Small is big: Phar­ma’s R&D brain drain con­tin­ues as GSK’s Chris Car­pen­ter jumps to up­start Ru­bius

Chris Car­pen­ter

The steady mi­gra­tion of top R&D ex­ecs out of Big Phar­ma and in­to lit­tle biotech is con­tin­u­ing this morn­ing.

Af­ter spend­ing the last decade in Big Phar­ma R&D, Chris Car­pen­ter is mak­ing the leap to biotech, join­ing the ris­ing star Ru­bius as chief med­ical of­fi­cer.

Car­pen­ter — a for­mer as­so­ciate pro­fes­sor at Har­vard Med, where he ran a lab for years — spent the last six years at GSK, where he wrapped up his stint as a se­nior VP and head of can­cer epi­ge­net­ics. He jumped from Har­vard to Mer­ck to GSK, where he was cred­it­ed with lead­ing the de­vel­op­ment of Votri­ent. And at Mer­ck he worked on MK-4827, which went on to be­come Tesaro’s PARP drug Ze­ju­la.

He’s go­ing to one of the best fi­nanced up­starts in biotech. Just a few months ago, Cam­bridge, MA-based Ru­bius lined up a $120 mil­lion round, with plans to de­vel­op a full pipeline of new drugs.

Car­pen­ter says he didn’t leave GSK’s Philadel­phia op­er­a­tions be­cause he was un­hap­py. Far from it.

“I re­al­ly en­joyed my time at GSK,” he tells me. “The DPU (Dis­cov­ery Per­for­mance Units) mod­el re­al­ly works and pro­vides a lot of in­no­va­tion.”

In­stead, once he had a chance to take a se­ri­ous look at the tech­nol­o­gy Ru­bius is work­ing with, he felt he couldn’t pass on the chance of play­ing a lead role de­vel­op­ing some­thing com­plete­ly nov­el, with ap­pli­ca­tions in a va­ri­ety of dis­eases.

“For me, it re­al­ly was some­thing that no one else was do­ing and I re­al­ly want­ed to get in on the ground floor.”

The red-cell ther­a­py tech they have is de­signed to iso­late hematopoi­et­ic stem cells from O neg­a­tive donors and use them as the build­ing blocks for new ther­a­pies, ge­net­i­cal­ly en­gi­neer­ing them in­to red blood drugs that can ex­press a mul­ti­tude of pro­teins on the cells while they still have a nu­cle­us, mod­u­lat­ing them for pro­tein ex­pres­sion and then shed­ding the nu­cle­us as they switch on the ther­a­peu­tic qual­i­ties of the cell.

The new ex­ec­u­tive chair­man of Ru­bius is David Ep­stein, the for­mer phar­ma chief at No­var­tis.

With biotech boom­ing, we’ve been see­ing a steady mi­gra­tion of se­nior re­search and man­u­fac­tur­ing ex­ecs leav­ing se­nior spots at the world’s biggest de­vel­op­ers in fa­vor of a start­up like Ru­bius. A few weeks ago, for ex­am­ple, we saw Tony Ho leave a top job at As­traZeneca for a role run­ning R&D at CRISPR Ther­a­peu­tics. At the same time Juan An­dres left a top job in No­var­tis’ glob­al man­u­fac­tur­ing di­vi­sion to take a lead role at Mod­er­na. And in re­cent days we’ve seen the likes of An­drew Wit­ty and Mon­cef Slaoui, the for­mer CEO and ex-R&D head at GSK, start new ca­reers in biotech ven­ture cap­i­tal firms. The list goes on.

Their places in Big Phar­ma R&D are of­ten filled by high-pro­file aca­d­e­m­ic in­ves­ti­ga­tors. And that is start­ing to look like the great cir­cle of drug R&D in this brave new world.

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan -- an­a­lysts turn thumbs down

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

AbbVie $ABBV has agreed to pay $188.24 a share — cash and stock — for the troubled Allergan, reflecting a 45% premium as investors bid up shares in anticipation of a much buzzed about company split. That price — with each share of Allergan worth 0.8660 AbbVie shares and $120.30 in cash — reflects a sharp fall from the $330 peak for Allergan and Saunders 4 years ago — but much better than anything shareholders had in mind for the near future.

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UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.

Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

That shouldn’t be long from now, as Der­mi­ra ex­pects to be­gin the late-stage tri­al work for atopic der­mati­tis be­fore the end of this year as it fol­lows a trail that ex­ecs in­sist leads to block­buster re­turns. Along the way, they’ll need to take on the 600-pound go­ril­la in atopic der­mati­tis: the IL-13/IL-4 drug Dupix­ent, from Re­gen­eron and Sanofi. Ri­vals al­so in­clude Leo Phar­ma, in its piv­otal with tralok­izum­ab, and Anap­tys­Bio in the hunt with a mid-stage pro­gram for etokimab, pre­vi­ous­ly re­ferred to as ANB020.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.