In an exclusive interview with The Fly, Aquestive Therapeutics (AQST) President and CEO Keith Kendall talked about the company, its pipeline, ongoing clinical trials and much more. Here are some highlights:
ROYALTIES MONETIZATION: Back in May, Aquestive said the company was planning to advance its strategy to monetize the anticipated royalties associated with Sunovion Pharmaceuticals' apomorphine sublingual film APL-130277, which received FDA approval to treat motor fluctuations experienced by people living with Parkinson's disease. Aquestive's CEO Keith Kendall explained to The Fly that, "Sunovion has announced its intention to launch the product in the U.S. in September of 2020. Based on the terms of our license agreement with Sunovion, we expect to receive a regular stream of royalties and license fees over the coming years from Kynmobi." "We have begun the process to monetize the asset, and believe that the market is stabilizing so that we can expect to be in a position in the coming weeks to evaluate the timing and structure of a transaction that is the most advantageous to the company. Our expectation is that we will raise $50M-$100M of gross proceeds from this monetization, subject to covenants in our debt agreements," he added.
AQST-108: Aquestive announced on Tuesday that it has submitted its IND application to the Food and Drug Administration for AQST-108, a "first of its kind" oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using the company's proprietary PharmFilm technologies. "We continue to expect to commence PK clinical trials later in 2020. The COVID-19 pandemic has not affected our anticipated timelines on this product," Kendall said. "The FDA acknowledged that there appears to be an unmet medical need among patients who resist the standard of care use of subcutaneous and intramuscular injection in the treatment of anaphylaxis. We believe that AQST-108 may potentially address some of those unmet needs."
LIBERVANT: Earlier this year, Aquestive announced that the FDA has accepted the New Drug Application for Libervant for the treatment of acute refractory/repetitive seizures, which was filed back in November 2019. The agency assigned a Prescription Drug User Fee Act date of September 27, 2020, and CEO Keith Kendall says the company has "no indication or reason to believe that there will be any delay." "As an organization, we worked closely with the FDA during the development process to do our best to provide the information that the FDA needs to approve our product. However, there can be no assurances with regard to the FDA decision regarding our application. The review to-date has progressed as we would have expected, with a normal exchange of information requests and answers to the requests," the executive added.
ENOUGH CAPITAL 'WELL INTO 2021': Looking out over the remainder of the year and into 2021, Aquestive’s CEO says that, "Through a combination of our revenue, cash on hand and monetizable assets, we believe that we have capital or visibility to capital that will enable us to fund our business well into 2021 and possibly beyond. These, combined with some licensee activities, present a significant number of potential value inflection points for shareholders over the coming 12-24 months."
'KEY VALUE DRIVERS': Aquestive's CEO sees near-term value being driven by the CNS/Epilepsy franchise "comprised of Sympazan, already launched, and Libervant, with its NDA currently pending at the FDA." "Additionally, significant value has the potential to be created if we are successful in the development and launch of AQST-108 sublingual epinephrine, a potentially significant disruptive change to the historically injectable therapies currently available. Moreover, we believe that the company has significant opportunity to continue to provide innovative therapies in complex conditions beyond the programs currently in our pipeline, and we will consider augmenting our PharmFilm technology and know-how with other technologies in order to expand what we do for patients in our targeted therapeutic areas and other disease states," the executive explained.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. A more detailed version of this interview to follow.
For more on Aquestive Therapeutics' Royalties monetization click here.Aquestive Therapeutics
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