The majority of adverse events in clinical trials were mild in nature and comparable to injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.”ĭata across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. 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. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. “ 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. “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy,” said Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.ĪRS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. (“ARS”) today announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. (Nasdaq: SBTX) (“Silverback”) and ARS Pharmaceuticals, Inc. SEATTLE & SAN DIEGO-( BUSINESS WIRE)-Silverback Therapeutics, Inc.
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