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Sanofi Advances in Multiple Sclerosis Market with Principia Acquisition Deal
In a move to expand its portfolio of transformative treatments for autoimmune diseases, Sanofi has struck an all-cash deal to buy its partner for $3.68 billion.
By Ruchi Jhonsa, Ph.D.
On August 17th, Sanofi announced its plans to acquire all outstanding shares of Principia Biopharma for $100 apiece, which is a 10% premium from the latter’s $90.74 when the market closed on Friday. This would amount to an aggregate equity value of approximately $3.68 billion. This is the second-largest pharma deal this year after Gilead acquired Forty Seven Inc., for $4.9 billion in March. The acquisition will give Sanofi full control of brain penetrant BTK inhibitor SAR442168 currently being developed for multiple sclerosis (MS) along with other drugs in Principia’s pipeline.
“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. By combining with Sanofi, we will bring significant resources to expand and accelerate the potential benefits of these therapies. The benefit of developing several BTK inhibitors will allow us to target specific organ systems for optimal patient benefit. The merger will provide global resources to get these novel therapies to patients faster,” said Martin Babler, President and CEO at Principia Biopharma.
Sanofi and Principia’s collaboration goes back to 2017 when the latter granted an exclusive worldwide license to Sanofi for the development and commercialization of its BTK inhibitor for MS and other central nervous system diseases. The collaboration has undoubtedly benefited Sanofi as the drug showed remarkable efficacy in the Phase 2 trial. The company is now moving forward with a Phase 3 trial to confirm drug benefits in a large cohort.
“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. Through this acquisition, we will be able to expand and accelerate development of BTK inhibitors across multiple indications. Both ‘168 and rilzabrutinib, have ‘pipeline in a product’ potential, and we look forward to unlocking their full treatment benefits across an array of diseases,” said John Reed, M.D., Ph.D., Global Head of Research & Development at Sanofi.
The deal is certainly a win-win for Sanofi on many fronts. By gaining full control of BTK inhibitor, the deal will eliminate future payments to Principia for the development-related milestone and increase the company’s reach in other CNS indications. Additionally, the company will gain other clinical-phase BTK inhibitors, which include oral BTK inhibitor, Rilzabrutinib, and topical agent for immune-mediated diseases. Rilzabrutinib is currently being evaluated in a Phase 3 program for patients with moderate to severe pemphigus and a Phase 2 program for patients with IgG4-related diseases. A Phase 3 program of Rilzabrutinib for immune thrombocytopenia-a disease that causes a high risk of bleeding event-is expected to begin by the end of this year. Principia’s topical treatment for immune-mediated diseases is currently in the Phase 1 trial.
Sanofi’s Leadership in MS
Since 2011, Sanofi has rapidly emerged as a leader in multiple sclerosis treatment. It has a USFDA approved infusion treatment, Lemtrada, and oral treatment, Aubagio, for relapsing MS patients in the market. In 2019, Sanofi recorded $2.4 billion in net sales from its MS business, close to 90% of which came from Aubagio alone. With BTK inhibitor in its pocket, Sanofi is expected to generate global sales of $2 billion, provided it succeeds in the phase 3 trial. Though Sanofi has big aspirations for its drug, it may have to do some catching up. Merck began Phase 3 testing of its BTK inhibitor in August last year with a primary completion date set for September 2023.
Editor: Rajaneesh K. Gopinath, Ph.D.
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