Apnimed Announces Launch of Joint Venture with Shionogi to Develop Novel Pharmacologic Therapies for Obstructive Sleep Apnea and other Sleep Disorders

$150M transaction supporting early and clinical-stage pipeline development in OSA and related sleep disorders to find oral pharmacologic solutions for people who cannot use or tolerate current therapies

CAMBRIDGE, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and other sleep disorders, announced a new joint venture with Shionogi & Co., Ltd., a leading global research-driven pharmaceutical company based in Japan, to develop novel pharmacologic therapies to treat obstructive sleep apnea (OSA) and other sleep disorders. The newly formed joint venture, Shionogi-Apnimed Sleep Science, LLC, initially focuses on accelerating the discovery, preclinical and clinical development of novel pharmacologic solutions designed to address the complex pathology of OSA.

Shionogi-Apnimed Sleep Science combines Apnimed’s deep knowledge of OSA, highly experienced clinical-stage drug development team and robust network of sleep medicine clinical sites with Shionogi’s highly efficient small molecule drug discovery engine and proven ability to create best-in-class compounds. The joint venture is owned equally by Apnimed and Shionogi.   In addition to making a cash contribution to fund the operations of the Shionogi-Apnimed Sleep Science JV, Shionogi is making an equity investment in Apnimed. Both companies will share development responsibilities and benefit from joint venture products that reach the market. Apnimed’s lead programs, AD109 (now in Phase 3 trials) and AD504 (in Phase 2 trials) are not included in the joint venture.

“Apnimed and Shionogi look forward to working together to transform the treatment of sleep apnea. This strategic collaboration builds on the strengths of both companies to accelerate the development of potential new treatments for the hundreds of millions of people worldwide with OSA who are looking for options that don’t require a device or surgery,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “Our new partnership is a win for Apnimed, Shionogi and, most importantly, patients.”

About Obstructive Sleep Apnea        
Obstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 45 million Americans and hundreds of millions more around the world, though underdiagnosis continues to be a serious problem and the number of affected people may be far greater. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which can cause dramatic reductions in overnight oxygen saturation and often leads to poor sleep, and in the long term, has been shown to cause or exacerbate hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA. In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator muscles. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated, undertreated and at risk.

About Shionogi
Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company based in Japan dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and well-being of the patients we serve." The company has discovered and developed novel medicines for HIV, influenza and antimicrobial resistance and currently markets products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin. The company is working to solve healthcare social issues by identifying disease areas with great social needs as core areas for research and development, with a focus on infectious diseases. For more information on Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en/

About Apnimed
Apnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Learn more at apnimed.com or follow us on X and LinkedIn.

Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Contacts for Apnimed

Media Contact:
Amanda Breeding

Investor Contact:
Wendy Gabel
Kendall Investor Relations