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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

David Veitch, Basilea CEO

Basilea toss­es an on­col­o­gy drug back to Mer­ck, dou­bling down on an­tibi­otics in re­vamp

Swiss biotech Basilea Pharmaceutica has shed one of its last pipeline ties with oncology as it makes a move to concentrate on antibiotics in a race to profitability next year. And they’ve followed up on that with news of a Phase III success they believe can help expand prospects for a key franchise player.

The company put out word on Monday that the execs are handing rights to the FGFR inhibitor derazantinib back to Merck by the end of this year as it shuts down clinical work on the tumor checkpoint controller lisavanbulin. They’re still working on partnering that out along with their TTK/PLK1-inhibitor BAL0891 and preclinical oncology assets.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.