Leo Phar­ma lines up an op­tion to buy Bridge­Bio's Pelle­Pharm and its PhI­II rare skin can­cer drug

Der­ma­tol­ogy com­pa­ny Leo Phar­ma’s vo­ra­cious ap­petite for part­ner­ships has been fu­eled with yet an­oth­er deal, this time with Bridge­Bio’s Pelle­Pharm. The Dan­ish drug­mak­er has tak­en a mi­nor­i­ty stake and agreed to pro­vide R&D sup­port to the Bay Area com­pa­ny, which is set to test its rare skin can­cer drug, patideg­ib, in a Phase III tri­al.

The cen­tu­ry old drug­mak­er, which con­sum­mat­ed a deal to swal­low Ger­man gi­ant Bay­er’s pre­scrip­tion der­ma­tol­ogy busi­ness in the Unit­ed States in ad­di­tion to forg­ing pacts with Mor­phoSys and Zymeworks $ZYME ear­li­er this year, has ini­tial­ly com­mit­ted $70 mil­lion com­prised of eq­ui­ty fi­nanc­ing and fi­nan­cial R&D sup­port for a late-stage tri­al eval­u­at­ing Pelle­Pharm’s patideg­ib for Gor­lin syn­drome – a rare, ge­net­ic skin dis­ease that af­fects 10,000 in the Unit­ed States.

Sanuj Ravin­dran

Un­der the terms of the deal, Leo Phar­ma has the op­tion to buy Pelle­Pharm, with the lat­ter and its stock­hold­ers el­i­gi­ble to re­ceive up to an ad­di­tion­al $690 mil­lion in­clud­ing merg­er con­sid­er­a­tion and mile­stone pay­ments. If the drug is ap­proved, Pelle­Pharm stock­hold­ers are al­so el­i­gi­ble to re­ceive a dou­ble-dig­it roy­al­ty up­on achiev­ing cer­tain com­mer­cial mile­stones.

Patideg­ib is a top­i­cal gel for­mu­la­tion de­signed to treat Gor­lin syn­drome, char­ac­ter­ized by mu­ta­tions in the tu­mor sup­pres­sor gene en­cod­ing Patched1 (PTCH1), which acts as the pri­ma­ry in­hibitor of the hedge­hog sig­nal­ing path­way that is known to play a role in cel­lu­lar func­tion and tis­sue de­vel­op­ment; this cul­mi­nates in the for­ma­tion of hun­dreds of basal cell car­ci­no­mas (BCCs), es­pe­cial­ly on on the face and sun-ex­posed ar­eas. With no FDA-ap­proved treat­ments for the dis­ease, the stan­dard-of-care is surgery, with pa­tients suf­fer­ing from a se­vere form of Gor­lin syn­drome un­der­go­ing as many as 30 pro­ce­dures an­nu­al­ly.

Ervin Ep­stein

Pelle­Pharm is ex­pect­ed to be­gin re­cruit­ing pa­tients for the Phase III in the first quar­ter of next year, and the com­pa­ny ex­pects to have a da­ta read­out by the sec­ond half of 2020, chief Sanuj Ravin­dran told End­points News, adding that if all goes well, he an­tic­i­pates ap­proval by 2021. Mid-stage da­ta on the drug, which has se­cured the or­phan drug sta­tus and break­through ther­a­py des­ig­na­tion from the FDA, have shown promise in mit­i­gat­ing BCC tu­mors in pa­tients with Gor­lin syn­drome by block­ing the dis­ease at its source with­in the hedge­hog sig­nal­ing path­way. The gel for­mu­la­tion is be­ing de­vel­oped to elim­i­nate the need for surg­eries.

Pelle­Pharm’s founders de­vel­oped a top­i­cal gel for­mu­la­tion af­ter li­cens­ing the drug from In­fin­i­ty Phar­ma­ceu­ti­cals, to help al­le­vi­ate cer­tain sys­temic ad­verse events ob­served with oral hedge­hog in­hibitors, such as Roche’s $RHB­BY Erivedge. Al­though Ravin­dran did not dis­close pric­ing plans for the drug, he not­ed oral HHIs are priced at around $100,000 an­nu­al­ly.

Pelle­Pharm was con­ceived by Ervin Ep­stein, Jean Tang, and Phil Beachy in 2012, as they had worked with oral HHIs and saw the need to de­vel­op such treat­ments with a more tol­er­a­ble safe­ty pro­file. Michael Hen­der­son, who co-found­ed Pelle­Pharm while at med­ical school aged 22, is now in charge of hunt­ing down po­ten­tial as­sets for Bridge­Bio to snap up.

In 1908, phar­ma­cists Au­gust Kong­st­ed and An­ton An­tons bought the Leo Phar­ma­cy in Copen­hagen, Den­mark. From start­ing out in the base­ment of the phar­ma­cy, to­day Leo Phar­ma’s prod­ucts — main­ly with­in der­ma­tol­ogy and throm­bo­sis — are used in over 100 coun­tries.

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.