion Healthcare have been awarded Innovate UK SMART Grant funding to develop a unique solution that will enhance the effect of post-surgical radiotherapy on aggressive brain tumours and reduce the chance of cancer regrowth. Xerion, an SME spin-out from the University of Oxford, has developed a unique nanoparticle solution that increases the effectiveness of radiotherapy, crucially, without damaging healthy tissue. The radiotherapy-enhancing nanoparticles will be released into areas of remaining tumour in an advanced clinically relevant in-vivo model developed by specialists at MDC. The group will then study tumour regrowth with and without the nanoparticles to demonstrate efficacy, using MDC’s pre-clinical radiotherapy platform and advanced imaging capability at its state-of-the-art laboratory in Cheshire. The data extracted from the collaborative project between MDC and Xerion is important, as it will form the basis of a submission to the Medicines and Healthcare Products Regulatory Agency (MHRA), enabling Xerion to take the novel therapeutic approach to clinical trials and one step closer to patients. © stock.adobe.com/merydolla 04-07.qxp_Layout 1 08/12/2022 11:07 Page 1Pharma Business International 5 www.pbiforum.net Latest news BRIM Biotechnology raises $20m in Series E funding round BRIM Biotechnology, a clinical-stage biotechnology company advancing novel regenerative therapies to help combat and cure ophthalmology and degenerative joint diseases, has raised $20 million in its Series E funding round. This demonstrates the heightened interest and growing demand for new treatments for Dry Eye Disease (DED). News of this latest funding round comes as BRIM prepares to initiate the Phase 3 clinical trial for its lead asset BRM421 for DED in the US. Since the company’s inception in 2013, BRIM has successfully developed several platform technologies, including the regenerative peptide technology (PDSP) upon which the lead asset BRM421 for the Phase 3 clinical trial is based. Two of the platforms were spun out as a new company, Ascendo Biotechnology, to reshape the future of immunotherapeutics. This series E funding investment will be used to accelerate the development of BRIM’s diverse pipeline of wholly-owned drug candidates as well as to invest in new innovation, leveraging BRIM’s extensive translation research experience. © stock.adobe.com/Monkey Business © stock.adobe.com/terovesalainen £20m research boost to help develop new obesity treatments Cutting-edge obesity treatments and technologies which can help people shed 20% of their weight could soon be offered to NHS patients thanks to a £20 million research boost, the UK government has announced. Obesity costs the NHS a massive £6 billion annually and this is set to rise to over £9.7 billion each year by 2050. The new investment is expected to save the NHS billions over time and ensure that vital funds are spent on key frontline services. The fund could lead to promising medicines and digital technologies being made available to patients, such as apps and online portals to encourage lifestyle changes, which have been shown in clinical trials to be safe and lead to a significant reduction in weight. An open competition will be run in early 2023 to identify sites to deliver this research, exploring how new and potentially transformative medicines can be combined with technologies such as digital tools to improve long-term health outcomes for people living with obesity. © stock.adobe.com/Kateryna_Kon Biocytogen enters into antibody agreement with ADC Therapeutics Biocytogen Pharmaceuticals has entered into an evaluation and option agreement with ADC Therapeutics. Biocytogen will grant ADC Therapeutics a license to evaluate its proprietary antibodies against three tumor targets, with an option to license selected antibodies at a later date for global ADC development and commercialization. Biocytogen reserves all global rights for these antibodies beyond ADC development. It will receive an upfront payment. For each option exercised, Biocytogen will be entitled to an option-exercise fee, and development and commercial milestone payments, which potentially total tens of millions of US dollars, as well as single-digit royalties on net sales. Under the agreement, Biocytogen will provide ADC Therapeutics with monoclonal and/or biparatopic antibodies directed against three tumor targets, generated through Biocytogen’s Project Integrum (also called RenMice HiTS Platform). ADC Therapeutics will carry out feasibility studies and be responsible for further development and commercialization of the ADC products if the company exercises an option. 04-07.qxp_Layout 1 08/12/2022 11:07 Page 26 Pharma Business International www.pbiforum.net Latest news Touchlight receives grant to advance doggybone DNA vaccine platform Touchlight, a biotechnology company pioneering enzymatic DNA production to enable the genetic medicine revolution, is furthering pre-clinical development of its proprietary doggybone DNA vaccine platform, financed by a new grant received from the Bill & Melinda Gates Foundation. The program aims to build on evidence that Touchlight’s rapid enzymatic doggybone DNA vaccines can produce strong neutralising antibodies and durable T cell responses following vaccine administration in nanoparticles. As part of the grant, Touchlight will also be investigating the performance of doggybone DNA for therapeutic monoclonal antibody production. Successful demonstration of the doggybone DNA platform’s effectiveness in DNA vaccine and gene therapy applications has the potential to support the global availability of innovative medicines and to further the application of the doggybone platform in enabling rapid pandemic response. Karen Fallen, CEO of Touchlight, said: “This grant is further evidence of the potential of our doggybone DNA platform. We are excited to start the program, which could potentially demonstrate that the doggybone DNA platform can support a rapid, scalable, durable and thermostable vaccine solution for future pandemic response.” Jnana Therapeutics and Roche reveal second collaboration to address challenging-to-drug targets in cancer, immune-mediated and neurological diseases Jnana Therapeutics, a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, has entered into a second collaboration and license agreement with Roche for the discovery of small molecule drugs for the treatment of cancer, immune-mediated and neurological diseases. The collaboration covers multiple targets from a diverse range of target classes to address diseases with high unmet need. Under the terms of the agreement, Jnana will receive an upfront payment of $50 million, significant near-term milestone payments, and additional potential future payments that could exceed $2 billion, as well as tiered royalties. Jnana will conduct discovery and preclinical activities against multiple cancer, immune- mediated and neurological disease targets, and Roche will be responsible for development and commercialization of any resulting products. © stock.adobe.com/Sundry Photography © stock.adobe.com/Alernon77 Funding boost for research finding new treatments for inflammatory bowel disease Research into finding new personalised treatments for inflammatory bowel disease has received funding to analyse and predict patient responses to drugs. The University of Nottingham will receive over £1m from AstraZeneca for a research program to establish patient cohorts in inflammatory bowel disease (IBD). The project will segment IBD patient populations based on their underlying drivers of disease to analyse and predict response to treatment. Within three years, the project will evaluate clinical information and biosamples from 240 volunteer patients as they start treatment with a currently approved therapy for IBD. The data will be analysed to inform ongoing clinical trials and help to develop new precision medicines. Patients will be invited to take part in this research as part of their current clinical care during a colonoscopy appointment. Harnessing this data will build an understanding of an individual’s response to treatments relative to their underlying disease and provide vital information to help with the development of new, precision medicines that are more targeted and can be matched to people who will most benefit. © stock.adobe.com/Khunatorn 04-07.qxp_Layout 1 08/12/2022 11:07 Page 3 Libtayo approved by EC as immunotherapy for cervical cancer The European Commission (EC) has approved Regeneron Pharmaceuticals’ Libtayo (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The EC approval in advanced cervical cancer is based on data from the global Phase 3 EMPOWER-Cervical 1 trial, which was conducted with the GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan. The trial evaluated Libtayo in comparison to an investigator’s choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology. In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival (OS) among squamous cell carcinoma (SCC) patients following a unanimous recommendation by the Independent Data Monitoring Committee. FDA approves first gene therapy to treat adults with Hemophilia B The U.S. Food and Drug Administration (FDA) has approved CSL Behring LLC’s Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Hemgenix is a one-time gene therapy product given as a single dose by IV infusion. Hemgenix consists of a viral vector carrying a gene for clotting Factor IX. The gene is expressed in the liver to produce Factor IX protein, to increase blood levels of Factor IX and thereby limit bleeding episodes. The safety and effectiveness of Hemgenix were evaluated in two studies of 57 adult men 18 to 75 years of age with severe or moderately severe Hemophilia B. Effectiveness was established based on decreases in the men’s annualized bleeding rate (ABR). In one study, which had 54 participants, the subjects had increases in Factor IX activity levels, a decreased need for routine Factor IX replacement prophylaxis, and a 54% reduction in ABR compared to baseline. Upstaza gene therapy granted marketing authorization for AADC deficiency by UK’s MHRA PTC Therapeutics’ Upstaza (eladocagene exuparvovec) has been granted authorization by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Upstaza is the first and only approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and the first marketed gene therapy directly infused into the brain. It is approved for patients 18 months and older. During Upstaza clinical studies, patients went from not achieving any developmental motor milestones to demonstrating a mastery of clinically meaningful motor skills, including the ability to ambulate independently. Milestone achievements including cognitive and language acquisition occurred from as early as three months following treatment, with clinically significant improvements shown to continue up to ten years after treatment. Upstaza also reduced symptoms that cause potentially life-threatening and morbid complications. Imfinzi and Imjudo with chemotherapy approved in the US for patients with metastatic non-small cell lung cancer AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy has been approved in the US for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The approval by the Food and Drug Administration (FDA) was based on the results from the POSEIDON Phase III trial. Patients treated with a limited course of five cycles of the anti-CTLA-4 antibody Imjudo added to Imfinzi plus four cycles of platinum-based chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options. An estimated 33% of patients were alive at two years versus 22% for chemotherapy. This treatment combination also reduced the risk of disease progression or death by 28% compared to chemotherapy alone. Updated results from the POSEIDON Phase III trial after approximately four years of follow-up demonstrated sustained survival benefit, improving overall survival (OS) by 25% compared to chemotherapy alone. An estimated 25% of patients treated with the combination were alive at three years versus 13.6% for those treated with chemotherapy alone. MHRA approves first new vaccine in a decade to protect children against pneumococcal diseases The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation, to extend the indication for MSD’s VAXNEUVANCE (PCV15) in the UK to include active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children, and adolescents from 6 weeks to less than 18 years of age. The approval was supported by eight randomised, double-blind clinical studies that enrolled approximately 8,400 individuals, including 5,400 who received PCV15. The data supporting the approval included findings from the pivotal PNEU-PED-EU-1 study which evaluated the safety, tolerability and immunogenicity of a two-dose infant series followed by a toddler dose in healthy infants. Results showed that immune responses were noninferior to PCV13 for the 13 serotypes shared between the two vaccines and superior for the two additional serotypes in PCV15, 22F and 33F, as assessed by serotype-specific anti-pneumococcal polysaccharide immunoglobulin G (IgG) response rates and geometric mean concentrations (GMCs) at 30 days post- toddler dose. www.pbiforum.netPharma Business International 7 04-07.qxp_Layout 1 08/12/2022 11:07 Page 4CXV GLOBAL Q&A 8 Pharma Business International www.pbiforum.net Q&A Automate or get left behind The pharmaceutical industry is put under increased pressure to get more out of their existing assets, particularly with regard to factory and line automation. We speak to Frank Madden, Founder and CEO of automation and digitalisation specialists CXV Global to learn more about how they’re helping clients optimise their processing lines. Can you tell us a little about yourself and CXV Global? I founded Crest Solutions in 1998 after having worked with Apple Inc on creating software to help improve their production and packaging lines. When many electronic giants sent their manufacturing eastward, I saw an opportunity to help other companies embrace Industry 4.0 and optimise their lines, and the company was founded from that. In 2020 we joined forces with US based Xyntek, and Belgian based VistaLink to create CXV Global. Through this joint venture, we have seen first-hand the greater impact we can make in serving our Life Sciences customers worldwide with an integrated global solution. Recently, we merged with US Based Panacea Technologies. Panacea specialises in automation for biopharma and gene therapy. We work in many different sectors including pharmaceutical, medical device, biotech, cosmetics, automotive, logistics, and food and beverage and this gives us a fantastic opportunity to evaluate and implement best in class process improvements and solutions. CXV Global has over 550 employees across the EU and US and we work extensively with large pharma companies – including working with each of the big 50 – to help optimise lines with a view to incorporating industrial vision, serialisation, and the assorted data that is created by it. We’ve been working with the life sciences industry for 25 years now, and we know the sector from the ground up, which gives us experience and insight into the very real problems factories face. Our products were born in the factories of clients where we saw the issues and inefficiencies in their lines and took the steps to optimise lines to increase throughput and minimise downtime, before, during and after the batch has run. The pharmaceutical industry is obviously heavily regulated. Do you find that manufacturers struggle to balance regulation and drives for improvement? How does CXV Global help? The pharmaceutical industry is heavily regulated and that means a lot of paperwork and compliance, which can get especially complicated when a line has to handle numerous different batches. It may surprise some people to hear that in terms of automation the pharma industry has lagged behind many other industries (like automotive and FMCG) for a long time, but since the introduction of serialisation in the last five or six years, the industry has leapfrogged the food and drink sector and really embraced automation. This is in no small part thanks to serialisation itself, which was introduced as an anti-counterfeit measure, but which has also allowed machine vision systems and software to track product more accurately on a line. IIoT and machine vision based systems can greatly enhance the efficiency of a line by automating the time consuming, cumbersome manual processes that require continual human intervention. Not only does this drive massive savings it also improves compliance at the same time. We help customers to digitalise their processes which helps to elevate their current line capabilities, at the click of a button. Digitalising these processes takes the burden away from the people running the line, allows them to move onto higher value add tasks and simplifies the associated compliance responsibilities and our solutions can Frank Madden, Founder and CEO of automation and digitalisation specialists CXV Global 08-09.qxp_Layout 1 12/12/2022 09:35 Page 1Pharma Business International 9 www.pbiforum.net CXV GLOBAL Q&A flag up any issues for intervention. These automated solutions create billions of Euros worth of value throughout our customer businesses by reducing line clearance times by up to 85%, by reducing batch setup times by 33% and reducing the overall paperwork burden by 50%. This delivers more efficient manufacturing facilities which can boast world class OEE and supply chain agility. They drive improved quality and regulatory compliance and assist with sustainability initiatives which are increasingly important to all our customers. What signs should companies look out for in order to recognise the inefficiencies in their existing lines? There are several things I personally tell prospective clients to look out for when assessing their lines, and any of these would be a serious red flag in my opinion. The first is to consider the real up-time of a line over a 24 hour period. How much is it being utilised during a day and how much down-time is there when considering batch change over and set- up? And are batch sizes getting smaller? In some cases, the realistic up-time of a line can be as low as 20% which is a serious problem, and an area we can improve drastically on. I would also advise companies to measure their line OEE% (Overall Equipment Effectiveness) to see what that number is. I would advise to pay particular attention to the time it takes to change from one batch to another. It's of little use if a line can produce and package incredibly quickly, if the line clearance takes several hours to complete. Reducing the line clearance time via digitalisation will help to increase line availability and reduce human error. This can lead to an increase in 10% operational capacity and enable hundreds of extra batches to be created over the course of a year – not to mention savings on labour. We regularly help our clients to achieve as much as 20% extra up-time following installation of our systems. With the pharma industry under so much pressure to perform at peak efficiency, what do you think are the biggest challenges the sector faces? Without a doubt the main focus now is on making the most of the assets you have rather than investing in new facilities. A new factory can cost up to £10 million (on the conservative side of things) and can take up to five years to be in full commission. Furthermore, with more mergers and acquisitions taking place all the time, factories are finding themselves having to make their lines work over an ever-increasing portfolio of product, which is again leading to down- time for batch change-over and set-up. CXV Global enables our customers to leverage the value of their existing investments in facilities and lines which can dramatically increase the efficiency of existing manufacturing processes. These solutions can be implemented at a fraction of the cost and time required to deliver new machines, lines or factories. CXV Global have offices in Pennsylvania, Illinois, California, Ireland, the United Kingdom, Belgium and Sweden. To find the office that is right for you, or to read up more on CXV Global and what they can do for you, visit www.cxvglobal.com CXV Global SmartFactorytm closes the gap by elevating current line capability; digitally enhancing the packaging inspection process; securely integrating the industrial Internet of Things (IIoT) automation technology of the production line with the corporate information (ERP and MES) systems, enabling the delivery of compliant products to market with maximum efficiency, quality and profitability. 08-09.qxp_Layout 1 12/12/2022 09:35 Page 2Next >