Pfizer Inc. / Excaliard Pharmaceuticals, Inc.

Skin Fibrosis / Hypertrophic and Surgical Scarring

$4.0B US annual cost of managing hypertrophic scars (estimate)

Disease Overview

Hypertrophic scars and other fibrotic dermal lesions are raised, often pruritic and disfiguring scars that result from over-production of CTGF-driven collagen during wound healing. They are common after surgery, burns, and trauma, disproportionately affect young patients and darker skin types, and have no FDA-approved pharmacological cure — current management relies on intralesional steroids, silicone, pressure therapy, laser, and surgical revision.

Competitive Landscape

At deal time (Nov 2011), there was no FDA-approved drug for excessive skin scarring; standard of care was intralesional triamcinolone, silicone gel sheeting, pressure garments, pulsed-dye laser, cryotherapy, and surgical revision — all device/procedural or off-label. Differentiated Rx pipelines were thin: Renovo's Juvista (avotermin, anti-TGF-β3) had failed Phase 3 in early 2011, vacating the lead biologic position; RXi Pharmaceuticals' RXI-109 (self-delivering RNAi against CTGF) was just entering Phase 1; Promedior's PRM-151 was focused on systemic fibrosis. EXC-001 (later renamed PF-06473871) entered Pfizer with positive Phase 2 data — a 24-week reduction in scar severity on Physician Assessment (p<0.001), Subject Assessment (p=0.003), and Expert Panel VAS (p<0.001). The deal handed Pfizer a Phase-2-validated antisense oligonucleotide against CTGF, with Isis (now Ionis) entitled to up to $14M plus future royalties. Pfizer subsequently de-prioritized the program; EXC-001 did not advance to approval, and CTGF inhibition has since been pursued in systemic fibrosis (e.g., FibroGen's pamrevlumab in IPF/DMD) rather than dermal scarring.