Your guide to the pharmaceutical world Volume 6 Issue 3HIV and AidsExposéFinding a functional cureDistributionManaging the fleetLaboratoriesQuality, control andmanagementPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingHIV and AidsExposéFinding a functional cureDistributionManaging the fleetLaboratoriesQuality, control andmanagementwww.pbiforum.net01.qxp_Layout 1 08/06/2018 09:55 Page 1ORGANISED BY25-27 SEPT 2018NEC, BIRMINGHAMORGANISED BYPROCESSING & PACKAGING MACHINERYMATERIALS I ROBOTS I INDUSTRIAL VISIONppmashow.co.ukTHE UK’S LEADING PRODUCTION LINE EVENTSee the latest processing and packaging machinery in actionFREETO ATTENDREGISTER NOW!NEW FOR 2018)NHMƏ@MƏHMɓTDMSH@KƏKHMDTOƏNEƏJDXƏMNSDƏROD@JDQRƏ@SƏNTQƏLTRSƏ@SSDMCƏRDLHM@QR-DSVNQJƏVHSGƏHMCTRSQXƏODDQR20-25.qxp_Layout 1 21/06/2018 09:18 Page 2@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 6 Issue 3News4Stay up to date with the latest industry updates fromthe global pharmaceutical technology industry.HIV and Aids Exposé8 Pharma Business International takes a look at someof the recent developments in the AIDS and HIVresearch and development space.M&A Round-up12 The latest M&A round-up explores the major dealsthat have taken place in the pharmaceutical sectorover the last two months. Although Takeda’s massivemulti-billion dollar acquisition of Shire dominates,there has been some key oncology activity as PharmaBusiness International explores.PPE16 Personal protective equipment is a necessity in anymanufacturing industry to reduce the risk to workers,but few industries have quite the same requirementsand pressure put upon them as the pharmaceuticalsector. Waste Management20 In any industry in which harmful or potentiallyhazardous materials are handled on a regular basis,there is a fundamental need to correctly manage anddispose of waste. And waste management has comeunder increased scrutiny from both governmentbodies and from consumers themselves. Distribution24 As one of the most expensive assets in apharmaceutical company’s arsenal, its fleet needs tobe constantly evaluated and new technology ishelping to safeguard the bottom line.Laboratories28 Research and development remains key to theprogress of many pharmaceutical firms, and also thefuture of the human race. In an era where pathogensare becoming increasingly resistant to commonmedicine, the safe and efficient running of a lab hasnever been more important. Events32We give a rundown of pharma events happeningaround the world.481620Group Editor:Steve Fisher (s.fisher@blmgroup.co.uk) Editor:Michael Fisher (m.fisher@blmgroup.co.uk) Journalist:Dominic Cuthbert(d.cuthbert@blmgroup.co.uk)Sales Director:Angie Cooper (a.cooper@blmgroup.co.uk)Sales Manager:Sam Trott (s.trott@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 310317Part of BLMGroup:Armstrong House, Armstrong Street,Grimsby, N E Lincs DN31 2QE EnglandAll rights reserved. No part of this publication may be reproduced,transmitted, photocopied, recorded or otherwise without expresspermission of the copyright holder, for which application should beaddressed first to the publisher. While every reasonable care istaken, neither the publisher nor its participating agents acceptliability for loss or damage to prints, colour transparencies,negatives or other material of whatever nature submitted to thispublication. The views expressed in this publication are notnecessarily the views of those held by the publisher.This magazine is now fully recyclable. By recycling magazines, youcan help reduce waste and add to the 5.5 million tonnes of paperalready recycled by the UK paper industry each year. Before yourecycle your magazine, please ensure you remove all plasticwrapping, free gifts and samples. COVER PHOTO: © SHUTTERSTOCK / CRYSTAL LIGHT 03.qxp_Layout 1 08/06/2018 09:56 Page 14Pharma Business International www.pbiforum.netLatest newsWuXi Biologics to build€325m biomanufacturingfacility in IrelandChina’s WuXi Biologics is investing €325 million to build thelargest biomanufacturing facility using single-use bioreactors inIreland.This state-of-the-art “facility of the future” will be built uponthe novel approach WuXi Biologics has pioneered deployingmultiple single-use bioreactors for commercialbiomanufacturing and is also designed to be able to runcontinuous bioprocessing, a next-generation manufacturingtechnology to be first implemented globally in this campus.A total of 48,000 L fed-batch and 6,000 L perfusionbioreactor capacity will be installed, representing the world’slargest facility using single-use bioreactors.The manufacturing project in a 26-hectare campus, thecompany’s first site outside of China, is supported by the Irish Government through IDA Ireland.Chris Chen, CEO of WuXi Biologics, said: “In addition, this is the start and a critical part ofour global biomanufacturing network to ensure that biologics are manufactured atthe highest quality and with a robust supply chain to benefitpatients worldwide.”Sanofi invests €350m in Canadianvaccine facilitySanofi is investing €350 million in the construction of a new state-of-the-art vaccinemanufacturing facility at its Sanofi Pasteur Canadian headquarters in Toronto, Canada.The investment bolsters the company’s Canadian operations and its commitment toadvancing public health around the world.“With this investment, Sanofi is renewing our longstanding commitment to makingCanada central in our effort to protect and improve human health across the globe,”said David Loew, Executive Vice President and Head of Sanofi Pasteur.He added: “Vaccines save three million lives every year and this new facility will takeus one step closer to a world where no one suffers or dies from a vaccine-preventable disease.”The new facility will allow Sanofi Pasteur, the vaccines global business unit of Sanofi, to meet the growing demand of five-component acellular pertussis(5-acP) antigen.Upon completion in 2021, the new building will also be equipped to produce the antigens used in the diphtheria and tetanus vaccines.US approves first non-opioid to treatopioid withdrawalLucemyra has become the first and only non-opioid medication indicated for tackling opioidwithdrawal symptoms approved in the US, developer US WorldMeds has said.Lucemyra suppresses the neurochemical surge that produces the acute and painfulsymptoms of opioid withdrawal.The FDA’s approval is supported by two randomised, double-blind, placebo-controlledclinical trials, an open-label study and clinical pharmacology studies with concomitantadministration of methadone, buprenorphine or naltrexone.The product’s development also involved a grant from and close collaboration with the NationalInstitute on Drug Abuse, part of the National Institutes of Health.Data show that compared to placebo, participants treated with Lucemyra experienced less severewithdrawal symptoms and were significantly more likely to complete a seven-day opioid discontinuation treatment.Lucemyra is not an opioid drug and is not a treatment for opioid use disorder (sometimes known as opioidaddiction). It is expected to be commercially available in the US in August 2018.© WuXi Biologics© Shutterstock / Nordroden© Shutterstock / Victor Moussa04-07.qxp_Layout 1 08/06/2018 09:58 Page 1Cure for thecommon cold?Researchers from Imperial College London have lab-tested a moleculethat, they claim, can combat the common cold virus by preventing it fromhijacking human cells. The results of initial tests have been published inNature Chemistry.Early lab tests with human cells have shown the molecule’s ability tocompletely block multiple strains of cold virus. The team are hoping tomove to animal and then human trials.Most cold remedies rely on treating the symptoms of the infection –such as runny nose, sore throat andfever – rather than tackling the virusitself.However this new molecule targetsN-myristoyltransferase (NMT), aprotein in human cells. Viruses“hijack” NMT from human cellsto construct the protein “shell”– or capsid – which protectsthe virus genome.The molecule targets ahuman protein and notthe virus itself, makingemergence ofresistant viruseshighly unlikely.Pharma Business International 5www.pbiforum.netLatest newsAmgen gains US approval for novel migraine treatmentAmgen has gained approval from USregulators for Aimovig, a novel treatmentdeveloped to prevent migraine in adults.Aimovig is the first and only FDA-approvedtreatment specifically developed to preventmigraine by blocking the calcitonin gene-relatedpeptide receptor (CGRP-R) – which is believed toplay a critical role in migraine.Aimovig 70 mg is self-administered oncemonthly via Amgen’s device, the SureClickautoinjector, and does not require a loading dose.“The FDA approval of Aimovig represents along-awaited and important therapeuticdevelopment for patients and their physicianswho are in need of additional treatment options for the prevention of migraine,” said Sean E Harper, Executive Vice President of R&D at Amgen.The European Medicines Agency Marketing Authorisation Application (MAA) for Aimovig is under review. An approval in the EU is expected in the comingmonths.CGT Catapult to advanceUK’s life sciences sector withskills investmentIn a bid to drive forward the life sciences sector in the UK, the Celland Gene Therapy Catapult is scaling-up its skills and capabilitytraining.Speaking at the World Advanced Therapies and RegenerativeMedicine Congress in London, CGT Catapult CEO Keith Thompsonsaid the new funding was made available by UK Research andInnovation, through Innovate UK, in response to Sir John Bell’s LifeSciences Industrial Strategy.It comprises £3 million, funded through the Government’s IndustrialStrategy Challenge Fund (ISCF) for Advanced Therapies TreatmentCentres (ATTCs) and awarded following the recommendations of theMedicines Manufacturing Industry Partnership (MMIP).Key to the success of the planned centres is using technology tofacilitate patient access to cell and gene therapy products. This willinvolve full traceability and appropriate patient follow up and datacapture.The centres will also provide important data to support futurereimbursement and payment, which otherwise would remain a keybarrier to widespread implementation.© Shutterstock / Matej Kastelic© Shutterstock / Kamira© Amgen04-07.qxp_Layout 1 08/06/2018 09:58 Page 26Pharma Business International www.pbiforum.netLatest newsLonza opens world’s largestcell therapy manufacturingfacilityLonza has opened the world’s largest dedicated cell-and-gene-therapyfacility to meet the rising demand from developers of cell and genetherapies.During a grand opening ceremony in Pearland, Texas, Lonzaexecutives and industry leaders unveiled the 300,000-square-foot facilityand its offerings – highlighting its state-of-the-art, fully integrated,everything-under-one-roof access to some of the world’s most innovativecell-and-gene-therapy manufacturing technologies.“Lonza Houston will serve as a centre of excellence for cell-and-gene-therapy process development from concept through pre-clinical, clinicaland commercialization, all the way to the patient,” said Andreas Weiler, Business Unit head for Emerging Technologies at LonzaPharma & Biotech.“This facility has the potential to produce treatment for thousands of patients suffering from rare geneticdisorders or life-threatening diseases, under one roof.”The Lonza Houston Centre of Excellence is already operational andmanufacturing for several customers.US doctors propose majorpharmaceutical reformsA group of prominent doctors in the US and Canada havepublished a comprehensive proposal to ensure universal access tosafe, innovative and affordable medicines.This sweeping pharmaceutical reform proposal in is response toDonald Trump’s speech in May which, they said, failed to offer anynew policies that would expand access, reduce costs, or increasethe safety and efficacy of prescriptions.Healing an ailing pharmaceutical system: prescription for reformfor the US and Canada identifies seven critical areas for reform,along with both short- and long-term solutions to improve thedevelopment, approval process, affordability, and marketing ofmedications:* Access * Affordability * Preclinical development and patent protection * Clinical testing * Approval reform * Postmarketing surveillance * PromotionPriority review for first-line treatment ofGenetech’s TecentriqGenentech has had its supplemental Biologics License Application rubber-stamped by the US FDA for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).The FDA has also granted Tecentriq Priority Review with a decision expected by September.This approval is based on results from the Phase III IMpower150 study, which met its co-primary endpoints ofoverall survival and progression-free survival in the initial treatment of people with advanced non-squamous NSCLC.The safety profile of the combination was consistent with the safety profiles of the individual medicines, and nonew safety signals were identified.Tecentriq is currently approved by the FDA to treat people with metastatic NSCLC who have disease progressionduring or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approvedtargeted therapy if their tumour has ALK or EGFR gene abnormalities.© Shutterstock / Africa Studio© Shutterstock / science photo© Genetech04-07.qxp_Layout 1 08/06/2018 09:58 Page 3Quay devises filling system for drugdelivery treatment of gastrointestinaldisordersQuay Pharma has developed a specialised filling system to enable a new treatment foranorectal diseases to enter Phase 3 clinical trials.The Capository™ from RDD Pharma is a proprietary delivery system for the precisedelivery of drugs that target conditions and diseases of the anorectal region. It allowsdirectly controlled and precise application of medication to the anal canal region. Thecompany has completed recruitment of a pivotal European Phase 3 study in chronic analfissure.Prior to Quay’s involvement, the only solution available to fill the drug into theCapository™ was manually. This would have been an extremely slow process as 70,000units were required for the initial trials. The Quay team worked to develop a suitable fillingprocess that would allow for accuracy, speed, efficiency and reproducibility.Quay Pharma has delivered in excess of 40,000 Capositories™ to support RDD’s clinical development programs. Pharma Business International 7www.pbiforum.netLatest newsPM reveals plans todeploy AI in healthcarePrime Minister Theresa May has outlined ambitious new plansto deploy artificial intelligence in healthcare which will see some22,000 fewer people dying from cancer each year by 2033.In a speech back in May, the Prime Minister challenged theNHS, artificial intelligence sector and health charities to use dataand AI to transform the diagnosis of chronic diseases.The plans will see at least 50,000 people each year diagnosedat an early stage of prostate, ovarian, lung or bowel cancer –people who would have otherwise been diagnosed at a later andmore deadly stage.This would be done through using emerging technologies tocross reference people’s genetics, habits and medical recordswith national data to spot those at an early stage of cancer –empowering doctors to make referrals to an oncologist earlier andeven ahead of clear symptoms developing.© Shutterstock / Zapp2PhotoScientists discover cause ofcancer resistance tobreakthrough treatmentsScientists at The Institute of Cancer Research in London have identified amutation that gives cancer cells resistance to the breakthrough cancer treatmentolaparib and other PARP inhibitors.The findings could help predict which patients will develop resistance to PARPinhibitors and allow doctors to alter treatment at the earliest possible opportunity.The team used gene editing to identify a specific mutation in the PARP1protein that prevents PARP inhibitors from working.Testing for this mutation could add another level of personalisation to analready targeted treatment – helping guide decisions about whether to use PARPinhibitors in the first place, and when to switch to other drugs, such as platinum-based therapies.The research, funded by Cancer Research UK and Breast Cancer Now, ispublished in the journal Nature Communications.© Shutterstock / crystal light04-07.qxp_Layout 1 08/06/2018 09:58 Page 4HIV AND AIDS EXPOSÉ8Pharma Business International www.pbiforum.netFinding a functional cure Pharma Business International takes a look at some of the recent developments in the AIDS and HIVresearch and development space. 08-11.qxp_Layout 1 08/06/2018 09:59 Page 1Pharma Business International 9www.pbiforum.netHIV AND AIDS EXPOSÉHIV marked the end of an era. Gonewas the free love of the sixties; now sexwas public enemy number one. Thedistressing advertising and publicannouncement campaigns that followedin the wake of the AIDS epidemic of the1980s gave rise to fears around sex,particularly towards homosexual men. Forthat reason, the disease has so oftenbeen associated in the same breath ashomophobia. Its other connotation, ofcourse, is poverty. The disease isepidemic across parts of Africa wherechildren are frequently born infected. Ongoing efforts to understand, disarmand manage AIDS have led to someremarkable developments. For peoplewho started treatment after 2008, lifeexpectancy is now near-normal. This is afar cry from the death sentence rhetoricthat so often accompanied the diseasesome four decades ago. The AIDS andHIV research and development space isan area of continuous innovation and hasheralded a number of breakthroughs overthe last few years. Last year, for example, saw theinnovation space take a major leapforward with Gilead Sciences launching aten-year $100 million commitmentfocused on the Southern United States.The commitment sees the companypartner with Emory University School ofPublic Health, the University of HoustonGraduate College of Social Work, and theSouthern AIDS Coalition to lead thecorporate giving program of the initiative. According to Gilead, the centres willidentify and provide funding to localorganisations that are committed toaddressing the epidemic throughout theregion. They will focus on capacitybuilding and shared knowledge as well asmental health and trauma-informed careand awareness, education and, just ascrucially, anti-stigma campaigns.Evidence shows that there is an AIDSepidemic in the United States among gayblack men, where stigma and other social© Shutterstock/MOHAMED ABDULRAHEEM10 Á08-11.qxp_Layout 1 08/06/2018 09:59 Page 2Next >