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Sanofi, after $8B outlay, sees M&A strategy deliver 2 more duds

2023-04-27

临床1期并购临床2期

The action adds to worries that Sanofi’s bet on Principia will fall flat.

Sanofi’s first-quarter update (PSanofiought bad Principiadrug candidates acquired in buyouts worth $8 billion, with the French drugmaker removing Ablynx and Principia Biopharma molecules from its pipeline after getting a look at clinical data.

Sanofi, bought for 3.9 billion euros ($4.3 billion) in 2018, and Principia, acquired for $3.7 billion two years later, are among the bigger bets SAblynxhas pPrincipia Biopharmayouts in recent years. Reeling from a big setback to its $2.5 billion Synthorx takeover, Sanofi needs its M&A strategy to start delivering, but the first-quarter results brought no relief on that front.

Ablynx update, Sanofi disclosed the discontinuation of trials of Principiaal BTK inhibitor atuzabrutinib and anti-TNFa/IL-6 nanobody SAR444419. SSanofiadded atuzabrutinib in the Principia deal, while SAR444419 is derived from the nanobody platforSynthorx heart of tSanofiynx takeover.

Working with SaSanofiPrincipia took atuzabrutinib into a phase 2a clinical trBTK in patientatuzabrutinibo moderateTNFapIL-6ermatitis in 2021. A Sanofit data atuzabrutiniby, whichPrincipiaup late last SAR444419 Sanofi to stop development “due to efficacy and sub-optimaAblynxmacokinetics.”

The action adSanofiwoPrincipiat Sanoatuzabrutinibrincipia, which had its knockers at the time, will fall flat. Sanoatopic dermatitisping Principia’s lead candidate in myasthenia gravis earlier this year, citingSanofievel of competition in the indication. Development of the asset, tolebrutinib, is ongoing in multiple sclerosis, but a partial clinical hold, which could stem from a classwide effect, has tempered expectations.

Sanofi’s presentation made no meSanofiof the parPrincipiaical hold on tolebrutinib, only stating that the firstSanofial readout is due arPrincipiaend of the year. The myasthenia gravised to resolve the hold by the end of last year, but the situation has dragged on, albeit without tolebrutinibofi from dosing multiple sclerosisnts or preventing work toward pivotal data.

Sanofiall with analysts this morning, Sanofi’s Global Head of R&D Diettolebrutinibaid the Big Pharma is “working closely” with the FDA to address the issues with the U.S. tolebrutinib trial.Sanofi

“What they're looking for is further uSanofianding of the patient population,” he added. “We have our program ongoing with regards FDAreally close monitoring. We have not tolebrutinib cases of liver toxicity in the same way since we introduced that level of monitoring, which is important to understand.”

“Obviously, the FDA is looking for more data on that and is also looking eventually for benefit-risk information, which we will have at the time when we will read out the study.”

The nanobody culFDA from the pipeline in the first-quarter update was in phase 1 development. Sanofi saw the candidate as a potential treatment for an inflammatory disease but has stopped work “based on the benefit/risk assessment.” The action comes months after Sanofi punted (PDF) a pair of nanobodies that were in phase 1 in atopic dermatitis and an inflammatory indication because of their clinical profiles.

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