Ovid ex­ec Yaron Wer­ber cross­es back to Cowen; Saqib Is­lam pro­mot­ed to Spring­Work­s' first CEO slot

Yaron Wer­ber

→ While a num­ber of an­a­lysts have been seen mi­grat­ing to the front lines of biotech, Yaron Wer­ber is mov­ing in the op­po­site di­rec­tion. Af­ter ro­tat­ing through a cou­ple of roles at rare dis­ease biotech Ovid Ther­a­peu­tics  and help­ing put to­geth­er its $75 mil­lion IPO $OVID — he’s head­ed back to Wall Street.

The for­mer Cit­i­group an­a­lyst is land­ing at Cowen as a man­ag­ing di­rec­tor and se­nior mem­ber of its biotech team, at a time in­vest­ment banks are pay­ing big dol­lars to scoop pop­u­lar biotech boost­ers from each oth­er.

“We are thrilled to wel­come Yaron back to eq­ui­ty re­search and back to Cowen, where he be­gan his im­pres­sive ca­reer in biotech. As a trained med­ical doc­tor, re­spect­ed pub­lic com­pa­ny CFO and a proven sell-side an­a­lyst, Yaron is an out­stand­ing ad­di­tion to Cowen’s lead­ing health­care and biotech re­search team,” said Cowen CEO Jef­frey Solomon in a state­ment.

Wer­ber, who first joined Ovid as CFO in 2015, has since added CBO and trea­sur­er to his ti­tle in ad­di­tion to a stint as sec­re­tary.

Spring­Works Ther­a­peu­tics will be cel­e­brat­ing its one-year an­niver­sary with their first per­ma­nent CEO in place. Tak­ing the helm is Saqib Is­lam, an ex-Mod­er­na ex­ec who’s been over­see­ing fi­nance and busi­ness de­vel­op­ment since the biotech spun out with four rare dis­ease as­sets from Pfiz­er. He will join the board of di­rec­tors, work­ing with ex­ec­u­tive chair­man Dan Lynch, and lead the charge for find­ing more promis­ing clin­i­cal-stage drugs from oth­er in­dus­try play­ers to grow their pipeline, which cur­rent­ly fea­tures lead pro­grams in desmoid tu­mors and neu­rofi­bro­mato­sis type 1. Spring­Works has al­so just en­tered a pact with BeiGene to test its MEK in­hibitor in com­bi­na­tion with the Bei­jing-based biotech’s RAF dimer in­hibitor to tar­get ad­vanced sol­id tu­mors with RAS mu­ta­tions.  

Lisa Ric­cia­r­di

→ As Suono Bio en­ters a new phase of its busi­ness marked by a new strate­gic in­vest­ment from Fu­ji­film, Carl Schoell­ham­mer is step­ping aside from the CEO role to make room for Lisa Ric­cia­r­di. Schoell­ham­mer, who helped found the com­pa­ny along­side MIT’s Robert Langer, Gio­van­ni Tra­ver­so of Brigham and Women’s Hos­pi­tal and Po­laris part­ner Amy Schul­man, will re­main as COO. A Pfiz­er vet with stints at Es­sex Wood­lands Health Ven­tures, Ex­press Scripts and Foun­da­tion Med­i­cine, Ric­cia­r­di is tasked with steer­ing Suono’s for­mu­la­tion-in­de­pen­dent de­liv­ery tech to the clin­ic.

David Schenkein’s long run as Agios CEO — grow­ing the com­pa­ny from his leg­endary blank sheet of pa­per to a high pro­file pub­lic biotech with close to 500 staffers, two ap­proved drugs on the mar­ket and more ad­vanc­ing in the pipeline — is com­ing to an end. In five months Schenkein is pass­ing the reins of the Cam­bridge, MA-based com­pa­ny $AGIO to Jack­ie Fouse, the ex-Cel­gene ex­ec who went on to run one of Vivek Ra­maswamy’s biotechs for a short stint. Af­ter Fouse jumped on the Agios board late last year, he says, reg­u­lar dis­cus­sions with the board about a tran­si­tion plan be­gan to gel. And “it be­came clear that Jack­ie had an in­ter­est in that role.” At Ra­maswamy’s Der­ma­vant, Fouse was in charge of grow­ing the Phoenix, AZ-based start­up. Af­ter she takes the new job at Agios Feb­ru­ary 1, she’ll be ex­pect­ed to con­tin­ue to build on Schenkein’s vi­sion for the com­pa­ny, look­ing to keep build­ing a sci­ence-dri­ven, re­search-ori­ent­ed bio­phar­ma along the lines of Genen­tech. Frank Tor­ti, who re­cent­ly joined Roivant as Vant In­vest­ment Chair, will step in as Der­ma­vant’s board chair­man.

→ Five months af­ter Third Rock part­ner Ab­bie Cel­niker of­fi­cial­ly launched Rheos Med­i­cines with an aim at be­com­ing a leader in im­munome­tab­o­lism, the start­up has wooed a top Roche sci­en­tist to the helm. San­jay Keswani has been named CEO at the Cam­bridge, MA-based com­pa­ny, join­ing a large mi­gra­tion of top ex­ec­u­tives leav­ing Big Phar­ma for the fast-grow­ing start-up crowd. He had been a se­nior vice pres­i­dent and glob­al head of the neu­ro­science, oph­thal­mol­o­gy and rare dis­eases unit for Roche’s pRED or­ga­ni­za­tion, based in Basel. Be­fore that he had a broad port­fo­lio at Bris­tol-My­ers Squibb, with ear­li­er gigs at Eli Lil­ly and Am­gen.

David Goren

→ Is­rael’s Vax­il has tapped Big Phar­ma vet David Goren to suc­ceed se­r­i­al en­tre­pre­neur Isaac Maresky as CEO. Goren first moved from New York to es­tab­lish and grow Pfiz­er’s Is­raeli com­mer­cial pres­ence. He stayed on to serve as gen­er­al man­ag­er in the coun­try for As­traZeneca and has re­cent­ly start­ed his own bou­tique con­sult­ing firm called Epi­one Strat­e­gy.

Found­ed on a plat­form de­vel­oped by Weiz­mann In­sti­tute sci­en­tists, Vax­il’s lead as­set is an or­phan drug des­ig­nat­ed im­munother­a­py that tar­gets a neoanti­gen known as MUC1. Hav­ing com­plet­ed a Phase I/II tri­al in mul­ti­ple myelo­ma, the biotech is look­ing to test Im­mucin in Phase II for ad­di­tion­al sol­id tu­mor in­di­ca­tions.

Gos­samer Bio has re­cruit­ed in­dus­try vet Luisa Salter-Cid to lead re­search and pre­clin­i­cal de­vel­op­ment ef­forts for its fledg­ling op­er­a­tion that’s mov­ing “at light speed,” ac­cord­ing to founder Fa­heem Has­nain. The new CSO jumps from a 13-year run at the im­munol­o­gy unit of Bris­tol-My­ers Squibb, where her path crossed with Gos­samer Bio CEO Sheila Gu­jrathi. She will be re­spon­si­ble for trans­lat­ing some of the pre­clin­i­cal pro­grams that Has­nain and Gu­jrathi have been busy snap­ping up, many of which re­main tight­ly un­der wraps. But one thing we know for cer­tain is that the biotech will have plen­ty of cash — $330 mil­lion at last count — to see them through.

Gin­na La­port

Gin­na La­port is tak­ing up her first CMO job since leav­ing acad­e­mia at Ver­sant-backed Tem­pest Ther­a­peu­tics as the biotech eyes its first clin­i­cal tri­als in 2019. A for­mer mem­ber of the FDA’s on­co­log­ic drugs ad­vi­so­ry com­mit­tee, La­port is ex­pect­ed to lever­age both her ex­per­tise in hema­tol­ogy/on­col­o­gy and re­cent ex­pe­ri­ence man­ag­ing clin­i­cal de­vel­op­ment at Corvus Phar­ma to ad­vance Tem­pest’s im­muno-on­col­o­gy as­sets in­clud­ing TPST-1120, a PPARα block­er de­signed to in­flame the tu­mor mi­croen­vi­ron­ment and ac­ti­vates im­por­tant tu­mor‐killing im­mune cells (the for­mer lead as­set, an IDO in­hibitor, ap­pears to have been dropped). Join­ing her in the C-suite will be Ali­cia Lev­ey, who’s been pro­mot­ed to chief busi­ness of­fi­cer from a VP po­si­tion.

→ The cell ther­a­py ex­perts at Tmu­ni­ty have brought in an ex­pe­ri­enced ex­ec to man­age the biotech’s fi­nan­cial op­er­a­tions, con­nect with the fi­nan­cial mar­kets and over­see IT and oth­er day-to-day tasks. Graeme Bell comes to the EVP and CFO af­ter serv­ing in the same roles at Ana­cor Phar­ma and In­tel­lia fol­low­ing a 20-year ca­reer at Mer­ck. CEO Us­man “Oz” Azam has this to say about his ap­point­ment: “Graeme’s ex­ten­sive knowl­edge in fi­nance and proven suc­cess in deal-mak­ing will be a tremen­dous as­set to Tmu­ni­ty as we con­tin­ue to cre­ate and pur­sue strate­gic busi­ness op­por­tu­ni­ties that align with our vi­sion” — to use CRISPR gene edit­ing tech to mod­i­fy im­mune cells.

→ Back in busi­ness af­ter a spell in lim­bo, Iron­shore Phar­ma­ceu­ti­cals has re­cruit­ed Scott Evan­ge­lista to lead the com­mer­cial roll­out of its AD­HD drug as pres­i­dent and COO. Ex­ecs like Evan­ge­lista’s years of ex­pe­ri­ence pro­vid­ing com­mer­cial­iza­tion sup­port at what is now IQVIA, which he will now use to launch Jor­nay, a ver­sion of a gener­ic stim­u­lant with a de­layed-re­lease tech that Iron­shore hopes will dis­tin­guish it from the crowd..

Hu­bert Chen

→ Days af­ter an­nounc­ing his de­par­ture from Pfenex, Hu­bert Chen is show­ing up as the new chief med­ical of­fi­cer at fel­low San Diego biotech Metacrine. The new job will take Chen back to his roots in en­docrinol­o­gy while lean­ing on the clin­i­cal de­vel­op­ment skills he’s built over the years with treat­ments for he­pati­tis, fi­bro­sis, and in­flam­ma­to­ry dis­ease at places like Aileron, Reg­u­lus, Amylin and Am­gen.

→ Af­ter eight years in the CSO seat at Amipo Phar­ma $AMPE, David Bar-Or says “the time is right” to re­tire. Though the lit­tle biotech’s BLA for Am­pi­on, its drug for os­teoarthri­tis in the knee, was spurned by from the FDA weeks ago, Bar-Or notes that prepa­ra­tion for an­oth­er fil­ing is on­go­ing. While stay­ing on Am­pio’s board of di­rec­tors and sci­en­tif­ic ad­vi­so­ry board, he will turn his at­ten­tion to some projects in trau­ma re­search at the Swedish Med­ical Cen­ter.

Ra­dius Health, the Waltham, MA-based biotech best known for its fierce os­teo­poro­sis ri­val­ry with Am­gen, has ap­point­ed can­cer ex­pert Charles Mor­ris to guide its ex­pan­sion in­to on­col­o­gy. As CMO, he will shep­herd all clin­i­cal, reg­u­la­to­ry and med­ical af­fairs for the com­pa­ny. “I be­lieve elaces­trant is unique­ly po­si­tioned to po­ten­tial­ly ad­dress un­met needs in the treat­ment of hor­mon­al breast can­cer,” said Mor­ris, who’s run a num­ber of ear­ly-stage pro­grams at Al­los Ther­a­peu­tics, Im­muno­Gen and most re­cent­ly PsiOxus Ther­a­peu­tics. “I have al­ready had the chance to re­view and pro­vide in­put to op­ti­mize elaces­trant’s clin­i­cal de­vel­op­ment plan and look for­ward to ini­ti­at­ing our Phase 3 study in the fourth quar­ter of this year.”

→ With the com­bo of its lead drug PEGPH20 with Abrax­ane near­ing Phase III, Halozyme $HA­LO has poached long­time Bris­tol-My­ers Squibb ex­ec Ben­jamin Hick­ey to be its chief com­mer­cial of­fi­cer. Hick­ey, who’s been man­ag­ing the phar­ma gi­ant’s UK and Ire­land op­er­a­tions in re­cent years, is join­ing the San Diego biotech’s com­mer­cial unit at ground ze­ro, with a broad man­date to build the sales, mar­ket­ing and mar­ket ac­cess teams.

→ Brain­Storm Cell Ther­a­peu­tics $BCLI has ap­point­ed No­var­tis vet Ar­turo Araya as chief com­mer­cial of­fi­cer. Araya had been glob­al head of com­mer­cial of No­var­tis’ Cell and Gene Ther­a­pies Unit and has been on the board at Brain­storm since Feb­ru­ary of last year.

→ Still in search for a CEO to re­place William Lis, Por­to­la will now be look­ing for a new chief com­mer­cial and busi­ness of­fi­cer as well. Tao Fu re­signed, ef­fec­tive lat­er this month, just as the biotech is be­gin­ning to roll out its blood thin­ner an­ti­dote An­dexxa and an­ti­co­ag­u­lant Bevyxxa. CFO Mar­di Di­er, who’s al­ready shoul­der­ing half of the in­ter­im pres­i­dent role,  will lead the com­mer­cial ac­tiv­i­ties in the in­ter­im.

John Na­son just got a pro­mo­tion at gener­ics gi­ant Te­va to head up its API unit, which de­vel­ops, man­u­fac­tures and mar­kets bulk API for both third-par­ty clients and the com­pa­ny it­self, as well as its bi­o­log­ics op­er­a­tions. Na­son held sim­i­lar roles for Bris­tol-My­ers Squibb and No­var­tis in Ire­land be­fore join­ing the Is­raeli com­pa­ny in 2015.

Welling­ton Sun

→ Fol­low­ing a decades-long ca­reer in gov­ern­ment agen­cies — capped by 10 years di­rect­ing the FDA’s di­vi­sion of vac­cines and re­lat­ed prod­uct ap­pli­ca­tions — Welling­ton Sun is mov­ing to the oth­er side of the ta­ble, tak­ing a job at biotech uni­corn Mod­er­na as head of vac­cine strat­e­gy and reg­u­la­to­ry af­fairs. His in­fec­tious dis­ease spe­cial­ty is es­pe­cial­ly ap­peal­ing to Mod­er­na as nine of its 21 de­vel­op­ment can­di­dates — sev­en out of the 10 in clin­i­cal de­vel­op­ment — fall in the field.

Mer­ck vet John Hunter is the new CSO at SiteOne Ther­a­peu­tics, a de­vel­op­er of non-opi­oid pain ther­a­pies. While his re­cent role in­volves car­dio-re­nal re­search, he has a back­ground in neu­ro­science and has led dis­cov­ery re­search in the area for both Scher­ing-Plough and Roche.  

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.