< PreviousALZHEIMER’S EXPOSÉ20Pharma Business International www.pbiforum.netAs the most common cause ofdementia, Alzheimer’s is a loaded term,bringing with it connotations of memoryloss, but sufferers become increasinglydisconnected with reality with theirdiagnosis, suffering delusions andhallucinations. Current statistics claimthere are more than 520,000 people inthe UK with Alzheimer’s disease, with44 million sufferers worldwide. Thesilver lining is that there is a number ofpromising treatments in development totackle the disease head on. According to the PharmaceuticalResearch and Manufacturers ofAmerica (PhRMA), there are currently 87potential new Alzheimer’s treatments inthe clinical trial stage of development.The latest research is focussed onpreventive measures, with the emphasison slowing or stopping the disease. Forexample, targeting the immune systemto enable to fight the disease, anddeveloping medicines that lowerinflammation in the brain. Though thismay seem like an encouraging number,the Alzheimer’s space is a fraught one,with many clinical trials failing, leavingpotential treatments dashed upon therocks. Though identifying, treating andpreventing Alzheimer’s still largelyeludes researchers, there is hope,PhRMA says, that even modestprogress can drastically change thetrajectory of treatments. To put that ineconomic context, if a new medicinecould delay the onset of Alzheimer’sdisease for, say, five years,approximately $367 billion annually inlong-term care and other healthcarecosts could be avoided by 2050. Forgetme notAlzheimer’s disease ranks alongside cancer and heart disease asone of the leading causes of death. So, what’s being done to tacklethe disease?22 Á20-23_Layout 1 05/10/2017 09:23 Page 1Pharma Business International 21www.pbiforum.netALZHEIMER’S EXPOSÉ© Shutterstock / Orawan Pattarawimonchai20-23_Layout 1 05/10/2017 09:23 Page 2ALZHEIMER’S EXPOSÉ22Pharma Business International www.pbiforum.netAlthough scientists have madesignificant progress in unravelling andidentifying the myriad complexitiesunderpinning Alzheimer’s, an effectivetreatment remains a daunting challenge.Considering the disease was firstdiscovered in 1906, the spectre of thisdisease on healthcare becomesapparent. However, GBI Researchrevealed that the level of first-in-classinnovation in this space is “exceptionallyhigh”. In findings released earlier thisyear, the healthcare-focussed businessintelligence provider found that theAlzheimer’s disease pipeline is significantwith some 646 products in activedevelopment. Given that – as above – 87of these are currently in clinical trial, it’ssafe to say that the Alzheimer’s space isone of the most innovative and activeresearch segments this side of cancer. Alzheimer’s wreaks havoc with anindividual’s cognitive function and,unsurprisingly, shares many of the samepathophysiological processes as a numberof other mental health issues such asanxiety and depression – both of whichcan be prevalent in sufferers of thedisease. Several first-in-class targetsidentified in the aforementioned pipelineare also in development for multipleassociated indications. Of those, Gprotein–coupled receptors were the mostprevalent signally pathway identifiedamong first-in-class targets for Alzheimer’sdisease and its associated indications. “Although the Alzheimer’s diseasespace is a challenging one… it maintainsa strong level of innovation, with manypipeline products specifically targetingproteins widely considered to beunderlying factors in diseaseprogression,” says GBI Research AnalystFiona Chrisholm. Though early on-set Alzheimer’s isbecoming more common – a phenomenasome have pinned on rising air pollutionlevels – it is a disease that predominatelyaffects older people. Higher lifeexpectancy and a growing elderlypopulation has brought with it highereconomic and social costs. Alzheimer’sputs a strain on a nation’s economy, itssocial care and, perhaps worst of all, onthe lives and families of sufferers. Ourcollective understanding of the diseaseand its pathophysiology is facilitating aflurry of new trials and potentialtreatments coming to the fray to addressthis awful disease. © Shutterstock / Atthapon Raksthaput20-23_Layout 1 05/10/2017 09:23 Page 3© Shutterstock / Eviart20-23_Layout 1 05/10/2017 09:23 Page 4ANIMAL HEALTH24Pharma Business International www.pbiforum.netAlongside the ethical benefits, reducingthe number of animal tests will save bothtime and money, with the knowledgegained though the data sharing resultingin more informed decisions about testedsubstances, and a better understandingof what tests to perform. This thoughtprocess is shared by the scientificorganisation the National Centre for theReplacement, Refinement & Reduction ofAnimals in Research (NC3Rs).Working with the Medicines andHealthcare Products Regulatory Agency(MHRA), NC3Rs launched an initiative,involving 32 organisations, which sharedthe data of 137 compounds and 259studies. Ultimately, the research identifiedthat the use of recovery animals could bereduced by 66 per cent, savingthousands of animals globally each year. A good example of how partnershipsand collaboration can advance the 3Rs isVitic Nexus – a structure-searchabletoxicity database and informationmanagement system. It offersresearchers and scientistsrapid access tosearchabletoxicological© Shutterstock / unoLTesting thefuture Increasing collaboration and thoroughly examining data is not just in thepublic interest, it is key to achieving a reduction in animal testing, asKatharine Briggs, Research Leader at Lhasa Limited, explains. Katharine Briggs 24-25_Layout 1 05/10/2017 09:23 Page 1Pharma Business International 25www.pbiforum.netANIMAL HEALTHinformation and was utilised by ‘The Dog Project’, acollaborative group formed to reduce the use of dogs intoxicity testing. The group comprised the RSPCA, FRAME andseveral European pharmaceutical companies, andproposed setting up a database of toxicologicaleffects of vehicles, to reduce the need fortesting. The resulting Vitic excipients databaseencourages data sharing between companies,thus reducing unnecessary animal testing.Today, members use the database to choose anappropriate vehicle and dosage for a specificstudy design (species, treatment route andduration). It has been used to optimise drugefficacy whilst ensuring excipients’ safety and thedata coverage is still being expanded. Ultimately, data collaboration isn’t just vital toavoid stagnation in innovation; it can also help meet thenew regulations of pharmaceutical companies. Datasharing and collaboration will help to reduce the testingon animals, and can also help to quicken drugdevelopment at a reduced cost – a process which theindustry and the wider public will benefit from.Lhasa Limited is a UK not-for-profit organisation andeducational charity that facilitates collaborative datasharing projects in the pharmaceutical, cosmetics andchemistry-related industries.© Shutterstock / Oshchepkov Dmity24-25_Layout 1 05/10/2017 09:23 Page 2ETHICS26Pharma Business International www.pbiforum.netDisgraced pharma boss and former hedge fundmanager Martin Shkreli became the face ofcorporate greed when he bumped the price of alife-saving drug up by over 5,000 per cent. Thoughhardly alone in his actions, Shkreli seemed to relishhis role as a corporate bogey man. He courtedcontroversy and seemed to delight in the dammingimage he cultivated in the media and public eye. Itwas an attitude that has earned him jail time, albeiton different charges. Though price-gougingremains one of the biggest issues and continuingcontroversies in the pharmaceutical sector, there isanother problem spiralling out of control. The blame of America’s ongoing opioid addictionhas largely been heaped at the feet of big pharma,with companies accused of encouraging addiction,bribing doctors to prescribe their medicines andturning a blind eye to the problem. To put the issuein perspective, Public health officials have cited thecurrent epidemic as the worst drug crisis inAmerican history. In 2015 alone, it killed over33,000 people, a death rate that is believed to berapidly increasing. Taking matters into their ownhands, a number of state and local governmentshave filed lawsuits against the biggest offenders in28 ÁCrisis, USAIn response to America’s ongoing opioid epidemic, state and local governmentsare filing lawsuits against some of the biggest drug makers, highlighting theimportance of ethics in big pharma. © Shutterstock / Aleksey Klints26-29_Layout 1 05/10/2017 09:24 Page 1© PureRadiancePhoto / Shutterstock26-29_Layout 1 05/10/2017 09:24 Page 2© Shutterstock / ittiponOctoberis medicineabuse awarenessmonth26-29_Layout 1 05/10/2017 09:24 Page 3Pharma Business International 29www.pbiforum.netETHICSthe ongoing crisis, with theintent of holdingpharmaceutical companiesaccountable. As of going to print,Washington state was thelatest to file a lawsuit, thisone specifically aimed atPurdue Pharma – the makersof OxyContin, one of themost notorious drugs in theepidemic. Even at regulardoses, the painkiller can behabit forming. A commonoccurrence is that patientsare prescribed the medicineto deal with chronic painbut subsequently becomedependent. If they aren’table to satisfy thisaddiction through normalchannels, i.e. prescriptions,they can turn tounregulated sellers on theinternet or move to heroin.Seattle has also filed aseparate lawsuit againstPurdue on top of othersaimed at units of TevaPharmaceutical, Johnson& Johnson, EndoInternational and Allergan. Specifically, the lawsuitspearheaded byWashington AttorneyGeneral Bob Fergusonclaimed Purdue ofdeceptive marketing ofOxyContin. It further accused thedrugmaker of convincing both doctorsand the public that its drugs had a low-risk of addiction as well as emphasis theireffectiveness at treating chronic pain. Asthe lawsuit claims that Purdue has reapedbillions of dollars profiting from the crisis,it aims to force the company to pay asignificant sum. Despite allegations and the mountinglawsuits, drugmakers including Purdueand others regularly deny anywrongdoing. In a statement, Purdue saidthat it was “deeply troubled” by the crisis.As if to further shift the blame, it addedthat its products are Food and DrugAdministration approved and account foronly 2 per cent of all opioid prescriptions.“We vigorously deny these allegationsand look forward to the opportunity topresent our defence,” the drugmakersaid. The temptation to make profit throughprice hikes has to tempered and© Shutterstock / Steve Heapbalanced against the ethicalconsiderations with working in anindustry where lives are constantly atstake. The recent spate of price hikes,both in and out of the media’s gaze, havehighlighted the need for an ethicaldialogue to tackle the festering problemendemic within the pharmaceuticalindustry. This has come to a head withthe opioid crisis in America where stategovernments are now taking matters intotheir own hands. 26-29_Layout 1 05/10/2017 09:24 Page 4Next >