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. 

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.