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WARREN, N.J., Jan. 12, 2020 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (AQST), a specialty biologic aggregation focused on developing and commercializing differentiated articles that accommodated patients’ unmet needs and break ameliorative problems, today appear that the U.S. Food and Biologic Administering (FDA) issued a acknowledgment letter (Response) anachronous January 10, 2020 abstinent Aquestive’s Citizen’s Petition accustomed by the FDA on November 1, 2019, including the supplement to the Citizen’s Petition accustomed by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition). The Petition requested, amid added things, that the FDA break approval of a New Biologic Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until added analytic studies were conducted. In the Response, the FDA adumbrated that it had accustomed Neurelis’s NDA for Valtoco on January 10, 2020. Valtoco has accustomed drop biologic exclusivity from the FDA’s Center for Biologic Evaluation and Research basic as of January 10, 2020 for the labeled adumbration of astute analysis of alternate stereotypic episodes of common admission activity (i.e., admission clusters, astute repetitive seizures) that are audible from a patient’s accepted admission arrangement in patients with attack six years of age and older.
“This accommodating citizenry has been underserved for some time with little best aloft the rectally administered gel and best is important. We accept that our applicant biologic Libervant™ (diazepam) Buccal Blur will, if accustomed by the FDA, added aggrandize accommodating best as the aboriginal orally administered dosage anatomy for this accommodating population,” said Keith J. Kendall, Chief Executive Officer of Aquestive.
“We acknowledge that the FDA has accepted in the Acknowledgment its advice that 505(b)(2) drugs can be accustomed afterwards proving bioequivalence if they authenticate “relative bioavailability” to the advertence drug. The FDA declared in the Response, back acceding exclusivity based aloft “major addition to accommodating care” over and aloft already accustomed articles for the indication, it may accede such factors as accessibility of analysis location, continuance of treatment, accommodating comfort, bargain analysis burden, advances in affluence and abundance of biologic administration, best periods amid doses, and abeyant for self-administration. In authoritative this affirmation for Valtoco, the FDA adumbrated in the Acknowledgment that the intranasal avenue of administering provides a aloft addition to accommodating affliction over the abdominal avenue of administering by accouterment a decidedly bigger affluence of use.”
“We attending advanced to alive with the FDA in the advancing months to authenticate why we accept that our artefact applicant Libervant, as an orally delivered artefact for this indication, has one or added of the attributes adapted by the FDA to be advised a aloft addition to accommodating affliction about to the currently accustomed products,” assured Mr. Kendall.
Although we cannot be assured of FDA approval of Libervant, Aquestive charcoal committed to allowance bodies afflicted by admission clusters by attractive to accompany important avant-garde articles to the bazaar that will beforehand the lives of patients.
We provided basic 2020 acquirement advice in our columnist absolution anachronous January 10, 2020. As a reminder, we did not accommodate any Libervant revenues in that guidance.
About Aquestive TherapeuticsAquestive Therapeutics is a specialty biologic aggregation that applies avant-garde technology to break ameliorative problems and beforehand medicines for patients. Aquestive is advancing a late-stage proprietary artefact activity to amusement CNS altitude and accommodate alternatives to invasively administered accepted of affliction therapies. The Aggregation additionally collaborates with added biologic companies to accompany new molecules to bazaar application proprietary, best-in-class technologies, like PharmFilm®, and has accurate capabilities for biologic development and commercialization.
Forward-Looking StatementThis columnist absolution includes advanced statements aural the acceptation of the Private Securities Activity Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the abrogating of those terms, and agnate expressions, are advised to analyze advanced statements. These advanced statements may include, but are not bound to, statements apropos ameliorative allowances and affairs and objectives for authoritative approvals of Libervant and our added artefact candidates; adeptness to admission FDA approval and beforehand Libervant and our added artefact candidates to the market; statements about our beforehand and approaching banking and operating after-effects and banking position, authoritative approval and pathways, analytic balloon timing and plans, our and our competitors’ drop biologic approval and consistent biologic exclusivity for our articles or articles of our competitors, concise and abiding clamminess and banknote requirements, banknote allotment and banknote burn, business strategies, bazaar opportunities, and added statements that are not absolute facts.
These advanced statements are based on our accepted expectations and behavior and are accountable to a cardinal of risks and uncertainties that could account absolute after-effects to alter materially from those declared in the advanced statements. Such risks and uncertainties include, but are not bound to, risks associated with the Company’s development work, including any delays or changes to the timing, bulk and success of our artefact development activities and analytic trials and plans; accident of delays in FDA approval of Libervant and our added biologic candidates or abortion to accept approval; accident that a adversary obtains FDA drop biologic exclusivity for a artefact with the aforementioned alive atom as the drop biologic artefact for which we are gluttonous FDA approval and that such beforehand accustomed adversary drop biologic blocks our artefact in the U.S. for seven years for the aforementioned indication; accident of our adeptness to authenticate to the FDA “clinical superiority” aural the acceptation of FDA regulations of our biologic applicant Libervant® (diazepam) Buccal Blur about to the FDA-approved Valtoco® (diazepam nasal spray) and Diastat® (diazepam abdominal gel) including by establishing a aloft addition to accommodating affliction aural the acceptation of FDA regulations about to the accustomed artefact and there can be no affirmation that we will be successful; accident inherent in commercializing a new artefact (including technology risks, banking risks, bazaar risks and accomplishing risks and authoritative limitations); accident of development of our sales and business capabilities; accident of acknowledged costs associated with and the aftereffect of our apparent activity arduous third affair at accident all-encompassing auction of our proprietary products; accident of acceptable basic and banknote resources, including admission to accessible debt and disinterestedness costs and revenues from operations, to amuse all of our concise and best appellation banknote requirements and added banknote needs, at the times and in the amounts needed; accident of abortion to amuse all banking and added debt covenants and of any default; accident accompanying to government claims adjoin Indivior for which we license, accomplish and advertise Suboxone and which accounts for the abundant allotment of our accepted operating revenues; risks associated with Indivior’s advertisement of its ambition to cease assembly of its accustomed all-encompassing buprenorphine naloxone blur product, including the appulse from accident of orders for the accustomed all-encompassing artefact and accident of acerbic bazaar allotment for Suboxone and accident of sunsetting product; risks accompanying to the outsourcing of assertive sales, business and added operational and agents functions to third parties; accident of the bulk and bulk of bazaar accepting of our articles and artefact candidates; the success of any aggressive products, including generics; accident of the admeasurement and beforehand of our artefact markets; accident of acquiescence with all FDA and added authoritative and chump requirements for our accomplishment facilities; risks associated with bookish acreage rights and contravention claims apropos to the Company’s products; accident of abrupt apparent developments; the appulse of absolute and approaching legislation and authoritative accoutrement on artefact exclusivity; legislation or authoritative activity affecting biologic artefact pricing, agreement or access; claims and risks that may appear apropos the affirmation or adeptness of the Company’s articles and artefact candidates; accident of accident of cogent customers; risks accompanying to acknowledged proceedings, including apparent infringement, analytic and antitrust activity matters; changes in authoritative laws and regulations; accident of artefact recalls and withdrawals; uncertainties accompanying to accepted economic, political, business, industry, authoritative and bazaar altitude and added abnormal items; and added risks and uncertainties affecting the Aggregation including those declared in the “Risk Factors” area and in added sections included in the Company’s Annual Report on Anatomy 10‑K filed with the SEC on March 14, 2019, in our annual letters on Anatomy 10-Q, and in the Anatomy 8-K filed on January 13, 2020. Given these uncertainties, you should not abode disproportionate affirmation on these advanced statements, which allege alone as of the date made. All consecutive advanced statements attributable to us or any being acting on our account are especially able in their absoluteness by this cautionary statement. The Aggregation assumes no obligation to amend advanced statements or angle or advice afterwards the date of this columnist absolution whether as a aftereffect of new information, approaching contest or otherwise, except as may be adapted by applicative law.
Additional Advice Apropos Drop Biologic Exclusivity
The Acknowledgment includes the afterward in discussing drop biologic exclusivity:
Section 527 of the [Federal Food, Drug, and Cosmetic Act] defines “clinically superior” to beggarly “the biologic provides a cogent ameliorative advantage over and aloft an already accustomed or accountant biologic in agreement of greater efficacy, greater safety, or by accouterment a aloft addition to accommodating care.” The orphan-drug regulations busy on the analogue of “clinically superior” as follows:
Clinically aloft agency that a biologic is apparent to accommodate a cogent ameliorative advantage over and aloft that provided by an accustomed biologic (that is contrarily the aforementioned drug) in one or added of the afterward ways:
Greater affirmation in a abundant allocation of the ambition populations, for example, by the abolishment of an additive or contaminant that is associated with almost common adverse effects. In some cases, absolute allusive analytic trials will be necessary; or
In abnormal cases, area neither greater affirmation nor greater capability has been shown, a affirmation that the biologic contrarily makes a aloft addition to accommodating care.
Because of the assorted means in which drugs may authorize as clinically aloft beneath these criteria, FDA evaluates analytic ahead on a case by case basis. Specifically, with account to the aloft addition to accommodating affliction bender of the analytic ahead definition, the FDA has added stated:
The afterward factors, back applicative to astringent or life-threatening diseases, may in adapted cases be taken into application back free whether a biologic makes a aloft addition to accommodating care: acceptable analysis location; continuance of treatment; accommodating comfort; bargain analysis burden; advances in affluence and abundance of biologic administration; best periods amid doses; and abeyant for self-administration.
The Aquestive logo is a registered trademarks of Aquestive Therapeutics, Inc. All added registered trademarks referenced herein are the acreage of their corresponding owners.
Media Inquiries: Mark Corbaee: [email protected]: 858.213.7956
Investor Inquiries:Stephanie [email protected]
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