Your guide to the pharmaceutical world Volume 9 Issue 6 Cover story A new variant Global trade Reducing the red tape Market research The digital age PharmaBUSINESS INTERN ATION AL The total package From development to dispensing The total package From development to dispensing Cover story A new variant Global trade Reducing the red tape Market research The digital age www .pbiforum.net 01.qxp_Layout 1 08/12/2021 12:12 Page 1 INTER N Food Food &&& Food Food & N ATI O N &&Drin Drin Drin &&Drin AL nk nk nkk app A r f hh hi ts a ews Ingredient spotlight End offline packkaaging For businesses that are serious about reducing their carbon footprint www.blmgroup.co.uk VOLUME 4 ISSUE 1 W W W. R E N E W A B L E S A N D E N V I R O N M E N T. C O M E A S T M I D L A N D S L E A E A D I N G B U S I N E S S M A G A A Z I N E APRIL 2020 0 £3. .50 BUS SUP SINES TT PPOR SS TING B THCART HEAL YY FACTOR RE OFF FICE ea Stopping the spr THCAR WW HEAL d thinkin Forwar TT AUTOMA Y AFACTOR ad WW EASTMIDL RE A hea SOL OFF ng factories ANDSBUSINE TION ficef althy of LUTIONS ESSLINK CO U FICE w UK www.blmgroup.co.uk EMPOWER Your Business Focus on TA Pharm rld o our guide to the pharmaceutical w Y B U S I N E S S I N T E R N A L ma olume 8 Issue 1 V T I O N declares g rrld Hea ooo W coron F ganisa geg l b l g l h O virus na g gency ti medic Nucle Prev aaccinV The nuclea e b f treatment ve The P l t kaage n e t eelopment t v om de rF w w w di i k . p b i f o r u m . n yorkshire & lincolnshhire’s leading business mamagazine april 2020 £3.5 50 TO T RES C THE SPOND CRISIS DING S ACTOR C OFF THCARE FICE safety Ensuring e TT HEAL e of factories The futur TION T AUTOMA YY AFACTOR fices healthy f Keeping of SOLUTIONS OFFICE employee THCARE V w VOLUME 35 ISSUE 4 .blmgroup.co.uk www Often Imitated - Never Equalled www.blmgroup.co.uk 02.qxp_Layout 1 08/12/2021 12:14 Page 1Contents Volume 9 Issue 6 12 22 26 30 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) Eleonora Gallina (e.gallina@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 As the year draws to a close it’s time to consider how 2021 has performed and what we can expect in 2022. Cover story12 With a new strain, panic over COVID-19 has flared once again - but what is Omicron and what do we know so far? Global trade16 Despite challenges posed by the COVID crisis, the UK’s pharmaceutical sector is still being impacted by Brexit red tape, risking the nation’s premiere life science status on the global stage. Alpega TMS Q&A20 Top pharmaceutical companies get future-proof logistics solutions from Alpega TMS. Market research22 Social media and digital channels aren’t only changing the way in which pharmaceutical and medical products are marketed but are changing how companies conduct their market research. Outsourcing 26 After proving its value during the COVID-19 pandemic, pharmaceutical outsourcing is ready to face its promising future. Temperature control30 Maintaining the cold chain is vital to ensure the efficacy of vaccines and vital medical products. As well as an upsurge in growth over the last decade, the sector was called on in the safe delivery and transportation of COVID-19 vaccines. Almac Pharma Services Q&A34 Exploring Ultra Low Temperature Packaging Solutions. Promotion36 Pharmaceutical companies invest large capitals on the promotion of their products but the new challenges rising might be the proof that a new direction is needed. Events 40 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy: stock.adobe.com/CROCOTHERY 03.qxp_Layout 1 08/12/2021 12:15 Page 14 Pharma Business International www.pbiforum.net Latest news FDA approves first treatment for common type of post-transplant infection that is resistant to other drugs The U.S. Food and Drug Administration has approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. “Transplant recipients are at a much greater risk for complications and death when faced with a cytomegalovirus infection,” said John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.” The FDA granted the approval of Livtencity to Takeda Pharmaceuticals Company Limited. Philips to expand cardiac diagnostics and monitoring portfolio with Cardiologs acquisition Royal Philips, a leader in health technology, has signed an agreement to acquire Cardiologs, a France-based medical technology company focused on transforming cardiac diagnostics using artificial intelligence (AI) and cloud technology. Cardiologs will further strengthen Philips’ cardiac monitoring and diagnostics offering with innovative software technology, electrocardiogram (ECG) analysis and reporting services. Roy Jakobs, Chief Business Leader Connected Care at Royal Philips, said: “Offering superb clinical insights, as well as automated clinical reporting, Cardiologs’ medical-grade AI technology and data scientists will be a strong addition to our growing portfolio of cardiac solutions for hospital and ambulatory settings. “Philips’ global footprint can accelerate the availability of Cardiologs’ technology to patients all over the world and further deliver on the quadruple aim of an improved patient care experience, better health outcomes, improved staff experience, and lower cost of care.” Yann Fleureau, Co-Founder and CEO of Cardiologs said: “We look forward to the opportunity to expand the business as part of Philips, maintaining vendor neutrality and continuing to work with third party vendors to drive further adoption of digital health solutions globally.” © stock.adobe.com/Mongkolchon © stock.adobe.com/ronstik Envirotainer launches CryoSure® – a revolution in -70°C cryogenic shipping Envirotainer, the global market leader in secure cold chain solutions for intercontinental shipments of pharmaceuticals, is launching the CryoSure® platform today. This -70°C solution, designed with today’s and tomorrow’s high demands in mind has unmatched performance, superior duration and is the most sustainable solution on the market. Shipping products at below -70°C is very challenging but there is no room for failure when shipping life-saving products. This is the reason why Envirotainer now launches the revolutionary CryoSure® platform, based on the Linde Seccurus® technology and Envirotainer’s 35 years of experience. With its superior duration of up to 3 weeks, heat resistance and unparalleled ease of use, CryoSure® is the most reliable choice for -70°C cryogenic shipments. Mattias Almgren, CryoSure® Platform Executive at Envirotainer said: “This new CryoSure® technology takes pharma transportation to the next level by mitigating most if not all risks currently faced when shipping pharma products below -70°C. It is a game changer and is going to revolutionize this part of the market.” 04-07.qxp_Layout 1 08/12/2021 12:17 Page 1Pharma Business International 5 www.pbiforum.net Latest news University of Oxford to begin Ebola vaccine human trials The University of Oxford have begun recruiting for a Phase I trial to test an Ebola vaccine in human volunteers – with the first vaccinations taking place November 11. The study will assess the immune response and safety of the new vaccine against the Zaire and Sudan species of Ebola. The vaccine is based on the ChAdOx1 virus, a weakened version of a common cold virus (adenovirus) that has been genetically modified so that it is impossible for it to replicate in humans. This vector has been previously used successfully in the ChAdOx1 nCoV-19 vaccine – or the Oxford-AstraZeneca vaccine. Dr Paola Cicconi, Chief Investigator of the trial at the Jenner Institute, University of Oxford, said: “The need for a multivalent vaccine, approved for use against multiple Ebolavirus species, remains unmet. Experience with ChAdOx1 nCoV-19 (Oxford-AstraZeneca COVID-19 vaccine) has shown the vaccine can be rapidly manufactured at high volume for low cost, with storage conditions amenable to use in the developing world. This study will provide valuable data on the safety and immunological aspects of a novel multivalent Ebolavirus ChAdOx1 vaccine.” First oral antiviral for COVID-19 approved in UK The antiviral Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), Lagevrio works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease. Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID- 19 test and within five days of symptoms onset Health and Social Care Secretary Sajid Javid said: “Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID- 19. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground- breaking treatment.” © stock.adobe.com/sdecoret © stock.adobe.com/alphaspirit © stock.adobe.com/jaddingt GreenLight Biosciences and Samsung Biologics collaborate to advance mRNA COVID-19 vaccine GreenLight Biosciences and Samsung Biologics have announced a partnership agreement in which Samsung Biologics will manufacture GreenLight’s messenger RNA COVID-19 vaccine candidate at commercial scale. The partnership aims to accelerate production of GreenLight’s COVID-19 vaccine candidate for Phase III clinical trials and, subject to regulatory approval, commercial sales. The collaboration with Samsung will leverage GreenLight’s existing manufacturing process, with technology transfer from GreenLight to Samsung starting immediately. John Rim, CEO of Samsung Biologics, said: “This collaboration demonstrates a major milestone for Samsung Biologics as we will commence our expanded capabilities and operations to provide one- stop end-to-end messenger RNA production from Drug Substance (DS) to Aseptic Fill Finish (DP) to commercial release, all from a single site. At this time of urgent global demand, we will strive for seamless service across our biomanufacturing network to fight the COVID pandemic and in turn, help make progress towards Korea’s vaccine hub goal.” 04-07.qxp_Layout 1 08/12/2021 12:17 Page 26 Pharma Business International www.pbiforum.net Latest news £1.2m project to improve global availability of microneedle drug delivery technology A £1.2m project, Optimisation of microneedle insertion and understanding the implications of repeat application as tools to support translation, has been funded by the UK’s Engineering and Physical Sciences Research Council (EPSRC) and aims to accelerate the development of microneedles – also known as microarray patches. The discreet patches contain dozens of microneedles that lightly penetrate the top layer of skin to deliver either rapid or controlled and continuous medication. Their ability to effectively deliver biopharmaceuticals, which when taken orally are often broken down in the stomach and do not reach their target, could eliminate the need for injections and could have huge implications for medical care. Project leader Professor Ryan Donnelly from Queen’s School of Pharmacy said: “If we can replace the need for a range of drugs and vaccines to be given by needle-and-syringe injection with a minimally-invasive and painless patch, healthcare organisations, such as the NHS, could soon benefit from reduced costs due to shorter hospital stays and more reliable drug dosing, resulting in enhanced patient quality-of-life.” © stock.adobe.com/weyo Drug combination helps children with acute promyelocytic leukemia avoid conventional chemotherapy A clinical trial has found that the combination of all-trans retinoic acid, which is a metabolite of vitamin A, and arsenic trioxide is highly effective in children with standard- and high-risk acute promyelocytic leukemia, or APL. Nearly all patients in the trial survived for two years without experiencing a relapse. None of the children with standard-risk APL required conventional chemotherapy, and those with high-risk APL received just four doses of the chemotherapy drug idarubicin (Idamycin PFS). “This is a remarkable achievement and will be the new standard of care,” said Malcolm A. Smith, M.D., Ph.D., of the Cancer Therapy Evaluation Program at the National Cancer Institute, which funded the multi-institutional, nonrandomized phase 3 cooperative group trial. “Twenty years ago, these patients would have been treated with intensive chemotherapy, including drugs that lead to heart problems later in life. By comparison, all-trans retinoic acid and arsenic trioxide have fewer acute or long-term side effects.” New approach provides potential vaccine and treatment for Alzheimer’s A promising new approach to potentially treat Alzheimer’s disease – and vaccinate against it – has been developed by a team of UK and German scientists. Both the antibody-based treatment and the protein-based vaccine developed by the team reduced Alzheimer’s symptoms in mouse models of the disease. The research is published in Molecular Psychiatry. The work is a collaboration between researchers at the University of Leicester, the University Medical Center Göttingen and the medical research charity LifeArc. Professor Mark Carr, from the Leicester Institute of Structural and Chemical Biology at the University of Leicester, explained: “This structure had never been seen before in amyloid beta. However, discovering such a definite structure allowed the team to engineer this region of the protein to stabilise the hairpin shape and bind to the antibody in the same way. Our idea was that this engineered form of amyloid beta could potentially be used as a vaccine, to trigger someone’s immune system to make TAP01_04 type antibodies.” © stock.adobe.com/LIGHTFIELD STUDIOS © stock.adobe.com/denisismagilov 04-07.qxp_Layout 1 08/12/2021 12:17 Page 3Eye on approvals Alembic Pharma receives approval for bronchoconstriction drug Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for formoterol fumarate inhalation solution per unit-dose vial. Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for long-term administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Zydus Cadila pre-surgery injection approved India-based pharma giant, Zydus Cadila received final approval from US Food and Drug Administration (FDA) for the Glycopyrrolate injection that is used before surgery to decrease the volume of secretions from the mouth, lungs and stomach. Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of a gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated. PharmaEssentia blood cancer drug approved by FDA The PharmaEssentia drug is an engineered version of interferon alpha, a signaling protein produced by the immune system that regulates and activates the immune response. This makes it the first drug therapy approved for polycythemia vera. Voxzogo approved for Achondroplasia Voxzogo, a C-type natriuretic peptide analogue, is the first FDA-approved treatment for increasing linear growth in patients 5 years of age and older with achondroplasia and open epiphyses, the most common form of dwarfism. The approval was based on data from a randomized, double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of Voxzogo in 121 children aged 5 to 14.9 years with genetically confirmed achondroplasia. Vuity approved for Presbyopia Vuity is a cholinergic muscarinic receptor agonist designed to improve near and intermediate vision without impacting distance vision. It is the first FDA-approved eye drop to treat presbyopia, a progressive eye condition. The approval was based on data from studies that evaluated the efficacy and safety of Vuity in a total of 750 patients aged 40 to 55 years with presbyopia. PreHevbrio™ approved for Hepatitis B in Adults VBI, a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, has announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults aged 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S. UK authorises Regeneron antibody cocktail for acute COVID-19 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Conditional Marketing Authorisation (CMA) to Regeneron for the casirivimab and imdevimab antibody cocktail to prevent and treat acute COVID-19 infection. In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA has also authorised emergency supply of the antibody cocktail – known as REGEN-COV in the US and Ronapreve in the UK and other countries – to prevent and treat acute COVID-19 infection for people in Northern Ireland. www.pbiforum.net Pharma Business International 7 04-07.qxp_Layout 1 08/12/2021 12:17 Page 4M&A ROUND-UP 8 Pharma Business International www.pbiforum.net Mergers & Acquisitions in 2021 and beyond As the year draws to a close it’s time to consider how 2021 has performed and what we can expect in 2022 08-11.qxp_Layout 1 08/12/2021 12:18 Page 1Pharma Business International 9 www.pbiforum.net M&A ROUND-UP © stock.adobe.com/JHVEPhoto The COVID-19 pandemic and lockdowns were obviously a big shake-up for the pharma industry, and this led to a rather slow rate of mergers and acquisitions in the 2021 year. Obviously, the race was on to develop a vaccine for COVID-19 and this took up much of the industry’s attention. With Governments pushing any and all potential vaccines and treatments to the front of approval and testing, this also meant that new, lower priority, drugs were slow to come to market. All of this combined to make 2021 a slow year in this regard, even if the pharma industry itself has been as busy as ever. The news was still of a stronger industry than 2020 which saw the biggest nosedive. The first half of 2021 saw a return to normal for mergers and acquisitions within the pharma and life sciences sector, but while the number of deals came closer to what we’d seen in previous years, what was absent was the large-scale spending – the big, jaw-dropping deals of yesteryears. This trend continued into the latter half of 2021, although there were some larger deals that took place. Still, deals within the $5 - $15 billion mark were limited, and those above even more so. The market was recovering slowly and surely, but there weren’t any big splashes to be made. As we step in 2022 however, eyes are on some of the giants in the industry who, after a busy year, may be sitting on as much as $500 billion in cash ready! It’s rare to find a time in any business where that much cash is sitting around. The adage is usually that liquid assets should be invested, and rightly so, but with few opportunities for investment in the last months of 2021, pharma giants are instead looking to 2022. According to SVB Leerink analyst Geoffrey Porges and his team, the money the eighteen US and European 10 Á 08-11.qxp_Layout 1 08/12/2021 12:18 Page 2Next >