ARS Pharma’s Clinical Differentiation
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What is ARS Pharma and its mission?
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Welcome to another episode of Bloomberg Intelligence's Vanguards of Healthcare podcast, where we speak with leaders at the forefront of change in the healthcare sector. I'm Anne Hunter-Van Kirk, Senior Biopharmaceuticals Analyst at Bloomberg Intelligence, the in-house equity research division of Bloomberg, and I'm very pleased to welcome today's guest, Richard Lowenthal, CEO of ARS Pharmaceuticals. ARS Pharma is a biopharmaceutical company dedicated to protecting patients from allergic reactions that could lead to anaphylaxis. The company is commercializing Nephi, which was approved August of last year, an epinephrine nasal spray for emergency treatment, including anaphylaxis. Rich, can we first start out with your background and what led you to co-found ARS?
Yes, certainly. Thank you. I've been in the industry about little over 30 years, started my career at the food and drug administration after graduate school. and then moved into industry after about five years at the FDA. And during my time in industry, I worked on a number of different programs, including some that were nasal spray products and including some experience with epinephrine. More recently, I was one of the people that helped develop Narcan nasal spray and, in fact, was the lead representative to the Food and Drug Administration and got Narcan approved. Also, some other emergency use nasal sprays, like where my clinical research organization Pacific link did all of the clinical work and regulatory work for that program.
And we got that approved for a company called, which is here in San Diego as well. And then we worked on a number of others, including Opvi, which is the second opioid antagonist, meaning for opioid overdose approved by the FDA that's a nasal spray. And then some others like Tesamra and other nasal products that we worked on. So based on that experience and working with the company that owned this absorption enhancing technology we're using, Intravail, The company is Aegis. We made an agreement with Aegis to license the technology for an attempt to see if it would work with epinephrine. And we did that basically as a small company. We started ARS based on that. And initially we are self-funded. And it was fairly high risk at the beginning because while Intravail works very well with some other drugs that are on the market, a few of them that are on the market now, all those drugs get absorbed intranasally.
But with epinephrine, there was literally zero absorption in an aqueous solution intranasally. So you couldn't get absorption unless you used solvents and things, but only at very, very high doses, which could be dangerous because they're above the lethal level of epinephrine. So, it was a little bit of a high risk, but it ended up working very well that in our 1st pilot studies in Australia, we showed that that with the interval formulation that that epinephrine could be very rapidly absorbed even faster than injection with a needle and syringe. And could get to therapeutic levels very, very easily with low doses that we maintain a good safety margin on when we consider. possible overabsorption from different conditions.
We stay very far south of where the limit is for inducing certain cardiovascular side effects, including cerebral hemorrhage, which can occur with epinephrine. So you need to keep the dose low, and that was very, very important. So that's a little bit of my background and how I got into developing epinephrine nasal spray in NEFI in the very early days, about 10 years ago when we started this company.
Fantastic.
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Chapters
5 chapters
1
What is ARS Pharma and its mission?
0:00–9:24
2
How does NEFI differentiate itself in a competitive market?
9:24–16:09
3
What challenges did ARS face during the commercial launch of NEFI?
16:09–27:00
4
How does NEFI's administration method impact patient outcomes?
27:00–42:13
5
What strategies does ARS use for pricing and copay assistance?
42:13–43:49
Speakers
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