Arde­lyx rolls out pos­i­tive PhI­II IBS-C da­ta on tena­panor as ri­vals prep for a show­down, but shares crater

Two days ago it was Syn­er­gy Phar­ma’s turn to tout pos­i­tive Phase III da­ta on its drug Tru­lance for ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion. To­day, ri­val Arde­lyx $ARDX is step­ping up with the first of its two Phase III read­outs on tena­panor as the new­com­ers look to chal­lenge Iron­wood’s mar­ket-lead­ing ther­a­py. And at first blush, in­vestors weren’t im­pressed.

All but one of the key da­ta points were all pos­i­tive. In the pri­ma­ry goal, ob­serv­ing the im­pact of their drug in 6 of 12 weeks of ther­a­py, 27% in the tena­panor arm scored a com­plete re­sponse on a sig­nif­i­cant 30% or greater re­duc­tion in ab­dom­i­nal pain and at least one added com­plete bow­el move­ment from base­line — com­pared to 18.7% in the place­bo group.

Mike Raab

There was a key sec­ondary miss, though, on in­di­vid­ual bow­el move­ment rates. Di­ar­rhea could al­so prove trou­ble­some for Arde­lyx, with a rel­a­tive rate of 14.6% for the drug arm vs 1.7% in the place­bo group. 5.9% of the pa­tients tak­ing tena­panor dis­con­tin­ued due to di­ar­rhea, but Arde­lyx CEO Mike Raab has been hit be­fore on di­ar­rhea rates for this drug, and an­a­lysts are like­ly to be re­lieved the rate wasn’t high­er.

Wed­bush’s David Nieren­garten looked the da­ta over and con­clud­ed that the drug looked ap­prov­able, but not a top per­former, land­ing “some­where in be­tween Linzess and Tru­lance (gen­er­al­ly not as ef­fi­ca­cious as Linzess or as well-tol­er­at­ed as Tru­lance). Al­though we view prod­uct as ap­prov­able (as­sum­ing suc­cess in T3MPO-2, read­ing out next half) the re­sults low­er our es­ti­mates and part­ner­ship in­ter­est for the drug, par­tic­u­lar­ly in light of the Tru­lance launch.”

That’s not what back­ers want­ed to hear, and the biotech’s stock cratered, plung­ing 32%.

You can be sure the ri­vals — in­clud­ing the team mar­ket­ing Iron­wood’s Linzess — will seize on any short­com­ings as they be­gin to square off over the mar­ket. Linzess has scored the high­est of the three on ef­fi­ca­cy (34%), with Arde­lyx trail­ing in third place, though all are with­in a few points of each oth­er. Linzess may have the worst rate for di­ar­rhea.

None of these drugs stand out as a dom­i­nant drug on ef­fi­ca­cy, and that may well lead to a near fu­ture sce­nario in which physi­cians send pa­tients home with a sam­pling so they can de­cide which is best for them.

Tru­lance (ple­ca­natide) in­ves­ti­ga­tor Ronald Fo­gel told me ear­li­er in the week that that is what they do in his prac­tice.

David Rosen­baum

“When we look at the to­tal­i­ty of the topline re­sults from T3MPO-1, we be­lieve tena­panor has the po­ten­tial to of­fer ben­e­fit to pa­tients with IBS-C,” said David Rosen­baum, chief de­vel­op­ment of­fi­cer at Arde­lyx. “We are en­cour­aged that the nine of 12 week da­ta demon­strate a durable and sus­tained re­sponse for con­sti­pa­tion and ab­dom­i­nal pain, as well as a nor­mal­iza­tion of bow­el move­ment fre­quen­cy, for many pa­tients. The in­di­vid­ual CS­BM re­spon­der rate from the six of 12 week analy­sis was the one sec­ondary end­point not met and those da­ta are not con­sis­tent with the re­sults from our pre­vi­ous clin­i­cal stud­ies. We plan to as­sess these da­ta along­side the re­sults from T3MPO-2, our six-month Phase 3 study, to eval­u­ate the to­tal ben­e­fit that tena­panor may pro­vide to pa­tients with this ex­treme­ly chal­leng­ing con­di­tion.”

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.

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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.”

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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.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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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.

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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.