Mitsubishi Tanabe Pharma America and Aquestive Therapeutics Announce U.S. Licensing and Supply Deal for Riluzole Oral Film for ALS Treatment
Mitsubishi Tanabe Pharma America, Inc. (MTPA) and Aquestive Therapeutics, Inc. (NASDAQ: AQST) today 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).
?Patients are always the central focus of our work as we try to make a difference in their lives,? said Atsushi Fujimoto, President, MTPA. ?This licensing deal will enable us to bring patients a riluzole oral film designed to address the needs of people with ALS, including those who have difficulties swallowing some medications. We are honored to have this opportunity to expand our offerings to the ALS community.?
As a result of the deal, MTPA will commercialize EXSERVAN in the U.S. Aquestive will serve as the exclusive sole manufacturer and supplier for the product.
MTPA plans to make EXSERVAN available to patients in the middle of 2021.
?As a company applying innovative technology to improve medicines for patients, we are delighted to be working with a world-leading innovator in ALS with a deep commitment to the patient community,? said Keith J. Kendall, President and Chief Executive Officer of Aquestive. ?Mitsubishi Tanabe Pharma America is the right partner for commercializing EXSERVAN oral film formulation of riluzole in the United States.?
Under the terms of the deal agreement, Aquestive will receive upfront consideration, milestone payments, royalties on net sales of EXSERVAN in the U.S., and will earn revenue pursuant to the exclusive supply agreement.
About EXSERVAN??(riluzole oral film)
EXSERVAN, an oral film formulation of riluzole, was developed by Aquestive using its PharmFilm??innovative drug delivery technology. The oral film is placed on the patient?s tongue and quickly dissolves without the need for liquids or food.?RILUTEK??(riluzole)?tablets was the reference product during the oral film development. Oral film riluzole was approved by the U.S. Food and Drug Administration (FDA) in November 2019.
IMPORTANT SAFETY INFORMATION
EXSERVAN? (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Do not use?if you are allergic to riluzole or to any of its ingredients.
Before using EXSERVAN, tell your healthcare provider about all the medicines you take and all your health conditions, including if you:
- Have hepatic (liver) impairment.
- Are taking strong or moderate CYP1A2 inhibitors such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton.
- Are pregnant or intend to become pregnant during EXSERVAN therapy, or if you are breastfeeding or intend to breastfeed during EXSERVAN therapy.
- Hepatic Injury:?Cases of drug-induced liver injury, some fatal, have been reported in patients taking riluzole. Consult your healthcare provider promptly if you experience unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
- Neutropenia:?Tell your healthcare provider if you develop a fever while taking EXSERVAN.
- Interstitial Lung Disease:?Tell your healthcare provider if you have respiratory symptoms such as dry cough and difficult or labored breathing. Discontinue EXSERVAN immediately if interstitial lung disease develops.