In a $3.68 billion transaction, Sanofi is preparing to acquire Principia Biopharma, a biopharmaceutical company focused on the development of therapies for disorders caused by dysregulation of the immune system, including multiple sclerosis (MS).
The decision was unanimously approved by the board of directors of both companies, and will enable Sanofi to have access to Principia’s extensive pipeline of Bruton tyrosine kinase (BTK) inhibitors, including SAR442168, which is being investigated as a potential treatment for those with relapsing forms of MS. The acquisition process should be completed before the end of this year.
“This acquisition advances our ongoing R&D [research and development] transformation to accelerate development of the most promising medicines that will address significant patient needs,” Paul Hudson, CEO of Sanofi, said in a press release.
SAR442168, formerly known as PRN2246, was being developed by Principia in collaboration with Sanofi, which also held its commercialization rights.
This oral BTK inhibitor is expected to lower inflammation throughout the body, including in the central nervous system (CNS, the brain and spinal cord) due to its ability to cross the blood-brain barrier, the highly selective barrier that separates the brain from the blood circulating in the rest of the body.
Like other BTK inhibitors, SAR442168 is able to exert these effects by blocking the activity of BTK, an enzyme that plays a key role in the activity and survival of immune B-cells, which are known drivers of inflammation in MS.
“The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas. Full ownership of our brain-penetrant BTK inhibitor [SAR442168] removes complexities for this priority development program and simplifies future commercialization,” Hudson said.
In a recently concluded dose-determining Phase 2b trial (NCT03889639) assessing the safety and effectiveness of SAR442168 in patients with relapsing-remitting MS (RRMS) or active secondary progressive MS (SPMS), the investigative treatment lowered the number of new MRI T1 lesions (areas of active, ongoing inflammation) by 85% when given at a daily dose of 60 mg.
Also, when given at the same dose, SAR442168 lowered the number of new or enlarging T2 lesions by 89% compared to the placebo. T2 lesions are areas where inflammation has caused damage, regardless of whether there is ongoing inflammation at the time of the MRI scan.
“The Phase 2b data in relapsing multiple sclerosis showed the strong potential of ‘168 to address disability and disease progression, and triggered the start of Phase 3 studies across the full spectrum of MS,” said John Reed, MD, PhD, global head of research and development at Sanofi.
Sanofi has launched four Phase 3 trials — GEMINI 1 (NCT04410978), GEMINI 2 (NCT04410991), PERSEUS (NCT04458051), and HERCULES (NCT04411641) — to investigate the therapeutic potential of SAR442168 to treat those with different forms of MS.
In June, the company announced it had enrolled the first patient in GEMINI 1, which is expected to accept 900 adults with relapsing forms of MS. Patient recruitment is ongoing at several sites in the U.S. for both GEMINI studies and the HERCULES trial. PERSEUS is not yet recruiting participants.
In addition to SAR442168, Sanofi now will have access to other BTK inhibitors that are part of Principia’s portfolio, including rilzabrutinib and PRN473 topical, which are being tested in other clinical trials for the treatment of different immune-related diseases.
“Principia’s successful design and development of a whole portfolio of BTK inhibitors for immunology is aimed to transform the treatment for patients with immune-mediated diseases,” said Martin Babler, president and CEO of Principia.
“By combining with Sanofi, we will bring significant resources to expand and accelerate the potential benefits of these therapies. The merger will provide global resources to get these novel therapies to patients faster,” Babler concluded.
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