Sympazan (clobazam) / Aquestive, Assertio - LARVOL DELTA

Drugs for epilepsy. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • CNS Disorders • Epilepsy

Comparison Table: Some oral antiseizure medications. (PubMed, Med Lett Drugs Ther) - No abstract available

Clinical • Journal • CNS Disorders • Epilepsy

Assertio Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "Net product sales increased 55% to $49.9 million. Increased sales of Indocin, a full quarter of Otrexup and the addition of Sympazan more than offset the expected declines in Zipsor and Solumatrix....The increase was driven by $1.4 million of higher stock-based compensation expense and $1.0 million in higher sales and marketing expenses due to the addition of Otrexup and Sympazan....At year-end 2022, cash and cash equivalents totaled $64.9 million, a slight increase from the third quarter even after funding $25.0 million of asset purchase payments for Otrexup and Sympazan in the fourth quarter."

Commercial • CNS Disorders • Epilepsy

Assertio Announces Partnership with the Lennox-Gastaut Syndrome (LGS) Foundation (GlobeNewswire) - "SYMPAZAN® (clobazam) oral film from Assertio is used for the adjunctive treatment of seizures associated with LGS in patients two years of age and older...Assertio Holdings, Inc...announced that it has provided the LGS Foundation a $100,000 educational grant to assist in efforts to raise awareness of LGS and provide educational materials to the LGS community."

Licensing / partnership • CNS Disorders • Epilepsy

Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan Oral Film Patent (GlobeNewswire) - "Assertio Holdings...announced that U.S. Patent, No. 11541002 for Sympazan oral film is now listed in the U.S. Food and Drug Administration ('FDA') publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book....The patent, which is valid until 2039, is assigned to Aquestive Therapeutics, Inc. and exclusively licensed to Assertio. It covers an oral film for delivering clobazam and methods for using the film to treat epilepsy and/or seizures. Aquestive will continue to prosecute additional US patent application(s) to further strengthen the portfolio on this product."

Patent • CNS Disorders • Epilepsy

Aquestive Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update (Yahoo Finance) - "Total revenues were $11.5 million in the third quarter 2022, compared to $13.3 million in the third quarter 2021. For the third quarter 2022 compared to the prior year period, the Company saw a 15% increase in Sympazan net revenue and a 15% increase in license and royalty revenue, offset by reductions in manufacture and supply revenue as well as co-development and research fees."

Commercial • CNS Disorders • Epilepsy

Assertio Holdings, Inc. Signs Exclusive License for Sympazan (clobazam) Oral Film from Aquestive Therapeutics, Inc. (GlobeNewswire) - "Assertio Holdings, Inc...announced a transaction to acquire an exclusive license for Sympazan® (clobazam) oral film from Aquestive Therapeutics, Inc....The transaction was made through a subsidiary of the Company....Under the terms of the definitive agreement, Assertio acquired an exclusive license for the Sympazan intellectual property from Aquestive for an upfront payment of $9.0 million. Assertio also entered into a long-term supply agreement with Aquestive for Sympazan. Additionally, Aquestive will continue to prosecute an existing patent application that could extend patent coverage to as late as 2039. Upon patent allowance, which Assertio believes will occur in 2023, Assertio will pay a $6.0 million milestone payment and royalties to Aquestive."

Licensing / partnership • CNS Disorders • Epilepsy

Aquestive Therapeutics Reports Full Year 2021 Results Exceeding Revenue and EBITDA Guidance (GlobeNewswire) - "The Company’s proprietary product Sympazan® (clobazam), an oral film for the treatment of seizures associated with Lennox-Gastaut syndrome, has grown for the twelve straight quarters since launch....Total revenues were $11.1 million in the fourth quarter 2021, compared to $7.1 million in the fourth quarter 2020, an increase of 55%. Comparing the fourth quarter 2021 to the prior year period, the Company saw a 77% increase in Sympazan net revenue, and a 60% increase in manufacture and supply revenue."

Commercial • CNS Disorders • Epilepsy

Aquestive Therapeutics, Inc. (AQST) Q3 2021 Earnings Call Transcript (The Motley Fool) - "Our total revenues were $13.3 million in the third quarter 2021, compared to $8.3 million in the third quarter of 2020. Comparing the third quarter 2021 to the prior period, the company saw an 18% increase in SYMPAZAN net revenue despite the continued market access limitations due to COVID-19 and a 77% increase in manufacturer and supply revenue."

Commercial • CNS Disorders • Epilepsy

Aquestive Therapeutics Reports Second Quarter 2021 Financial Results, Provides Business Update and Raises Full Year Revenue Guidance (GlobeNewswire) - "Total revenues were $15.3 million in the second quarter 2021, compared to $21.7 million in the second quarter 2020. Second quarter 2020 included a one-time $12 million recognition of license and royalty revenue as a result of the KYNMOBI® FDA approval. For the second quarter 2021 compared to the prior year period, the Company saw a 57% increase in Sympazan net revenue and a 47% increase in manufacture and supply revenue....Aquestive’s net loss for the second quarter 2021 was $12.4 million, or $0.33 loss per share. The net loss for the second quarter 2020 was $2.3 million, or $0.07 loss per share."

Sales • CNS Disorders • Epilepsy • Parkinson's Disease

Aquestive Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Sympazan® (clobazam) continues to meet key performance metrics and gain market share...Total revenues were $11.1 million in the first quarter 2021, compared to $8.8 million in the first quarter 2020. This year-over-year increase reflected higher license and royalty revenue and growth in Sympazan revenue. Aquestive saw net revenue growth in the first quarter 2021, compared to the prior year period, of 56% for Sympazan, the first of its proprietary products to be launched."

Sales • CNS Disorders • Epilepsy

Aquestive Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (GlobeNewswire) - "Sympazan® (clobazam), an oral film for the treatment of seizures associated with Lennox-Gastaut syndrome, continues to meet key performance metrics. Shipment volume has grown 6% sequentially quarter over quarter and by 59% over the same period last year. Sympazan net revenue grew 132% for the three-month period ended December 31, 2020 versus the same period last year, and 97% for the twelve month period ended December 31, 2020 versus the same period last year....Total revenues were $7.1 million in the fourth quarter 2020, compared to $16.4 million in the fourth quarter 2019. This year-over-year decrease reflected...lower license and royalty revenue, offset partially by growth in Sympazan revenue."

Sales • CNS Disorders • Epilepsy

Aquestive Therapeutics, Inc. (AQST) Q1 2020 earnings call transcript (The Motley Fool) - "The Aquestive team has begun the process to seek to monetize the anticipated royalties associated with APL-130277, apomorphine. The monetization would occur only after Sunovion receives approval from the FDA with an expected PDUFA goal date of May 21, 2020....We have begun to communicate with potential investors that would buy our royalty rights to Sunovion's licensed apomorphine product subject to approval by the FDA....Continued growth in SYMPAZAN, an expected $4 million milestone that would be payable for apomorphine six months after FDA approval, as well as co-development fees and modest licenses and royalties."

Commercial • CNS Disorders • Parkinson's Disease