Gaining FDA approval for its epinephrine nasal spray came nearly a year later than expected for ARS Pharmaceuticals. But after the recent approval of neffy, the San Diego drugmaker is poised for an October launch and a “blue sky opportunity,” according to analysts at Leerink Partners.
By offering a needle-free alternative, ARS has a chance to gain users among the 13.5 million in the United States who have been diagnosed with type 1 allergic reactions and who do not have current epinephrine prescriptions, according to a Leerink note. Another potential group of users is the 3.3 million patients who have let their prescriptions lapse over the last three years.
These numbers—which come from ARS—compare to the 3.2 million patients with type 1 allergic reactions who hold active prescriptions for autoinjector-delivered epinephrine.
The company also believes there is another untapped market, which includes airlines, emergency medical units and first responders. ARS's management told Leerink that police officers and fire and rescue workers are unable to carry autoinjectors because of regulations against needle-based therapies.
“Management believes Neffy’s needle-free design could fit well with widespread use among these first responders,” the Leerink team wrote in a note to clients. “Along these lines, management drew a parallel with Narcan (naloxone nasal spray), which is now carried by almost all police officers and fire rescue workers in the US and has captured a majority share of a (once) all-injection market.”
In the US, ARS is deploying a sales force of 110 area managers and field reps who are targeting 12,000 physicians, primarily allergists, who cover approximately half of the epinephrine market.
The company told Leerink that it has received “overwhelmingly positive” feedback from media and patient advocacy groups on its pricing of Neffy. ARS plans to set a $25 copay for those who are commercially insured and a $199 price—which is comparable to autoinjectors—for those without coverage. The wholesale acquisition cost of Neffy will be $710.
ARS has manufactured several lots of Neffy and is currently scaling up production, the company's management told Leerink.
Meanwhile, ARS also is gearing up for a potential launch of Neffy in Europe by the end of the year. The company expects to initially launch Neffy in Germany because of its advantageous “reimbursement approach,” with the U.K. likely to follow, according to the note. The two countries make up half the market in Europe, ARS told Leerink.
“Investors were intrigued by the fact that they are already seeing demand from Europe in reaction to US approval of Neffy,” the Leerink team wrote.
In September of last year, the FDA rejected ARS’s application for approval, asking for more study data on repeat doses of Neffy compared to repeat doses of injectable epinephrine.
The complete response letter was a stunner because four months earlier the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) had recommended the product for approval. Additionally, the FDA had already aligned with ARS on its final labeling and a post-marketing study plan.