- Provides access to $ 30 million of capital subject to FDA approval and US market access for Libervant
WARREN, NJ, Aug 09, 2021 (GLOBE NEWSWIRE) – Aquestive Therapeutics (formerly MonoSolRx) Inc. (NASDAQ: AQST), a pharmaceutical company focused on the development and commercialization of differentiated products that meet unmet patient needs and solve therapeutic problems. problems, announced today that it has reached an agreement with its lenders to amend the Basic Deed providing for an extension of the term of six months until June 30, 2022 to provide additional debt in the total amount of $ 30.0 million. Pursuant to the extension to June 30, 2022, Aquetive has the right, at its discretion, to draw up to $ 10 million following FDA approval for Libervant, the first orally administered diazepam product for the management of epilepsy groups, and up to an additional $ 20 million following the FDA granting access to the US market for Libervant.
“We continue to believe that our non-invasive and innovative product for refractory epilepsy represents a significant improvement in the treatment options available for this patient population and a significant business opportunity. We appreciate the continued support of our lenders and their flexibility given the current PDUFA date for Libervant. With this six-month extension, we maintain the principal option and can access up to $ 30 million under our existing credit facility that we can potentially use to finance the launch of Libervant, if access to market is approved, ”said Keith Kendall, President and CEO. of Aquestive.
The FDA has agreed to resubmit a New Drug Application (NDA) for the Libervant ™ buccal film (diazepam) for the management of epilepsy groups. The FDA has set a target date for the Prescription Drug User Fee Act (“PDUFA”) of December 23, 2021. Aquetive received a Complete Response Letter (CRL) from the FDA in September 2020, concluded a Type A meeting with the FDA in November 2020 and received additional guidance from the FDA in February 2021. Based on the Agency’s guidance, the submission included additional statistical modeling and analysis to support existing clinical data. The Company continues to believe that no additional clinical studies will be required for FDA approval of Libervant for access to the US market.
About Aquestive Therapeutics
Aquetive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medications for patients. The Company has marketed to date an exclusive product developed in-house, the oral film Sympazan® (clobazam), has a portfolio of exclusive commercial products focused on the treatment of diseases of the central nervous system, or CNS, and others. unmet needs, and is developing complex orally administered molecules to provide alternatives to standard, invasively administered therapies. The Company also collaborates with other pharmaceutical companies to commercialize new molecules using cutting-edge proprietary technologies, such as PharmFilm®, and has proven capabilities in drug development and commercialization.
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. To this end, words such as “believe”, “anticipate”, “plan”, “expect”, “Intend”, “may”, “will” or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the advancement of Libervant ™, including our belief that the resubmitted NDA addresses all issues raised in the CRL, through the regulatory and development pipeline and strategies. trade, market opportunities, and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the global COVID-19 pandemic on our business, including with respect to our clinical trials, including site launch, patient recruitment, timing and adequacy. clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; supply chain, manufacture and distribution of pharmaceutical ingredients and other raw materials; sales and demand for our products; our liquidity and the availability of our capital resources; customer demand for our products and services; the ability of customers to pay for goods and services; and the continued availability of an appropriate workforce and skilled professionals. Given these uncertainties, the Company is unable to provide assurance that operations can be maintained as planned before the COVID-19 pandemic.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the development work of the Company, including any delay or change in the timing, cost and success of our product development and clinical trial activities; the risk of delays in FDA approval of Libervant or failure to obtain approval; ability to address concerns identified in the FDA’s full response letter dated September 25, 2020 regarding the new drug application for Libervant; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of Libervant’s FDA regulations for FDA-approved rectal gel and diazepam nasal spray products including establishing a major contribution to patient care at the meaning of FDA regulations relating to approved products as well as the risks associated with other pathways or potential positions that are or may in the future be advanced to the FDA to overcome the seven-year exclusivity on orphan drugs granted by the FDA for a competitor’s approved nasal spray product in the United States, and there can be no assurance that we will be successful in obtaining such approval; risk that a competitor will obtain orphan drug exclusivity from the FDA for a product with the same active moiety as one of our other drug candidates for which we are seeking FDA approval and that this competing orphan drug previously approved blocks these other product candidates in the US for seven years for the same indication; the risk of gaining market access for other reasons; the risk inherent in bringing a new product to market (including technological risks, financial risks, market risks and implementation risks and regulatory limitations); risk of developing our sales and marketing capabilities; the risk of sufficient capital and cash resources, including access to available debt and equity financing and operating income, to meet all of our short- and long-term cash and other cash requirements, at the times and for the amounts required; the risk of non-compliance with all financial and other covenants and any default; the approval of our orphan drugs and that of our competitors and the resulting drug exclusivity for our or our competitor’s products; short and long term liquidity and cash requirements, cash financing and cash consumption; risks associated with the outsourcing of certain marketing and other operational and personnel functions to third parties; the risk of the rate and degree of market acceptance of our products and product candidates; the success of any competing product, including generics; the risk of the size and growth of our product markets; risks of compliance with all FDA and other government and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; the risk of unexpected patent developments; the impact of existing and future legislation and regulations on product exclusivity; legislation or regulatory measures affecting the pricing, reimbursement or access of pharmaceutical products; claims and risks that may arise regarding the safety or efficacy of the Company’s products and product candidates; risk of loss of important customers; risks associated with legal proceedings, including matters of patent infringement, antitrust investigation and litigation; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, commercial, industrial, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in our annual report on Form 10 K, in our quarterly reports on Form 10-Q and in our current reports on Form 8 -K filed with the Securities Exchange Commission (SEC). In view of these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date of their publication. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update any forward-looking statements, outlook or guidance after the date of this press release, whether as a result of new information, future events or otherwise, except as required by law. applicable requires it.
PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.
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