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Meet Neffy, the friendly epinephrine nasal spray from ARS Pharma awaiting FDA approval

Friendly epinephrine? Meet Neffy, ARS Pharmaceuticals’ nasal spray epinephrine to treat severe allergic reactions to food, medicines and insect bites.

Neffy, now awaiting FDA approval, aims to flip the script on past epinephrine autoinjector marketing that focused on fear around the severe reactions called anaphylaxis. Anaphylaxis is indeed scary—hives, extreme swelling, breathing difficulties, loss of consciousness and even death can happen quickly.

Remember the chilling 2016 “Face Your Risk” awareness campaign from Epi-Pen maker Mylan, now Viatris? Its TV ad featured a teenage girl at a party who accidentally eats a brownie with peanut butter, showing her rapid descent into anaphylaxis as her friends panic around her.

“We want to be the complete opposite,” said Richard Lowenthal, president, CEO and co-founder of ARS referencing the past work. “We’re not going to run a fear campaign. We’re going to run a campaign that you should treat your disease and relieve your symptoms and not be afraid. That’s the message.”

Neffy would be the first nasally dispensed epinephrine—the adrenaline copycat med today is only available in injectable forms, including the most commonly carried Epi-Pen along with Kaleo’s AuviQ and Teva’s generic auto-injector. Novartis Sandoz offers also offers an injection device Symjepi.

The FDA granted ARS-1, now Neffy, a fast track designation in February 2019, and while Lowenthal declined to disclose a timeline, he did say FDA has been “very positive” about the product. It even asked ARS to push its use to younger children, from six years now to four and up.

Other evidence it’s readying for launch? ARS drummed up $55 million in series D funding recently, earmarked “to advance Neffy through approval, to support initial launch activities and to evaluate Neffy in clinical studies for additional indications.”

The pharma is already on the hunt for a chief commercial officer and other key marketing team positions, Lowenthal said.

ARS’ marketing efforts will be squarely aimed at consumers—moms, dads and loved ones of kids with life-threatening allergies. Not only because they’re the chief decision-makers, but also because all the physicians ARS spoke to say if parents or caregivers ask for the nasal version after approval, they’ll write the prescription.

“It’s an Rx, but it’s a consumer product,” Lowenthal said. “We will be heavily focused on a consumer marketing approach. That doesn’t necessarily mean just advertising—a big pillar of our thinking right now is patient education.”

ARS plans to work through allergy advocacy organizations and provide funding to help them expand their messages along with its own work.

The company anticipates 60% of epinephrine pen users will switch to Neffy immediately and 80% within two years. Along with current autoinjector patients, ARS plans to target people with allergies who should carry the emergency med but don’t because of inconvenience or cost. While ARS hasn’t put a price tag on Neffy yet, the pharma aims to price it “comparably” with the pens on the market, Lowenthal said.

About 4 million people in the U.S. have been prescribed epinephrine auto-injectors, ARS says, pointing to IQVIA prescription data. However, it also pointed to claims data showing more than 20 million people experience severe allergic reactions every year. The Allergy and Asthma Foundation estimates anaphylaxis occurs in about 5%, or 1 in 20 Americans.

Another Neffy target? Unspecified use adoption at restaurants, on airplanes and other public places where food or insect allergies can cause life-or-death emergencies. Similar to the adoption of Narcan, the opioid reversal agent naloxone delivered in intranasal form, ARS hopes to capitalize on the easy-to-use nasal form for public emergency use, along with the individual patient push.

Along with its series D funding announcement last week, ARS added several big names to its board including Peter Kolchinsky, managing partner and founder of RA Capital, and well-known allergy advocate and parent, along with Rajeev Dadoo, managing partner of SR One.

They join Brent Saunders, former Allergan and AbbVie chief, now CEO, president and chairman of Vesper Healthcare, who joined the ARS board in May.