Fi­deli­ty, Val­or pool $71.8M for Jeff Aron­in's plan to re­for­mu­late a gener­ic for but­ter­fly skin dis­ease at Cas­tle Creek Phar­ma

Jeff Aronin is back.

To be sure, Aronin didn’t ex­act­ly go away. The for­mer Marathon Phar­ma­ceu­ti­cals CEO mere­ly sold off a con­tro­ver­sial drug, shut­tered his em­bat­tled com­pa­ny, and ducked from the scan­dal (we’ll ex­plain). But he held on as chair­man and chief ex­ec­u­tive of Paragon Bio­sciences, which has con­tin­ued in­cu­bat­ing rare dis­ease ven­tures like Marathon.

For the first time since last May, though, Aronin is now ready to hus­tle an­oth­er re­pur­posed or­phan drug through the reg­u­la­to­ry process — with $71.8 mil­lion he just raised.

The drug, di­ac­ere­in, is a IL-1β in­hibitor used in a num­ber of coun­tries to treat joint swelling or pain, al­though its use has been re­strict­ed in the EU due to the risks of di­ar­rhea and liv­er prob­lems. It is not ap­proved in the US.

Michael Der­by

Cas­tle Creek Phar­ma, a der­ma­tol­ogy-fo­cused biotech in Paragon’s port­fo­lio of six, wants to turn this gener­ic com­pound — usu­al­ly tak­en oral­ly — in­to a top­i­cal oint­ment for the treat­ment of epi­der­mol­y­sis bul­losa sim­plex, a sub­type of the al­ready rare ge­net­ic con­di­tion known as “but­ter­fly skin.”

The com­pa­ny is go­ing to con­tin­ue a Phase II/III study with the mon­ey Paragon just raised from old sup­port­er Fi­deli­ty Man­age­ment & Re­search Com­pa­ny and new in­vestor Val­or Eq­ui­ty Part­ner on its be­half, hav­ing ob­tained the FDA’s rare pe­di­atric dis­ease des­ig­na­tion a few months ago.

Sound fa­mil­iar? It should.

Es­sen­tial­ly, Marathon ran on the same mod­el — buy­ing an old gener­ic steroid avail­able for decades in coun­tries like Cana­da and the UK along with the old da­ta pack­age, then gain­ing an FDA ap­proval through the or­phan chan­nel — un­til a price goug­ing scan­dal blew it up. Where­as some DMD pa­tients in the US had been buy­ing the drug, called de­flaza­cort, from a UK sup­pli­er for lit­tle more than $1,000 a year, Marathon at­tempt­ed to charge a list price of $89,000, pro­vok­ing out­rage from DMD pa­tients and sen­a­tors alike. Marathon swift­ly sold the drug, now Em­flaza, to PTC Ther­a­peu­tics and closed its doors.

The key dif­fer­ence here, of course, is that Cas­tle Creek is go­ing af­ter a dif­fer­ent in­di­ca­tion than the gener­ic has been used to treat. The com­pa­ny, split be­tween of­fices in Par­sip­pa­ny, NJ and Chica­go, has not brought up price in its dis­cus­sions so far.

In an ear­li­er Phase II clin­i­cal tri­al in­volv­ing 17 young EBS pa­tients, the drug was shown to help 40% of them re­duce the num­ber of blis­ters in treat­ed ar­eas by 60%, com­pared to 15% for place­bo.

Michael Der­by, pres­i­dent and gen­er­al man­ag­er of the CNS unit at Marathon, is the co-founder and CEO of Cas­tle Creek.

“We are fo­cused on de­vel­op­ing CCP-020 as an im­por­tant treat­ment for EBS and look for­ward to tar­get­ing the new in­vest­ment from Fi­deli­ty and Val­or to­wards the late-stage de­vel­op­ment of this in­ves­ti­ga­tion­al drug,” he said in a state­ment.

Im­age: Jeff Aronin.

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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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.

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).

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.

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