ARS Pharmaceuticals plans to merge with Silverback Therapeutics, the companies said, with the combined company focused on approval and launch of ARS’s Neffy (ARS-1) epinephrine nasal spray for the treatment of allergic reactions. Shareholders of Silverback, whose pipeline consists of a therapy for the treatment of chronic hepatitis B in early development, will own a little more than a third of the new company, with ARS shareholders owning the remainder.
The combined company will be called ARS Pharmaceuticals and will be headed by current ARS CEO Richard Lowenthal. According to Lowenthal, the company had “a favorable pre-NDA meeting” with the FDA and expects to submit and NDA for Neffy in the next few months. ARS submitted an MAA for Neffy to the EMA in November 2020.
In August 2021, ARS announced that it had raised $55 million to support the continued development and potential launch of Neffy. ARS-1 was granted Fast Track designation by the FDA in February 2019. In September 2020, Recordati acquired marketing rights to Neffy in the EU and a number of other countries.
Lowenthal said, “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of Neffy. Neffy is on the cusp of achieving what has not been possible before, the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple-to-administer nasal spray. . . .This merger positions ARS and our experienced team to execute on the potential launch of Neffy in 2023 by providing the requisite capital needed for launch.”
Silverback CEO Laura Shawver commented, “This transaction represents the result of a thorough and thoughtful strategic review process by Silverback. ARS is an exciting late-stage company with compelling clinical data demonstrated with Neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as Narcan. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at risk for Type 1 severe allergic reactions.”
Read the ARS Pharmaceuticals press release.
