Otsuka Licenses Pre-Phase 3 Topical Atopic Dermatitis Treatment to Medimetriks

Otsuka Pharmaceutical Co., Ltd. and Medimetriks Pharmaceuticals, Inc. have entered into a licensing agreement granting Medimetriks exclusive development, manufacturing and commercialization rights for OPA-15406 in the U.S. and Puerto Rico.

OPA-15406 is a topical, non-steroidal phosphodiesterase IV (PDE-4) inhibitor, a new treatment class for atopic dermatitis.

In a Phase II clinical trial, OPA-15406 demonstrated clinically significant results versus placebo and appeared to be safe and well tolerated. Specifically, OPA-15406 achieved a statistically significant effect on the primary endpoint versus vehicle control; identifying a therapeutic benefit of the compound as measured by improvement in IGA score (Investigators Global Assessment) and percentage change in EASI scores (Eczema Area and Severity Index).

OPA-15406 was also associated with improvements in patient-reported outcomes, most notably rapid and sustained itch relief. OPA-15406 reduced inflammation in affected skin by inhibiting production of cytokines and chemical mediators that are believed to cause the signs and symptoms of atopic dermatitis.

"Our currently approved treatments are limited to topical corticosteroids and topical calcineurin inhibitors that do not provide enough opportunity for safe, effective and well tolerated treatments to control the disease in many patients,” says Linda Stein Gold, MD, director of clinical research, Department of Dermatology at Henry Ford Hospital, in a news release. “OPA-15406 has the potential to offer patients with an efficacious and safe option and could help fulfill an important need in dermatology.”

Under the terms of the new agreement, Otsuka will receive an upfront payment of $22 million from Medimetriks and additional milestones through NDA approval.  In addition, Otsuka will participate in the success of OPA-15406 through sales royalties. Medimetriks will fund and be responsible for Phase III studies for the U.S.