Your guide to the pharmaceutical world Volume 5 Issue 4DistributionDriving the bottom lineHardware& SoftwareThere’s an app for thatLaboratoriesWorking to standardPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingDistributionDriving the bottom lineHardware& SoftwareThere’s an app for thatLaboratoriesWorking to standardwww.pbiforum.net01_Layout 1 07/08/2017 11:03 Page 1PROCESSINGNEWSINTERNATIONALFood&DrinkFood&Drinkwww.fdiforum.netJUNE 2017£3.50 STERLINGSUSTAINABLEPACKAGINGSustainablebusinessSustainablebusinessFor businesses that areserious about reducing theircarbon footprintwww.blmgroup.co.ukVOLUME 4 ISSUE 1WWW.RENEWABLESANDENVIRONMENT.COMJUNE 2017EAST MIDLANDS LEADING BUSINESS E-MAGCYBERSECURITYTop tipsFAMILYBUSINESSGood governanceFASTEST 40All the winnerswww.blmgroup.co.ukWWW.EASTMIDLANDSBUSINESSLINK.CO.UKTHE ELECTIONISSUE-WHAT CAN BUSINESSES EXPECTFROM THE NEXT GOVERNMENT?THE ELECTIONISSUE-WHAT CAN BUSINESSES EXPECTFROM THE NEXT GOVERNMENT?WWW.EASTMIDLANDSBUSINESSLINK.CO.UKEMPOWERYour BusinessYour guide to the pharmaceutical world Volume 5 Issue 2Clinical TrialsThe final testProcessingAutomate or expireHealth & SafetyBarrier to contaminationTrainingThe next generationPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingClinical TrialsThe final testProcessingAutomate or expireHealth & SafetyBarrier to contaminationTrainingThe next generationwww.pbiforum.netJUNE 2017 £3.50YORKSHIRE & LINCOLNSHIRE’S LEADING BUSINESS MAGAZINEwww.blmgroup.co.ukVOLUME 32 ISSUE 6CHRISTMAS INJUNEJingle bells?LINCOLNSHIRESHOW It’s all set to happen at the133rd Lincolnshire ShowPORTS &LOGISTICSAll changeLOOKINGAHEAD…LOOKINGAHEAD…Often Imitated -Never Equalledwww.blmgroup.co.uk02_Layout 1 07/08/2017 11:04 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 5 Issue 4News4Stay up to date with the latest industry updatesfrom the global pharmaceutical technologyindustry.Distribution8 As one of the most expensive assets in apharmaceutical company’s arsenal, its fleet needsto be constantly evaluated and new technology ishelping to safeguard the bottom line.Hardware & Software12 Mobile applications promised a new dawn forconsumer healthcare, but pharma’s love affairwith apps is on the decline. Pharma BusinessInternational investigates.Marketing16 Video sharing, social media and smart phoneshave left video marketing a powerful tool forpharmaceutical companies looking to connectwith consumers, raise awareness of social issuesand showcase new products.Q&A - Stefano Buono20 Pharma Business International recently sat downwith Stefano Buono, CEO of radiopharmaceuticalcompany Advanced Accelerator Applications(AAA), to discuss nuclear medicines, the effect ofBrexit on Britain’s life sciences and futuredevelopments. Procurement22 Procurement is a complex task within the pharmaindustry and sometimes it’s easy to get boggeddown with your own procurement strategy. It isworth, however, looking at your majorcompetitor’s procurement strategies as well.Laboratories26 Laboratory practice is important to ensure validityand minimise risk. One of the most well-knowndocuments on this is the Good LaboratoryPractice code, or GLP. Hygiene30 Many pharma manufacturers consider matters ofhygiene to be common sense, but nothing isquite that simple.Events34We give a rundown of Pharma events happeningaround the world481226Group 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. 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COVER PHOTO: © SHUTTERSTOCK / VICTOR MOUSSA 03_Layout 1 07/08/2017 11:05 Page 14Pharma Business International www.pbiforum.netLatest newsAZ and Merck forge strategiconcology allianceAstraZeneca will develop and commercialise its Lynparza formultiple cancer types alongside Merck & Co.Lynparza is a first-in-class oral poly ADP ribose polymerase(PARP) inhibitor currently approved for BRCA-mutated ovariancancer in multiple lines of treatment.Its pipeline has grown significantly over the last few years,with 14 indications currently being developed across severaltumour types – including breast, prostate and pancreatic.The collaboration is expected to further increase the numberof treatment options available to patients.The companies will jointly develop and commercialiseLynparza, both as monotherapy and in combination trials withother potential medicines.The companies will also jointly develop and commercialiseAZ’s selumetinib – an oral, selective inhibitor of MEK, part of themitogen-activated protein kinase pathway, currently beingdeveloped for multiple indications including thyroid cancer.Independently, they will develop and commercialise the inhibitor incombinations with their respective PD-L1 and PD-1 medicines, Imfinzi andKeytruda.GSK streamlines UK manufacturing network GSK is streamlining its UK manufacturing network in a bid to boost efficiency.The drugmaker confirmed its efforts are in no way related to Brexit. Among its efforts are fresh investments in both its respiratory and HIVmedicines manufacturing competencies.It also includes the sale of a number of products as well as a proposal toclose a UK manufacturing site.Between now and 2020, the company plans to invest more than £140 millionat its Ware, Hertfordshire, Barnard Castle, Co Durham and Montrose, Scotlandsites.This new investment is in addition to the £275 million announced last year andinvestment of over £1.2 billion in UK manufacturing since 2012.The company has also decided not to proceed with a previously plannedinvestment to build a biopharmaceutical facility in Ulverston as it no longerneeds the additional capacity.In addition, GSK intends to sell the MaxiNutrition brand in the UK. Lilly and Nektar to develop novelautoimmune therapyEli Lilly and Nektar Therapeutics will co-develop NKTR-358, Nektar’s novel immunologicaltherapy, as part of a new collaboration. NKTR-358, which achieved first human dose in Phase 1 clinical development in March 2017,has the potential to treat a number of autoimmune and other chronic inflammatory conditions.It is a potential first-in-class resolution therapeutic that may address an underlying immunesystem imbalance in patients with many autoimmune conditions.It targets the interleukin receptor complex in the body in order to stimulate proliferation ofpowerful inhibitory immune cells known as regulatory T cells.By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organfunction in autoimmune conditions.Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones.© Shutterstock / fusebulb© Shutterstock / RalwelPhoto courtesy of GSK04-07_Layout 1 07/08/2017 11:06 Page 1Study shows dearth ofinterest in uptake of abuse-deterrent opioidsDespite gaining regulatory approval, a lack of willingness by insurers toreimburse patients is hindering the uptake of opioid products with abuse-deterrent formulations (ADF).According to the Tufts Centre for the Study of Drug Development, 10 newopioid products with ADF have been approved in the US. Despite this, anapparent lack of interest by insurers to front the cost for patients is a primarychallenge in overall uptake.96% of all opioid products prescribed in the US in 2015 lacked abuse-deterrent properties, and only four of the 10 opioid products with abuse-deterrent properties thus far approved for sale by the FDA have been launched.Despite these obstacles, new ADF product development is moving ahead, asmore than two dozen applications for new ADF drug products are pendingbefore the FDA.Drug developers face a special challenge in creating abuse deterrents fororal medications, as pills are the most common means by which pain medicineis administered.Pharma Business International 5www.pbiforum.netLatest newsSanofi acquires USbiotech company in$650m dealSanofi is acquiring Protein Sciences, a US-based privately heldvaccines biotechnology company, for $650 million.On top of the upfront payment, Sanofi will also pay up to $100 millionin milestone payments.Protein Sciences received US Food and Drug Administration approvalfor its Flublok Quadrivalent Influenza Vaccine in October last year. It is theonly recombinant protein-based influenza vaccine approved by theregulator.“The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg based vaccine,” said David Loew, pictured,Sanofi Executive Vice President and Head of Sanofi Pasteur – the company’s vaccines division.The acquisition is expected to close in the third quarter of 2017.UK to identify antibacterialdrug targets UK medical research charity, LifeArc is working with theGovernment’s Centre for Drug Research and Development andCanada’s Defence Science and Technology Laboratory to identifyantibacterial drug targets.Antibiotic resistance is a major world-wide health problem that isthreatening our ability to treat common infectious diseases.A growing list of infections – such as pneumonia, tuberculosis,sepsis and gonorrhoea – are becoming harder (and sometimesimpossible) to treat as antibiotics become less effective.To date, the majority of antibacterial drug discovery programs havefocused on very specific aspects of resistance, or single pathogenspecies.This new collaborative project will take a more holistic approach,looking at commonality across pathogens to identify which genes or“targets” express proteins that lead to the production of multi-drugresistant bacteria, and are therefore the most promising from abiophysical and drug discovery based perspective.Once targets have been selected and scientifically validated, resultswill be openly published.© Shutterstock / Pressmaster© Shutterstock / Victor Moussa Photo courtesy of Sanofi04-07_Layout 1 07/08/2017 11:06 Page 26Pharma Business International www.pbiforum.netLatest newsValeant completes$800m sale of DendreonValeant Pharmaceuticals has completed the sale of all of theoutstanding equity interests in its former subsidiary DendreonPharmaceuticals to the Sanpower for $819.9 million.Valeant said the deal reiterates its expectation to pay down$5 billion in debt from divestiture proceeds and free cash flowwithin 18 months of August 2016.“We continue to deliver on our commitments to reduce debtand simplify our portfolio, while focusing resources on our corebusinesses,” said Chairman and CEO Joseph C. Papa.He added: “The proceeds from this sale along with therecently announced sale of the iNova business move us closerto paying down $5 billion of debt from divestitures and freecash flow, and we are confident we will meet and potentiallyexceed this commitment.”The Company estimates that the expected revenue andAdjusted EBITDA from the Dendreon business in the second half of 2017 would have beenapproximately $170 million and $65 million, respectively.Oxford BioMedica signs supplyagreement with NovartisGene and cell therapy group Oxford BioMedica has built on its earliercollaboration with Novartis with a new major supply agreement. The new agreement covers the commercial and clinical supply of lentiviralvectors used to generate CTL019 (tisagenlecleucel) and other undisclosedChimeric Antigen Receptor T cell products.Oxford BioMedica could potentially receive in excess of $100 million fromNovartis over the next three years.This amount includes a $10 million upfront payment, various performanceincentives and bioprocessing and development services.The supply agreement is for three years, extendable to five years subject to theagreement of both parties.In addition, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis’s CAR-T products.Novartis hits 5 year milestonefor psoriasis treatmentNovartis has clocked up five year efficacy and safety results for Cosentyx from aPhase III long-term extension study in patients with moderate-to-severe plaquepsoriasis.5 year Phase III data are a recognised milestone for assessing long-term efficacyand safety of innovative treatments.“Cosentyx has consistently demonstrated sustained efficacy and safety providingpsoriasis patients a new standard of long-term care,” said Vas Narasimhan, GlobalHead of Drug Development and Chief Medical Officer, Novartis.He added: “With the first data from a pivotal trial with 5 years of follow up,Cosentyx continues to demonstrate it can provide what psoriasis patients want, alife with clear skin.”Cosentyx was launched in 2015 as the first and only fully-human IL-17A inhibitor to treat psoriasis and is now licenced for the treatment of psoriatic arthritisand ankylosing spondylitis as well.© Shutterstock / Hriana© Shutterstock / YURALAITS ALBERT04-07_Layout 1 07/08/2017 11:06 Page 3US approves first sickle celltreatment in 20 yearsThe US Food and Drug Administration has green-lit Endari, the first sickle celltreatment approved in the US for paediatric patients, and the first for adults in 20years.Endari is intended to reduce the severe complications of sickle cell disease(SCD) in adult and paediatric patients aged 5 and older.The treatment reduces oxidant damage to red blood cells by improving the redoxpotential of nicotinamide adenine dinucleotide, a coenzyme that has been identifiedas the primary regulator of oxidation.SCD is a rare, debilitating and lifelong hereditary blood disorder that affectsapproximately 100,000 patients in the US and up to 25 million patients worldwide,the majority of which are of African descent as well as Latinos and other minoritygroups.Approximately one in every 365 African American children is born with SCD and children between the ages of 2 and 7 are 400 times more likely to sufferfrom stroke.Pharma Business International 7www.pbiforum.netLatest newsDiasome Pharma scoops $30mfunding for insulin developmentDiasome Pharmaceuticals has received fresh funding of up to $30million led by Medicxi, a European life sciences venture capital firm.This is the first investment from Medicxi’s recently announcedGrowth Fund I. Other investors in this round include the JDRF T1DFund, Black Beret Life Sciences and an investor group led byMcDonald Partners.Diasome’s Hepatocyte Directed Vesicles (HDV) technology additiveto commercial insulin therapies allows preferential delivery of insulinto the liver’s hepatocytes.HDV-insulin is the most clinically advanced novel pre-meal insulinin the global insulin pipeline, and if approved would represent the firstinsulin therapy specifically designed to mimic the mealtime exposureof the liver to insulin.The company will use the proceeds of this funding to continue itsclinical development program and general operations, including theexecution of its ongoing ISLE-1 (InSulin Liver Effect) Phase 2b studyof HDV-Insulin in subjects with Type 1 diabetes.UK SMEs to test new tech andmedicine with £86m fundA new £86 million funding packaging will allow UK SMEs to develop and testnew technologies in the NHS.This could include innovations such as digital technologies to help patientsmanage their conditions from home instead of a hospital, or to develop newmedicines.Access to this funding will also speed up the time it takes to get newtechnologies from the lab to patients in the NHS.The announcement is the first step in taking forward the Accelerated AccessReview (AAR) – an independently chaired review, which made recommendationsto government on speeding up patient access to new technologies.Health Minister Lord O’Shaughnessy said: “The government’s ambition is thatNHS patients get world-leading, life-changing treatments as fast as possible.“That can’t happen unless we support medical innovation and tear down thebarriers – like speed to market and access to funding – that can get in the way,especially for SMEs.”© Shutterstock / Sebastian Kaulitzki© Shutterstock / hamofking© Shutterstock / Ink Drop04-07_Layout 1 07/08/2017 11:06 Page 4Driving thebottom line DISTRIBUTION8Pharma Business International www.pbiforum.net© Shutterstock / Don PabloDriving thebottom line 08-11_Layout 1 07/08/2017 11:07 Page 1Pharma Business International 9www.pbiforum.netDISTRIBUTIONxpenditure is endemic to anymanufacturing industry, from fronting thecost of raw goods, investing profits intoresearch or the latest equipment, and topay workers’ wages. Among its mostexpensive budget items is its fleet.Pharmaceutical companies are dependent ontheir fleet to transport ingredients and finishedproducts from warehouses to suppliers andstockists. Far from the cost of the fleet alone, acompany must also factor in the added expenseof fuel, maintenance and repairs. Pharmaceutical sales fleets are a formidablesector in their own right, with the combinedfleets in Europe, the United Kingdom and Europetotalling some 300,000 vehicles. To put that inperspective, the average size of a pharma salesfleet is around 1,000 vehicles which can be asmuch as five times higher for the largest 15companies. Much like the rest of thepharmaceutical industry itself, sales vehicles areevolving. However, as newer models enter themarket, older, lower-end vehicles hold less valueto a company, meaning they need to be sold tomake way for the next generation of models. For fleet managers, this tipping point hascome at an ideal time, as they embrace newtechnologies enabling them to track and managethe data that comes from their drivers andvehicles like never before. The way in whichmanagers look at their fleets has changed,allowing them to scrutinise every phase of avehicle’s life span – from point of purchase toeverything in between. This allows them to knowexactly when the time is right to sell a vehicle on,or get real time feedback on a new addition to afleet. According to Partha Ghosh, Director of NorthAmerican Vehicle Supply Chain at fleetAs one of the most expensiveassets in a pharmaceuticalcompany’s arsenal, its fleet needsto be constantly evaluated, andnew technology is helping tosafeguard the bottom line. 10 ÁE08-11_Layout 1 07/08/2017 11:07 Page 2Next >