Expansion of Board of Directors Adds Commercialization and Financial Expertise,
Further Augments Clinical and Scientific Acumen of Medical and Scientific Advisory Board
SAN DIEGO – June 18, 2019 – ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, today announced the appointment of two new members to its Board of Directors – Michael Kelly, former president of U.S. operations for Adapt Pharma, and Phillip Schneider, board member and chairman of the audit committee for Pfenex Inc. and former chief financial officer and senior vice president of IDEC Pharmaceuticals Corporation.
“Mr. Kelly and Mr. Schneider will bring important perspectives to the company as we prepare for the commercialization of ARS-1. Both have deep experience in the life sciences sector and share our commitment to improve the treatment of anaphylaxis for at-risk patients and caregivers,” said Richard Lowenthal, Founder, Chief Executive Officer and President of ARS Pharmaceuticals. “Mr. Kelly was instrumental in the launch and successful market introduction of NARCAN Nasal Spray, and will bring invaluable experience in the commercialization of pharmaceutical products, including nasal drug delivery systems for use in emergency situations. Mr. Schneider brings decades of financial expertise and a deep understanding of Wall Street to our Company to help us prepare the company for future fund raising events.”
About Michael Kelly
Mr. Kelly brings more than 25 years of pharmaceutical industry expertise. He recently served as president of U.S. operations for Adapt Pharma, which developed and commercialized NARCAN® (naloxone HCl) Nasal Spray, the first and only needle-free formulation of naloxone approved by the U.S. Food and Drug Administration (FDA) and Health Canada. Under Mr. Kelly’s leadership, NARCAN rapidly gained market share in the U.S. from needle-based delivery of naloxone, with sales estimated to reach $200 million to $220 million in 2019, at the time of the acquisition of Adapt Pharma by Emergent Biosolutions in October 2018 for $735 million.
Prior to Adapt, he served as chief executive officer and board member for Covis Pharmaceuticals, Inc. Mr. Kelly was also a member of the founding management team of Azur Pharma and later, following a strategic merger, served as senior vice president of sales and marketing for Jazz Pharmaceuticals plc. Prior to his tenure at Azur, he served as vice president of commercial operations at Guilford Pharmaceuticals, vice president of sales and marketing at ViroPharma Incorporated, and held various commercial and medical roles at TAP Pharmaceuticals. He holds a Bachelor of Science in business administration from The College of New Jersey and a Master of Business Administration from Rider University.
“I am pleased to have the opportunity to join ARS’ Board of Directors and work with the company’s accomplished and talented life science board members. I was drawn to ARS based on the company’s unique approach to developing a simple to use intranasal epinephrine spray that has the potential to help a broad population,” said Mr. Kelly. “I believe ARS has the potential to bring a first-of-its-kind treatment to at-risk patients and caregivers to help better protect them from severe allergic reactions potentially leading to anaphylaxis.”
About Phillip Schneider
Mr. Schneider brings decades of financial expertise to help us prepare the company to successfully manage our growth and success. He currently serves as board member and chairman of the audit committee for Pfenex Inc. Most notably, Mr. Schneider was chief financial officer and senior vice president for IDEC Pharmaceuticals Corporation. During his tenure, he helped to raise more than $1 billion in financing as the company went from a start-up through its initial public offering, to a company valued in excess of $7 billion. Prior to IDEC, Mr. Schneider held various management positions at Syntex Pharmaceuticals Corporation and KPMG, LLC, where he earned his certified public accountant license. Mr. Schneider has previously served as audit committee chairman and director for Arena Pharmaceuticals and was board member and chairman of the audit committee for Auspex Pharmaceuticals and Gen Probe Inc. until their respective sales. He holds a Master of Business Administration from the University of Southern California and a Bachelor of Science in biochemistry from the University of California, Davis.
“I am excited about joining the ARS Board,” stated Mr. Schneider. “I look forward to working alongside my fellow Board members and company management to advance a truly innovative drug product which can be a potential life-saving benefit to children and adults.”
Medical and Scientific Advisory Board
The expansion of ARS Pharmaceuticals’ Board of Directors adds additional commercialization and financial expertise to the company to further augment the strong Medical and Scientific Advisory Board, which is comprised of the following leaders in the treatment of anaphylaxis:
- Estelle R. Simons, M.D., FRCPC, FAAP, FACAAI, FAAAAI, FCAHS, FRSC, professor emerita at the University of Manitoba, who served as founder and head of the division of allergy and clinical immunology in the department of pediatrics and later as training program director in allergy and clinical immunology at the university
- Michael Kaliner, M.D., founder of the Institute for Asthma and Allergy and former director of the Allergic Diseases Section of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health
- Richard F. Lockey, M.D., division chief at the college of medicine internal medicine, director of allergy and immunology and leader of the clinical research unit at USF Health
- Phillip Lieberman, M.D., clinical professor of medicine and pediatrics in the departments of internal medicine and pediatrics (divisions of allergy and immunology) at the University of Tennessee College of Medicine in Memphis, Tenn.
- Motohiro Ebisawa, M.D., Ph.D., vice-director of clinical research center for allergy and rheumatology, Sagamihara National Hospital and the visiting professor of the Jikei University School of Medicine. He is a leading expert in food allergies in Japan and currently serves as the president-elect of World Allergy Organization (WAO), where he has served in different leadership roles since.
- Guy Ludbrook Ph.D., M.B.B.S., F.A.N.Z.C.A., G.A.I.C.D., professor at the University of Adelaide and director of PARC clinical research at the Royal Adelaide hospital and critical care expert
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 investigational intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, needle-free, 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.
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 clinical studies using a low and safe intranasal dose (1.0 mg epinephrine administered). 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 also designed to be user-friendly, needle-free and easily portable to carry in a pocket or purse anytime, anywhere.
ARS-1 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in February 2019. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need by providing a therapy where none exist or by providing a therapy which may be potentially better than available therapy. Its purpose is to get important new drugs to patients earlier.
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.
The sprayer is uniquely formulated with Intravail®, an absorption enhancing technology. Intravail® enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs (up to 30,000 daltons in size) that can currently only be administered by injection.