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.

The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

Gilead CEO Daniel O'Day attends a meeting with the President and other biopharma leaders at the White House on March 2, 2020 (AP Photo)

Ramp­ing up glob­al pro­duc­tion of remde­sivir, Gilead CEO Dan O’Day de­tails plans to dis­trib­ute 1.5M dos­es to fight Covid-19 — for free

Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.

In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.

An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.

Af­ter putting aside a bit­ter le­gal feud, Al­ny­lam and Dicer­na chiefs make nice with an RNAi col­lab­o­ra­tion

John Maraganore and Douglas Fambrough used to be at each other’s throats as Alnylam pursued claims that its RNAi rivals at Dicerna had improperly purloined the IP it had picked up from Merck in a bargain basement fire sale.

But that was all settled up close to 2 years ago with a settlement from Dicerna’s Fambrough. And now the two are moving ahead in a close R&D partnership that makes them collaborators on a couple of key disease targets.