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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Jeff Albers, Blueprint Medicines CEO

Look­ing past Big Phar­ma ri­vals, Blue­print buys a pre­clin­i­cal biotech for $250M+

J&J’s Rybrevant scored the first approval back in May for a small group of lung cancer patients with a rare EGFR mutation. Despite a swarm of other biopharma companies angling for a piece of that market, Blueprint Medicines is betting nearly $500 million on a candidate it thinks will stand out.

Blueprint is putting down $250 million in cash and another $215 million in biobucks for Lengo Therapeutics and its preclinical non-small cell lung cancer program LNG-451. Though it hasn’t been tested in humans, Blueprint says the candidate was “highly brain-penetrant” in preclinical trials, and has the potential to inhibit all common EGFR exon 20 insertion variants — which are found in just 2% to 3% of NSCLC patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.

What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.

Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC Forbion is hopping on the ever-lengthening SPAC train.

To be led by Jasper Bos, who joined Forbion Growth as a general partner back in May just after the fund closed at $428 million, Forbion European Acquisition will target late-stage opportunities in the life sciences industry in Europe to merge with and bring onto Nasdaq.

Cyril Lesser, senior controller at Forbion, will be the CFO while Bos serves as CEO.