Sunovion slammed by FDA re­jec­tion of neb­u­lized LAMA for COPD as ri­val lines up a com­pet­ing NDA

The FDA has re­ject­ed a new COPD ther­a­py from the US sub­sidiary of Sum­it­o­mo Dainip­pon, but there’s no word on what trig­gered the CRL. The set­back of­fers Ther­a­vance Bio­phar­ma $TBPH and its part­ner My­lan a chance to catch up with a promi­nent ri­val ther­a­py that’s wind­ing through the fi­nal months of a late-stage pro­gram.

Late on Fri­day lead­ing in­to the long Memo­r­i­al Day week­end, Sunovion put out a short state­ment say­ing on­ly that reg­u­la­tors had is­sued a com­plete re­sponse let­ter for SUN-101 (dubbed gly­copy­rro­late, which is used with an ex­per­i­men­tal neb­u­liz­er), its top late-stage ther­a­py. The Marl­bor­ough, MA-based biotech added that reg­u­la­tors were not de­mand­ing any new tri­als and that ex­ecs would work with the FDA on mov­ing for­ward.

The twice-dai­ly ther­a­py aimed at be­com­ing the first neb­u­lized long-act­ing mus­carinic an­tag­o­nist for COPD af­ter the com­pa­ny claimed back-to-back suc­cess­es in Phase III — though their lat­est up­date on the da­ta didn’t in­clude key re­sults on trough FEV1.

Sunovion, which was es­tab­lished through a 2010 deal by Sum­it­o­mo Dainip­pon to ac­quire Sepra­cor for $2.6 bil­lion, got this drug 5 years ago in a $430 mil­lion buy­out — $100 mil­lion up front — bag­ging El­e­va­tion Phar­ma­ceu­ti­cals right af­ter it boast­ed about “gold stan­dard” Phase IIb COPD da­ta for its top drug EP-101.

Over the past year the Japan­ese sub has been lead­ing the race with Ther­a­vance, which has boast­ed about the once-dai­ly neb­u­lized ther­a­py it’s been work­ing on. Un­like Sunovion’s lat­est state­ment, Ther­a­vance and its part­ner My­lan post­ed Phase III da­ta, with an eye on fil­ing for an ap­proval for reve­fe­nacin lat­er in the year when their safe­ty study wraps. Their sta­tis­ti­cal­ly sig­nif­i­cant re­sults:

The im­prove­ments in trough FEV1, the pri­ma­ry ef­fi­ca­cy end­point, ver­sus place­bo for the in­tent-to-treat pop­u­la­tions across both stud­ies were 118 mL and 145 mL for 88 mcg and 175 mcg, re­spec­tive­ly (p ≤ 0.001).

Here, by com­par­i­son, are the re­sults Sunovion har­vest­ed:

Place­bo-ad­just­ed change from base­line in trough FEV1 at Week 12 (ITT pop­u­la­tions)

Ther­a­vance and My­lan — which bought in­to the part­ner­ship in 2015 with $45 mil­lion for an up­front and eq­ui­ty stake — say they plan to file for an ap­proval lat­er in the year. Sunovion has not re­leased a time­line of its own.

Sunovion has gen­er­al­ly kept a low pro­file over the last 7 years. But it’s been do­ing a few deals to build up the US pipeline. Last fall CEO Nobuhiko Tamu­ra no­tably bagged Cy­nap­sus and its late-stage Parkin­son’s drug for $640 mil­lion.

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.

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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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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