SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. [2395.T]
TOKYO, May 11 (Pulse News Wire) – Shin Nippon Biomedical Laboratories,ltd. (2395.T) held a board meeting today to address the business strategy for its nasal migraine medication Atzumi™, developed by its US subsidiary Satsuma Pharmaceuticals, Inc.
Despite securing FDA approval in April 2025, negotiations for licensing agreements did not meet expectations due to Atzumi™ being positioned as a secondary treatment option and its unique combination product design. An independent evaluation by Trinity Life Sciences confirmed the significant potential of the US migraine drug market, noting that just 2,600 doctors (representing 0.6% of all prescribers) account for approximately 20% of total prescriptions. According to Trinity's revenue model, peak annual sales for Atzumi™ could exceed $200 million. In light of this assessment, SHIN NIPPON SCIENTIFIC plans to proactively prepare Satsuma Pharmaceuticals for early market entry in the US while simultaneously pursuing partnerships outside the US.
This dual approach aims to accelerate the realization and expansion of Atzumi™'s commercial value. Going forward, Satsuma Pharmaceuticals will focus on organizational setup for market introduction, engaging in discussions with distribution partners, health insurance companies, and prescribing physicians, as well as negotiating regional licenses abroad. These efforts aim to visualize Atzumi™’s business potential and create optimal business outcomes. For the fiscal year ending March 2027, SHIN NIPPON SCIENTIFIC does not anticipate incorporating revenues from Atzumi™ sales or licensing fees but has included projected operating losses of ¥3.528 billion (compared to ¥2.545 billion for the fiscal year ending March 2026).
Any events significantly impacting performance will be promptly disclosed based on changes in market conditions, progress in business activities, and partnership status.
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