Fast For­ward 2017- What’s in store for life­sciences?

BioSpectrum (Asia) - - Cover Story - Aish­warya Venkatesh

Find out what the top com­pa­nies from Asia Pa­cific have lined up for the year

How was 2016 for Novotech?

It was an­other record year for Novotech along a num­ber of di­men­sions. Our rev­enues in­creased over 30 per cent, and our pipe­line in­creased by over 50 per cent. Our book: bill ra­tio is one of the high­est in the in­dus­try giv­ing us enor­mous con­fi­dence about medium-term growth and our abil­ity to in­vest across the re­gion. Our clin­i­cal op­er­a­tions depart­ment has made sig­nif­i­cant progress, and we have seen im­prove­ments in start-up times and re­cruit­ment rates in our fa­cil­i­ties across coun­tries. We have seen im­prove­ments in lev­els of staff en­gage­ment across the com­pany.

Busi­ness plans for 2017?

We will con­tinue to in­vest in Asia plat­form, where we now have an un­par­al­leled abil­ity to serve the com­plex needs of Western biotechs un­der­tak­ing clin­i­cal tri­als in Asia Pa­cific. We have a very rig­or­ous three-year plan­ning process at Novotech (which we re­fresh ev­ery year), and have around 60 projects run­ning at any point of time to en­sure con­tin­ued im­prove­ment in the busi­ness. To cap­ture a few high­lights for the year ahead, we have many im­por­tant ser­vice ex­pan­sion, sys­tems and learn­ing and de­vel­op­ment ini­tia­tives un­der­way. In terms of new ser­vices, we will con­tinue to grow the safety ser­vice that we launched in 2016 as we have been very happy with the sub­stan­tial in­vest­ment that we made in Or­a­cle Ar­gus. We have soft launched a cen­tral lab ser­vice in con­junc­tion with one of the largest lab­o­ra­tory ser­vices in the world, and we are very ex­cited about the ef­fi­cien­cies and real-time ac­cess to data that this will be able to pro­vide our clients as we ex­pand this ser­vice in 2017. We will con­tinue our in­vest­ments in a range of sys­tems in­clud­ing ma­jor up­grades of our Or­a­cle CTMS sys­tem and eTMF sys­tems. Fi­nally, we will be launch­ing many train­ing pro­grammes for our lead­er­ship and clin­i­cal op­er­a­tions teams.

How will the life­sciences sec­tor per­form this year?

While the biotech sec­tor has come off its 2015 peak, there is still an enor­mous pool of cap­i­tal avail­able to be in­vested and this will be a pos­i­tive for the sec­tor. Most of our clients are US and Euro­pean biotechs and so we are very in­ter­ested in the in­creas­ing num­ber of biosim­i­lar ap­provals in the US as well as the more lib­eral ap­proach that the US FDA has re­cently taken to or­phan and ul­tra­or­phan ap­provals. The im­pact that pres­i­dent-elect Trump will have on the sec­tor is a lit­tle un­clear, but in­vestors clearly feel that there will be net-pos­i­tives, with the biotech sec­tor out­per­form­ing the mar­ket since the US fed­eral elec­tion. A few poli­cies driv­ing this are the com­mit­ments made to in­fra­struc­ture in­vest­ment, as well as po­ten­tial in­cen­tives to en­cour­age multi-na­tional phar­ma­ceu­ti­cal com­pa­nies to repa­tri­ate off­shore cash to the US.

In our own part of the world, the reg­u­la­tory en­vi­ron­ment is rapidly evolv­ing and we are see­ing many pos­i­tive ini­tia­tives that will im­prove time­lines in Thai­land, the Philip­pines, China and In­dia. There are also pro­pos­als in Korea that may ma­te­ri­ally re­duce the cost of clin­i­cal tri­als.

Emerg­ing trends in bio­science/medtech/drug dis­cov­ery/tech­nol­ogy

Tech­nol­ogy trends take a long time to play out, and short-term trends are of­ten driven by reg­u­la­tory changes or trial fail­ure. To this ex­tent, we will see in­creas­ing in­ter­est in biosim­i­lars in the US driven by reg­u­la­tory be­hav­iour, and re­cent big-pharma trial fail­ures will see

many com­pa­nies re-ex­am­in­ing their pipe­lines in im­munother­a­pies and Alzheimer’s.

New tech­nolo­gies and trends the com­pany is fo­cus­ing on

We are in­vest­ing in many ar­eas that will im­prove clin­i­cal trial per­for­mance for our clients, in­clud­ing Cloud-based clin­i­cal trial man­age­ment plat­forms. We are also in­vest­ing in new sys­tems to mea­sure the per­for­mance of sites and in­ves­ti­ga­tors in our re­gion. In re­la­tion to longer term trends, we are par­tic­u­larly in­ter­ested in ad­vances in adap­tive trial de­sign and the sig­nif­i­cant im­pact this can have on our client’s re­turn on in­vest­ment.

How was 2016 for JHL Biotech?

It was a piv­otal year for JHL Biotech. We re­ceived UK MHRA ap­proval to con­duct hu­man clin­i­cal tri­als of our rit­ux­imab biosim­i­lar. We opened the world’s largest mod­u­lar, sin­gle-use cell cul­ture fa­cil­ity in Wuhan, China. We made great progress on our in­ter­nal pipe­line pro­grammes and plan to file an in­ves­ti­ga­tional new drug (IND) in China be­fore the end of this year. We an­nounced a strate­gic part­ner­ship with Sanofi that in­cludes a US$100 mil­lion cap­i­tal in­jec­tion.

Busi­ness plan for 2017?

In 2017, we plan to start Euro­pean tri­als of our rit­ux­imab biosim­i­lar and also have a rich pipe­line for INDs. Due to com­pet­i­tive rea­sons, we can­not di­vulge too much.

How will the Biosim­i­lars sec­tor per­form in 2017?

We be­lieve 2017 will be an im­por­tant year for biosim­i­lars. Co­herus is chal­leng­ing ABBVIE in the US and we will see some re­sults from their patent chal­lenge. Later in 2017, we will see how Rem­i­cade sells in de­vel­oped mar­kets, and like­wise, Sam­sung has restarted tri­als of its rit­ux­imab biosim­i­lar. Ad­di­tion­ally, we be­lieve we will see more biosim­i­lars firms tar­get­ing niches—spe­cialty ther­a­peu­tic biosim­i­lars and or­phan prod­ucts.

Emerg­ing trends in bio­science/medtech/drug dis­cov­ery/tech­nol­ogy? Asian coun­tries that will flour­ish in biosim­i­lar space in 2017? New tech­nolo­gies and trends that com­pany is fo­cus­ing on?

We be­lieve a ma­jor trend in the bi­o­log­ics world is the shift to­wards de­vel­op­ment of bis­pecifics, ADCs, and com­bi­na­tion ther­a­pies. We are very keen on the de­vel­op­ment of these ther­a­pies, as we feel they will drive de­mand for our biosim­i­lars. Like­wise, an­a­lyt­ics and man­u­fac­tur­ing tech­nolo­gies are chang­ing the face of the in­dus­try. In 2016, we opened the world’s largest mod­u­lar cell-cul­ture bio­pro­cess­ing fa­cil­ity in China, and we be­lieve mod­u­lar and sin­gle-use tech­nolo­gies will be­come more and more preva­lent. Ad­di­tion­ally, we be­lieve an­other ma­jor trend is the fur­ther growth of the Greater China bi­o­log­ics com­mu­nity. Very good work is be­ing done in China and Tai­wan on next-gen­er­a­tion dis­cov­ery plat­forms and we be­lieve next year will see new great part­ner­ships an­nounced and new ther­a­pies com­mer­cialised.

How was 2016 for Bio­nomics?

2016 was an in­cred­i­bly ex­cit­ing year for Bio­nomics as we made sig­nif­i­cant progress across our broad and di­verse clin­i­cal port­fo­lio. In Septem­ber, we an­nounced pos­i­tive re­sults from our Phase 2 trial of BNC210 in Gen­er­alised Anx­i­ety Dis­or­der (GAD). The sin­gle cen­tre, double-blinded, placebo and lo­razepam-con­trolled, 4-way cross-over Phase 2 clin­i­cal trial was con­ducted in 24 pa­tients with un­treated GAD. The ob­jec­tive of the study was to eval­u­ate the ca­pac­ity of BNC210 to en­gage brain sys­tems rel­e­vant to anx­i­ety while rest­ing and in re­sponse to anx­i­ety-re­lated tasks. The co-pri­mary end­points were change in cere­bral per­fu­sion mea­sured by ar­te­rial spin la­belling and change in taskre­lated brain ac­tiv­ity, specif­i­cally in the amyg­dala as mea­sured by func­tional Mag­netic Res­o­nance Imag­ing (FMRI) dur­ing the Emo­tional Faces Task (EFT). Re­sults from the study showed that BNC210 in­duced sta­tis­ti­cally sig­nif­i­cant changes in cere­bral per­fu­sion (300mg BNC210, p<0.05) and also sig­nif­i­cantly re­duced amyg­dala ac­ti­va­tion in re­sponse to fear­ful faces dur­ing the EFT (300mg BNC210, p<0.05). In com­par­i­son, lo­razepam ex­erted a mod­est sup­pres­sive ef­fect on amyg­dala ac­ti­va­tion dur­ing per­for­mance of the

EFT (1.5mg lo­razepam, p=0.069). Ear­lier this year, we ini­ti­ated a Phase 2 clin­i­cal trial of BNC210 for the treat­ment of Post-Trau­matic Stress Dis­or­der (PTSD) and from our on­col­ogy pro­gramme, we ini­ti­ated a Phase 1 study of BNC101 for the treat­ment of metastatic col­orec­tal can­cer in March.

Busi­ness plan for 2017?

We in­tend to build on the in­cred­i­ble mo­men­tum we’ve built over the last year as we head into 2017. Im­por­tantly, we an­tic­i­pate topline re­sults from our Phase 1 clin­i­cal trial of BNC101 for the treat­ment of metastatic col­orec­tal can­cer in mid-2017. This is an open la­bel, multi-cen­tre clin­i­cal trial aimed to demon­strate the safety and tol­er­a­bil­ity of BNC101 and its abil­ity to de­lay dis­ease re­lapse in treated pa­tients. It is be­ing con­ducted at specialist cen­tres across Aus­tralia and will run in two parts, firstly with BNC101 alone and then in com­bi­na­tion with stan­dard of care chemo­ther­apy. Each part has two phases, an es­ca­la­tion to find the op­ti­mal dose level and then an ex­pan­sion of the study at that dose level.

In tandem, we will con­tinue to ad­vance BNC210 with our Phase 2 trial in Post-Trau­matic Stress Dis­or­der (PTSD). The study’s pri­mary ob­jec­tive is to de­ter­mine whether BNC210 causes a de­crease in symp­toms of PTSD as mea­sured by the glob­ally-ac­cepted Clin­i­cian Ad­min­is­tered PTSD Scale (CAPS5). Sec­ondary ob­jec­tives in­clude the de­ter­mi­na­tion of the ef­fects of BNC210 on anx­i­ety, de­pres­sion, qual­ity of life, and safety. The trial is re­cruit­ing 160 sub­jects with PTSD at 8-10 clin­i­cal re­search cen­tres through­out Aus­tralia and New Zealand. The study is a ran­domised, double-blind, placebo-con­trolled de­sign with sub­jects to be treated over 12 weeks with BNC210 or placebo. We look for­ward to re­port­ing topline re­sults from this study in 2018.

How will the life sciences sec­tor per­form in 2017?

Based on cur­rent mar­ket per­for­mance, we are ex­pect­ing 2017 to be an ex­cel­lent year for the life sciences sec­tor. With the po­lit­i­cal un­cer­tainty of the US pres­i­den­tial elec­tion be­hind us, we ex­pect the sec­tor to of­fer key growth op­por­tu­ni­ties in 2017.

Emerg­ing trends in bio­science/medtech/drug dis­cov­ery/tech­nol­ogy?

Our de­vel­op­ment work in­ter­sects two of the most im­por­tant ar­eas of great un­met med­i­cal need: can­cer and CNS dis­or­ders. We are ex­cited to be bring­ing forth very promis­ing ther­a­pies in both ar­eas and be­lieve that we can make a mean­ing­ful dif­fer­ence in pa­tients’ lives.

New tech­nolo­gies and trends that com­pany is fo­cus­ing on?

Bio­nomics is a fully in­te­grated biotech­nol­ogy com­pany that has cre­ated pro­pri­etary tech­nol­ogy plat­forms, which in­clude IONX, MULTICORE and CSCRx, for each step in the drug dis­cov­ery and de­vel­op­ment process. IONX is an in­te­grated plat­form of ge­nomics dis­cov­er­ies and tech­nolo­gies that serves as the foun­da­tion for our CNS drug dis­cov­ery and de­vel­op­ment ac­tiv­i­ties. IONX in­cludes sys­tems for high through­put elec­tro­phys­i­ol­ogy for early, high con­tent eval­u­a­tion of drug hits. Our tech­nol­ogy in­volves a suite of in­te­grated syn­thetic meth­ods that gives ac­cess to com­plex drug­like mol­e­cules. Many mar­keted drugs and nat­u­rally oc­cur­ring bioac­tive mol­e­cules have com­plex ring struc­tures. While the im­por­tance of this type of struc­ture is recog­nised, these com­plex mol­e­cules are of­ten too dif­fi­cult to syn­the­sise for drug dis­cov­ery pur­poses. Bio­nomics’ CSC Rx Dis­cov­ery plat­form is a val­i­dated method for dis­cov­er­ing highly ac­tive, func­tional ther­a­peu­tic an­ti­bod­ies and small mol­e­cule can­di­dates that tar­get can­cer stem cells at the root of can­cer. Each of these ad­vanced tech­nolo­gies is a source of com­pet­i­tive ad­van­tage of­fer­ing the com­pany the op­por­tu­nity to iden­tify and progress unique new phar­ma­ceu­ti­cal prod­ucts, such as our cog­ni­tion and pain pro­grams with Merck & Co. which com­bines the plat­form ex­per­tise from IONX and MULTICORE.

How was the year for Avestha­gen?

It was the year for clean­ing up and fi­nal­is­ing the strat­egy for the next five years.

Busi­ness plan for 2017?

We will con­vert our patents and prod­ucts into vi­able busi­ness step by step and fund raise for each project.

How will the pharma sec­tor per­form in 2017?

Pharma will do well ex­cept that they will feel the rum­ble of new drugs in the in­ter­na­tional mar­kets as gener­ics will give way to pre­ci­sion medicine.

Emerg­ing trends in bio­science/medtech/drug dis­cov­ery/tech­nol­ogy

A com­bi­na­tion of Crisper Cas, pluripo­tent cells, ro­bot­ics and bio mark­ers. Health­care in­dus­try will gear it­self for the new era Mi­cro­biome led im­mune Ther­apy.

New Tech­nolo­gies and Trends that com­pany is fo­cus­ing on

Avestha­gen Lim­ited will be the hold­ing com­pany that will in­vest in re­search de­vel­op­ment. The R&D fo­cus will be on Avestagenome Project where the fo­cus will be on build­ing ex­per­tise in the new tech­nol­ogy plat­forms of Crispr-Cas, Mi­cro­biome, Stem Cells for Can­cers, Metabolic dis­or­ders, and auto im­mune con­di­tions. We will work to­wards a pipe­line of novel bio mark­ers and new drugs for these con­di­tions. The R&D of the past 15 years will be com­mer­cialised through part­ner­ing by spin­ning three com­mer­cial com­pa­nies Avesta Nordic Nutrition, Ava Seeds, and Am­gen Pharma.

2016 for Sproxil?

The year has been chal­leng­ing for SNG. The de­clin­ing Nige­rian econ­omy was plunged into re­ces­sion at the end of sec­ond quar­ter. The gov­ern­ment has de­val­ued the cur­rency and the gap be­tween the of­fi­cial and par­al­lel mar­ket has widened as a re­sult of the in­abil­ity of the gov­ern­ment to meet de­mand for for­eign ex­change re­quired for im­ports. Nige­ria be­ing an im­port de­pen­dent econ­omy im­plies that the vol­ume of busi­ness has re­duced due to lim­ited ac­cess to for­eign ex­change. Over­all, the econ­omy is hit by re­duc­tion in ag­gre­gate de­mand, spi­ralling in­fla­tion and lull in the busi­ness en­vi­ron­ment. - Chine­dum Chi­jikoe - Sproxil West Africa

We have rein­vented our­selves in the 2016. Ear­lier we were mainly de­ployed though our mo­bile au­then­ti­ca­tion-based Coun­ter­feit­ing So­lu­tion in Pharma Sec­tor, we now have ex­panded our so­lu­tion to cover all sec­tors that are im­pacted by Coun­ter­feit­ing.

Busi­ness plan for 2017?

We are fo­cus­ing on spe­cific sec­tors where we see op­por­tu­ni­ties for growth, lev­er­ag­ing prod­uct in­no­va­tion to en­able us achieve our over­ar­ch­ing ob­jec­tives. We are also stream­lin­ing our op­er­a­tions and re­think­ing our op­er­at­ing model with a view to en­sur­ing we re­main ef­fi­cient and nim­ble to re­spond to mar­ket changes and clients de­mands.

In 2017, we would ex­pand to new ge­ogra­phies in Asia-Pac & Mid­dle East as well as add new ver­ti­cal sec­tors to our busi­ness. We have been fo­cused mainly on In­dia and Pak­istan till 2015. In 2016 we started to ex­plore other South Asia & Mid­dle Eastern coun­tries by es­tab­lish­ing re­la­tion­ships. We would de­ploy in some of these places in 2017.

Cor­po­rate clients have al­ways been keen to avoid men­tion­ing the is­sue of coun­ter­feit­ing that is faced by their prod­ucts. This is es­pe­cially true in phar­ma­ceu­ti­cals where al­ter­na­tive brands are avail­able. It is feared that the end cus­tomer may choose to not opt for any brand that dis­closes that it had coun­ter­feit­ing prob­lems even if that brand is ac­tu­ally tak­ing mea­sures to counter this while other brands might just be ig­nor­ing the is­sue. We have now de­ployed a so­lu­tion that not just con­firms that the prod­uct is gen­uine but also re­wards the con­sumer for the par­tic­i­pa­tion in mul­ti­ple ways. -

How will the life­sciences sec­tor per­form in 2017?

In 2017 we see an optimistic out­look to­wards life­sciences sec­tor in 2017 in West Africa, South Asia & Mid­dle East.

New tech­nolo­gies and trends that com­pany is fo­cus­ing on.

We have up­graded our tech­nol­ogy plat­forms and built in higher lev­els of se­cu­rity, ro­bust­ness be­sides mak­ing it more flex­i­ble to the re­quire­ments of spe­cific cor­po­rate. We have been work­ing on ways by which we can in­crease ROI for our cor­po­rate clients. We have lined up and de­ployed a few new so­lu­tions that en­able cor­po­rate us­ing our so­lu­tions en­gage more holis­ti­cally with the end cus­tomers. Now cus­tomers can re­fer other like minded / in­ter­ested cus­tomers to our clients or even en­gage in a dis­cus­sion with the prod­uct man­u­fac­tur­ers. Our clients in turn are able to pro­vide rel­e­vant ad­vice to the con­sumers.

John Moller, coo Asia, novotech, Aus­tralia

Deb­o­rah rath­jen, ceo and Man­ag­ing Di­rec­tor, bio­nomics, Aus­tralia

Jhl Biotech, Tai­wan

Dr Vil­loo Mo­rawala Pa­tel, cMD, Avestha­gen, In­dia

Anand C Me­hta Man­ag­ing Di­rec­tor Sproxil South Asia & Mid­dle east

Chine­dum Chi­jikoe Man­ag­ing Di­rec­tor Sproxil West Africa

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