Acor­da is shift­ing in­to sur­vival mode. And it’s go­ing to start by ax­ing more than 100 staffers.

PHO­TO: Co­hen at BIO 2016


One month af­ter a US dis­trict court tossed four key patents on its flag­ship drug Ampyra, leav­ing it with one to stand on in­to next year, Acor­da $ACOR is chop­ping 20% of its staff as it scram­bles to re­struc­ture while gam­bling that it can field new drugs in short or­der. Those cuts will fall dis­pro­por­tion­ate­ly on the com­pa­ny’s R&D staff, CEO Ron Co­hen tells me, as Acor­da cir­cles its wag­ons around its two late-stage drugs while con­serv­ing its mar­ket­ing mus­cle.

The shift calls for a move away from the ear­ly-stage clin­i­cal work at the biotech, which leaves an ar­ray of pro­grams on the ta­ble for pos­si­ble deals as Co­hen’s team takes a look at mon­e­tiz­ing as­sets, in­clud­ing its ex­ist­ing roy­al­ty streams. And there are oth­er op­er­at­ing cost cuts be­ing planned as well. But the CEO leaves no doubt that it’s the staff cuts that hurt.

“This is trau­mat­ic for the en­tire or­ga­ni­za­tion,” he says. But it’s up to the lead­ers in the group now to “hold it to­geth­er and keep fo­cused so we can move ahead.”

Co­hen couldn’t spec­i­fy ex­act­ly how many staffers are be­ing cut in the re­struc­tur­ing, but said the com­pa­ny had 500 to 600 staffers and is cut­ting 20% of them. That cut will save the com­pa­ny $21 mil­lion a year.

Not on the chop­ping block: The mar­ket­ing team. If the com­pa­ny does lose patent pro­tec­tion on Ampyra in the sum­mer of 2018, says the CEO, the team can shift “seam­less­ly” to CVT-301 — pro­vid­ed it wins an ap­proval on sched­ule af­ter be­ing filed lat­er in this quar­ter.

Their mul­ti­ple scle­ro­sis drug Ampyra wasn’t just Acor­da’s main drug, it was a life­line and sup­port for every­thing the com­pa­ny was plan­ning for its pipeline. The ther­a­py pro­vid­ed $493 mil­lion out of $520 mil­lion in rev­enue last year. And with gener­ics loom­ing as ear­ly as 2018 – though the com­pa­ny is ap­peal­ing the court rul­ing and hasn’t giv­en up the fight — all re­main­ing hands will be on deck hus­tling up a loom­ing NDA for its lead ther­a­py while push­ing a fol­low-up drug, tozadenant, for Parkin­son’s through late-stage test­ing in ear­ly 2018.

Acor­da has $159 mil­lion in cash to help fund the tran­si­tion stage.

The re­or­ga­ni­za­tion can’t come as a sur­prise. Co­hen has blunt­ly told an­a­lysts on sev­er­al oc­ca­sions that he was pre­pared to cut, and cut deep, to pre­serve the com­pa­ny in the event of a set­back on the patent front.

Among the as­sets Co­hen will look to part­ner or li­cense out:

— rHIgM22, a re­myeli­nat­ing an­ti­body be­ing stud­ied for the treat­ment of mul­ti­ple scle­ro­sis in a sec­ond Phase I study.

— BTT1023, a ful­ly hu­man mon­o­clon­al an­ti­body that tar­gets VAP-1 (vas­cu­lar ad­he­sion pro­tein-1). That’s an as­set from Bi­otie.

— Tozadenant has al­so aroused some in­ter­est in its us­es in on­col­o­gy, which could help kin­dle a pact.

Co­hen would like to keep SYN0120, though, a dual-mech­a­nism drug which could have broad us­es in psy­chosis and cog­ni­tion that ex­tend fur­ther than its im­me­di­ate in­ter­est in Parkin­son’s dis­ease.

It’s not what he want­ed for Acor­da, but Co­hen sounds re­solved to do what he has to to get through un­cer­tain times.

“The fact that a sin­gle judge can com­plete­ly up-end every­one’s ex­pec­ta­tions is a pro­found risk,” says Co­hen. And in biotech, risks tran­scend any one area, stretch­ing from a huge risk of clin­i­cal fail­ure through reg­u­la­to­ry risk, re­im­burse­ment risk and on to patent risk.

“It reem­pha­sizes just how risky this busi­ness is,” says the CEO. Build­ing a com­pa­ny in biotech re­quires some hard choic­es in nav­i­gat­ing risk and ad­vanc­ing new prod­ucts. And Acor­da is at a cross­roads.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Massachusetts-based, oncolytic virus biotech Replimune is feeling bullish now that it has lifted the cover on data for its lead product.

Replimune said Thursday it looks to nab about $225 million from a public offering after giving a snapshot of some initial data from its IGNYTE clinical study earlier this week. The trial is investigating RP1 in combination with Opdivo, for patients with melanoma and who did not have a response when being treated with a PD-1.