Bio­gen, UCB step up to kick the tires at Acor­da as buy­out buzz grows — re­port

Ron Co­hen

Acor­da $ACOR CEO Ron Co­hen ap­pears to have stirred up some high-lev­el in­ter­est in a po­ten­tial auc­tion.

Ru­mors have been swirling that days af­ter the biotech re­port­ed­ly brought in ad­vis­ers to help prep for a sale, some bid­ders have be­gun to step up to the ta­ble. And ear­ly Fri­day Bloomberg re­port­ed that Bio­gen and UCB have stepped up to kick the tires, along with pos­si­ble in­ter­est from Asian drug­mak­ers.

The one key as­set on the ta­ble right now is the lev­odopa drug CVT-301, which is back in front of reg­u­la­tors af­ter the FDA kicked it back with a refuse-to-file let­ter.

Acor­da has seen its share price swell back up as talk of a buy­out be­gan to heat up 12 days ago. Its mar­ket cap is at $1.16 bil­lion, and the spec­u­la­tion now cen­ters on what kind of a pre­mi­um the strug­gling biotech can fetch for its one key as­set.

Buy­out buzz, though, is just what the mar­ket loves the most. And this morn­ing Acor­da’s shares are up 17% in pre-mar­ket trad­ing.

At JP­Mor­gan, Co­hen of­fered a best case sce­nario for their late-stage drug, say­ing they had boost­ed the mar­ket po­ten­tial for the ther­a­py to $800 mil­lion. Tout­ing prospec­tive num­bers like that dur­ing the an­nu­al con­fab — a pa­rade of bull­ish talk — un­der­scored the auc­tion process that was un­der­way.

The set­back on CVT-301, though, high­light­ed the per­ilous po­si­tion that Acor­da and Co­hen’s team find them­selves in af­ter a judge in­val­i­dat­ed key patents for Ampyra last year. The biotech now ex­pects to start to lose the fran­chise to gener­ic com­pe­ti­tion mid-year and was anx­ious­ly hus­tling ahead with CVT-301 to re­place Amypra, which has pro­vid­ed the bulk of the com­pa­ny’s op­er­at­ing cash.

Just two months ago Acor­da had to scrap its late-stage drug tozadenant af­ter 5 pa­tients died in a clin­i­cal tri­al. Acor­da paid $363 mil­lion in cash to ac­quire a Finnish com­pa­ny so it could add the drug to the pipeline.

Even be­fore the litany of pipeline dis­as­ters oc­curred, the cri­sis spawned by the Ampyra patent case in­spired Acor­da’s biggest share­hold­er to push for a sale, which Co­hen and his team ini­tial­ly re­sist­ed by adopt­ing a poi­soned pill de­fense.

Any sale of Acor­da now would amount to a sim­ple bolt-on for any ac­quir­er. Co­hen made it clear that he was get­ting rid of much of the rest of the pipeline when he an­nounced cut­backs last year. And the re­main­ing staff would face deep, deep cuts by any ac­quir­er look­ing to jus­ti­fy the price.

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.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Watch out, Roche: No­var­tis inks $1.5B deal to chase down promi­nent Parkin­son’s tar­get

Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Glax­o­SmithK­line, Ox­ford un­veil new part­ner­ship pit­ting buzzy R&D ad­vances against neu­ro­log­i­cal dis­ease

When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.

GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

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.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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