Sanofi closes Principia's San Francisco laboratory biospace after BTK failure

2021-11-12 10:16:55 By : Mr. Tim Wang

Published: September 15, 2021, by Mark Terry

When Sanofi acquired Principia Biopharma for US$3.68 billion in 2020, many analysts were skeptical, and Kerrisdale Capital called Principia’s pipeline “valueless”. Since they changed their minds, not much has happened. On September 9, the company announced that its phase III PEGASUS trial of rilzabrutinib for pemphigus failed the study and failed to meet the primary or key secondary endpoints. The drug is part of Principia's acquisition.

According to the California WARN notice, Sanofi will close Principia's San Francisco laboratory and lay off approximately three dozen employees. The pink list will take effect on October 8. According to a Sanofi spokesperson, after the high turnover rate, they are reassessing their plans in the South San Francisco area. By April 2022, these laboratories will be completely empty.

Principia's transaction mainly revolves around its Bruton tyrosine kinase (BTK) inhibitor. BTK is present in the signaling pathways of key innate and adaptive cell types in the immune system. Inhibiting or blocking these pathways may prevent inflammation and tissue damage caused by autoimmune diseases. The pipeline also includes '168, which Sanofi previously licensed from Principia in 2017. In addition to rilzabrutinib, it also acquired PRN473, a topical BTK inhibitor.

On September 8, Sanofi acquired Kadmon Holdings, headquartered in New York, for approximately US$1.9 billion. The transaction aims to increase Sanofi's core assets of General Medicines. Kadmon recently approved a drug Rezurock (belumosudil), a first-in-class drug for the treatment of chronic graft-versus-host disease (cGVHD), for adults and children aged 12 years and older who have been at least twice before Systemic treatment failed.

Kadmon President and CEO Harlan Waksal, MD, said: "We are very pleased that Sanofi recognizes the value of Rezurock and the great potential of our pipeline. "By leveraging Sanofi's global resources and long-term development and commercialization of innovative drugs With expertise, Rezurock is now in a good position to achieve global access faster. I would like to thank the entire Kadmon team, including the management and board of directors, and the Sanofi organization, for their continued commitment to patients and their caregivers. "

Kadmon's pipeline compounds include drugs for immune and fibrotic diseases and immuno-oncology treatments.

On September 14, Sanofi announced the completion of the acquisition of Translate Bio for approximately US$3.2 billion. Translate Bio has an mRNA technology platform, which is not only one of the hot new development areas for vaccines, such as COVID-19 developed by Pfizer, BioNTech and Moderna, but also potential cancer and other indications.

Although the future of rilzabrutinib is in doubt, the multiple sclerosis drug tolebrutinib is being evaluated in four key clinical trials, although data is not expected to be available until 2023. Sanofi undoubtedly hopes that the drug is worth the money, especially since March 2021, the US Food and Drug Administration (FDA) approved Johnson & Johnson’s MS drug Ponvory (ponsimod), which is in the head-to-head III. The MS drug Aubagio (teriflunomide) proved to be superior to Sanofi in the phase trial. The FDA first approved Aubagio for MS in 2012.

In April 2020, tolebutinib reached the primary and secondary endpoints in a phase IIb trial of relapsing MS, significantly reducing disease activity associated with MS, as measured by magnetic resonance imaging (MRK). This sounds promising, but the data is not so clear because they use surrogate endpoints, and other critics point to their complicated trial design and low patient numbers.

As Jacob Plieth, who wrote for Evaluate Vantage, pointed out in February 2020, “The mid-term study of SAR442168 has such a complex design that it requires detailed analysis to sort out its real benefits.... Today’s study only recruited 128 Relapsing multiple sclerosis subjects, but no less than 8 cohorts, including four different doses given before or after placebo. In addition, its primary endpoint has nothing to do with recurrence rate or MS progression, but with The new Gd-enhanced T1 hyperintensity lesion is related to the number of lesions. Investors should ask themselves, how can such a complicated trial that measures MRI alternative endpoints produce positive results?"

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