< PreviousHIV AND AIDS EXPOSÉ10Pharma Business International www.pbiforum.netand economic issues mean that manyhaven’t heard about it. There is a particular concentration ofsuffers in the Southern United States,with nearly half of all people dying fromHIV and AIDS in the US living in aSouthern State. According to the Centresfor Disease Control, the Southern UnitedStates accounts for approximately forty-five per cent of all people living with anHIV diagnosis in the country, this despitebeing home to only one third of thepopulation. These stark statistics alonedemonstrate the need for drasticmeasures and new methods to beexplored. The old adage goes that prevention isjust as good as a cure, but there are limitsto that sentiment in modern healthcare.Yes, prevention is one part of thecomplicated equation in solving the HIVand AIDS crisis globally, but finding afunctional cure must remain a priority. One of the most promisingdevelopments in this arena comes fromParisian biotech Abivax who are focussedon harnessing the immune system todevelop a functional cure for HIV. Thecompany recently presented positive datafor its lead Phase 2 clinical candidate,ABX464, at the 16th European Meetingon HIV & Hepatitis. According to new data, ABX464 hasbeen shown to bind to the cap bindingcomplex which enhances the splicing oftwo types of RNA. The first is a segmentof viral RNA which the HIV virus requiresfor replication, thus inhibiting replication;the second is a long non-coding humanRNA which, upon splicing, results inincreased expression of miR124 – a smallmicroRNA with potent anti-inflammatoryproperties. As the increased splicing wasshown to produce a novel viral RNA© Shutterstock /science photo08-11.qxp_Layout 1 08/06/2018 09:59 Page 3Pharma Business International 11www.pbiforum.netHIV AND AIDS EXPOSÉspecies, this may trigger immunerecognition of cells infected with HIV,Abivax says. “These latest results explain whyABX464 could be delivering a dual anti-HIV effect via its antiviral and anti-inflammatory properties,” explainsProfessor Hartmut Ehrlich, Abivax CEO.“In addition, taken together with theobserved presence of a new RNAspecies, they provide a compellingrationale for our demonstration, for thefirst time in the HIV-field, of a reduction ofthe HIV reservoir in our previous clinicaltrials.” The innovation space for HIV and AIDSremains one of the most promising R&Dfields in modern medicine. Ongoingefforts from healthcare providers andinnovative biotechnology andpharmaceutical companies are pursuingnew and, sometimes, radical lines ofinvestigation and continue to pursue afunctional cure. These combined effortswill continue to provide better quality oflife for suffers coping with the disease ormanaging a recent diagnosis. © Shutterstock /jannoon028© Shutterstock /science photo08-11.qxp_Layout 1 08/06/2018 09:59 Page 4M&A ROUND-UP12Pharma Business Internationalwww.pbiforum.netIt’s been a steady period punctuated by potentiallygame-changing deals for the mergers and acquisitionsmarket since our last instalment. Though the marketremains largely healthy, experts worry that companies areusing acquisitions to block out competition which, theycaution, could diminish access to medicines. The numberof new medicines being developed could also besignificantly reduced. Be that as it may, that hasn’tdeterred some of the industry’s biggest players fromswooping in. Let us first begin by getting the elephant in the roomout the way with Japanese pharma giant Takeda acquiringIreland’s Shire for £46 billion in what is believed to be thebiggest acquisition of a drug company since 2000.Unveiled in May, the announcement put an end to weeksof will-they-won’t-they speculation. According to Takeda,the deal will create a “global, values-based and R&Ddriven” biopharma behemoth headquartered in Japan. Moving on, we turn our attention to Novartis whocompleted its $8.7 billion acquisition of AveXis, theNasdaq-listed clinical stage gene therapy company, inMay. The closing of the deal followed just a month after itwas first announced, where Novartis CEO Vas Narasimhansaid it would be “transformational” for spinal muscularIn the shadow ofShire and TakedaThe latest M&A round-up explores the major deals that have taken place in the pharmaceutical sector over thelast two months. Although Takeda’s massive multi-billion dollar acquisition of Shire dominates, there hasbeen some key oncology activity as Pharma Business International reports. © Shutterstock /pichetw14 Á12-15.qxp_Layout 1 08/06/2018 10:00 Page 1© Shutterstock /robtek12-15.qxp_Layout 1 08/06/2018 10:00 Page 2M&A ROUND-UP14Pharma Business Internationalwww.pbiforum.netatrophy by adding AveXis’ lead genetherapy candidate, AVXS-101.Novartis Pharmaceuticals CEO PaulHudson concurred, adding that the twocompanies are highly complementaryand are united under a shared purpose –that being, of course, “transforming thecare of patients with life-threateningneurological genetic diseases”. Next up, we have a deal which tookplace in April with Proctor & Gamble(P&G) strengthening its healthcareportfolio – which includes Vicks, Crestand Oral-B – with the addition of Merck’sConsumer Health business. P&G said atthe time that the €3.4 billion expands itsexisting consumer health competencesby adding a flourishing portfolio ofdifferentiated, physician-supportedbrands across a broad geography. Thatlatter point is especially prudent with thedeal improving P&G’s brand portfolio andcategory footprint in the majority of theworld’s top fifteen over the countermarkets. Shire follows next after selling itsoncology business to French pharmaoutfit Servier for $2.4 billion. For Servier,the deal provides a foothold in the USwith an immediate presence tocapitalise on and scale up. The deal,which Shire CEO Flemming Ornskovhailed as a “key milestone”, providesServier with in-market productsincluding multi-agent treatments foracute lymphoblastic leukaemia andmetastatic pancreatic cancer postgemcitabine-based therapy. For Shire,the deal was motivated by its oncologyposition no longer lining up with itslonger-term strategy, despite thebusinesses’ high-growth andprofitability. That means Servier can nowmake a name for itself as a globaloncology player. Watch this space. April also saw the completion ofRoche’s $1.9 billion acquisition of FlatironHealth, the privately-held healthcaretechnology and services companyheadquartered in New York City. The dealwas originally announced back inFebruary where Roche said it wouldallow both companies to accelerateefforts towards data-driven personalisedhealthcare in cancer. With the deal nowconcluded, Flatiron Health will continue itsoperations as a separate legal entity.Moreover, its current business model,partnership networks and overallobjectives will remain unchanged. Last up for the deals over the billiondollar mark is Eli Lilly’s $1.6 billionacquisition of late-stage immune-oncology company ARMO BioSciences.This includes the latter’s lead immune-oncology asset, pegilodecakin, which iscurrently being studied in multiple tumourtypes. Eli Lilly said the addition ofpegilodecakin will bolster its immune-oncology programme. The asset hasdemonstrated clinical benefit as a singleagent and in combination with bothchemotherapy and checkpoint inhibitortherapy across several tumour types. Littlewonder, then, that Eli Lilly was so keen toadd it to its development slate. With the billion-dollar-plus deals takencare of, we shift our attention to AlexionPharmaceuticals who in April announcedits intentions to acquire Swedishbiopharmaceutical outfit WilsonTherapeutics for $855 million. The deal,which was facilitated via one of Alexion’swholly-owned subsidiaries, grants thecompany access to Wilson’s product,WTX101, which is currently in Phase 2development for Wilson disease. This raregenetic disorder has devastating hepaticand neurological consequences forpatients. Lastly, we take a brief look at UnitedTherapeutics $216 million acquisition ofspecialty pharmaceutical companySteadyMed in a deal dependent onmilestones of the latter’s product, Trevyent.Trevyent is a development-stage drug-device combination product that combinesSteadyMed’s two day, single use,disposable PatchPump technology withtreprostinil, a vasodilatory prostacyclinanalogue, for the subcutaneous treatmentof pulmonary arterial hypertension (PAH).United Therapeutics said in May that thedeal is expected to close in the thirdquarter of this year, depending, of course,of customary closing conditions. For another round-up of the latestpharmaceutical acquisitions, be sure andcheck out our August/September issue. 12-15.qxp_Layout 1 08/06/2018 10:00 Page 3© Shutterstock /santoelia12-15.qxp_Layout 1 08/06/2018 10:00 Page 4PPEThere are many omnipotent dangers in thesupply chain that pose a constant threat toworkers. The production, distribution andsupply of pharmaceuticals and medicalequipment often involves the handling andtransportation of hazardous or sensitivematerials. Safeguarding employees is at theforefront of any business to help ensure asatisfied workforce and keep reputationaldamage to a minimum - a lawsuit from aninjured or disgruntled employee could behighly damaging. There will, of course, benumerous safeguards and security measuresin place to keep workers in the manufactureof pharma products safe. Productionequipment has fail-safes, guards and deadswitches incorporated into its design, butthese alone cannot guarantee safety. PPE refers to wearable equipment thatprotects the wearer’s body from injuries,illness and an assortment of heat-borne, fire-borne, electrical, physical, chemical-borneand airborne particulate matter. Some of themost commonly used PPE products includeprotective clothing, goggles, industrialfootwear, boots, face masks, hard hats, earplugs, respirators, gloves, safety harnessesand helmets. The PPE market is driven mainly byadvancement in technology and risingawareness about workplace safety. Risingforeign investments, rapid industrialisationand government regulations are all expectedto fuel the market in the near future. However,high raw material costs and inexpensiveproducts may pose challenges to the marketgrowth in the next few years. Moreover, risingdemand in flourishing markets is projected toopen new growth opportunities for personalprotective equipment in the years to come.Factors such as the increasing awarenessfor workers safety is the major reason fuellingthe demand for the personal protectiveequipment market. Accidents taking place inworkplaces have paved the way for the influxof equipment. People working in thePerfectprotection Personal protective equipment is a necessity in any manufacturing industry toreduce the risk to workers, but few industries have quite the same requirementsand pressure put upon them as the pharmaceutical sector. 18 Á16Pharma Business International www.pbiforum.net16-19.qxp_Layout 1 08/06/2018 10:00 Page 1© Shutterstock /Sergey Mironov16-19.qxp_Layout 1 08/06/2018 10:00 Page 2PPE18Pharma Business International www.pbiforum.netpharmaceutical manufacturing industry require propersafety, thereby pushing the demand. Additionally,approval for the usage of personal protectiveequipment by the regulating bodies on account of theincreasing incidents of workplace accidents is alsofuelling the demand for the personal protectiveequipment market. Increasing demand for advanced technology is oneof the major factors that is actually inhibiting thegrowth of the PPE market. It may seem strange, givenhow technology is also helping to grow the market,but the demand for automation has reduced the needfor human employees as automated systemsguarantee a better output, subsequently reducing theoverall need for PPE. But there will always be a placefor a human workforce in manufacturing, and forworkers, PPE shouldn’t be something they are forcedto endure. Traditionally, comfort wasn’t a benefit factored in bythe design of PPE, instead it favoured functionalityand, of course, protection. But the industry is makingefforts to find equilibrium between dependableprotection and the need for workers to becomfortable. As workers are spending entire shiftswrapped up in various types of protective equipment,it should go without saying that their comfort shouldbe a priority. After all, if a workforce is uncomfortable,attention to tasks will wane and the overall safetylevel is, ironically, likely to fall. The use of high performance fabrics, with moisturemanagement and thermal regulation, has becomecommonplace. As with every other area across theindustry, sustainability has become a hot topic. Thishas been factored in to the design of PPE gear, withdesigners experimenting with more environmentallyfriendly methods and materials for use across thesupply chain. The increasing awareness on workplace safety andthe rise in government regulations has shifted thespotlight onto PPE, and fuelled the rising demand forpersonal protective equipment across the globe.Demand is also being fuelled by the rapidindustrialisation and increasing foreign investment.This increase will see the sustained rise of personalprotective equipment designed with sustainability andcomfort in mind. 16-19.qxp_Layout 1 08/06/2018 10:00 Page 3© Shutterstock /TRAIMAK16-19.qxp_Layout 1 08/06/2018 10:00 Page 4Next >