Shionogi Expands Agreement with Apnimed on Sleep Disorder Treatments

OSAKA, Japan – On April 25, 2025, Shionogi & Co., Ltd., a pharmaceutical company headquartered in Osaka with Isao Teshirogi, Ph.D., serving as CEO, announced a collaborative agreement with Apnimed, Inc., a company based in Massachusetts and led by CEO Lawrence G. Miller, MD. This partnership focuses on introducing sulthiame, a carbonic anhydrase inhibitor that is already approved as an antiepileptic drug in some regions, into a new drug development program targeting sleep disorders.

Sulthiame has undergone two successful Phase 2 trials in Europe involving over 300 patients with obstructive sleep apnea (OSA), demonstrating promising results over a three-month period. The agreement grants Shionogi a shared ownership stake in the intellectual property rights associated with the use of sulthiame for sleep apnea and other related drug development initiatives from Apnimed. This acquisition involved a one-time payment to Apnimed, and both companies have equally contributed this intellectual property to their joint venture, Shionogi-Apnimed Sleep Science, LLC (SASS). SASS will spearhead future research and development efforts for sulthiame and additional drug programs.

Shionogi retains exclusive rights to negotiate the development and sales of these treatments in Japan, Korea, Taiwan, and China. John Keller, Ph.D., Senior Executive Officer and Senior Vice President of the R&D Supervisory Unit at Shionogi, expressed enthusiasm about this development, emphasizing that the joint venture leverages the combined scientific and medical expertise of both companies. This collaboration aims to provide innovative pharmacological treatments for sleep apnea and associated disorders on a global scale.

Larry Miller, MD, CEO of Apnimed, remarked on the impact of this transaction in strengthening the SASS pipeline, noting the dire need for more effective and convenient treatments for the estimated 80 million OSA patients in the United States and hundreds of millions worldwide. He highlighted the importance of directly addressing the root causes of OSA through this collaboration.

Shionogi has identified contributing to a healthy and prosperous life as a primary goal, striving to offer innovative solutions for diseases with significant unmet medical needs, such as sleep apnea. This partnership with Apnimed aligns with Shionogi's mission to deliver groundbreaking treatments to patients as swiftly as possible.

Apnimed, located in Cambridge, Massachusetts, specializes in developing novel drug therapies for sleep-related breathing disorders. Their leading candidate, AD109, is designed to maintain airway patency during sleep using a once-daily oral medication. If approved, AD109 could revolutionize traditional OSA therapies.

Established in November 2023, the Shionogi-Apnimed Sleep Science, LLC joint venture aims to address the unmet needs in sleep disorder treatments. With a 50-50 ownership between the two companies, SASS capitalizes on Shionogi's experience in small molecule drug discovery and Apnimed's expertise in sleep disorder pharmacology. This collaboration enhances translational research efforts, facilitating the rapid development of innovative solutions for sleep disorders beyond what either company could achieve independently.