Protagonist announces Johnson & Johnson received approval for ICOTYDE

Protagonist Therapeutics (PTGX) announced that Johnson & Johnson (JNJ) received FDA approval for ICOTYDE, or icotrokinra, an interleukin-23 receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. ICOTYDE will be commercialized by Johnson & Johnson under the license and collaboration agreement established in 2017 between Protagonist and Janssen Biotech, a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. FDA approval of ICOTYDE triggers a $50M milestone payment to Protagonist. Protagonist is eligible to receive up to $580M in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales, corresponding to 7.25% on a weighted-average basis at $4B in annual sales, with the top royalty tier of 10% applying to sales above $4B.