Satsuma Pharmaceuticals Announces FDA Acceptance Of 505(b)(2) NDA For STS101, A Novel And Investigational Dihydroergotamine Nasal Powder Product For The Acute Treatment Of Migraine

• January 2024 PDUFA date expected
• If approved, STS101 would become the only DHE product evaluated in a randomized, placebo-controlled trial (the SUMMIT trial) against modern outcome measures recommended by both the U.S. Food and Drug Administration (FDA) and International Headache Society
• Unlike current DHE products, STS101 is designed to be easy-to-carry, quick and easy to self-administer within seconds without need for involved administration procedures and to rapidly achieve high drug plasma levels believed necessary for robust efficacy and to be below those levels associated with adverse events such as nausea and vomiting
• As announced on April 13, 2023 Satsuma entered into a definitive agreement to be acquired by Shin Nippon Biomedical Laboratories, Ltd. (SNBL; TSE: 2395), and on May 5, 2023 SNBL commenced a tender offer for Satsuma, which will expire at 12:00 A.M. (Eastern time) at the end of June 5, 2023 unless extended or earlier terminated

SOUTH SAN FRANCISCO, Calif., May 18, 2023 (GLOBE NEWSWIRE) --  Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a development-stage biopharmaceutical company today announced that its 505(b)(2) new drug application (NDA) for STS101, a novel and investigational therapeutic product candidate for the acute treatment of migraine, has been accepted for review by the FDA.

Satsuma's President and Chief Executive Officer, John Kollins, stated, "We are proud to announce the FDA acceptance for review of our STS101 NDA, as it represents an important milestone for our company and an important step toward achieving our goal of making STS101 available as an easy-to-use, effective, and safe and well-tolerated DHE treatment that can address the significant unmet clinical needs of many people with migraine."  

Satsuma's STS101 NDA is supported primarily by clinical trials results from the Phase 1 comparative pharmacokinetic and safety trial of STS101 completed in June 2021 and the STS101 ASCEND Phase 3 long-term, open-label safety trial in which 446 subjects treated more than 9,000 migraine attacks with more than 10,500 doses of STS101 for up to 18 months.

Although not required for approval based on Satsuma's communications with the FDA, results from the 1,600-subject STS101 SUMMIT Phase 3 double-blind, placebo-controlled efficacy trial are also included in the NDA. Satsuma announced topline SUMMIT trial results in November 2022 and subsequently announced further results in December 2022. Although STS101 demonstrated numerical, but not statistical significance on SUMMIT trial primary outcome measures (% of subjects free from pain and % of subjects free from most-bothersome-symptom1 at two hours post-dose), STS101 did demonstrate robust and sustained effects (p<0.001) on those endpoints at all post-dose timepoints after two hours (3, 4, 6, 12, 24 and 48 hours). STS101 also demonstrated robust and sustained antimigraine effects across numerous secondary endpoints considered relevant and recommended for assessment in efficacy trials by the FDA in its current industry guidance document and/or the International Headache Society's guidelines for controlled trials of acute treatment of migraine attacks2,3.

Pending acquisition of Satsuma by SNBL

On April 16, 2023, Satsuma Pharmaceuticals announced that it had entered into a definitive agreement to be acquired by Shin Nippon Biomedical Laboratories, Ltd. (TSE: 2395, "SNBL") for $0.91 in cash per share at the closing of the transaction plus one non-tradeable contingent value right ("CVR") of up to $5.77 per share. CVR holders will be entitled to receive payments related to proceeds received by SNBL in a future transaction involving STS101, including a potential sale, license, or other grant of rights ("Monetization Event"). The CVR is based on cumulative proceeds received by SNBL from the Monetization Event after making certain deductions. On May 5, 2023 SNBL commenced a tender offer for Satsuma, which will expire at 12:00 A.M. (Eastern time) at the end of June 5th unless extended or earlier terminated.