< PreviousDIABETES EXPOSÉ10Pharma Business International www.pbiforum.netdiabetes and cancer. A study publishedin The Lancet Diabetes & Endocrinologyand spearheaded by Imperial CollegeLondon for the first time has quantifiedthe number of cancers expected to becaused by diabetes and high BMIsworldwide. It found that almost six percent of new worldwide cancer cases in2012 were caused by the combinedeffects of diabetes and being overweightor obese. Further, for the twelve cancertypes studied, diabetes and high BMIcombined were responsible for almost800,000 new cancer cases. Although being overweight wasresponsible for twice as many cancers asdiabetes – 544,300 and 280,100respectively – it does highlight thepreviously hypothesised phenomenonthat diabetes can put sufferers at ahigher cancer risk. The findings are astartling look at the rising levels ofdiabetes which could herald even greaternumbers of cancer cases worldwide.Study authors say that if the rates ofdiabetes and overweightness observedcontinue, then the share of cancersattributable to the combined factors willincrease by over 30 per cent in womenand by 20 per cent in men by 2035. 08-11_Layout 1 05/12/2017 13:02 Page 3Pharma Business International 11www.pbiforum.netDIABETES EXPOSÉGiven this prevalence, it’s little surprisethat the R&D space for treating diabetesis in overdrive, exploring new treatments,medicines and breakthroughs. Stemmingthe rising tide of diabetes worldwidewould have the enviable knock-on effectof curbing some cancers from formingand helping to ease the strain ofhealthcare. And this is as true for onetype of diabetes as the other. Among themany resources and areas lining thedisease up in the crosshairs is the T1DExchange Diabetes Innovation Challengetaking place next year where it will offer$250,000 in cash, as well as in-kindprizes, to diabetes innovations. T1D Exchange is a non-profit born outof the need to understand healthoutcomes, address health disparities,improve care and accelerate researchand development. The organisationseeks to connect researchers to patientsfor studies, providing clinical, biologicaland patient-reported data. This model, itsays, fosters collaboration among T1Dstakeholders. To date, it has helpedsuccessfully accelerate a newformulation of glucagon into a potentiallygame-changing approach to thetreatment of severe hypoglycaemia. Diabetes will affect all of us in one wayor another, either directly or through afriend or loved one. The rising levels oftype 2 diabetes and its contributing factorin developing cancer means that it is nowmore than even critical to accelerateresearch and get new treatments andmedicines to market and in the hands ofpatients. Fortunately, collaborationsbetween industry and academia, andresearch organisations are doing just that,and while diabetes may be one of thebiggest health threats of our time, it is abattle we look set to win.© Shutterstock / Syda ProductionsWorld Diabetes Day takes place every year on14th November and sees millions of people around theglobe come together to raise awareness of diabetes andthose living with the condition.08-11_Layout 1 05/12/2017 13:02 Page 4COUNTERFEIT DRUGS12Pharma Business International www.pbiforum.netThe counterfeit pharmaceuticalsindustry can cost the sector between$150-200 billion a year, and comes with awide range of terrible side effects for theworld at large. Figures suggest that450,000 preventable malaria deathshappen each year due to counterfeitdrugs, while over a million die from toxiccounterfeits that poison them. More thanthat, 1-30% of all drugs in circulation areexpected to be counterfeit.Naturally, the industry feels strongly onthe matter, be it from the damagewrought or the financial impact of $200billion going elsewhere. Whatever thecase, the issue is one many have beenlooking to solve for years. The largestareas affected by counterfeit drugsremain Asia, North America and LatinAmerica, but even the EU experiences anexpected €10 billion in losses per year. Pharmaceutical packaging has comeunder pressure lately to do more toprevent counterfeit drugs being pushedas branded. With so many requirementsalready in place, the industry is beingsqueezed from every angle. The industryrelies on innovation, which is itself drivenby the need for products to give acrossmore information than ever before,remain totally secure throughout and alsoshrink the carbon footprint as much aspossible. In many markets, governmentregulations are already stipulating thetraceability of pharmaceutical packaging,or will do so in the near future.This has led to major overhauls of thepackaging process in many companies –and some find this a challenge.Manufacturers can spend a lot of moneyto be theoretically compliant and thenthrough simple operational or productchangeover errors do something likeputting the wrong label on the package.When there are multiple changeovers,short batch runs and often a largeFraudulentPharmaThe counterfeit drugs industry could be costing the industryas much as $200 billion annually, so it’s importantcompanies work together to limit it where possible. 14 Á12-15_Layout 1 05/12/2017 13:03 Page 1Pharma Business International 13www.pbiforum.netCOUNTERFEIT DRUGS© Shutterstock / A_Lesik12-15_Layout 1 05/12/2017 13:03 Page 2COUNTERFEIT DRUGS14Pharma Business International www.pbiforum.netproduct portfolio to manage, there arecertainly many potential flashpoints.Packaging has a larger role to play inanti-counterfeit measures than manyother aspects of the supply chain. Withbootleg or counterfeit pharmaceuticalproducts being a multi-billion poundblack market, there is a need to crackdown on it where possible. Counterfeit-proof packaging is one such approach,with seals and locks to show a consumerwhen something has already beenopened. But there are other aspects tokeep in mind, namely that as the industrybecomes more proficient – so too dothose operating on the illegal side ofthings. Authorisation signs such ashologram stamps can be harder tomimic, but it’s important that theconsumers know to look for these –otherwise there isn’t going to be anybenefit. One way to draw attention to it isthrough marketing – perhaps with somekind of “always look for the stamp”campaign to draw attention to the threat.Visible holograms with company logos,combinations of letters and digits,instantly identify the blister packs asoriginals. Invisible codes that can beverified quickly and easily can also beincorporated into the hologram. All that isrequired for verification of a hidden logoor data matrix code is a simple laserpointer.The need for effective labelling andserialisation are also major concerns forinnovation in pharmaceuticals packaging.For example, this year will see the© Shutterstock / Dmitry Kalinovsky12-15_Layout 1 05/12/2017 13:03 Page 3Pharma Business International 15www.pbiforum.netCOUNTERFEIT DRUGSimplementation of new guidelines inSaudi Arabia, where drug packagingmust be equipped with a data matrixcode step by step, with serial numbershaving become required in 2016. InBrazil, individual batches must now beserialises, while the US Food and DrugAdministration aspires to implement astandardised identification for allprescription drugs in form of a 2D datamatrix code in a step-by-step approachuntil the end of 2023. The EuropeanUnion’s Falsified Medicines Directive,meanwhile, stipulates coded packagingwith a 2D data matrix code and a uniqueserial number for nearly all prescriptiondrugs, which is expected to be requiredby 2018. The aim is all cases is to ensureconsumers and dispensers can becertain that the products are official.For several years it’s been possible tocompletely automate the remote settingup of date code and barcode scanners,ensuring the label is correct, andcorrectly applied, right first time, everytime. To virtually eliminate the operatorrisk, such systems, as one might expect,are not cheap, but compared with therisk of batch rejection, rework, scrap,fines for non-compliance and upsetcustomers, this automation should beseen as a manufacturing necessity.It’s not enough to have a single line,however, and a certain degree offlexibility will be required in order to caterto the varied and stringent labellingrequirements of different markets.Perhaps, with all that in mind, it’s easy tosee why many have turned to outsourcedcontract packagers within the industry.© Shutterstock / Dmitry Kalinovsky12-15_Layout 1 05/12/2017 13:03 Page 4END OF YEAR SUCCESS16Pharma Business International www.pbiforum.netOn theacquisition trailDespite economic uncertainty and an oft hostile political landscape, therehave been a number of multi-billion dollar deals in the pharmaceuticalM&A market, but stormy weathers affected the industry throughout 2017.Here, Pharma Business International explores some of the biggest deals ofthe last twelve months. 16-19_Layout 1 05/12/2017 13:04 Page 1Pharma Business International 17www.pbiforum.netEND OF YEAR SUCCESSThroughout 2016, political tensionswere running high with Britain pulling outof the European Union and demagogueDonald Trump getting elected into theWhitehouse; both upending the statusquo. For pharma, stress was found in theopioid crisis and price gougingcontroversies, which courted courtroomdrama and a media circus. Coupled witheconomic uncertainty and a cluster ofhigh-profile deaths in the entertainmentsector, many were glad to see the backof 2016. But despite the general consensus,last year was a profitable one for thepharmaceutical M&A market with a slewof successful and high-profile deals, withhighlights including Allergan spending atotal of $2.8 billion; Shire forking out $32billion on its merger with Baxalta, andfour deals from Pfizer totalling $21 billion.This trend continued going into 2017,with the year claiming the biggest startfor US pharma deal-making in sevenyears. A grand total of 333 dealscomprising a total $35.7 million tookplace in the first nine days of Januaryalone. Many were convinced that thiswas a sign M&A activity was on the up.Except it wasn’t. This trend was ultimately unsustainableand by June, big deal-making in the USpharma sector had fallen to its lowestlevel in five years. Even by its mid-waypoint, it quickly became clear that 2017was a year of extremes for thepharmaceutical sector, building on themixed industrial response to Trump’sinauguration and what that meant for UShealthcare. Indeed, analysts pointed thefinger at Trump for the depression indeals, with companies shying away fromlarge takeovers following the President’sfailure to move ahead with overhaulingthe American tax code – something thathad helped woo voters during hiscampaign trail. 18 Á© Shutterstock / IhorL16-19_Layout 1 05/12/2017 13:04 Page 2END OF YEAR SUCCESS18Pharma Business International www.pbiforum.netThe effect was profound, and by thishalfway point, there had been just twodeals in the US M&A space over the $5billion mark – namely Takeda’s $5.2billion acquisition of ARIADPharmaceuticals, and Thermo Fisher’s$7.2 billion deal for Patheon. Whencomparing that to the flurry of deals lastyear, it becomes clear that 2017 sufferedsomething of a downturn. At the time ofannouncing the deal in February, TakedaPresident and CEO Christophe Webersaid the addition of ARIAD’s targetedtherapies and R&D knowhowstrengthened its oncology business. Announced in May, Thermo Fisher’smulti-billion deal bolstered its biopharmaoffering by welcoming Patheon to itslaboratory products and servicessegment. The company was clearly anattractive buy, generating revenue ofaround $1.9 billion in 2016, and boastingdevelopment and manufacturingprowess. No stranger to the M&A market, thefinal quarter of 2017 saw Novartis shellout $3.9 billion to acquireradiopharmaceutical company AdvancedAccelerator Applications in a bid tobolster its oncology profile. The deal sawNovartis take charge of the nuclearmedicine specialists’ first-in-class RLTproduct – Lutathera – for treatingneuroendocrine tumours.In August, where California-headquartered Gilead Sciences revealedit was acquiring LA’s Kite Pharma in adeal valued at $11.9 billion. The deal,expected to close during the fourthquarter of 2017, saw Gilead beef-up itscellular therapy capabilities and continueits innovative approach to people withadvanced cancers. But perhaps the biggest deal wasJohnson & Johnson’s $30 billionacquisition of Actelion, which completedin June after J&J made its acquisitiveintentions clear in January. Although the global M&A market was16-19_Layout 1 05/12/2017 13:04 Page 3up the maximum 74 per cent stake inGland. 2017 has been a year of cautiousoptimism for the pharmaceutical industry,with the M&A market revealing thatcompanies are making more pragmaticpurchasing decisions as they negotiatethe choppy political and economicwaters. Though the Trumpadministration, Brexit negotiations andgeopolitical tensions still present muchuncertainty to acquisitive companies,deal-making goes on. Though thebeginning of 2018 won’t replicate theflurry that began 2017, they will mostcertainly be a number of billion dollarplus deals ahead. Pharma Business International 19www.pbiforum.netEND OF YEAR SUCCESSoverall more cautious than in recentyears, there were a number of high-profile international deals over the onebillion dollar mark. Among them wasOhio’s Cardinal Health offloading itsChina business to ShanghaiPharmaceuticals in a deal worth $1.2billion. For Shanghai Pharma it was anopportunity with Chairman Zhour Junclaiming it would mean growth for itsmanufacturing business and allow thecompany to “play a significant role in theGovernment’s ‘Healthy China’ initiative.”China was also at the epicentre of oneof the most controversial and widelycovered pharmaceutical deals in recentyears. Back in March, FosunPharmaceutical agreed to acquire amajority stake in India’s Gland Pharmafor $1.2 billion, making it the largestoverseas acquisition from a Chinesepharmaceutical company. However, thedeal was blocked by the IndianGovernment for trying to claim too largea stake. Last year, New Delhi relaxedinvestment rules meaning that foreigncompanies could now acquire up to 74per cent of local drugmakers withoutneeding government approval. With thenew rules in place, the deal wasrenegotiated and Fosun agreed to snap-© Shutterstock / Khongtham16-19_Layout 1 05/12/2017 13:04 Page 4Next >