ARS Pharmaceuticals, a company focused on developing novel treatments for severe allergic reactions has signed an exclusive licensing agreement with Recordati, under which the latter would receive marketing rights in the European Union, Iceland, Liechtenstein, Norway, Switzerland, United Kingdom, Russia, Turkey, Middle East and French speaking African countries for their proprietary products ARS-1, an epinephrine nasal spray known as Neffy™ in the United States.
Under the agreement, ARS will continue working on obtaining regulatory approvals for ARS-1 in the U.S. and other regions globally. In exchange for an upfront and subsequent regulatory and commercial milestone payments, Recordati will gain exclusive rights to develop, register and commercialise the product in 93 countries. Additionally, ARS will manufacture and supply the product to Recordati and will be entitled for tiered royalties based on net sales.
Neffy™ (ARS-1) leverages its novel delivery mechanism for treatment of severe allergic reactions leading to anaphylaxis, a potentially fatal allergic reaction if not treated timely. Intranasal administration offers a needle free, easier to utilize patient friendly alternative for administration of epinephrine and received FDA fast track designation in February 2019. Marketing authorization application for the product is expected to be filed in EU by the end of 2020. The nasal spray was reported to have bioequivalence and comparable absorption rates to epinephrine injections.
EpiPen Auto-injectors are the currently available treatment alternatives as first-line therapy for severe allergic reaction but their use amongst the patients has been hindered by various barriers including steep pricing in the US market, risks and fear associated with needles etc. Pricing of these products have been of concern in the past few years, the cost of EpiPen developed by Mylan is around USD 600 – 700. The price skyrocketed after the only other competing products, Adrenaclick and Twinject were discontinued in 2012 by Shionogi. Increased prices were addressed with concerns from the healthcare providers and policymakers due to which generic versions of the product were also launched. Mylan even released its own generic version at half the price. Genericization of pharma products tends to increase competition and hence promotes availability of products at significantly reduced prices, but that hasn’t been the scenario in case of epinephrine auto-injectors which are still expensive in the US market. However, a stark difference in pricing can be observed in the European countries where the government negotiates with pharma companies for the pricing of the products. Hence, Epinephrine auto-injectors are available at much cheaper options in those regions. Pricing of ARS-1 in the regulated markets will play an integral role in a possible shift that in the epinephrine market due to its easier administration technology. The companies will have the potential to capture a large share of the market and provide patients with better alternatives.