Dal­cor taps new CEO Fouzia Laghris­si-Th­ode as piv­otal PhI­II looms; Kel­ly Mar­tin set­tles in at No­van; Ed­ward Stew­art takes over Com­mense

Fouzia Laghris­si-Th­ode

As­traZeneca vet Fouzia Laghris­si-Th­ode will be lead­ing Dal­Cor Phar­ma­ceu­ti­cals through pa­tient en­roll­ment in­to its piv­otal Phase III tri­al. The new­ly mint­ed CEO has her work cut out for her — Lon­don-based Dal­Cor is try­ing to prove that dal­cetrapib, a CETP in­hibitor Roche aban­doned, has a strong car­dio ben­e­fit for a sub­group of pa­tients with a cer­tain geno­type by test­ing it in 6000 peo­ple. Laghris­si-Th­ode be­gan tack­ling this field at Roche, where she was a fran­chise leader for sev­er­al drugs.

→ Af­ter more than 15 years play­ing sup­port­ive ex­ec roles at Mer­ri­mack, Ed­ward “Tad” Stew­art is tak­ing the helm of a con­tro­ver­sial PureTech Health start­up fo­cused on the mi­cro­bio­me. Stew­art had been work­ing as CBO at Crescen­do Bi­o­log­ics since Mer­ri­mack be­came part of Ipsen in 2017, flex­ing the busi­ness mus­cles he gained in Mer­ri­mack’s jour­ney from pre­clin­i­cal to com­mer­cial stage. His new com­pa­ny, Boston-based Com­mense, stirred some crit­i­cism when it launched with an ex­plic­it goal to im­prove in­fants’ health by swab­bing new­borns with mi­crobes from their mom’s vagi­na — a prac­tice al­so known as “vagi­nal seed­ing.” It is now Stew­ard’s du­ty as pres­i­dent and CEO to lead the re­sult­ing ther­a­peu­tics to fruition, con­vinc­ing in­vestors and part­ners along the way.

Kel­ly Mar­tin

No­van did not find a per­ma­nent re­place­ment for Kel­ly Mar­tin af­ter all, so the CEO will take the “in­ter­im” tag off his ti­tle af­ter 10 months in the job. Mar­tin is al­so tasked with in­spir­ing faith in ex­ist­ing and po­ten­tial in­vestors to­ward No­van’s $NOVN ni­tric ox­ide plat­form, es­pe­cial­ly as the biotech mounts a come­back for its lead ac­ne drug. The com­pa­ny has al­so of­fi­cial­ly in­stalled An­drew No­vak, for­mer­ly se­nior di­rec­tor of re­port­ing and analy­sis, as VP and chief ac­count­ing of­fi­cer in an ef­fort to set the lead­er­ship struc­ture in place. Sup­port­ing them on the clin­i­cal de­vel­op­ment side will be new SVP of clin­i­cal op­er­a­tions Eliz­a­beth Messer­smith, whose com­bined ex­pe­ri­ence at Quark Phar­ma, Bal­ance Ther­a­peu­tics and Elan Phar­ma shaped her up to over­see the di­verse pro­grams at No­van.  

→ Less than a year af­ter the ac­tivist in­vestors at ven­Bio crashed a $2 bil­lion col­lab­o­ra­tion deal with Seat­tle Ge­net­ics on the lead drug at Im­munomedics $IM­MU, the new crew in charge has wooed the top I/O re­search ex­ec at As­traZeneca to take a lead­ing de­vel­op­ment role as chief med­ical of­fi­cer and R&D chief. Robert Ian­none played a top role in the de­vel­op­ment of Imfinzi (dur­val­um­ab), the PD-L1 check­point star at As­traZeneca/Med­Im­mune. Now he’s jump­ing in­to biotech, tak­ing the lead­ing re­search role at a com­pa­ny with a mar­ket cap of $2.4 bil­lion. He’ll now be fo­cused on sac­i­tuzum­ab govite­can (IM­MU-132), a late-stage drug for metasta­t­ic triple neg­a­tive breast can­cer look­ing for an ac­cel­er­at­ed ap­proval.

Ken­neth New­man is end­ing his three-year CMO tenure at res­pi­ra­to­ry dis­ease com­pa­ny Verona Phar­ma $VR­NA to pur­sue oth­er op­por­tu­ni­ties. His fi­nal month at the biotech was marked by pos­i­tive da­ta from two Phase II tri­als, for cys­tic fi­bro­sis and chron­ic ob­struc­tive pul­monary dis­ease, re­spec­tive­ly. The Lon­don-based com­pa­ny has yet to find a re­place­ment.  

Neomed Ther­a­peu­tics 1 has tapped ex­pe­ri­enced tri­al in­ves­ti­ga­tor Frank Giles as its first chief med­ical of­fi­cer, re­spon­si­ble for both in-house de­vel­op­ment and col­lab­o­ra­tions and part­ner­ships of its epi­ge­net­ics-mod­u­lat­ing can­cer ther­a­peu­tics. Giles joins Mon­tre­al-based Neomed from a brief stint at Ac­tu­ate Ther­a­peu­tics, which he jug­gled with his di­rec­tor roles at North­west­ern Uni­ver­si­ty.

→ With a Phase III tri­al of ef­gar­tigi­mod set to launch this year, ar­genx $ARGX has ap­point­ed Kei­th Woods as COO to run ear­ly com­mer­cial plan­ning for that as­set, which spans mar­ket­ing, mar­ket­ing ac­cess, pro­gram man­age­ment and sup­ply chain op­er­a­tions. Ef­gar­tigi­mod will first be test­ed for myas­the­nia gravis, a chron­ic au­toim­mune dis­or­der re­sult­ing in mus­cle weak­ness. Woods’ pre­vi­ous roles at Alex­ion have sent him run­ning busi­ness on both sides of the At­lantic. Be­fore that, he’s spent a com­bined 20 years at Roche, Am­gen and Ei­sai.

→ Gene ther­a­py com­pa­ny Gen­prex $GN­PX has liked COO Julien Pham’s work since he joined in 2016, and they now want him to bring On­co­prex, its im­muno­gene ther­a­py for non-small cell lung can­cer, to mar­ket as the com­pa­ny’s new pres­i­dent. A clin­i­cian in train­ing, Pham takes over from chair­man and CEO Rod­ney Varn­er. He is now tasked with grow­ing strate­gic part­ner­ships in ad­di­tion­al to lead­ing the clin­i­cal pro­gram at the in­ter­sec­tion of on­col­o­gy and non-vi­ral gene ther­a­py. The Austin-based com­pa­ny be­lieves that On­co­prex can bol­ster both tar­get­ed ther­a­pies and im­munother­a­pies when used in com­bos.

At­las-backed Gen­er­a­tion Bio has brought on two new ex­ecs to cham­pi­on its non-vi­ral ap­proach to gene ther­a­py. Will Mc­Carthy is join­ing as chief busi­ness of­fi­cer from the same role at Igny­ta, where he be­came fa­mil­iar with ge­net­i­cal­ly de­fined can­cers. Be­fore that, he’s held po­si­tions at ge­nom­ic di­ag­nos­tics com­pa­ny Foun­da­tion Med­i­cine and can­cer biotech Halozyme. Jen­nifer El­liott, mean­while, takes on the role of head of le­gal af­fairs and in­tel­lec­tu­al prop­er­ty. For­mer­ly di­rec­tor of IP at the Broad In­sti­tute and as­so­ciate gen­er­al coun­sel at Genen­tech, El­liot brings a back­ground in patent ap­pli­ca­tion to the Cam­bridge, MA biotech as it ex­plores a wide range of ther­a­peu­tic ap­pli­ca­tions with a $100 mil­lion Se­ries B.  

→ Cana­da’s In­Med has wooed a sea­soned ex­ec­u­tive to es­tab­lish the com­pa­ny’s pres­ence in the emerg­ing field of cannabi­noid-based drugs. Hav­ing served as CFO at fel­low cannabi­noid drug­mak­er Ther­a­pix and liv­er dis­ease com­pa­ny Galmed, Joshua Blach­er joins In­Med as CBO, with a man­date to raise its pro­file in the cap­i­tal mar­kets in ad­di­tion to ex­e­cut­ing fi­nan­cial and BD ini­tia­tives.

Rober­to Cu­ca — the CFO and SVP — an­nounced that he is re­sign­ing from Treve­na $TRVN, just a week af­ter found­ing CEO Max­ine Gowen tapped Car­rie Bour­dow to be her suc­ces­sor. The for­mer lawyer and one-time an­a­lyst had been with the com­pa­ny for al­most five years.  

Rhon­da Chicko

→ With an IND in sight for its spinal mus­cu­lar dy­s­tro­phy treat­ment, Schol­ar Rock has named Iron­wood vet Rhon­da Chicko its new CFO along­side a slate of ap­point­ments and pro­mo­tions. Chicko brings fresh mem­o­ry and skills need­ed in an ear­ly-stage op­er­a­tion from Ed­i­tas Med­i­cine, where she built the fi­nance team. Oth­er new em­ploy­ees at the Cam­bridge, MA com­pa­ny are Ryan Iar­robi­no, VP of clin­i­cal op­er­a­tions and Cather­ine Hu, ex­ec­u­tive di­rec­tor of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Mean­while in recog­ni­tion of their work to ad­vance the pro­tein growth fac­tors plat­form, Gre­go­ry Car­ven has been pro­mot­ed to SVP of an­ti­body dis­cov­ery and pro­tein sci­ences; At­suko Polzin to VP of in­tel­lec­tu­al prop­er­ty; and Dodzie So­gah to VP of cor­po­rate de­vel­op­ment and strat­e­gy.

Dirk Ehlers is the new COO at di­ag­nos­tics com­pa­ny Cen­to­gene, which spe­cial­izes in de­tect­ing rare dis­ease ge­net­ics. Ehlers had gone in and out of the di­ag­nos­tics busi­ness through­out his ca­reer in life sci­ences, fea­tur­ing an ex­ec role at Roche years ago.

→ Waltham, MA-based Ave­dro, an oph­thalmic phar­ma and med­ical de­vice com­pa­ny, has ap­point­ed James Schuer­mann as CBO. The medtech vet­er­an will be busy over­see­ing all as­pects of com­mer­cial­iza­tion, in­clud­ing gov­ern­ment af­fairs, re­im­burse­ment, sales, com­mu­ni­ca­tions and field ser­vice.

→ The team of neu­ro­log­ic ex­perts at BioAx­one has re­cruit­ed Ronald Gold­stein to strength­en the com­pa­ny’s fi­nan­cial un­der­pin­nings. Cam­bridge, MA-based BioAx­one is part­nered with Ver­tex on its lead ther­a­py for spinal cord in­jury, cur­rent­ly in PhI­Ib/PhI­II de­vel­op­ment. With his back­ground in pub­lic ac­count­ing and bank li­ai­son, Gold­stein is ex­pect­ed to keep the com­pa­ny on track as it grows.

→ DNA test­ing spe­cial­ist Nat­era $NTRA has tapped dec­o­rat­ed schol­ar Paul Billings as its CMO. A ge­nom­ic ex­pert who con­sult­ed for Ther­mo Fish­er Sci­en­tif­ic, Billings has served on the sci­en­tif­ic ad­vi­so­ry boards of sev­er­al gov­ern­ment agen­cies in­clud­ing the FDA.

→ The change mas­ter of biotech is knock­ing at Iron­wood Phar­ma­ceu­ti­cals’ front door. And he wants in with plans to stay for awhile. Alex Den­ner, known for forc­ing out old CEOs and forc­ing through new buy­outs, has now set his sights on the long­time Boston/Cam­bridge play­er guid­ed by found­ing CEO Pe­ter Hecht, who launched the com­pa­ny 20 years ago with a plan for the long haul. In an un­usu­al move, Iron­wood put out word of Den­ner’s move to join the board in a press re­lease Mon­day. And the com­pa­ny took the op­por­tu­ni­ty to point­ed­ly praise the board Hecht has al­ready as­sem­bled, which in­cludes 8 in­de­pen­dent di­rec­tors on the 9-mem­ber group. It’s clear that Den­ner is out to shake things up at Iron­wood, a com­pa­ny best known for its fran­chise drug Linzess and a pipeline of ther­a­pies in the same space. Sev­er­al an­a­lysts think the com­pa­ny could do bet­ter on the stock price, and Den­ner is all about val­ue cre­ation — with a big ap­petite for prof­it­ing from tur­bu­lence.

→ As Tam­pa, FL-based In­tezyne ramps up in-house de­vel­op­ment ef­forts, Brad­ford Sul­li­van and Adam Curie were hand­ed in­creased re­spon­si­bil­i­ties for the an­ti-can­cer ther­a­pies it’s de­vel­op­ing. Sul­li­van will as­sume di­rec­tor­ship of chem­istry, man­u­fac­tur­ing and con­trols of ex­ist­ing poly­mers and APIs, while Curie will fo­cus on prod­uct de­vel­op­ment for po­ten­tial new can­di­dates.

Mer­ck vet John Renger is climb­ing up the lead­er­ship lad­der at Pur­due Phar­ma, where he’s just been named VP, head of R&D and reg­u­la­to­ry af­fairs. Where­as he was fo­cused on neu­ro­sciences, his new role will put him in charge of the over­all sci­en­tif­ic di­rec­tion and strat­e­gy.

→ An­tibi­ot­ic mak­er Spero Ther­a­peu­tics $SPRO has hired Ian Critch­ley to head clin­i­cal mi­cro­bi­ol­o­gy, trust­ing him to not on­ly steer the late-stage tri­als planned for the year but al­so build up a clin­i­cal port­fo­lio to ad­dress mul­tidrug-re­sis­tant bac­te­ria. That wouldn’t be new to Critch­ley, who had man­aged pre­clin­i­cal and clin­i­cal stud­ies on sev­er­al an­ti-in­fec­tives com­pounds dur­ing a three-year run at Al­ler­gan.

→ As Re­zo­lute read­ies its or­phan drug for con­gen­i­tal hy­per­in­su­line­mia, RZ358, to en­ter Phase IIb, it is bring­ing in Chris­tine Fer­rara as di­rec­tor of clin­i­cal de­vel­op­ment with a pri­ma­ry fo­cus on the pro­gram.

→ An­tic­i­pat­ing an NDA for Ro­cla­tan lat­er this year, Aerie Phar­ma­ceu­ti­cals has ap­point­ed for­mer UCB staffer Scott Laran­jo to plan for its mar­ket­ing.

Michael Moore has added Macrophage Phar­ma to the list of boards he’s chair­ing. Moore, who served as the founder chair­man of Tril­li­um Ther­a­peu­tics and PsiOx­is Ther­a­peu­tics, said he’s im­pressed by the po­ten­tial of Macrophage’s im­mune mod­u­la­tion plat­form tech in can­cer and be­yond.

Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

UP­DAT­ED: Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird's leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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A uni­corn stalks Wall Street in search of IPO cash; CASI Phar­ma in-li­cens­es CD19 ther­a­py from Chi­na’s Ju­ven­tas

→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

UP­DAT­ED: Sanofi Gen­zyme deserts gene ther­a­py de­vel­op­er Voy­ager Ther­a­peu­tics

While gene ther­a­py com­pa­nies re­joice as the sec­tor gains trac­tion with ap­provals and a flur­ry of M&A ac­tiv­i­ty, one play­er is feel­ing the heat.

Back in 2015, Voy­ager Ther­a­peu­tics joined forces with Sanofi Gen­zyme in a deal worth up to $845 mil­lion ($100 mil­lion up­front + a po­ten­tial $745 mil­lion in mile­stones) to co-de­vel­op gene ther­a­pies for se­vere cen­tral ner­vous sys­tem dis­or­ders. But two years lat­er, the French drug­mak­er re­treat­ed, elect­ing to not pick up the op­tion to work on Voy­ager’s Parkin­son’s dis­ease pro­gram. (Last year, the FDA dis­ap­point­ed Voy­ager, telling the com­pa­ny that it was not open to an ac­cel­er­at­ed fil­ing on the Parkin­son’s drug on the ba­sis of Phase II da­ta — in­stead of re­quir­ing an ad­di­tion­al piv­otal study.)

In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

John Oyler, Founder & CEO of BeiGene, at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

UP­DAT­ED: As Bris­tol-My­ers/Cel­gene tie up loose ends, BeiGene pock­ets $150M from PD-1 breakup

As soon as Bristol-Myers Squibb announced its $74 billion buyout for Celgene, BeiGene emerged as a prominent example of a player whose pact with the big biotech could sour, as its PD-1 candidate seems to overlap with Opdivo. After six months of suspense, the partners say they are finally bringing the 2-year-old deal to an amicable end.

BeiGene $BGNE gets $150 million for the termination in addition to full global rights to tislelizumab. In 2017 Celgene had paid $263 million in upfront license fees to develop the PD-1 inhibitor for solid cancers in the US, Europe, Japan and the rest of the world outside Asia. It also threw in a $150 million equity investment in exchange for BeiGene handling its commercial operations — think Abraxane, Revlimid and Vidaza — in China.

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Exterior of the 1 million square foot Discovery Labs in Upper Merion, PA (PR Newswire)

Philadel­phia cham­pi­ons life sci­ences 'co-work­ing,' re­viv­ing for­mer GSK cam­pus in $500M makeover

In a boost to Philadel­phia’s thriv­ing life sci­ences scene, a for­mer Glax­o­SmithK­line cam­pus and a near­by site has been turned in­to what its de­vel­op­er calls “the largest cowork­ing ecosys­tem” for health­care com­pa­nies in the coun­try.

The Dis­cov­ery Labs, a com­pa­ny spawned by MLP Ven­tures, has se­lect­ed two lo­ca­tions in the King of Prus­sia area as the $500 mil­lion test case for its strat­e­gy of ac­quir­ing and con­vert­ing old phar­ma­ceu­ti­cal R&D fa­cil­i­ties world­wide. The sites add up to 1.64 mil­lion square feet.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.