Af­ter a $200M fi­nanc­ing, High­land Ther­a­peu­tics falls silent on AD­HD drug’s fate as PDU­FA sails by

David Lick­r­ish

Back at the be­gin­ning of this year, the folks at Toron­to-based High­land Ther­a­peu­tics cel­e­brat­ed a $200 mil­lion fi­nanc­ing com­plet­ed through Mor­gan Stan­ley. That cash, they said, would go to com­mer­cial­iz­ing their AD­HD drug HLD200 through their whol­ly owned sub­sidiary Iron­shore, tout­ing a drug they have fre­quent­ly her­ald­ed as a break­through in the field as it faced a Ju­ly 30 PDU­FA date. They even hired some Shire vets to help grab mar­ket share.

But that PDU­FA dead­line has come and gone and there’s no word on what the FDA has done with it. And the com­pa­ny CEO tells me there isn’t go­ing to be.

Con­tact­ed by phone, David Lick­r­ish told me ear­li­er to­day that “we’re still in dis­cus­sions with the agency.” Pressed that the FDA would ei­ther re­ject the drug, OK it or de­lay the de­ci­sion — pick one — Lick­r­ish told me I’d caught him at a bad time and he’d get back to me.

In an email, he stuck with no com­ment.

With re­spect to the fil­ing, as a pri­vate­ly held com­pa­ny, and for com­pet­i­tive rea­sons, we are not com­ment­ing on the sta­tus of our NDA.  Hav­ing said that our pack­age con­tained 10 tri­als in­clud­ing two piv­otal stud­ies which at­tempt to eval­u­ate AD­HD dur­ing both the ear­ly morn­ing rou­tine and evening rou­tine pe­ri­ods, us­ing rat­ing scales not cur­rent­ly in Clin­i­cal Out­comes and As­sess­ment Com­pendi­um.  Be­yond this we won’t be com­ment­ing fur­ther on the on­go­ing in­ter­ac­tions with the Agency.

I asked the FDA for com­ment, which has stuck with a strict no com­ment pol­i­cy of its own be­fore Scott Got­tlieb ar­rived and ad­vo­cat­ed pub­lish­ing the CRLs.

They haven’t changed — yet. Their re­sponse:

Please un­der­stand that in­for­ma­tion about an ap­pli­ca­tion is con­fi­den­tial un­less it has been pub­licly dis­closed by a spon­sor.

At the time of the fi­nanc­ing in Jan­u­ary, Craig Lewis, pres­i­dent of Iron­shore Phar­ma­ceu­ti­cals, cel­e­brat­ed the com­pa­ny’s loom­ing trans­for­ma­tion from an R&D com­pa­ny to a full-fledged op­er­a­tion with a com­mer­cial­iza­tion wing. HLD200, he said in a state­ment, was on its way to be­com­ing a stan­dard ther­a­py for AD­HD. He added: “Our com­mer­cial or­ga­ni­za­tion is be­ing pur­pose-built with this ob­jec­tive in mind.”

In the mean­time, the com­pa­ny al­so her­ald­ed the ar­rival of two Shire vet­er­ans — Bar­ry K. Her­man as SVP, head of med­ical af­fairs and Paul J. Casano­va as SVP of sales. Shire has a ma­jor AD­HD fran­chise.

I would sus­pect that af­ter all the buildup, an ap­proval would have been shout­ed from the roof tops. So there may well have been at least been a snag in their plans. Or worse. The way the rules work now, a pri­vate com­pa­ny is free to say what­ev­er it likes. Or noth­ing at all.

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

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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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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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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