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Richard Lowenthal

👤 Person
347 total appearances

Appearances Over Time

Podcast Appearances

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

I've been in the industry about little over 30 years, started my career at the food and drug administration after graduate school.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

and then moved into industry after about five years at the FDA.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

And we got that approved for a company called, which is here in San Diego as well.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

And then some others like Tesamra and other nasal products that we worked on.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

So based on that experience and working with the company that owned this absorption enhancing technology we're using, Intravail,

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

The company is Aegis.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

We made an agreement with Aegis to license the technology for an attempt to see if it would work with epinephrine.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

And we did that basically as a small company.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

We started ARS based on that.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

And initially we are self-funded.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

But with epinephrine, there was literally zero absorption in an aqueous solution intranasally.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

Vanguards of Health Care by Bloomberg Intelligence
ARS Pharma’s Clinical Differentiation

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.

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