MTPA to Commercialize ALS Therapy Exservan in the US

Mitsubishi Tanabe Pharma America (MTPA) has entered an agreement with Aquestive Therapeutics to market Exservan, an oral film formulation of riluzole, for treating amyotrophic lateral sclerosis (ALS) in the United States.

Under terms of the agreement, Aquestive — the developer of Exservan — will be the exclusive manufacturer and supplier of the product and will receive an upfront payment, specified milestone payments, as well as royalties on the therapy’s net sales in the U.S.

MTPA, which also is the developer of ALS treatment Radicava (edaravone), plans to make Exservan available to patients later this year.

“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,” Keith J. Kendall, president and CEO of Aquestive, said in a press release.

“Mitsubishi Tanabe Pharma America is the right partner for commercializing Exservan oral film formulation of riluzole in the United States,” Kendall added.

Exservan is a dissolving oral film form of riluzole that earned its approval in the U.S. for the treatment of ALS in 2019. Its active ingredient also is available as a pill under the brand name Rilutek (generic versions available), and in a liquid form with the brand name Tiglutik.

The exact mechanism of action of riluzole is still not fully understood, but studies point to a number of effects on neurons, including blocking certain receptors that are associated with nerve damage, and an extension of overall survival in ALS patients.

A common symptom of ALS is difficulty swallowing due to the loss of nerve cells controlling voluntary movement. As a result, most patients cannot take medications that involve swallowing a pill or a liquid, as is necessary with earlier formulations of riluzole.

Exservan, a thin film that is placed on the tongue (lingual delivery), addresses the problem of prior formulations. The therapy consists of an orange thin film strip containing 50 mg of riluzole, and is taken twice a day, at least one hour before or two hours after a meal. It dissolves automatically and requires no water.

The treatment was developed using Aquestive’s PharmFilm technology, which allows an easy and steady delivery of riluzole throughout the lining of the mouth.

The most commonly reported side effects included reduced sensation or numbness in the mouth, lack of energy or general weakness, nausea, decreased lung function, high blood pressure, and abdominal pain.

“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,” said Atsushi Fujimoto, president of MTPA.

“Patients are always the central focus of our work as we try to make a difference in their lives,” Fujimoto said. “We are honored to have this opportunity to expand our offerings to the ALS community.”