Exservan (riluzole oral soluble film) / Aquestive, Zambon, Mitsubishi Tanabe - LARVOL DELTA

Assessing the efficacy of amyotrophic lateral sclerosis drugs in slowing disease progression: A literature review. (PubMed, AIMS Neurosci) - "These FDA-sanctioned treatments are Qalsody, Relyvrio, Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta...However, despite these advancements in pharmaceutical interventions, finding a definitive cure for ALS remains a significant challenge. Continuous investigation into ALS pathophysiology and therapeutic avenues remains imperative, necessitating further research collaborations and innovative approaches to unravel the complex mechanisms underlying this debilitating condition."

Journal • Review • Amyotrophic Lateral Sclerosis • CNS Disorders

Hiseco terminates the introduction of riluzole orodispersible film and makes an asset impairment provision of RMB 53.45 million [Google tranlation] (Beijing News) - "On April 30, Hiseco issued an announcement stating that it plans to terminate the licensing agreement with Aquestive of the United States regarding the Riluzole Oral Disintegrating Film EXSERVAN project, and will stop related development and import registration work....Hisun said that due to changes in the market and competition environment, there are great uncertainties in the future market access and commercialization prospects in China. After carefully considering the investment risks of continuing to develop riluzole orodispersible film and the future market and competition risks, it terminated the introduction license cooperation with Aquestive and stopped the related development and import registration of riluzole orodispersible film....Hisun will apply to the State Food and Drug Administration to withdraw the drug import registration application."

Licensing / partnership • Amyotrophic Lateral Sclerosis • CNS Disorders

Tofersen (Qalsody) for ALS. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Amyotrophic Lateral Sclerosis • CNS Disorders

Biological aspects of nitrogen heterocycles for amyotrophic lateral sclerosis. (PubMed, Appl Microbiol Biotechnol) - "Currently, the Food and Drug Administration (FDA) approved drugs such as Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta to treat ALS. • Neurodegenerative diseases and their drawbacks are discussed in detail. • Recent survey of nitrogen heterocycles in treating ALS disease are highlighted."

Journal • Review • Amyotrophic Lateral Sclerosis • CNS Disorders

Pharmacokinetics, Bioavailability, and Swallowing Safety With Riluzole Oral Film. (PubMed, Clin Pharmacol Drug Dev) - "Riluzole oral film (ROF; Exservan™) contains riluzole in a polymer-based film matrix. No evidence of deterioration of swallowing function was observed post-dose. The ROF was bioequivalent to riluzole tablets, was well tolerated, and had no detrimental effect on swallowing."

Journal • PK/PD data • Amyotrophic Lateral Sclerosis • CNS Disorders • Gastrointestinal Disorder

Aquestive Therapeutics and Haisco Pharmaceutical Group Enter Licensing and Supply Agreement for Riluzole Oral Film for ALS Treatment in China (BioSpace) - “Aquestive Therapeutics…announced the execution of a License, Development and Supply Agreement with Haisco Pharmaceutical Group Co., Ltd. (SZSE: 002653) (‘Haisco’), a pharmaceutical company based in the People’s Republic of China (‘China’), for Haisco to develop and exclusively commercialize EXSERVAN™ (riluzole oral film) for the treatment of amyotrophic lateral sclerosis (‘ALS’) in China….Pursuant to the agreement, Haisco will lead the regulatory and commercialization activities for EXSERVAN in China…Aquestive will receive a $7million upfront cash payment, regulatory milestone payments, and double-digit royalties on net sales of EXSERVAN in China, and will earn manufacturing revenue as the exclusive supplier of EXSERVAN.”

Licensing / partnership • Amyotrophic Lateral Sclerosis • CNS Disorders

Mitsubishi Tanabe Pharma America Highlights ALS Research at Northeast Amyotrophic Lateral Sclerosis 20th Annual Meeting (PRNewswire) - “Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that five presentations on amyotrophic lateral sclerosis (ALS) will be shared as part of the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting, being held virtually October 6–7. ‘We look forward to sharing our latest research updates as we continue to work diligently to further understand the impact of treatment with RADICAVA® (edaravone) and the investigational oral formulation of edaravone, as well as EXSERVAN™ (riluzole),’ said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA….Mitsubishi Tanabe Pharma Corporation (MTPC) will present an overview of the Phase 3 study design for an investigative oral formulation of edaravone, as well as the design of a clinical trial evaluating bioavailability of the oral formulation.”

Clinical protocol • Review • Amyotrophic Lateral Sclerosis • CNS Disorders

PANTHERx Rare Selected by Mitsubishi Tanabe Pharma America, Inc. (MTPA) as Exclusive Provider of U.S. Specialty Pharmacy Services for EXSERVAN (riluzole) oral film (PRNewswire) - “PANTHERx Rare announced today that it was selected by Mitsubishi Tanabe Pharma America, Inc. (MTPA) as the exclusive U.S. pharmacy distribution partner for EXSERVAN™ (riluzole). The drug, an oral film formulation of riluzole, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS).”

Commercial • Amyotrophic Lateral Sclerosis • CNS Disorders

"Mitsubishi Tanabe Pharma America Announces EXSERVAN™(riluzole) is Now Available in the U.S. for the Treatment of #ALS #UniteAgainstALS #EndALS @MTPA_US" (@unite_ALS)

Amyotrophic Lateral Sclerosis

Mitsubishi Tanabe Pharma America Announces EXSERVAN (riluzole) is Now Available in the U.S. for the Treatment of ALS (PRNewswire) - “Mitsubishi Tanabe Pharma America…announced that EXSERVAN™ (riluzole), the first oral film formulation of riluzole, is now available in the U.S. for the treatment of amyotrophic lateral sclerosis (ALS). EXSERVAN, which dissolves on top of the tongue, was developed to help meet the needs of people with ALS, including those who have difficulty swallowing some medications.”

Launch US • Amyotrophic Lateral Sclerosis • CNS Disorders

MTPA Announces PANTHERx Selected as Exclusive Provider of U.S. Specialty Pharmacy Services for EXSERVAN (riluzole) Oral Film (PRNewswire) - “Mitsubishi Tanabe Pharma America…announced PANTHERx Rare Pharmacy has been selected as the exclusive provider of specialty pharmacy services for EXSERVAN™ (riluzole), an oral film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS)....Once a patient is prescribed EXSERVAN, they may be enrolled in access information services. Upon enrollment, PANTHERx will provide patients with a review and summary of insurance benefit options...MTPA plans to make EXSERVAN available to patients by the end of June 2021."

Commercial • Launch US • Amyotrophic Lateral Sclerosis • CNS Disorders

Mitsubishi Tanabe Pharma America and Aquestive Therapeutics Announce U.S. Licensing and Supply Deal for Riluzole Oral Film for ALS Treatment (PRNewswire) - “Mitsubishi Tanabe Pharma America, Inc. (MTPA) and Aquestive Therapeutics…announced a licensing and supply deal for the U.S. rights to commercialize EXSERVAN™ (riluzole), an oral film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS).”

Licensing / partnership • Amyotrophic Lateral Sclerosis • CNS Disorders

AQST soars on FDA approval (Nasdaq) - “Shares of Aquestive Therapeutics…are up 21.15% in pre-market trading on Monday, following FDA approval of its drug Exservan for the treatment of neurological disorder amyotrophic lateral sclerosis (ALS).”

Stock price

FDA approves Aquestive’s ALS treatment (Reuters) - “The U.S. Food and Drug Administration on Friday approved...Aquestive Therapeutics' treatment for neurological disorder amyotrophic lateral sclerosis (ALS). Shares of the company, which developed riluzole oral film (ROF) and will market the film under the brand name Exservan, rose 4% at $6.76 after the bell.”

NDA

Aquestive Therapeutics announces U.S. Food and Drug Administration (FDA) acceptance of New Drug Application for riluzole oral film for treatment of ALS (PRNewswire) - “Aquestive Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for the investigational product riluzole oral film (ROF)…under the brand name Exservan…The PDUFA (Prescription Drug User Fee Act) goal date is November 30, 2019.”

NDA • PDUFA date