Al­ler­gan, Richter steer past an­oth­er late-stage pile­up with cariprazine

Cariprazine’s hit-and-miss record in late-stage de­vel­op­ment has been ex­tend­ed by a sting­ing set­back. In­ves­ti­ga­tors for Al­ler­gan ($AGN) and its part­ner Gedeon Richter say that the drug flopped in a Phase III de­pres­sion study, but will nev­er­the­less go back in­to an­oth­er piv­otal study in search of more promis­ing re­sults.

Per­sis­tence in late-stage work is the on­ly rea­son this drug is still in the spot­light. Back in ear­ly 2015 I cov­ered their small, suc­cess­ful Phase III tri­al for cariprazine in schiz­o­phre­nia, which was good enough for the de­vel­op­ers to send back to the FDA for a lat­er ap­proval (as Vray­lar), even though they had re­ject­ed the drug in 2013. Richter has dogged­ly main­tained its faith in the drug af­ter once pro­ject­ing peak po­ten­tial sales at a block­buster rate of $2 bil­lion a year, which shrinks to $200 mil­lion in the hands of some an­a­lysts.

As the com­pa­nies not­ed in their state­ment this morn­ing, it’s not un­usu­al for a Phase III de­pres­sion study to fail. Alk­er­mes re­cent­ly ran in­to the same is­sue with its first shot at a Phase III. The com­pa­ny failed and saw $4 bil­lion in mar­ket cap dis­solve, though it too be­lieves that a fol­lowup Phase III can still de­liv­er the goods. The track record on Phase III de­pres­sion stud­ies is lit­tered with fail­ure and just the oc­ca­sion­al suc­cess.

Reg­u­la­tors of­ten re­quire sev­er­al late-stage stud­ies for a de­pres­sion drug, large­ly be­cause the place­bo ef­fect can be so strong in a de­pres­sion study it’s the on­ly way to ad­vance new drugs, which of­ten go on to be­come wild­ly hit-and-miss in a ther­a­peu­tic mar­ket that re­quires plen­ty of ex­per­i­men­ta­tion. In­ves­ti­ga­tors point­ed to an­oth­er study (MD-75) in which they say they got a pos­i­tive read­out for de­pres­sion, but this time around the drug arm failed to sep­a­rate from a place­bo, of­fer­ing no more help than a sug­ar pill.

Richter didn’t lose the same per­cent­age of eq­ui­ty as Alk­er­mes, but its stock was still dam­aged on the news.

David Nichol­son, Chief R&D Of­fi­cer, Al­ler­gan

The com­pa­nies are al­so con­duct­ing two Phase III stud­ies for bipo­lar de­pres­sion. Al­ler­gan wound up with rights to the drug af­ter a se­ries of merg­ers, trac­ing its own­er­ship back to a pact by For­est Lab­o­ra­to­ries.

“We are dis­ap­point­ed with the re­sults of this tri­al. How­ev­er, we be­lieve that our plan to move for­ward with an­oth­er Phase III study in (ma­jor de­pres­sion) cou­pled with our pre­vi­ous pos­i­tive clin­i­cal tri­al would pro­vide the two stud­ies need­ed for sub­mis­sion. This is an im­por­tant next step to fur­ther de­vel­op the cariprazine pro­gram,” said David Nichol­son, chief R&D of­fi­cer at Al­ler­gan.

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.