Durham, NC June 15, 2023 – Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that three abstracts describing efficacy and safety results from the STS101 Phase 3 efficacy trial were selected for presentation at the American Headache Society’s (AHS) 65th Annual Scientific Meeting. The 2023 meeting will be held in a hybrid virtual and in-person format at the JW Marriott in Austin, Texas from Thursday, June 15 to Sunday, June 18, 2023. Full abstracts are now available on the AHS website and will be published in the journal Headache®.
Oral Presentation Details:
Title: Sustained Efficacy of STS101 DHE Nasal Powder for the Acute Treatment of Migraine: Results from the Phase3 Double-Blind, Randomized, Placebo-Controlled SUMMIT Study
Presenter: Alan Rapoport, MD, Professor of Neurology, David Geffen School of Medicine, University of California Los Angeles (UCLA)
Date: Saturday, June 17, 2023
Time: 7:50 AM - 8:00 AM CT (8:50 AM – 9:00 AM ET)
Location: Lone Star Ballroom D-E
Poster Presentation Details:
Title: Efficacy of STS101 DHE Nasal Powder for the Acute Treatment of Difficult to Treat Migraines: Results from the Phase 3 Double-Blind, Randomized, Placebo-Controlled SUMMIT Study
Presenter: Jessica Ailani, MD
Date: Friday, June 16, 2023
Time: 1:35 PM – 2:50 PM CT (2:35 PM – 3:50 PM ET)
Title: Efficacy and Safety of STS101 DHE Nasal Powder for the Acute Treatment of Migraine: Results from the Phase 3 Double-Blind, Randomized, Placebo-Controlled SUMMIT Study
Presenter: Richard B. Lipton, MD
Date: Saturday, June 17, 2023
Time: 1:45 PM – 3:09 PM CT (2:45 PM – 4:09 PM ET)
About Satsuma and STS101
Satsuma Pharmaceuticals, a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company that is currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101, a novel, investigational therapeutic product for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary nasal delivery device. STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for robust efficacy, and sustained DHE plasma levels over time with low dose-to-dose variability. DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring an easy-to-carry and easy-to-use dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.
Satsuma is headquartered in Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
Shin Nippon Biomedical Laboratories, Ltd. (“SNBL”) (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of “We are a company that values the environment, life, and people”, and with a proven record of accomplishment as the oldest and established CRO in Japan, SNBL is proud to be the only company in Japan that can provide a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL’s Translational Research business has engaged in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. SNBL also operates the Medipolis business, making use of a large tract of land and forests it owns in Ibusuki-City in Kagoshima prefecture, to promote the local economy and environmental conservation at the same time thorough its power generation and hospitality businesses. The aim of the Medipolis business is to contribute to people’s well-being, improved quality of life, and happiness. For further information, visit https://www.snbl.co.jp. Inquiries: SHIN NIPPON BIOMEDICAL LABORATORIES, LTD. IR & Corporate Communications (E-mail: firstname.lastname@example.org)
Cautionary Note on Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding SNBL’s future business, future position and results of operations, including estimates, forecasts, targets and plans for SNBL. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL’s business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of product candidates; the impact of health crises such as the coronavirus pandemic on SNBL and its clients and suppliers, including foreign governments in countries in which SNBL operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to SNBL’s operations and the timing of any such divestment(s); and other factors identified in SNBL’s most recent securities report (“Yuka Shoken Houkokusho”) and SNBL’s other reports filed with the Financial Services Agency, available on SNBL’s website at: https://www.snbl.co.jp/ir/library/ or at https://disclosure.edinet-fsa.go.jp/. SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL’s future results.
This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
Satsuma Pharmaceuticals, Inc.