CEO Ron Cohen (Acorda)

Acor­da of­floads man­u­fac­tur­ing op­er­a­tions to Catal­ent for $70M amid lat­est re­struc­tur­ing to keep the ship afloat

Just over a year af­ter the Supreme Court quashed any hopes Acor­da had of pro­tect­ing its once-lu­cra­tive mul­ti­ple scle­ro­sis drug Ampyra from cheap­er knock­offs, the New York biotech con­tin­ues to bleed cash. Now, as part of its third re­struc­tur­ing since 2017, the drug­mak­er is of­fload­ing one of its key as­sets.

As part of a sweep­ing over­haul Acor­da will sell its man­u­fac­tur­ing op­er­a­tions for In­bri­ja — an in­haled pow­der for­mu­la­tion of lev­odopa — to Catal­ent for $70 mil­lion in up­front cash that will save Acor­da an ad­di­tion­al $10 mil­lion.

Catal­ent will ab­sorb all Acor­da em­ploy­ees who work at the Chelsea, MA fa­cil­i­ty, but that’s not the case for much of the com­pa­ny’s re­main­ing work­force. CEO Ron Co­hen an­nounced that be­tween the Ard­s­ley, NY head­quar­ters and its Waltham, MA fa­cil­i­ty, Acor­da would lay off rough­ly 16% of its work­force.

Co­hen por­trayed the re­struc­tur­ing, which is es­ti­mat­ed to re­duce op­er­at­ing ex­pens­es by $40 mil­lion, as “dif­fi­cult” but need­ed, and a way to bol­ster Acor­da’s bal­ance sheet and en­sure that the sup­ply of In­bri­ja was not in­ter­rupt­ed.

“The re­struc­tur­ing is nec­es­sary for Acor­da to have an in­fra­struc­ture and ex­pens­es that are right-sized for our prod­ucts and rev­enue,” Co­hen said. “This is a dif­fi­cult step for us all, not least for those who will no longer be em­ployed at the com­pa­ny.”

The sale of the man­u­fac­tur­ing op­er­a­tions is ex­pect­ed to close in the first quar­ter, the com­pa­ny said in a press re­lease.

Acor­da on Wednes­day al­so an­nounced it had en­tered in­to a $15.25 mil­lion at-the-mar­ket of­fer­ing, which comes less than two weeks af­ter a re­verse 1-for-6 stock split. That split re­duced the com­pa­ny’s to­tal stock shares from 371 mil­lion to 61.6 mil­lion af­ter the stock price had fall­en be­low the re­quired $1 per share price to con­tin­ue trad­ing on the Nas­daq.

The com­pa­ny last re­struc­tured in Oc­to­ber, when Co­hen slashed a quar­ter of Acor­da staff while cut­ting back R&D and SG&A ex­pens­es af­ter Ampyra rev­enue plum­met­ed and In­bri­ja rev­enue wasn’t near­ly enough to make up the dif­fer­ence. Ampyra rev­enue con­tin­ued to drop in Q4, falling from $37 mil­lion in Q3 to $25 mil­lion (the drug brought in $138 mil­lion in net rev­enue in 2018 Q3).

In 2017, Acor­da laid off 20% of its staff (which at the time amount­ed to over 100 staffers) in an ef­fort to pre­empt loom­ing loss­es over the Ampyra patent de­ba­cle. That move saved the com­pa­ny $21 mil­lion, but those moves didn’t ul­ti­mate­ly staunch the bleed­ing.

Acor­da didn’t an­nounce specifics Wednes­day on any plans to re­struc­ture its debt — which End­points News re­port­ed in Oc­to­ber sat around $345 mil­lion — oth­er than to say the man­u­fac­tur­ing op­er­a­tions sale would pro­vide more flex­i­bil­i­ty to “re­duce” debt.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Robert Habib (file photo)

Once laser-fo­cused on liv­er, Mi­NA takes swing at neu­rol­o­gy with Servier's back­ing

Once focused on hard-to-treat liver diseases, MiNA Therapeutics is joining forces with Servier to engage its small activating RNA technology on another difficult front: neurology.

MiNA and Servier announced a new research alliance Thursday centered around neurological disorders. While the partners are keeping quiet about their targets for now, MiNA CEO Robert Habib vaguely revealed that the first one was nominated by Servier, which has an option over it. MiNA stands to receive up to $266.3 million (€220 million) in an upfront payment and milestones on that target alone, though they declined to break those numbers down any further.