NASH hope­ful Gen­fit pro­motes Dean Hum to pres­i­dent; Im­mune Ther­a­peu­tics CEO pass­es ba­ton to suc­ces­sor

In 1999, while Dean Hum was an as­so­ciate pro­fes­sor at Laval Uni­ver­si­ty in Que­bec, Gen­fit reached out to him. An ex­pert in the mod­u­la­tion of tran­scrip­tion fac­tors and nu­clear re­cep­tors as­so­ci­at­ed with en­docrine and car­diometa­bol­ic dis­eases, Hum jumped aboard the com­pa­ny as CSO and has been with them ever since, cur­rent­ly serv­ing as the com­pa­ny’s COO.

Dean Hum Gen­fit

He has now been ap­point­ed as pres­i­dent of GEN­FIT Corp, GEN­FIT’s sub­sidiary in the US — but will still re­tain his du­ties as COO — and will be mov­ing from the com­pa­ny’s head­quar­ters in Lille, France to Gen­fit’s US-based of­fice near Boston.

“What this move means is that we’re re­al­ly push­ing for­ward to build­ing our pres­ence in the Unit­ed States and car­ry­ing over the lead­er­ship pres­ence we have here in Lille to the tal­ent­ed pool of peo­ple at the Boston group and build­ing up and man­ag­ing that team,” he told End­points News. 

The com­pa­ny is now fo­cus­ing its at­ten­tion on NASH and the up­com­ing Phase III read­out of elafi­bra­nor —  which was award­ed or­phan drug sta­tus, months ago, by US and EU reg­u­la­tors to treat pa­tients with pri­ma­ry bil­iary cholan­gi­tis (PBC) — that is ex­pect­ed in Q1 of 2020.

In ad­di­tion, Suneil Hos­mane has been pro­mot­ed to head of glob­al di­ag­nos­tics af­ter serv­ing as ex­ec­u­tive vice pres­i­dent of strate­gic de­vel­op­ment.

Suneil Hos­mane

In his new role, Hos­mane will man­age the de­vel­op­ment and mar­ket­ing ac­tiv­i­ties re­lat­ed to NIS4 — the com­pa­ny’s pro­pri­etary blood test de­signed to iden­ti­fy NASH pa­tients el­i­gi­ble for treat­ment.

These tran­si­tions come af­ter Gen­fit CEO Jean-François Mouney an­nounced that he was pass­ing the reigns down to his cho­sen suc­ces­sor, Pas­cal Pri­gent, whilst re­main­ing Chair­man of the Board of Di­rec­tors.

 

 


Im­mune Ther­a­peu­tics — a T-Cell ac­ti­va­tion bio­phar­ma­ceu­ti­cal com­pa­ny fo­cused on the treat­ment of au­toim­mune and in­flam­ma­to­ry con­di­tions, can­cer, HIV/AIDS and an­i­mal dis­eases — has tapped Michael Han­d­ley to head the com­pa­ny as CEO and a mem­ber of the board of di­rec­tors. Han­d­ley will suc­ceed Noreen Grif­fin, who is re­sign­ing. Han­d­ley is the cur­rent CEO and chair­man at can­cer-fo­cused Aletheia Ther­a­peu­tics. He draws ex­pe­ri­ence from his pre­vi­ous ex­ec po­si­tions, in­clud­ing CEO and di­rec­tor of Armis Bio­phar­ma, vice pres­i­dent of qual­i­ty, clin­i­cal and reg­u­la­to­ry af­fairs at Ves­six Vas­cu­lar (ac­quired by Boston Sci­en­tif­ic) and chief com­pli­ance of­fi­cer and vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs at The Spec­tra­net­ics (ac­quired by Phillips). Han­d­ley has al­so held stints at J&J, Am­gen and Genen­tech — where he helped in the launch of Avastin and Tarce­va

→ New York-based Neu­ro­gene — tack­ling rare neu­ro­log­i­cal con­di­tions with a pipeline of gene ther­a­pies us­ing AAV tech — has wel­comed Chris­tine Mikail aboard as the com­pa­ny’s pres­i­dent. Mikail draws from ex­pe­ri­ence as co-founder of Neu­men­tum and Fer­n­dale Ad­vi­sors. She was the chief ad­min­is­tra­tive of­fi­cer and head of ex­ter­nal busi­ness de­vel­op­ment/al­liance man­age­ment & gen­er­al coun­sel at Ax­o­vant Sci­ences, where she helped the team raise $362 mil­lion for the com­pa­ny’s IPO. In ad­di­tion to those, she has held stints at NPS Phar­ma­ceu­ti­cals, Den­dreon, Eli Lil­ly and Im­Clone Sys­tems.

For­ma Ther­a­peu­tics has made some new ad­di­tions to its lead­er­ship team with the ap­point­ments of for­mer Syn­log­ic CFO Todd She­gog as SVP, CFO and Take­da vet Jean­nette Potts as SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. At the same time, the com­pa­ny re­cent­ly pro­mot­ed Patrick Kel­ly to SVP, CMO and Mary Wadlinger to SVP, cor­po­rate af­fairs and chief hu­man re­sources of­fi­cer. In ad­di­tion, the com­pa­ny al­so ap­point­ed for­mer Boston Con­sult­ing Group prin­ci­pal Scott Boyle as vice pres­i­dent, busi­ness and cor­po­rate de­vel­op­ment and Genen­tech vet Bri­an Less­er as vice pres­i­dent, ther­a­peu­tic head. 

Joshua Brumm, COO and CFO of Kalei­do Bio­sciences — fo­cused on the mi­cro­bio­me or­gan to treat dis­ease — is hit­ting the ex­it to serve as pres­i­dent and CEO of an un­named “biotech­nol­o­gy com­pa­ny.” The com­pa­ny has ini­ti­at­ed the search for a new CFO, and in the mean­time, Richard Scal­zo, the com­pa­ny’s cor­po­rate con­troller, has been ap­point­ed to serve as prin­ci­pal ac­count­ing of­fi­cer and will tem­porar­i­ly as­sume Brumm’s re­spon­si­bil­i­ties. 

Francesco Gal­i­mi

Adicet Bio — fo­cused on the de­vel­op­ment of al­lo­gene­ic cell ther­a­pies for can­cer us­ing gam­ma delta T cells — has en­list­ed Francesco Gal­i­mi as SVP and CMO. Gal­i­mi makes the shift to the com­pa­ny from Am­gen, where he served as glob­al pro­gram gen­er­al man­ag­er, ear­ly de­vel­op­ment. Pri­or to his time at Am­gen, Gal­i­mi was the head of clin­i­cal de­vel­op­ment at Onyx Phar­ma­ceu­ti­cals and served at GNF/No­var­tis.

→ James Wil­son’s gene ther­a­py start­up, Pas­sage Bio — which re­cent­ly scored $110 mil­lion in a Se­ries B fi­nanc­ing led by bil­lion­aire Len Blavat­nik’s con­glom­er­ate — has wel­comed Gary Ro­mano as CMO and Edgar (Chip) Cale as gen­er­al coun­sel. Ro­mano joins the com­pa­ny af­ter a stint as the head of clin­i­cal de­vel­op­ment for neu­rode­gen­er­a­tive dis­ease and the deputy leader of the neu­rode­gen­er­a­tive dis­ease ther­a­peu­tic area at Janssen. Pri­or to that, he held po­si­tions at Mer­ck Re­search Lab­o­ra­to­ries in the de­part­ments of clin­i­cal neu­ro­science and ex­per­i­men­tal med­i­cine. Cale jumps aboard af­ter a stint as SVP of le­gal cor­po­rate func­tions at GSK and gen­er­al coun­sel of GSK’s vac­cine unit. Pri­or to his time at GSK, Cale was a cor­po­rate and se­cu­ri­ties lawyer at Ven­ture Law Group and Brobeck, Phleger & Har­ri­son

→ Ge­nomics-dri­ven re­search and di­ag­nos­tics com­pa­ny, MedGenome, ap­point­ed An­drew Pe­ter­son as the com­pa­ny’s CSO. Pri­or to his ap­point­ment, Pe­ter­son was the se­nior di­rec­tor of mol­e­c­u­lar bi­ol­o­gy at Genen­tech, fo­cused on the ge­nom­ic ap­pli­ca­tions for ther­a­peu­tics in ar­eas such as car­dio­vas­cu­lar dis­eases and liv­er dis­eases. Pe­ter­son is al­so cred­it­ed with lead­ing the sci­en­tif­ic ef­forts of a con­sor­tium that, as part of the GenomeA­sia 100k con­sor­tium. pro­duced a com­pre­hen­sive cat­a­log of ge­net­ic vari­a­tion in more than 35,000 genomes across Asia.

OnKure has named James Win­kler as vice pres­i­dent of dis­cov­ery and trans­la­tion­al bi­ol­o­gy, R. Michael Car­ruthers as CFO and Kei­th Olivia as gen­er­al coun­sel and vice pres­i­dent of cor­po­rate af­fairs. Win­kler brings ex­pe­ri­ence to this new role from po­si­tions he has served at FOR­MA Ther­a­peu­tics, Arv­inas, Ar­ray Bio­Phar­ma, GSK, SmithK­line Beecham and J&J. Car­ruthers draws from his pre­vi­ous ex­pe­ri­ence as CFO at Ni­valis, Ar­ray Bio­Phar­ma and Siev­ers In­stru­ments. Olivia hops aboard the com­pa­ny af­ter serv­ing as OnKure’s out­side cor­po­rate coun­sel since its found­ing in April 2011. 

Joseph Perekup­ka Brain­sway

Pa­lo Al­to Health Sci­ences — whose prod­uct, Frees­pi­ra, is the on­ly FDA-cleared dig­i­tal ther­a­peu­tic for treat­ing pan­ic at­tacks, pan­ic re­lat­ed dis­or­ders and PTSD — has an­nounced the ad­di­tion of Joseph Perekup­ka as CCO. Most re­cent­ly, Perekup­ka served as the SVP of North Amer­i­ca at Brain­sway, where he helped with the com­ple­tion of the com­pa­ny’s US IPO ear­li­er this year. Pre­vi­ous­ly, Perekup­ka served in po­si­tions at St Jude Med­ical and Biotron­ik.

EMD Serono — the US bio­phar­ma busi­ness for Mer­ck KGaA — has tapped Kirk Tay­lor as se­nior vice pres­i­dent, North Amer­i­can med­ical af­fairs. Pri­or to join­ing the com­pa­ny, Tay­lor was the se­nior vice pres­i­dent, med­ical af­fairs strat­e­gy and op­er­a­tions for Ve­rastem On­col­o­gy. In ad­di­tion, he has served as chief of strat­e­gy and late phase de­vel­op­ment as well as CMO for Finch Ther­a­peu­tics Group.

Beam Ther­a­peu­tics — which was launched by CRISPR trail­blaz­ers and Ed­i­tas’ sci­en­tif­ic founders David Liu, Feng Zhang, and J Kei­th Jounghas en­list­ed Bri­an Ri­ley as the com­pa­ny’s se­nior vice pres­i­dent of tech­ni­cal op­er­a­tions. Pri­or to jump­ing aboard to Beam, Ri­ley led the bi­o­log­ics busi­ness of Catal­ent Phar­ma So­lu­tions. His pre­vi­ous stints in­clude roles at bio­Merieux, Bio­gen, Am­gen and Diosynth Biotech­nol­o­gy

Fang Wang Fog­Phar­ma

Gre­go­ry Ver­dine, founder of Fog­Phar­ma, has made two new ad­di­tions to its team. The com­pa­ny wel­comed Fang Wang as vice pres­i­dent of bi­ol­o­gy and Nan­cy Wilk­er as vice pres­i­dent and lead IP coun­sel. Wang joins the com­pa­ny af­ter a decade at Agios Phar­ma­ceu­ti­cals, where she was di­rec­tor of bi­ol­o­gy and cham­pi­oned the rare ge­net­ic dis­ease “type II D-2HG aciduria” pro­gram. She al­so led the de­vel­op­ment of the an­ti-mu­tant EGFRT790M an­ti­body at Aveo Phar­ma­ceu­ti­cals and helped de­vel­op the an­ti-ERBB3 an­ti­body that was part­nered with Bio­gen. Wilk­er hails from Bio­gen, where she held the po­si­tion of IP coun­sel. Pri­or to her time at Bio­gen, Wilk­er served as IP coun­sel at CSL com­pa­ny Se­qirus, was a part­ner at Sun­stein Kann Mur­phy and Tim­bers and held stints at Cell Sig­nal­ing Tech­nol­o­gy, PerkinElmer, Wilmer Cut­ler Pick­er­ing Hale and Dorr and Clark and El­bing

Nan­cy Wilk­er Fog­Phar­ma

Mi­crosoft is try­ing to make a big­ger push to­wards health­care — ink­ing an al­liance with Adap­tive Biotech­nolo­gies to de­vel­op a blood test that can help with the ear­ly de­tec­tion of dis­ease. Mak­ing fur­ther strides to­wards that goal, it was an­nounced that the com­pa­ny had nom­i­nat­ed GSK CEO Em­ma Walm­s­ley to its board of di­rec­tors. In ad­di­tion, the com­pa­ny an­nounced that two of the com­pa­ny’s board mem­bers, Charles Nos­ki, for­mer vice chair­man of AT&T and Bank of Amer­i­ca and Hel­mut Panke, for­mer chair­man of the board of man­age­ment at BMW AG, have de­cid­ed not to seek re-elec­tion to the board. 

Kally­ope CEO Nan­cy Thorn­ber­ry has hopped on­to the board of di­rec­tors at Schrödinger, which re­ceived $110 mil­lion in its first ven­ture round back in May. Thorn­ber­ry will be join­ing GV en­tre­pre­neur-in-res­i­dence Rosana Kapeller on the board, who en­tered in Jan­u­ary

Em­ma Walm­s­ley GSK

William “Bill’’ Alis­ki is join­ing the board of di­rec­tors of X4 Phar­ma­ceu­ti­cals — which back in May teamed up to col­lab­o­rate with the Leukemia & Lym­phoma So­ci­ety to ac­cel­er­ate the de­vel­op­ment of their lead prod­uct can­di­date, ma­vorix­afor, for the treat­ment of Waldern­ström’s macroglob­u­line­mia. Alis­ki brings ex­pe­ri­ence to the role from his time as CCO of Fol­dRX Phar­ma­ceu­ti­cals and as gen­er­al man­ag­er for Bio­marin Eu­rope

→ Sero­tonin 2A re­cep­tor ag­o­nists (or psy­che­delics)-fo­cused Eleu­sis — which re­cent­ly fund­ed a mice study that found that (R)-DOI could be used to treat car­dio­vas­cu­lar dis­ease and po­ten­tial­ly curb di­a­betes — has ap­point­ed David Guy­er to its board of di­rec­tors. Cur­rent­ly, Guy­er serves as the ex­ec­u­tive chair­man of IVER­IC bio and has had stints as CEO of Eye­tech Phar­ma­ceu­ti­cals (lat­er ac­quired by OSI Phar­ma­ceu­ti­cals) and as a part­ner at VC firm SV Life Sci­ences Ad­vis­ers

Nan­cy Thorn­ber­ry Kally­ope

Qrons — a com­pa­ny fo­cused on the de­vel­op­ment of stem cell-syn­thet­ic hy­dro­gel-based so­lu­tions for the treat­ment of trau­mat­ic brain in­juries, like con­cus­sions and pen­e­trat­ing in­juries — has brought on for­mer NFL de­fen­sive line­man Der­rick Cham­bers to the com­pa­ny’s ad­vi­so­ry board. The com­pa­ny’s CEO, Jon­ah Meer, not­ed that Cham­bers will make a great ad­di­tion to the team due to his aware­ness of the “po­ten­tial for Chron­ic Trau­mat­ic En­cephalopa­thy, a pro­gres­sive de­gen­er­a­tive dis­ease of the brain that re­sults from repet­i­tive con­cus­sions and is of­ten found in long­time play­ers of the sport.”

→ A few months af­ter hav­ing their shares dent­ed be­cause of un­der­whelm­ing Phase III HAE da­ta — they failed to cut the at­tack rate by at least 50% — BioCryst has wel­comed He­len Thack­ray to the com­pa­ny’s board of di­rec­tors. Thack­ray is the CMO and se­nior vice pres­i­dent of clin­i­cal de­vel­op­ment at Gly­coMimet­ics — which re­cent­ly had its own woes af­ter Pfiz­er dis­missed their lead drug as a Phase III fail­ure. 

He­len Thack­ray Gly­coMimet­ics

Escient Phar­ma­ceu­ti­cals — fo­cused on ad­vanc­ing G pro­tein cou­ple re­cep­tor (GCPR)-tar­get­ed drugs — has wel­comed co-founder and for­mer CEO of Plexxikon (lat­er ac­quired by Dai­ichi Sankyo in 2011) K. Pe­ter Hirth to the com­pa­ny’s board of di­rec­tors. Pri­or to his stint at Plexxikon — where two of their drugs, Zelb­o­raf and Tu­ralio, re­ceived FDA ap­proval — Hirth served at Sug­en and Boehringer Mannheim.

Fen­nec Phar­ma­ceu­ti­cals — fo­cused on the de­vel­op­ment of PED­MARK (sodi­um thio­sul­fate) for the pre­ven­tion of plat­inum-in­duced oto­tox­i­c­i­ty in pe­di­atric pa­tients — has ap­point­ed Jo­di Cook to the com­pa­ny’s board of di­rec­tors. Cook cur­rent­ly serves as head of gene ther­a­py strat­e­gy at PTC Ther­a­peu­tics. Her pri­or ex­pe­ri­ence spans roles in­clud­ing the COO of Ag­ilis Bio­ther­a­peu­tics and as di­rec­tor of the hear­ing aid pro­gram at Mayo Clin­ic

Paula Soteropou­los Akcea

→ UK-based ear­ly can­cer de­tec­tion com­pa­ny Oncim­mune Hold­ings has wel­comed Tariq Sethi as CSO, Matthew Lut­trell as CMO and Cléa Rosen­feld as head of in­vestor re­la­tions. Sethi is a pro­fes­sor of res­pi­ra­to­ry med­i­cine at King’s Col­lege Lon­don. Be­fore jump­ing on board at Oncim­mune, Sethi was chief physi­cian-sci­en­tist, vice pres­i­dent in the clin­i­cal dis­cov­ery unit at As­traZeneca. He is al­so the founder of Galec­to Biotech. Lut­trell joins the com­pa­ny af­ter a stint as head of hema­tol­ogy, growth and emerg­ing mar­kets at Shire (now Take­da). He’s served in oth­er roles at Eli Lil­ly, No­vo Nordisk, Gilead, and GSK. Rosen­feld brings ex­pe­ri­ence to her new role from her time as head of in­vestor re­la­tions at Shire, where she helped bring the com­pa­ny from an FTSE 250 Com­pa­ny to a top 50 FTSE com­pa­ny.

→ The top 3 ex­ecs run­ning Io­n­is’ ma­jor­i­ty-owned spin­off Akcea are hit­ting the ex­it in a sur­prise twist Mon­day morn­ing. Akcea $AK­CA re­port­ed that CEO Paula Soteropou­los, Pres­i­dent Sarah Boyce and COO Jef­frey Gold­berg are out in a clean sweep. The board has placed Damien McDe­vitt — the chief busi­ness of­fi­cer on the moth­er ship — in the in­ter­im chief ex­ec­u­tive spot as they hunt for some per­ma­nent re­place­ments. Michael J. Yang and Joseph ‘Skip’ Klein III, mean­while have joined the com­pa­ny’s board of di­rec­tors. Mod­er­na vet Soteropou­los and Gold­berg will now switch out to ad­vi­so­ry roles to “help en­sure a smooth tran­si­tion.” 

Bri­an A. Johns HIV Cure Cen­ter

Bri­an A. Johns, a top HIV sci­en­tist at GSK’s Vi­iV, is fol­low­ing the well-trav­eled road in­to biotech, af­ter a 20-year stint as VP in charge of ex­ter­nal dis­cov­ery sci­ences. Not­ed as a co-in­ven­tor of do­lute­gravir — a best­selling HIV drug mar­ket­ed alone as Tivicay — as well as the long-act­ing cabote­gravir, Johns was fea­tured in PhRMA’s Go Bold­ly cam­paign cel­e­brat­ing the in­dus­try’s break­through suc­cess­es and the peo­ple who made them hap­pen. And now he’s join­ing He­mo­S­hear in Char­lottesville, VA as their new CSO. In a state­ment, Johns said he was par­tic­u­lar­ly ex­cit­ed to be fo­cus­ing on rare pe­di­atric meta­bol­ic dis­eases. A cou­ple of years ago He­mo­S­hear al­so lined up a $470 mil­lion col­lab­o­ra­tion with Take­da on NASH, an­oth­er big in­di­ca­tion that has at­tract­ed a slew of com­peti­tors look­ing to make their mark.

→ Uni­ver­si­ty of Basel, Switzer­land spin­out T3 Phar­ma­ceu­ti­cals wel­comed aboard Claire Bar­ton as CMO af­ter hav­ing been with the com­pa­ny as a con­sul­tant for the past 18 months. Her pre­vi­ous stints in­clude roles at Glax­oW­ell­come, Lil­ly and Roche. This comes at the same time that the com­pa­ny raised 12 mil­lion CHF at the close of its sec­ond fi­nanc­ing round, which will help pro­pel the can­cer-fo­cused com­pa­ny’s lead prod­uct, T3P-Y058-739, in­to clin­i­cal test­ing, ex­pect­ed to be­gin in the mid­dle of 2020.


In­for­ma­tion added for clar­i­fi­ca­tion re­gard­ing Gen­fit

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,600+ biopharma pros reading Endpoints daily — and it's free.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,600+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,600+ biopharma pros reading Endpoints daily — and it's free.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,600+ biopharma pros reading Endpoints daily — and it's free.

Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,600+ biopharma pros reading Endpoints daily — and it's free.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,600+ biopharma pros reading Endpoints daily — and it's free.