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.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Is there a recipe for M&A suc­cess? The best and worst buy­out deals in the past decade of­fer some keys to suc­cess — and fail­ure

It’s not easy achieving a solid win in M&A in this industry. But if you follow a few simple guidelines, you may be able to increase your odds of success.
Geoffrey Porges and the team at SVB Leerink went about the “notoriously difficult” task of scoring the biopharma buyout of 2009 to 2019. Sizing up current and expected revenue from the products that were gained, they came up with the 5 winners:
Merck/Schering Plough
Bristol/Medarex
Gilead/Pharmasset
Sanofi/Genzyme
AstraZeneca/Acerta
It says a lot about the field that it’s much easier sorting out the 5 worst deals, though there’s also a lot more competition for that title, notes Porges. As picked by the analysts:
J&J/Actelion
Merck/Cubist
Alexion/Synageva
AbbVie/Stemcentrx
Gilead/Kite

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