< PreviousBIOSIMILARS10Pharma Business International www.pbiforum.netto the Novartis-owned generic specialists Sandoz forZarxio, a biosimilar to Amgen’s Neupogen (filgrastim)which was first licenced back in 1991. While talk of lowering drug prices, boostingcompetition and turbocharging the biosimilars marketis all well and good, actions speak louder than words.In July, the FDA took a potentially game-changingstep forward with the launch of its Biosimilars ActionPlan. The clear through-line of the plan is to balancecompetition and innovation, and Gottlieb has made itclear that it’s the latter on which he’s most focussed. In a recent speech to The Brookings Institute, aresearch group in Washington DC, Gottlieb pickedapart the main reasons why biosimilar competition is“anaemic”. “It’s anaemic,” he say, “because consolidationacross the supply chain has made it more attractivefor manufacturers, Pharmacy Benefit Managers,Group Purchasing Organisations and distributors tosplit monopoly profits through lucrative volume-basedrebates on reference biologics—or on bundles ofbiologics and other products—rather than embracebiosimilar competition and lower prices.” “It’s anaemic because litigation has delayed marketaccess for biosimilar products that are, or shortly willbe, available in markets outside the U.S. several yearsbefore they’ll be available to patients here. Thesedelays can come with enormous costs for patientsand payors.”On the surface of it, it’s evident that Gottlieb and,by extension, the FDA have valid points to be made.The plan was met with near universal praise frominterested parties, commentators and pharmaceuticalstakeholders. However, some critics have said thatthe Commissioner and the regulatory body both havelimited power when it comes to directly intervening inthese issues. Ultimately, the issue is whether or not –and, indeed, how – the FDA can change the way inwhich biosimilars are approved and adopted. As a foundation to build from, the plan marks animportant step for the biosimilars market, though it’shardly a watershed moment. Though the pointsoutlined in the plan present the means through whichthe market can mature and evolve, without furthersteps to follow, it’s unlikely whether there’ll really beany upheaval of the status quo. © Shutterstock /Marian WeyoM&A ROUND-UP12Pharma Business International www.pbiforum.net© Shutterstock /macgyverhhIn our previous issue, our regular peek into thepharmaceutical mergers and acquisition market was,understandably, dominated by Takeda’s game-changing£46 billion acquisition of Shire as the plucky Japanesepharma looks to compete with the sector’s giants. Sincethe deal was officially announced back in May, followingmuch speculation, it’s been a staple of our round-up andnow the deal has taken another important step forward. Takeda has now gained unconditional clearance fromthe United States Federal Trade Commission. While that’sone hurdle cleared, there’s still a long way to go before itcan properly welcome Shire into the fold. There’sregulatory approval needed in China, the European Unionand elsewhere, not to mention from the shareholders ofboth companies. Despite the approvals needed to seal thedeal, Takeda is still confident of closing the acquisition inthe first half of 2019. Takeda wasn’t alone with a billion-dollar dealconcluding over the last few months. French pharma giantSanofi confirmed in June that it had completed its €3.9acquisition of Ablynx. This was no doubt a welcome relieffor the boards of both companies, given the deal wasoriginally announced back in January. Sanofihas now taken the reins of Ablynx’soutstanding shares, warrants andSealing the It’s the season for deal completion with some of the biggest pharmacompanies closing multi-billion-dollar deals. 14 ÁSealing the www.pbiforum.net deal dealM&A ROUND-UPM&A ROUND-UP14Pharma Business International www.pbiforum.netconvertible bonds following the expiration of thesqueeze-out period which commenced back inMay.As well as snapping up Ablynx, Sanofi has alsosold off Zentiva, its European generics business,to US private investment firm Advent Internationalfor €1.9 billion. The two companies entered intoexclusive talks in April. The latest update fromeither company stated a Share PurchaseAgreement has been signed with the acquisitionlikely completing during the fourth quarter of2018. That is if it gains the approval of therequisite regulatory authorities. We could scarcely have one of our bi-monthly round-ups without at least apassing mention of Roche. TheSwiss multinational hasbeen busy of late havingsnapped up theoutstanding shares ofFoundation Medicine’scommon stock (thatisn’t already owned byitself or affiliates) for $2.4billion. Clearly the move isa step in the right directionfor Roche in expandinginto emerging categories,with the merger approvedby its board as well as aSpecial Committee of theindependent directors ofCambridge,Massachusetts-basedmolecular informationcompany, FoundationMedicine. Roche CEO Daniel O’Daysaid of the deal: “This isimportant to ourpersonalised healthcarestrategy as we believemolecular insights and thebroad availability of highquality comprehensivegenomic profiling are key enablers for thedevelopment of, and access to, new cancertreatments.”Although Johnson and Johnson (J&J) is stillmired in the controversy over its talcum powder,the company has been making a splash in themergers and acquisitions market. Rather thanbringing another company into the fold, J&J isinstead offl oading its LifeScan business – whichspecialises in blood glucose monitoring andproduces the OneTouch brand ofproducts – to private equity firmPlatinum Equity for $2.1 billion. The deal, hailed by PlatinumEquity Chairman CEO Tom Goresas an “important investment”, isexpected to close by the end of2018, meaning we should havemore details for you in our end ofyear issue. Moving on and we have theclosing of another billion-dollar-plus deal, this time withIndiana’s Eli Lilly completing its$1.6 billion acquisition of late-stageimmuno-oncology company, ARMOBioSciences. With the deal nowconcluded, Lilly said it will bereflected in its reported results andfinancial guidance. Speaking at the close of the deal,Lilly’s Senior Vice President SueMahony said: “We are pleased toannounce the completion of ouracquisition of ARMO BioSciences,which adds a promising clinicalimmunotherapy asset,pegilodecakin, to Lilly’s oncologyportfolio.”There we have it, another round-up done and dusted. Be sure andcheck in with our next issue formore of the biggest deals takingplace in the mergers and acquisitionmarket. © Shutterstock /Damian Koziel© Shutterstock /Casimiro PTPharma Business International 21ONCOLOGY16Pharma Business International www.pbiforum.netPharma Business International 17www.pbiforum.netONCOLOGY© Shutterstock /CI PhotosNew studies have shown that people who take complementary medicine,therapies like homeopathy that fall outside of mainstream healthcare, are morelikely to shun conventional treatment and, therefore, die sooner. So say researchersfrom the Yale Cancer Centre and the Cancer Outcomes, Public Policy andEffectiveness Centre at Yale School of Medicine writing in JAMA Oncology. Butwhat new breakthroughs do patients have at their disposal?Although immunotherapy is a standard treatment for some cancers, it is yieldingsome of the most exciting and promising developments in the oncology space.Immunotherapy makes an arsenal of our own immune system to fight cancer. ItSeek anddestroy Immunotherapy is harnessing the cancer killing potential coded withinour own DNA to help treat patients. Here biotechnology and oncologycome together for some of the most exciting breakthroughs,developments and studies taking place in the field of modern medicine. 18 ÁONCOLOGY18Pharma Business International www.pbiforum.netdoes this by helping the immune system recognise and,therefore, attack cancer cells. Depending on the specificneeds of a patient, immunotherapy can be used on its ownor in combination with other treatments. In June, researchers from UC San Francisco confirmedthat they had identified a key biological pathway in humancancer patients which, they said, appears to prime theimmune system for successful response toimmunotherapy drugs known as checkpointinhibitors. The findings were reportedin Nature Medicineand couldbetter enable clinicians topredict which patients willnaturally benefit fromthese promising newtreatments and,potentially, tomodify theimmuneresponse inother patients toallow morepeople tobenefit fromthese therapies. The researchersclaim that anotherpotential applicationof these findings wouldbe to use the presence ofspecific cells as a biomarkerto identify patients who arenaturally most likely to respond toimmunotherapy. This could help outcomesfor patients and provide immunotherapy to thosethat would best respond to it.This is far from the only exciting outcome in the researchand development space to affect the future ofimmunotherapy. Danish biotech Genmab has recently joinedforces with Immatics Biotechnologies to discover anddevelop next-generation bispecific immunotherapies. Andthey’ve lined up multiple cancer indications in the crosshairs. The research collaboration sees Genmab combine itspropriety technologies and the expertise it has accruedworking with antibodies with Immatics’ Xpresident targetsand T-cell receptor capabilities. The specifics of theagreement mean that Genmab receives an exclusive licenseto three proprietary targets from Immatics with an option tolicense up to two additional targets. Perhaps one of the most exciting developments of latecomes from researchers from the University of California,San Diego and the University of Minnesota. The team hasdeveloped an immunotherapy that, they say, uses immunecells cultured from stem cells to seek and destroy cancercells. This method differs from the norm where cells aretypically taken from patients, potentially creating a new wayin which immunotherapies are undertaken. The scientists say that this new approach may lead to off-the-shelf stocks of cancer-killing cells. In research publishedin Cell Stem Cell, the team detail how the cells showedenhanced anti-tumour activity in mice withovarian cancer seeded from humancancer cells. This type ofimmunotherapy ischimeric antigenreceptor therapy – orCAR, for short.Basically, itbolsters thecancer killingpower inherentin immune cellsbyreprogrammingthem to expressCAR protein,which has beenspecificallyengineered to bindonly to cancer cells.Much of the researchtaking place, and indeedwhere much of the funding isdirected, is CAR-T cellimmunotherapy. This more typicalapproach uses genetically altered T cells grownfrom cells taken from patients. This new approach, however, uses natural killer cellsobtained from human induced pluripotent stem cells insteadof patient specific T cells. According to senior study authorDan N Kaufman, a professor of at the University of California,San Diego, natural killer cells are advantageous because theydon’t have to be matched to a specific patient. So thisdevelopment can shorten the times in which patients aremade to wait and create a more universal and robust solutionfor all patients. Though this brief whistle-stop tour around some of themost promising developments taking place in the oncologyspace hardly begins to scratch the surface, it doesdemonstrate the diversity of developments taking place. It’san exciting time, especially in immunotherapy, with researchpointing towards ever more reliable and ground-breakingtreatments.© Shutterstock /MR.BEE PhotographerPharma Business International 19www.pbiforum.netONCOLOGY© Shutterstock /science photoNext >