ARS Pharmaceuticals Advances Clinical Program for Intranasal Epinephrine Spray

“Our focus is to get our novel intranasal epinephrine spray approved and into the hands of people to better protect themselves and their loved ones from risk of a severe allergic reaction that could lead to anaphylaxis,” said Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals. “We feel fortunate to have Deerfield as an anchor investor and, together, we are working to realize our vision of potentially providing a reliable needle-free option that is easier to carry and use for the treatment of patients who experience severe allergic reactions.”

ARS-1 is an aqueous formulation of epinephrine nasal spray uniquely developed with Intravail^®, a novel nasal absorption enhancing technology. ARS-1 has demonstrated comparable pharmacokinetics to an intramuscular injection of epinephrine in pilot studies using a low and safe intranasal dose. As a result, the Company believes that the ARS-1 formulation may enable people to easily deliver epinephrine in emergency situations more rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine auto-injectors. The intranasal epinephrine spray is designed to be user-friendly, needle-free and easily portable to carry in a pocket or purse anytime, anywhere.

“The optimal first aid treatment recommended for anaphylaxis occurring in community settings is epinephrine given promptly through an auto-injector; however, many people at risk for out-of-hospital anaphylaxis do not carry epinephrine auto-injectors, and some do not use their auto-injectors when anaphylaxis occurs,” says Dr. Estelle Simons, Professor Emerita at the University of Manitoba and anaphylaxis researcher. “Also, miss-firings and injuries have been reported with auto-injectors, as well as some older-generation patients who have difficulty in using auto-injectors correctly. Many of todays’ user-related challenges could be addressed by a simple to use intranasal epinephrine spray. The early data on ARS-1 are promising as a potential solution to improve treatment of anaphylaxis in the community.”

ARS Pharmaceuticals has submitted an Investigational New Drug (IND) application for its intranasal epinephrine sprayer with the U.S. Food and Drug Administration (FDA) based upon an agreed regulatory pathway for the studies necessary to support filing of a New Drug Application (NDA) for the sprayer to treat patients with severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur very quickly — as fast as within a couple of minutes — and could be fatal if not treated immediately. According to published literature up to 5.3 million people in the United States are at risk of having an anaphylaxis reaction that may warrant immediate emergency medical treatment, with more than 200,000 emergency room visits due to severe reactions from food allergies reported annually.

About ARS Pharmaceuticals, Inc.

ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing ARS-1, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis. For more, visit www.ars-pharma.com.

About Deerfield Management Company

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy. For more information about Deerfield, visit www.deerfield.com.

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