Your guide to the pharmaceutical world Volume 10 Issue 2 Clinical trials Clinical or social End of line packaging Sustainable, traceable, profitable Transport and logistics An industry under siege Clinical trials Clinical or social End of line packaging Sustainable, traceable, profitable Transport and logistics An industry under siege www.pbiforum.net 01.qxp_Layout 1 08/04/2022 13:38 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 08/04/2022 13:39 Page 112 16 20 24 Group Editor: Steve Fisher (s.fisher@blmgroup.co.uk) Editor: Michael Fisher (m.fisher@blmgroup.co.uk) Journalists: Tess Egginton (t.egginton@blmgroup.co.uk) Sales Director: Angie Cooper (a.cooper@blmgroup.co.uk) Sales: Vicky Hunt (v.hunt@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Accounts & Subscriptions: Angela Sharman (a.sharman@blmgroup.co.uk) Design & Production: Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Editorial: Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 Part of BLMGroup: 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 We look at some of the big mergers and acquisitions that happened these last two months and highlight some of the large movers and shakers in the industry. Transport and logistics12 Rising fuel costs and staff shortages have put the haulage industry in an impossible situation – are alternative fuel sources the only way out? Labelling, coding and marking16 Labelling, coding, and marking are key in the pharmaceutical sector - to product traceability, integrity, and safety. End of line packaging20 Given rising fuel costs and difficulties in the transport and logistics sector, pharmaceutical companies cannot afford to get end of line packaging wrong. Clinical trials24 Social media is the future and clinical trials might soon be organised and recruited for on platforms such as Facebook, Twitter or TikTok. What are the risks involved and how can companies minimise them? Waste management 28 The pharmaceutical industry produces a significant amount of waste. As a result manufacturers are being called upon to improve waste management in the name of sustainability, but this also presents an opportunity to reduce costs and find a new revenue stream. 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/Sergey Ryzhov 03.qxp_Layout 1 08/04/2022 14:25 Page 14 Pharma Business International www.pbiforum.net Latest news Neuron23 closes $100m Series C financing round advancing Parkinson’s disease therapy Neuron23™, an early stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, has closed a $100 million Series C financing round led by SoftBank Vision Fund 2, bringing the company’s total financing raised to date to $213.5 million. Neuron23’s Series A and B investors – Westlake Village BioPartners, Kleiner Perkins, Redmile Group, Cowen Healthcare Investments, Acorn Bioventures, HBM Partners, Perceptive Advisors, and Surveyor Capital (a Citadel company) – also participated in the Series C financing round. Proceeds from the Series C financing will be invested in the company’s lead programs against leucine-rich repeat kinase 2 (LRRK2), a gene associated with Parkinson’s disease and systemic inflammatory diseases, and tyrosine kinase 2 (TYK2), a JAK family protein that plays a role in pathological immune signaling. The funds will also be used to build Neuron23’s clinical development team, precision neuroimmunology platform, and data sciences capabilities. Pfizer completes acquisition of Arena Pharmaceuticals Pfizer has completed its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases, in a $6.7 billion deal. Arena Pharmaceuticals brings to Pfizer a portfolio of diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including ulcerative colitis, Crohn’s Disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata. “We are excited to add the impressive experience and pipeline of Arena Pharmaceuticals to Pfizer’s Inflammation and Immunology therapeutic area, helping us further our purpose of developing breakthroughs to change the lives of those with immuno-inflammatory diseases,” said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. “In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.” © stock.adobe.com/cbies $4 million research program seeks therapy for rare genetic condition ADNP syndrome Researchers at the UC Davis MIND Institute are launching a $4 million program to find transformative therapies for ADNP syndrome. The rare genetic condition causes developmental delays and can affect the brain, heart, gastrointestinal system and more. The ambitious three-year project is funded through a unique partnership between the ADNP Kids Research Foundation and international textile company Simba Global. The research will involve the MIND Institute’s interventional genetics team, which includes internationally recognized experts in mouse models for therapeutic development and in gene therapy, including the use of the gene editing tool CRISPR. “This is a groundbreaking interdisciplinary project. We are grateful to the ADNP Kids Research Foundation and Simba Global for investing in this research that we hope will have a meaningful impact on the lives of individuals with ADNP syndrome,” said MIND Institute Director Leonard Abbeduto. © stock.adobe.com/LIGHTFIELD STUDIOS © stock.adobe.com/Gorodenkoff 04-07.qxp_Layout 1 08/04/2022 14:26 Page 1Pharma Business International 5 www.pbiforum.net Latest news New analysis shows that Kesimpta® (ofatumumab)-treated adults with relapsing remitting multiple sclerosis (RRMS) are not at increased risk of severe COVID-19 infections Novartis has announced that the peer-reviewed journal Neurology and Therapy has published new data on COVID-19 infections in people living with relapsing remitting multiple sclerosis (RRMS) treated with Kesimpta® (ofatumumab). This data was compiled from the ongoing, single-arm, open-label, long-term extension phase 3b ALITHIOS study and from post-marketing reports submitted through the Novartis Global Safety Database. Of the 1703 participants in ALITHIOS, 245 (14.4%) reported COVID-19, most cases were mild (44.1%) or moderate (46.5%) and the vast majority of patients had either recovered or were recovering or recovered with sequelae (98.4%). The overall fatal outcome (0.8%) and hospitalization rates (9.4%) due to COVID-19 in ofatumumab-treated patients were lower than the rates reported in the general MS population (1.97% fatal outcome and 15.5%-21.5% hospitalisation). EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice EMA, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), has launched the Cancer Medicines Forum (CMF). Bringing together representatives from academic organisations and the European medicines regulatory network, the forum aims at advancing research into optimising cancer treatments and will contribute to foster high standards in cancer care in the European Union (EU). Since its establishment in 1995, EMA has reviewed and recommended for approval over 170 cancer medicines that have gone on to play an important role in the treatment and management of various types of cancers. The field of oncology has seen the emergence of major innovations in recent years, including the arrival of personalised medicines, immunotherapies, and advanced therapy medicinal products. Such innovations have helped cancer patients across Europe by offering them new tools in their fight against the disease. © stock.adobe.com/ doucefleur © stock.adobe.com/diy13 © stock.adobe.com/Thaut Images U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults The U.S. Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. A decision on U.S. FDA approval is expected in the second half of this year. “The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Roche. “More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.” 04-07.qxp_Layout 1 08/04/2022 14:26 Page 26 Pharma Business International www.pbiforum.net Latest news LogiPharma leads the way as Tower takes cold chain containers on the road In its first appearance at the renowned LogiPharma conference, Tower Cold Chain is speaking about the key challenges in temperature-controlled logistics, as well as exhibiting its robust, reliable and reusable containers. With the world’s biggest names in pharmaceutical manufacturing and cold chain logistics attending the Nice-based conference, Tower will share insight and advice on helping companies to transport temperature-critical products around the world. The company’s Global Head of Supply Chain, Kevin Doran, will be speaking at the LogiPharma conference as part of a panel discussion on using technology to improve sustainability in global logistics. Tower’s container range uses phase-change materials to keep contents at a stable temperature, and integrated datalogger technology to monitor performance during transit. Backed by a growing global network of hubs, Tower can meet all pharmaceutical temperature configurations and standards, in a variety of consignment sizes from multi-pallet to pallet to sub-pallet. Croda International awarded £15.9m UK government grant to expand manufacturing facility Croda International, the company that uses smart science to create high performance ingredients and solutions that improve lives, has been awarded a £15.9 million grant by the UK government to expand its manufacturing facility in Leek, Staffordshire. The investment will significantly enhance the development of high-purity lipid systems, essential delivery systems for next generation nucleic acid drugs such as mRNA vaccines. Croda will also invest £15.9m in the expansion. The expansion will include building a state- of-the-art lipid system synthesis facility and enhancing innovation and analytical laboratory capabilities at Leek. The site specialises in the production of lipids, that are currently used in a number of COVID-19 mRNA vaccines, as well as other Croda health care technologies such as speciality excipients. The investment will expand the range of speciality lipids produced at the site and add significant additional production capacity. © stock.adobe.com/ Irina © stock.adobe.com/Stephen Davies Construction begins on facility to support the manufacture of cannabis-based medicines in the UK Jazz Pharmaceuticals and its subsidiary, GW Pharmaceuticals, have initiated the construction of a new manufacturing facility at Kent Science Park (KSP) in Sittingbourne. The new facility will be approximately 60,000 sq ft, with an investment of over $100 million (approximately £75m). Once operational, the facility will create more than 100 highly skilled new jobs. Jazz currently manufactures the extract, active pharmaceutical ingredients and the formulated drug products at KSP, occupying 12 buildings with more than 400 employees, making it, and the UK, the heart of its global cannabinoid manufacturing operations. The new facility has been designed with careful consideration to the environment, and this will continue through its build phase and use. Animal refuge boxes will be installed to promote wildlife in the local area, the use of single use plastics will be minimised and more than 1,100 solar panels will be installed to provide a portion of the building’s energy usage. 04-07.qxp_Layout 1 08/04/2022 14:26 Page 3 FDA approves treatment for wider range of patients with heart failure The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. For this approval, Jardiance’s safety and effectiveness were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received Jardiance, 10 mg, once daily to 2,991 participants who received the placebo. The main efficacy measurement was the time to death from cardiovascular causes or need to be hospitalized for heart failure. Of the individuals who received Jardiance for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo. This benefit was mostly attributable to fewer patients being hospitalized for heart failure. Saphnelo becomes first new medicine for systemic lupus erythematosus to gain approval in Europe in over a decade AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. Saphnelo is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity. The approval by the European Commission (EC) was based on results from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial. Across clinical trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo. Minimising OCS use while reducing disease activity is an important treatment goal in SLE to reduce the risk of organ damage. China approves Benlysta for adult patients with active lupus nephritis China’s National Medical Products Administration (NMPA) has approved GlaxoSmithKline’s (GSK) Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard of care. The approval extends the current indication in China as add-on therapy in adults and children aged five years and older with active systemic lupus erythematosus (SLE). This approval makes belimumab China’s first and only biologic medicine approved for SLE and LN. The NMPA approval is based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) phase III trial, which showed that over two years, belimumab added to standard therapy increased renal response rates and helped to reduce the risk of worsening of kidney disease in patients with active LN compared to standard of care alone. EC approves Novartis’ Beovu for people living with diabetic macular edema The EC has approved Novartis’ Beovu (brolucizumab) 6 mg for the treatment of visual impairment due to diabetic macular edema (DME). The approval in DME represents the second indication for Beovu granted by the EC, which was first approved for the treatment of wet age-related macular degeneration in 2020. The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway and Liechtenstein. The EC approval was based on year one data from the Phase III, randomized, double-masked KESTREL and KITE studies, which met their primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at year one. MHRA approves AstraZeneca’s Evusheld for COVID-19 prevention Evusheld (tixagevimab/cilgavimab) has been authorised for COVID-19 prevention by the Medicines and Healthcare products Regulatory Agency (MHRA) after meeting the UK regulatory standards of safety, quality and effectiveness. Developed by AstraZeneca, Evusheld is a combination of two long-acting antibodies that works by binding to the spike protein on the outside of the SARS-CoV-2 virus. This in turn prevents the virus from attaching to and entering human cells. Evusheld is authorised to be used before being exposed to the risk of COVID-19 infection in order to prevent disease (known as ‘pre-exposure prophylaxis’). Evusheld has been approved for use in adults who are unlikely to mount an immune response from COVID-19 vaccination or for whom vaccination is not recommended. In a clinical trial in adults, Evusheld was found to reduce the risk of developing symptomatic COVID-19 by 77%, with protection from the virus continuing for at least 6 months following a single dose. www.pbiforum.netPharma Business International 7 04-07.qxp_Layout 1 08/04/2022 14:26 Page 4M&A ROUND-UP 8 Pharma Business International www.pbiforum.net FUJIFILM Corporation – Cell manufacturing facility from Atara Biotherapeutics FUJIFILM Corporation has completed the acquisition of a dedicated cell therapy manufacturing facility from Atara Biotherapeutics for USD $100 million. As part of a long-term manufacturing and services agreement, FUJIFILM Diosynth Biotechnologies will support the production of Atara’s promising clinical and commercial-stage allogeneic cell therapies at the site, including tabelecleucel (tab-cel®), currently in phase 3 clinical development and under review to support registration in Europe, for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+PTLD). “FUJIFILM Corporation has invested over USD $5.5 billion to grow the Bio CDMO business unit in order to provide our customers with long-term support across a full-range of modalities, and manufacturing scales,” said Takatoshi Ishikawa, senior executive vice president, general manager Bio CDMO Division, FUJIFILM Corporation. “With the addition of the dedicated site in California, Fujifilm continues to build for the future to meet the growing need of advanced therapies globally.” Pfizer – Arena Pharmaceuticals Pfizer has completed its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases, in a $6.7 billion deal. Arena Pharmaceuticals brings to Pfizer a portfolio of diverse and promising We look at some of the big mergers and acquisitions that happened these last two months and highlight some of the large movers and shakers in the industry. 10 Á Mergers & Acquisitions 08-11.qxp_Layout 1 08/04/2022 14:28 Page 1Pharma Business International 9 www.pbiforum.net M&A ROUND-UP © stock.adobe.com/wladimir1804 08-11.qxp_Layout 1 08/04/2022 14:28 Page 2Next >