Pfizer, Roivant spin out new company to advance anti-inflammatory drugs

Dive Brief:

• Pfizer and Roivant Sciences have formed a company to develop anti-inflammatory drugs, announcing Tuesday that the new biotech, named Priovant Therapeutics, will advance two Pfizer treatments for autoimmune conditions. Pfizer will own 25% of Priovant.
• The deal comes a month after Roivant, known for a web of subsidiaries developing drugs in different therapeutic areas, disclosed one of its units had won approval of a psoriasis treatment called Vtama. In explaining the rationale for the partnership, Pfizer research and development head Mikael Dolsten cited Roivant’s “proven track record” advancing medicines for inflammatory skin conditions.
• Roivant simultaneously revealed plans to reorganize its pipeline, stopping work on six experimental programs to redirect cash toward Priovant and the launch of Vtama. The company has more than $2 billion in cash, giving it two years to become profitable before needing to raise more money.

Dive Insight:

Pfizer signaled in an earnings presentation last year that it planned to sell off the main drug in the Priovant deal, known as brepocitinib. That announcement came after the drug completed a number of Phase 2 trials in various inflammatory diseases and was ready for late-stage testing.

Priovant will now take on that task, but a tough regulatory environment may lie ahead. Brepocitinib works by blocking the activity of two members of a family of proteins called Janus kinases, known as TYK2 and JAK1. Drugs that inhibit JAK enzymes, including Pfizer’s own Xeljanz, now carry safety warnings because of a risk of heart problems, cancer and infections.

Recently, drugmakers have sought to develop more targeted medicines to avoid the safety problems tied to the currently available JAK inhibitors. Bristol Myers Squibb, for example, awaits an FDA decision on a drug that targets TYK2, although it’s unclear whether the FDA will view the medicine differently from other drugs in its class.

Priovant, meanwhile, is staying away from common autoimmune conditions like psoriasis and eczema, for which multiple JAK inhibitors are already approved. Instead, it’s testing brepocitinib in a Phase 3 trial for a rare skin and muscle disorder called dermatomyositis, which affects an estimated 34,000 people in the U.S. No treatments are specifically approved for it and patients are typically treated with steroids and immunosuppressive drugs.

A second trial, which Pfizer began in 2019, is also underway in lupus. That study could serve as one of two trials for FDA submission, according to Priovant. Results are expected by the end of 2023.

The deal also includes a second drug, ropsacitinib, that only targets the TYK2 protein.

Roivant is canceling six programs to help fund Priovant’s work. Three drugs for skin conditions are being shelved, along with an experimental anti-infective drug, a gene therapy for sickle cell disease and a cancer cell therapy.

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