Agreement will give access to millions at risk for severe allergic reaction to new pain-free delivery method for epinephrine and will help in efforts to gain regulatory approval for ARS-1 (known as NeffyTM in the U.S.) around the world
SAN DIEGO SEPTEMBER 22, 2020—ARS Pharmaceuticals (ARS) announced that it has entered into an exclusive licensing agreement with Recordati for marketing rights in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia/CIS, Turkey, Middle East and French-speaking African countries, for ARS-1 (known as NeffyTM in the United States), an epinephrine nasal spray. This agreement will allow ARS, a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, to continue the important work of gaining regulatory approval in the United States and globally by providing additional capital through licensing milestones and future royalties on sales.
“We are thrilled that Recordati has recognized the importance of this new delivery technology for epinephrine that will provide an improved therapy for the millions of people in Europe living with life-threatening allergies. With their strong track-record in specialty medicines, we are excited to work with the team at Recordati, to help deliver a new, easier to dose, pain-free way to treat severe allergic reactions and prevent progression to anaphylaxis,” said Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals. “The agreement with Recordati is critical in our continued journey towards Neffy™ (ARS-1) approval in the United States and Worldwide.”
Recordati will receive exclusive rights to develop, register and commercialize ARS-1 (known as NeffyTM in the United States) in 93 countries including Europe in return for an upfront and subsequent payments based on successful achievement of regulatory and commercial milestones. ARS Pharmaceuticals will manufacture and supply ARS-1 (known as NeffyTM in the United States) to Recordati as part of the agreement, and receive tiered royalties based on net sales.
Because of its innovative delivery method, NeffyTM (ARS-1) has the potential to be a much more effective treatment in preventing severe allergic reactions than currently available. Its needle-free, small and easy-to-use delivery system may help eliminate anxiety and overcome hesitation that is common with injectable epinephrine. The marketing authorization application for the 1 mg dose, for patients 30kg or greater, is expected to be filed in the EU by the end of 2020. A dosage strength of 0.65 mg is under development for children weighing between 15kg and 30kg and is expected to be filed shortly after the initial approval.
In Europe, based on epidemiology data about 4% of the general population have experienced an anaphylactic episode. Overall annual net sales of epinephrine auto-injectors in Europe are around $120 million USD based on IQVIA prescription data, representing less than 10% of the eligible population. According to the European Anaphylaxis Registry, less than 15% of anaphylaxis episodes are self-treated with an auto-injector. The introduction of Neffy™ (ARS-1) would be a welcome new tool to safely, quickly and painlessly administer lifesaving epinephrine.
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 NeffyTM (ARS-1), an 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.
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations throughout the whole of Europe, Russia, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. Consolidated revenue for 2019 was € 1,481.8 million, operating income was € 465.3 million and net income was € 368.9 million.