Pfizer continues to bet on JAK inhibitors. This morning, the company entered into a licensing agreement with Theravance Biopharma for a preclinical program for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors that can be rapidly metabolized.
Pfizer handed over $10 million in upfront money and dangled a potential $240 million more if the program hits certain development and sales milestones. Theravance will also be eligible for royalties on any worldwide sales of products that receive regulatory approval. The compounds in the program the companies are focused on target validated pro-inflammatory pathways and are specifically designed to possess skin-selective activity with minimal systemic exposure.
Theravance Chief Executive Officer Rick Winningham said the agreement with Pfizer validates its expertise in the discovery and development of innovative, organ-selective JAK inhibitors. Winningham pointed to Pfizer’s position as a global leader in the field of JAK inhibition and said the pharma powerhouse is “ideally positioned” to advance the preclinical program and “unlock its therapeutic potential.”
Michael Vincent, chief scientific officer of inflammation and immunology at Pfizer, said the Theravance JAK inhibitor program will “nicely complement” Pfizer’s current portfolio of preclinical and clinical-stage molecules. Each of those molecules has unique selectivity profiles and are matched to conditions in which the company believes will have the greatest potential to address unmet need, Vincent said in a statement.
“Topical JAK inhibitors that can be rapidly metabolized have potential to reach more patients with mild-to-moderate skin conditions, for whom treatment is currently limited,” Vincent said.
Pfizer has a strong interest in JAK inhibitors, which inhibit the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3 and TYK2) which play a key role in cytokine signaling. Pfizer’s approved JAK inhibitor Xeljanz has been a strong financial performer for the company. Last year, it generated $1.77 billion in revenue. It has been approved for rheumatoid arthritis and psoriatic arthritis. Earlier this month, the U.S. Food and Drug Administration approved an extended release version of Xeljanz as a treatment for ulcerative colitis for patients who have had an inadequate response or intolerance to tumor necrosis factor inhibitor (TNFi) blockers.
In September, Pfizer announced positive results from its second pivotal Phase III study of the JAK inhibitor Abrocitinib in moderate-to-severe atopic dermatitis. The two JADE trials showed that treatment with Abrocitinib resulted in statistically significantly higher outcomes than placebo. In addition, a statistically significant number of patients achieved a reduction in pruritus, Pfizer said.
