Acor­da’s aw­ful, no good, just plain bad week gets worse as FDA hands ex­ecs an­oth­er de­lay on In­bri­ja — bat­tered shares tum­ble again

Acor­da’s sna­fu-plagued at­tempt to get a fast FDA mar­ket­ing de­ci­sion on a crit­i­cal­ly im­por­tant new drug has just run in­to a fresh set­back — and it’s painful to watch.

Two days af­ter the biotech’s shares $ACOR cratered on the loss of an ap­peal aimed at pro­tect­ing its patents on Ampyra — its on­ly re­al as­set on the mar­ket — the biotech is back with news that the FDA wants more time to con­sid­er new in­fo it asked for on CMC re­lat­ed to In­bri­ja (lev­odopa in­hala­tion pow­der), adding a three-month de­lay to the process and ex­tend­ing the PDU­FA to Jan­u­ary 5 of next year.

Ron Co­hen

Usu­al­ly a de­lay of this na­ture would be seen as a speed bump to a bio­phar­ma com­pa­ny. But Acor­da’s first at­tempt to file their ap­pli­ca­tion was met with a rare refuse-to-file no­tice, say­ing the pack­age was in­com­plete. That forced the com­pa­ny to re­set the clock on In­bri­ja, a Parkin­son’s drug which it needs to start mar­ket­ing last year, as they look to re­place Ampyra with the new drug.

Ev­i­dent­ly, though, the re-filed ap­pli­ca­tion was still light on re­quired in­for­ma­tion. And at this stage that qual­i­fies as an­oth­er self-in­flict­ed wound Acor­da can’t af­ford. Now’s the time to ex­e­cute, not ex­plain.

Paul Mat­teis at Stifel was quick to weigh in Thurs­day morn­ing.

We ex­pect the stock to be un­der pres­sure on the news; one of the over­ar­ch­ing fears (or bear cas­es) has been that as a drug-de­vice com­bo, In­bri­ja, de­spite hav­ing rel­a­tive­ly clean clin­i­cal da­ta, is at greater than av­er­age risk of re­ceiv­ing a com­plete re­sponse let­ter. In turn, the ex­ten­sion, ac­cord­ing to Acor­da, is re­lat­ed to re­cent sub­mis­sions made by the com­pa­ny re­gard­ing “CMC” (man­u­fac­tur­ing). FDA de­ter­mined these sub­mis­sions con­sti­tute a ma­jor amend­ment – such de­ter­mi­na­tion is a stan­dard ra­tio­nale for ex­tend­ing a PDU­FA date by 3 months (from Oc­to­ber to now Jan­u­ary). Our the­sis on the stock is that In­bri­ja is like­ly to at­tain ap­proval and even­tu­al­ly grow in­to an im­por­tant drug for Parkin­son’s OFFs, but that the ini­tial roll­out may be slow.

Ampyra, mean­while, faces im­mi­nent gener­ic com­pe­ti­tion for the fran­chise that will carve it to a frac­tion of its for­mer size as the com­pa­ny waits im­pa­tient­ly to get on the field with their new drug — pro­vid­ed they get an OK, which is not guar­an­teed.

Ear­li­er in the week the com­pa­ny’s stock dropped 25%. This morn­ing it’s down 17% in pre-mar­ket trad­ing.

“We look for­ward to con­tin­u­ing our con­struc­tive di­a­logue with FDA,” said Acor­da CEO Ron Co­hen in a state­ment. 

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.

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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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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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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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).

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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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.