Your guide to the pharmaceutical world Volume 5 Issue 6CounterfeitDrugsFraudulent PharmaInvestmentMarketsWhere innovation andinvestment collideDiabetes ExposéPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingCounterfeitDrugsFraudulent PharmaInvestmentMarketsWhere innovation andinvestment collideDiabetes Exposéwww.pbiforum.net01_Layout 1 05/12/2017 12:59 Page 1Driving your business.Get your off er today. www.alphabet.com/aboutalphabetYou deal with tomorrow’s ideas. We’ll make sure your team has the right drive.In a fast-changing business environment, you need innovative solutions to stay ahead. At Alphabet, we offer smart Business Mobility from electric fleets to corporate carsharing and flexible mobility budgets. Together, we take your company beyond today’s crossroads and on to tomorrow.02_Layout 1 05/12/2017 13:09 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 5 Issue 6News4Stay up to date with the latest industry updatesfrom the global pharmaceutical technologyindustry.Diabetes Exposé8 Research has quantified a link between diabetesand developing cancer, fortunately the R&D spaceis up to the challenge as Pharma BusinessInternational finds out.Counterfeit Drugs12 The counterfeit drugs industry could be worth asmuch as $200 billion annually, so it’s importantcompanies work together to limit it where possible. End of Year Success16 Despite economic uncertainty and an oft hostilepolitical landscape, there have been a number ofmulti-dollar deals in the pharmaceutical M&Amarket, but stormy weathers affected the industryall through 2017. Here, Pharma BusinessInternational explores some of the biggest deals ofthe last twelve months. International Markets20 Ireland is a key market for pharmaceutical innovationand exports, here Pharma Business International satdown with Sheila O’Loughlin, Senior Market Advisorat Enterprise Ireland, to talk exports, investors,developments and, of course, Brexit. Regulation and Approval24 Ensuring new products meet with the approval ofgoverning bodies can be a long and frustratingprocess, but ensures greater success in the longrun.Intellectual Property28 Any pharmaceutical company is only as great astheir intellectual property – but shakeups acrossthe world are making the act of keeping an IPdifficult.Events32We give a rundown of Pharma events happeningaround the world8122428Group 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 / HYWITT DIMYADI 03_Layout 1 05/12/2017 12:59 Page 14Pharma Business International www.pbiforum.netLatest newsFDA approves world’sfirst ‘digital pill’The US Food and Drug Administration has approvedthe world’s first drug with a digital ingestion trackingsystem.Otsuka Pharmaceutical’s Abilify MyCite has aningestible sensor embedded in the pill that records thatthe medication was taken.The product is approved for the treatment ofschizophrenia, acute treatment of manic and mixedepisodes associated with bipolar I disorder and for useas an add-on treatment for depression in adults.It works by sending a message from the pill’s sensorto a wearable patch. The patch transmits theinformation to a mobile application so that patients cantrack the ingestion of the medication on their smartphone.Patients can also permit their caregivers andphysician to access the information through a web-based portal.Abilify was first approved by the FDA in 2002 to treat schizophrenia.Biosimilars couldcurb US health spendby $54bnBiosimilars aimed at treating cancer and rheumatoidarthritis could cut US health care spending by $54 billionover the next decade, according the RAND Corporation.The savings estimate is about 20% larger than a similaranalysis done by RAND researchers three years ago,representing both improved analysis methods and rapidgrowth in spending for biologics overall.“Biologics account for the fastest-growing segment of prescription drug spending, but biosimilars have the potential to help slow some of the increase,”said Andrew Mulcahy, lead author of the study and a policy researcher at RAND.“However, there remain many important industry, regulatory and policy decisions to be made that will influence whether such savings are realised.”While 1% to 2% of the nation’s population is treated with a biologic each year, the drugs accounted for 38% of prescription drug spending in 2015.In addition, biologics accounted for 70% of the growth in prescription drug spending in the US between 2010 and 2015.US approval for 2-drug HIV regimenThe US FDA has approved ViiV Healthcare’s Juluca, which for the first time combines dolutegravir and rilpivirine, fortreating HIV.“This is the start of a new era in HIV treatment,” said CEO Deborah Waterhouse. “We are delighted to be able toprovide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction oflong-term ART exposure as they receive life-long treatment for their chronic condition.”This approval is based primarily upon data from two pivotal phase III clinical trials – SWORD-12 andSWORD-2,2 – which showed the 2-drug regimen achieved non-inferior viral suppression at 48 weeks.“Juluca is the first medicine in our 2-drug regimen pipeline, which looks to help lessen the lifetimeburden of treatment for people living with HIV,” said John C Pottage, Jr, MD, Chief Scientific andMedical Officer, ViiV Healthcare.© Shutterstock / any_keen© Shutterstock / HQuality04-07_Layout 1 05/12/2017 13:01 Page 1Amsterdam crowned newhome of the EMAAmsterdam has been named the new home of the EuropeanMedicines Agency (EMA) with the agency relocating from its currentLondon base where it has been based since 1995.The move is a direct result of the UK pulling out of the EuropeanUnion, the Agency said.It will now begin “working immediately” with the Dutch governmentto ensure a smooth and successful move slated for the end of March2019.Though the EMA had nothing to do with the selection process,Executive Director Guido Rasi seems to be satisfied with the decision.“We welcome today’s decision on the new location of EMA,” hesaid. “Now that we finally know where our journey is taking us, we cantake concrete actions for a successful move.“Amsterdam ticks many of our boxes. It offers excellent connectivityand a building that can be shaped according to our needs.”Pharma Business International 5www.pbiforum.netLatest newsTakeda to develop Portal’s needle-free drug deliveryTakeda is leveraging Portal Instruments’ needle-free drug delivery device as a means of deliveringits investigational or approved biologicalmedicines.The Portal device was developed at theMassachusetts Institute of Technology (MIT) in thelaboratory of Professor Ian Hunter.The technology has the potential forapplications across a range of biologic medicinesthat currently require administration through aninjection.The device delivers the biologic through apressurised liquid instead of a needle, and has been clinically shown to be less painful and preferred by patients compared to a standard needle-basedinjection.The first Takeda development program to potentially utilise this device will be for investigational use with Entyvio.Entyvio is a monoclonal antibody for adults with moderately to severely active ulcerative colitis or Crohn’s disease, which is currently administered throughintravenous infusion.UK Gov supports life sciencessector with £17m investmentThe UK’s life sciences sector is set to benefit to the tune of £17million after fresh funding was announced by Chancellor PhilipHammond.The funding – part of the Government’s wider industrial strategy –will help to unlock “real benefits for the NHS and patients”, Hammondsaid.It will lay the groundwork for new drug discovery as well assupporting mental health treatment.The aim is to capitalise on the UK’s scientific prowess andtransform it into “real life treatments”.Though the UK represents just 0.9% of the global population, itproduces 15.2% of the world’s most highly-cited articles.“The UK has world-leading expertise in life sciences… and it isthrough supporting growth in these cutting edge industries that we willbuild a competitive economy that works for everyone,” Hammondsaid.© Shutterstock / Sovastock© Shutterstock / fotolupa Photo: Portal InstrumentsChancellorPhilip Hammond04-07_Layout 1 05/12/2017 13:01 Page 26Pharma Business International www.pbiforum.netLatest newsPromising new medicinefor ALS discoveredA series of experiments have yielded the discovery of a promisingmedication for amyotrophic lateral sclerosis (ALS – also known asLou Gehrig’s disease or motor neurone disease).This neurodegenerative disease normally leads to a progressiveparalysis of the skeletal muscles and, on average, three years afterthe onset of symptoms, to death.Researchers from the University of Montréal Hospital ResearchCentre (CRCHUM) and the Cumming School of Medicine (CSM) atthe University of Calgary have discovered a medication that couldmake it possible to treat individuals with ALS.The experiments were conducted on worms, zebrafish, mice and,finally, on human subjects in a limited clinical trial conclude thatpimozide may be effective in treating the disease.An article published in JCI Insight concludes that pimozide was found to be safe and over the shortterm, preliminary data shows that it could stabilise the progression of ALS.AZ and Incyte expand clinicalcollaborationAstraZeneca and its global biologics R&D arm, MedImmune, have expanded itsclinical collaboration with Incyte Corporation.The companies will now evaluate the efficacy and safety of epacadostat,Incyte’s investigational selective IDO1 enzyme inhibitor, in combination with AZ’sImfinzi (a human monoclonal antibody directed against PD-L1), compared toImfinzi alone.The exclusive collaboration for the study population allows for the twocompanies to conduct a Phase III trial in patients with locally-advanced,unresectable non-small cell lung cancer whose disease has not progressedfollowing platinum-based chemotherapy concurrent with radiation therapy.The Phase III trial, which will be co-funded by the two companies and will be conducted by AstraZeneca, is expected to begin enrolling patients in the firsthalf of 2018.This agreement builds on an existing clinical collaboration for Imfinzi and epacadostat announced back in May 2014.Cue Biopharma to developnext-gen biologics via MerckcollaborationCue Biopharma will leverage its CUE Biologics platform to develop next-genbiologics to treat autoimmune diseases in a new collaboration with Merck.Specifically, the Massachusetts-based immunotherapy company will use itsplatform to develop biologics engineered to selectively modulate disease-relevant T cell subsets for the treatment of autoimmune disease.The multi-year collaboration will encompass multiple disease targets acrosscertain primary disease indication areas.Though specific financial arrangements weren’t disclosed by either party,Cue Biopharma said that it will receive an up-front payment.The company is also eligible to earn up to $374 million in research, development, regulatory and commercial milestone payments in addition to tieredroyalties on sales.© Shutterstock / Syda Productions© Shutterstock / PressmasterAlex Parker & Pierre Drapeau,who spearheaded the research 04-07_Layout 1 05/12/2017 13:01 Page 3Bill Gates invests $50m todevelop novel dementia therapiesBill Gates has invested $50 million in the Dementia Discovery Fund (DDF) toexplore a novel approaches to develop disease modifying dementia drugs.Gates is no stranger to making investments in the healthcare sphere, but this isthe first time the tech mogul has provided funds to accelerate therapies aimed atAlzheimer’s disease.Since its launch in October 2015, the DDF has made significant progressbuilding an initial portfolio of 12 investments in drug discovery companies andprojects.The team believes that there is a significant opportunity to apply insights fromareas such as oncology and immunology to develop novel drugs targeting theseother biological pathways that may drive different forms of dementia.“I believe we are at a turning point in Alzheimer’s research and development, which the Dementia Discovery Fund is playing an important role in byexploring new approaches to treat the disease,” Gates said.Pharma Business International 7www.pbiforum.netLatest newsRoll-out of PrEP inEngland would be‘cost-effective’A UCL study has found that a national roll-out of PrEP medicationto men who have sex with men in England would be cost-effective.The research – published in The Lancet Infectious Diseases– alsofound that up to one in four cases of HIV.This follows a groundbreaking study which legitimised thetreatment’s efficacy in gay and bisexual adolescent boys.UCL found that providing PrEP could become cost effective within40 years of introduction, but timeframes may be even shorter if thecost of the drugs reduces as patents expire.Over 80 years, the study estimates savings of up to £1 billion as aresult of fewer men needing lifelong HIV treatment.Numbers of new HIV diagnoses in men who have sex with men inthe UK have been at high levels for several years, with over 3,000new cases per year from 2012 to 2015, and there is a need for newprevention approaches.Genomics taps novel MStargets with BiogencollaborationOxford’s Genomics has entered into a collaborative deal with US biotech firmBiogen to work on multiple sclerosis drug therapies.Genomics will use its platform to assess the genetic support for early-stageBiogen MS drug targets and to find novel targets.Biogen claims to have the “broadest MS portfolio in the industry”.“The combination of big data analytics with the growing volumes of humangenetic data offers the potential to transform aspects of drug development,” saidProfessor Peter Donnelly, Founder and CEO of Genomics.Genomics has developed an integrated platform which quantifies the effects ofover 7 million genetic variants on more than 1,000 different human phenotypes,which range from molecular measurements, through biomarkers, to diseaseoutcomes.© Shutterstock / JStone© Shutterstock / Marc Bruxelle© Shutterstock / sfam_photoBill Gates04-07_Layout 1 05/12/2017 13:01 Page 4DIABETES EXPOSÉ8Pharma Business International www.pbiforum.netDiabetes is the name given to the condition wherean individual’s ability to produce or respond to thehormone, insulin, is impaired resulting in elevatedlevels of glucose in the blood. It’s categorised into two distinct types, with thefirst a lifelong condition where the body’s immunesystem attacks and destroys the cells thatproduce insulin while the second, oftenrelated to lifestyle, occurs when thebody doesn’t produce enoughinsulin. Diagnoses of diabetes arerapidly rising, in tandem,perhaps, with theexplosive populationgrowth, and moreunhealthy lifestyles. Inthe UK alone, thenumber of thosediagnosed with diabeteshas risen from 1.4 million in1996 to 3.5 million today –or 6 per cent of the entire UKpopulation. But, taking intoaccount those living withundiagnosed diabetes, the figure is morelikely in excess of 4 million and rising. By 2025,experts estimate that the figure will rise to 5 million.This is more startling still when looked at in a globalcontext, with an estimated 415 million people livingwith the disease worldwide. 46 per cent of these goundiagnosed, representing a failure in globalhealthcare systems, poor access for patients andfacilities and a general lack of understanding allround. It is type 2 diabetes, however, that is by far andaway the most prevalent category of the disease,accounting for 90 per cent of all diabetes cases inthe UK. This type has been growing at a startlingrate and has become one of the world’s mostcommon long-term health conditions withmost countries reporting risingnumbers. It is now largelyconsidered a lifestyle disease,occurring as a direct result ofpoor diet and lack ofexercise and being obeseor overweight, thoughage and genetics areboth still precursors.Such is the severity ofthis rising number ofdiagnoses, a veritableepidemic, that research hasidentified a “pre-diabetes”.This proto-version of thedisease can progress to fullblown type 2 diabetes if preventativesteps – such as eating healthily, losingweight and getting plenty of exercise – aren’tmet. Though pre-diabetes can be a gateway todeveloping type 2, the latest research hasdiscovered a clear and present link betweenBlood sugarResearch has quantified a link between diabetes and developing cancer, fortunatelythe R&D space is up to the challenge as Pharma Business International finds out. 10 Á© Shutterstock / Montri Thipsorn08-11_Layout 1 05/12/2017 13:02 Page 1© Shutterstock / Gemalbarra08-11_Layout 1 05/12/2017 13:02 Page 2Next >