Paratek shares shoot up on a pos­i­tive PhI­II and a slow-mo shot at FDA/EMA OK for its an­tibi­ot­ic

Chem­i­cal Struc­ture

Shares of Paratek shot up 30% $PRTK in af­ter-mar­ket trad­ing on Mon­day as in­vestors re­act­ed to the Boston biotech’s procla­ma­tion of a clean sweep for its piv­otal test of its new an­tibi­ot­ic omada­cy­cline. Ex­ecs said that their broad spec­trum an­tibi­ot­ic hit its pri­ma­ry and sec­ondary end­points for the FDA as well as the co-pri­maries need­ed for the EMA in their sec­ond pos­i­tive late-stage tri­al.

Re­searchers went look­ing for ev­i­dence that omada­cy­cline matched up with mox­i­floxacin in the treat­ment of pa­tients with com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CABP). And that’s what they got, with ear­ly clin­i­cal re­sponse rates scor­ing 81.1 % and 82.7% in new and old an­tibi­otics.

Evan Loh, Paratek

The co-pri­ma­ry end­points for the EMA were non-in­fe­ri­or­i­ty in the in­tent-to-treat group and the evalu­able CABP pop­u­la­tions in those pa­tients with Pneu­mo­nia Sever­i­ty In­dex (PORT) III and IV at the post treat­ment eval­u­a­tion time point. And the safe­ty pro­file looked com­pa­ra­ble as well. Fol­low­ing a suc­cess­ful Phase III for skin in­fec­tions, Paratek has the two pos­i­tive stud­ies it needs to sat­is­fy the FDA.

This an­tibi­ot­ic is start­ed as an IV and doc­tors can then switch to an oral ver­sion.

An­tibi­ot­ic de­vel­op­ment, though, can be a slow process and Paratek says it has around a year left on the clock be­fore it files for an ap­proval. The ap­pli­ca­tions may ar­rive at the FDA “as ear­ly as” Q1 2018, the com­pa­ny says, with the EMA on the re­ceiv­ing end some­time af­ter that.

With ap­pli­ca­tions that late, don’t look for any po­ten­tial ap­provals be­fore late 2018.

While the threat of drug re­sis­tant bac­te­ria has in­creased the need for new an­tibi­otics, Paratek is one of on­ly a hand­ful of biotechs which dived in­to this area. There are a num­ber of cheap, gener­ic an­tibi­otics avail­able for front­line use. And any new an­tibi­ot­ic is go­ing to face an up­hill bat­tle gain­ing trac­tion in this mar­ket.

Leerink not­ed re­cent­ly:

For 2025 we cur­rent­ly mod­el ~$230MM and ~$330MM op­por­tu­ni­ties in skin and pneu­mo­nia and al­so in­clude a small amount of risk-ad­just­ed (at 15%) cred­it for uri­nary tract in­fec­tion.

Paratek and its US part­ner Al­ler­gan $AGN post­ed pos­i­tive da­ta from two Phase III stud­ies of sara­cy­cline for ac­ne. But Al­ler­gan con­trols the bulk of the rev­enue, and the com­pa­ny ex­pects peak sales to tap out around $275 mil­lion. That FDA ap­pli­ca­tion will ar­rive soon­er, though, with reg­u­la­tors get­ting the pack­age in the sec­ond half of this year.

“We now have ex­pe­ri­ence with omada­cy­cline in more than 1,500 pa­tients in our clin­i­cal pro­gram and we are very pleased with the safe­ty, tol­er­a­bil­i­ty, and ef­fi­ca­cy pro­file that we have seen to date,” said Evan Loh, pres­i­dent and CMO at Paratek.

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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