J&J buys in­to Pro­tag­o­nist’s next-gen pep­tide sto­ry with $50M up­front and $940M in mile­stones

J&J’s ven­ture arm par­tic­i­pat­ed in the start­up rounds for Pro­tag­o­nist Ther­a­peu­tics’ ear­ly de­vel­op­ment, fu­el­ing its work on a new group of oral pep­tide ther­a­pies built to with­stand a per­ilous jour­ney in the gut. And that front row seat J&J took is now pay­ing added div­i­dends with a Big Phar­ma li­cens­ing pact for the Newark, CA-based biotech’s $PT­GX sec­ond drug in the pipeline.

J&J has come in with a $50 mil­lion up­front — a siz­able amount for a pre­clin­i­cal pro­gram — and a full slate of mile­stones worth up to $940 mil­lion to gain ex­clu­sive world­wide li­cens­ing rights to Pro­tag­o­nist’s PTG-200. The IL-23 pep­tide an­tag­o­nist is be­ing built to treat Crohn’s dis­ease, one of its top in­flam­ma­to­ry bow­el dis­ease tar­gets.

Pro­tag­o­nist’s shares shot up 37% on the news.

This drug has a long way to go. It’s slat­ed to go in­to a Phase I tri­al with healthy hu­mans be­fore be­ing steered in­to an IBD study. But Pro­tag­o­nist has a more ad­vanced lead drug in the clin­ic, which like­ly pro­vid­ed some of the proof-of-con­cept da­ta J&J was look­ing for on the drug class.

Pro­tag­o­nist will part­ner with J&J on the de­vel­op­ment work through Phase II, giv­ing the phar­ma gi­ant rights to car­ry it on from there. And the lit­tle biotech is hang­ing on to co-de­tail mar­ket­ing rights in the US.

In an 8-K fil­ing Tues­day morn­ing, Pro­tag­o­nist pro­vid­ed some key de­tails on the pact you won’t find in the re­lease.  J&J is pay­ing 80% of the shared de­vel­op­ment costs on this drug. If the phar­ma part­ner de­cides to stay on af­ter Phase IIa, J&J will hand over $125 mil­lion. And if it picks up the op­tion for Phase III, J&J will add $200 mil­lion more.

Di­nesh Pa­tel

Pro­tag­o­nist CEO Di­nesh Pa­tel took the com­pa­ny pub­lic in 2016, watched shares dou­ble up and then slide to a lack­lus­ter $8.22 on Fri­day’s close, well be­low its IPO price.

As Pa­tel told me a cou­ple of years ago, the biotech set out to build a new kind of oral pep­tide ther­a­py which could with­stand the harsh en­vi­ron­ment of the stom­ach to do its work. Its lead ther­a­py is PTG-100, an al­pha-4-be­ta-7 (α4β7) in­te­grin-spe­cif­ic pep­tide drug now in a mid-stage pro­gram for ul­cer­a­tive col­i­tis.

Su­san B. Dil­lon, the im­munol­o­gy chief at Janssen, says this part­ner­ship is the lat­est in sev­er­al steps the biotech and phar­ma gi­ant have tak­en to­geth­er.  “To­geth­er with John­son & John­son In­no­va­tion, we have forged a strong re­la­tion­ship with the Pro­tag­o­nist Ther­a­peu­tics team over the course of sev­er­al years.”

“Our oral pep­tide PTG-200 works by block­ing the IL-23 path­way, a mech­a­nism which has been proven by in­jectable an­ti­bod­ies, in­clud­ing an ap­proved drug and oth­ers in dif­fer­ent stages of clin­i­cal de­vel­op­ment,” said David Y. Liu, Pro­tag­o­nist’s chief sci­en­tif­ic of­fi­cer and head of R&D. “As ev­i­denced by PTG-200, we be­lieve our tech­nol­o­gy plat­form is val­i­dat­ed in its abil­i­ty to gen­er­ate po­ten­tial first-in-class oral pep­tides as the next gen­er­a­tion of tar­get­ed ther­a­py drugs for IBD.”

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.

Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,000+ biopharma pros reading Endpoints daily — and it's free.