Peer Re­view: aTyr pro­motes da­ta ex­pert San­jay Shuk­la as CEO

A guy with a pen­chant for tech and da­ta will be tak­ing the reins of San Diego pub­lic biotech aTyr Phar­ma $LIFE as the com­pa­ny’s for­mer CEO John Mendlein steps down.

The new chief ex­ec­u­tive and pres­i­dent is San­jay Shuk­la, a physi­cian and clin­i­cal de­vel­op­ment ex­pert who’s been serv­ing as aTyr’s chief med­ical of­fi­cer since March 2016. This will be Shuk­la’s first gig as CEO of a biotech, but he be­lieves his da­ta-crunch­ing back­ground makes him well-pre­pared for the job.

“Through­out my whole ca­reer I’ve en­joyed un­der­stand­ing dif­fer­ent parts of the busi­ness and be­ing as func­tion­al­ly ver­sa­tile as I can be,” Shuk­la said.

Shuk­la is one of those rare birds who was in the biotech in­dus­try be­fore be­com­ing a doc­tor (you nor­mal­ly see it the oth­er way around). He be­gan his ca­reer in sta­tis­ti­cal pro­gram­ming and med­ical in­for­mat­ics in the 1990s, when the in­dus­try was try­ing to catch up with oth­er high-tech in­dus­tries. He be­came a bit of a da­ta sci­en­tist first, and lat­er a physi­cian. He didn’t ex­pect to come back to in­dus­try af­ter get­ting his med­ical de­gree, but his skills were in high de­mand.

“Hav­ing an op­er­a­tional back­ground and a med­ical back­ground right out of the gate is pret­ty rare,” Shuk­la said. “I worked for many years in da­ta cri­sis man­age­ment in clin­i­cal de­vel­op­ment.”

Be­fore join­ing aTyr as CMO, Shuk­la was vice pres­i­dent and glob­al head of in­te­grat­ed med­ical ser­vices for No­var­tis, where he led glob­al med­ical af­fairs op­er­a­tions with over­sight of brands in­clud­ing Glenya, Cosen­tyx, and En­tresto.

At aTyr, Shuk­la ex­pects his da­ta-ori­ent­ed back­ground will come in handy. The com­pa­ny, which spe­cial­izes in drugs de­rived from a new class of nat­ur­al pro­teins called phys­iocrines, is cur­rent­ly try­ing to make sense of a lot of da­ta. Their lead drug Reso­laris is now in three clin­i­cal pro­grams for se­vere, rare my­opathies with an im­mune com­po­nent.

“We are an emerg­ing bi­ol­o­gy com­pa­ny, and the sci­ence is ac­cel­er­at­ing at a rapid pace,” Shuk­la said. “With this new learn­ing comes a tremen­dous amount of da­ta that must be crys­tal­lized, dis­tilled down, and trans­lat­ed in­to clin­i­cal pro­grams. There’s a lot of da­ta that needs to be crunched, and you have to make mean­ing of it. And that’s what I think good da­ta sci­en­tists do.”

Shuk­la said the com­pa­ny re­cent­ly launched a new pro­gram look­ing at how their tech­nol­o­gy could be ap­plied to im­muno-on­col­o­gy. The pro­gram, called Pro­ject Or­ca, is still in the dis­cov­ery stage.

ATyr’s out­go­ing CEO Mendlein, who served as aTyr’s CEO since 2011, will re­main on the com­pa­ny’s board of di­rec­tors.

“Af­ter six in­cred­i­ble years as CEO, I am very pleased to pass the lead­er­ship torch to San­jay and con­tin­ue to ad­vise him as a board mem­ber,” Mendlein said. “Hav­ing worked ex­ten­sive­ly with San­jay, I am con­fi­dent he will con­tin­ue to el­e­vate aTyr to greater heights for pa­tients and all stake­hold­ers alike. I would like to ex­press my im­mense grat­i­tude to all our amaz­ing em­ploy­ees, board, pa­tients, and in­vestors for all that we have ac­com­plished so far at aTyr.”


More Peer Re­view

Daniel Wech­sler

→ Wrap­ping up their merg­er (which has yet to be ap­proved by Cem­pra’s share­hold­ers, with a vote sched­uled to­day), pri­vate Melin­ta Ther­a­peu­tics and Cem­pra $CEMP has named ex-Bausch + Lomb top ex­ec Daniel Wech­sler CEO of the com­bined com­pa­ny.

Markus En­zel­berg­er has of­fi­cial­ly been ap­point­ed Mor­phoSys’ (FSE: MOR) chief sci­en­tif­ic of­fi­cer, hav­ing served as in­ter­im CSO since April. A vet­er­an of the Ger­man com­pa­ny, En­zel­berg­er was part of the team that in­vent­ed Hu­CAL, the an­ti­body li­brary tech­nol­o­gy that helped J&J’s Janssen de­vel­op guselkum­ab. He suc­ceeds Mar­lies Spro­ll, who re­signed for fam­i­ly rea­sons.

Chir­fi Guin­do is join­ing Bio­gen as its first ex­ec­u­tive vice pres­i­dent and head of glob­al mar­ket­ing, mar­ket ac­cess and cus­tomer in­no­va­tion. Guin­do, whose work at Mer­ck has tak­en him to Cana­da, France, the Nether­lands and Africa, gets on board as the biotech gi­ant goes all in on its late-stage Alzheimer’s drug ad­u­canum­ab.

→ Lex­ing­ton, MA-based Xe­net­ic Bio­sciences $XBIO an­nounced that cur­rent COO Jef­frey Eisen­berg is tak­ing over from Scott Maguire. As CEO — a po­si­tion he’s held for years at Noven Phar­ma­ceu­ti­cals be­fore join­ing Xe­net­ic — Eisen­berg says he’s in­ter­est­ed in ad­vanc­ing the biotech’s flag­ship XBIO-101 and build­ing part­ner­ships.

→ Hav­ing com­plet­ed the tran­si­tion to a stand­alone com­pa­ny, Den­dreon re­cruit­ed Bruce Brown as SVP, med­ical. Most re­cent­ly at Astel­las’ on­col­o­gy di­vi­sion, Brown will lead R&D as the com­pa­ny con­tin­ues to push the lim­its of Provenge.

Pe­ter Ho

→ As Epizyme $EPZM braces it­self for the first FDA in­ter­ac­tion on its NHL drug tazeme­to­stat, chief med­ical of­fi­cer Pe­ter Ho, who is more in­ter­est­ed in ear­ly-stage de­vel­op­ment, has de­cid­ed to leave at the end of the year.

Su­jal Shah is of­fi­cial­ly the pres­i­dent and CEO of CymaBay $CBAY, hav­ing been CFO and then in­ter­im CEO of the biotech. Ac­cord­ing to Shah, CymaBay’s goals for 2018 are to ini­ti­ate a PhI­II study in PBC and a PhII study in NASH.

Gre­go­ry Bates is now the se­nior vice pres­i­dent of reg­u­la­to­ry af­fairs at Ax­i­al Bio­ther­a­peu­tics, join­ing fel­low De­poMed vet (and CMO) Srini­vas Rao in prepar­ing the start­up’s ASD and Parkin­son’s pro­grams for the clin­ic.

Dana-Far­ber Can­cer In­sti­tute has cre­at­ed a new po­si­tion called di­rec­tor of can­cer ge­nomics, and Matthew Mey­er­son is fill­ing it. The long­time di­rec­tor of the Cen­ter for Can­cer Genome Dis­cov­ery will lead re­search ef­forts at a range of part­ner or­ga­ni­za­tions in­clud­ing the Broad In­sti­tute, where he will hold the same po­si­tion.

Aerie Phar­ma­ceu­ti­cals $AERI named Al­ler­gan vet John Malt­man as vice pres­i­dent of med­ical af­fairs. Malt­man will be re­spon­si­ble for lead­ing the strate­gic ef­forts of Aerie’s med­ical af­fairs de­part­ment across “a broad spec­trum of prod­uct-re­lat­ed ac­tiv­i­ties.”

Eyal Ru­bin

Eyal Ru­bin is leav­ing Te­va to be CFO at Brain­Storm Cell Ther­a­peu­tics $BCLI, the Is­raeli biotech that just ini­ti­at­ed a PhI­II tri­al for its ALS drug.

→ Rid­ing the tide of its promis­ing IPO, Opti­Nose $OPTN is adding five vice pres­i­dents to its team: Ric­ci Whit­low, VP of tech­ni­cal op­er­a­tions; Har­ry Sacks, VP of med­ical af­fairs and cor­po­rate med­ical of­fi­cer; John Pe­terkins, VP of mar­ket ac­cess; David Fab­bri, VP of sales; and An­drew Muzsi, VP of mar­ket­ing. “Adding these lead­ers to our or­ga­ni­za­tion will strength­en our abil­i­ty to ex­e­cute as we pre­pare for the planned sec­ond quar­ter 2018 launch of XHANCE,” said CEO Pe­ter Miller in a state­ment.

→ Rare dis­ease biotech Nov­e­l­ion Ther­a­peu­tics has tapped Jef­frey Hack­man to head com­mer­cial ef­forts in the role of chief op­er­at­ing of­fi­cer.

→ Fol­low­ing his high-pro­file ar­rest, In­sys Ther­a­peu­tics $IN­SY founder John Kapoor re­signed from the com­pa­ny’s board of di­rec­tors, in or­der not to draw “un­nec­es­sary at­ten­tion” to In­sys.

Har­poon Ther­a­peu­tics, a T cell ther­a­py biotech found­ed by Patrick Baeuer­le and MPM Cap­i­tal, has hired Su­san Jones and Rachael Lester as SVP of prod­uct de­vel­op­ment and VP of cor­po­rate de­vel­op­ment, re­spec­tive­ly. The two will man­age and ex­pand the com­pa­ny’s port­fo­lio as it looks to be­gin clin­i­cal tri­als on its prostate can­cer treat­ment in 2018.

→ The board of Is­rael’s In­tec Phar­ma $NTEC says good­bye to founder Zvi Joseph and for­mer CEO Gio­ra Carni as it seeks “ad­di­tion­al in­de­pen­dent di­rec­tors to pro­vide in­sight and strate­gic coun­sel.” An­tho­ny Mad­dalu­na, for­mer ex­ec­u­tive vice pres­i­dent and pres­i­dent of Pfiz­er glob­al sup­ply, is the first can­di­date up for elec­tion lat­er this year.

→  Astel­las has pro­mot­ed James Mit­eff to na­tion­al vice pres­i­dent, health sys­tems pay­er & chan­nel ac­count man­age­ment, to re­place 17-year vet­er­an Bruce Maz­er, who’s re­tir­ing. Gre­go­ry Apos­tol will be na­tion­al vice pres­i­dent, key ac­count man­age­ment.

Am­ber Tong con­tributed to this re­port.

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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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.

Image: Shutterstock

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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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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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.

Af­ter watch­ing its share price soar on a Bloomberg re­port and heat­ed ru­mors, Bio­haven stock takes a bil­lion-dol­lar bath

Back in April, Biohaven Pharmaceutical became one hot biotech stock $BHVN based on a report in Bloomberg that some “potential bidders” had been kicking the tires at the biotech, which has a lead drug for migraines. Then the rumor mill really started to smoke when execs canceled a presentation at an investor conference a little more than a week ago.

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UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.