J&J gets a $30B Acte­lion buy­out and a new part­ner as Clozel’s team spins out with the pipeline

One of the big hur­dles fac­ing any­one who want­ed to buy Acte­lion was find­ing a way to come up with an ac­cept­able ac­qui­si­tion val­ue for its pipeline, which was high­ly prized by its in­de­pen­dent-mind­ed man­age­ment. So in the end, J&J got a buy­out deal done by be­ing cre­ative, spin­ning out a big part of the pipeline, with Acte­lion’s team in charge, while grab­bing rights to some prized late-stage as­sets for it­self.

In a deal an­nounced ear­ly this morn­ing, J&J agreed to pay $30 bil­lion for Acte­lion, ac­quir­ing an im­pres­sive port­fo­lio that in­cludes its block­buster new flag­ship ther­a­py for pul­monary ar­te­r­i­al hy­per­ten­sion. But they’re spin­ning its dis­cov­ery and ear­ly-stage ex­per­i­men­tal drugs in­to a new com­pa­ny — tem­porar­i­ly named R&D New­Co — while keep­ing a mi­nor­i­ty stake in the busi­ness.

Acte­lion CEO Jean-Paul Clozel will stay at the helm of the spin­out, while chair­man Jean-Pierre Gar­nier al­so re­tains his ti­tle in the new ven­ture.

J&J is pay­ing $280 a share in cash for the Swiss biotech and leav­ing R&D New­Co with a bil­lion dol­lars in liq­uid­i­ty as it lists on the Swiss ex­change. Acte­lion’s share­hold­ers are gain­ing shares in the new com­pa­ny as a div­i­dend. In ad­di­tion to a slate of mar­ket­ed drugs that in­cludes Op­sum­it, Up­travi and the orig­i­nal, pi­o­neer­ing PAH drug Tr­a­cleer, J&J al­so gains glob­al rights to pones­i­mod, an S1P1 re­cep­tor mod­u­la­tor in Phase III de­vel­op­ment for mul­ti­ple scle­ro­sis, along with cada­zol­id, a late-stage an­tibi­ot­ic in de­vel­op­ment for Clostrid­i­um dif­fi­cile-as­so­ci­at­ed di­ar­rhea.

J&J’s Alex Gorsky

J&J al­so gains an op­tion on the Phase II drug ACT-132577 for re­sis­tant hy­per­ten­sion. And the phar­ma gi­ant keeps a 16% stake in its spin­out, with a chance to dou­ble that amount through a con­vert­ible note.

The deal un­der­scores the high pre­mi­um that sought-af­ter drug as­sets can com­mand in this sell­er’s mar­ket. J&J is pay­ing 21 times es­ti­mat­ed 2020 earn­ings per share for the com­pa­ny, ac­cord­ing to Bloomberg’s Sam Fazeli, a very steep price for a deal like this. It al­so high­lights yet again how in­ef­fec­tive Sanofi has been in find­ing a ma­jor deal to help re­struc­ture the com­pa­ny as its di­a­betes fran­chise wanes. J&J es­sen­tial­ly el­bowed Sanofi aside, just as Pfiz­er did with Medi­va­tion.

J&J’s Alex Gorsky had this to say about the deal:

Adding Acte­lion’s port­fo­lio to our al­ready strong Janssen Phar­ma­ceu­ti­cals busi­ness is a unique op­por­tu­ni­ty for us to ex­pand our port­fo­lio with lead­ing, dif­fer­en­ti­at­ed in-mar­ket med­i­cines and promis­ing late-stage prod­ucts. We ex­pect to lever­age our es­tab­lished glob­al pres­ence and com­mer­cial strength to ac­cel­er­ate growth and pa­tient ac­cess to these im­por­tant ther­a­pies. Fur­ther, we be­lieve R&D New­Co will be strong­ly po­si­tioned to con­tin­ue Acte­lion’s lega­cy of in­no­va­tion and look for­ward to col­lab­o­rat­ing on the de­vel­op­ment of cut­ting-edge new ther­a­pies.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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