Aquestive Licenses ALS Therapy Riluzole Oral Film to Zambon in the European Union

Aquestive Therapeutics has granted a development and commercialization license to Zambon Pharma for its investigational oral film formulation of riluzole as a treatment for amyotrophic lateral sclerosis (ALS) in the European Union (EU).

Under the terms of the agreement, Zambon will be responsible for the regulatory approval and marketing of the new formulation in the EU, and Aquestive will be responsible for manufacturing the product.

Zambon will pay Aquestive an undisclosed sum for the rights of commercialization, as well as specified milestone payments, and royalties on the net sales of the therapy.

“We are pleased to announce our collaboration with Zambon to develop and commercialize [rulizole oral film] in the European Union,” Keith J. Kendall, CEO of Aquestive, said in a press release.

“Thanks to this collaboration with Aquestive, Zambon will further strengthen its commitment to orphan diseases and the [central nervous system] area, enriching its portfolio with a new formulation that will concretely help patients. Zambon is committed to improving people’s quality of life through innovative medicines and modern therapeutic solutions where they are most needed,” said Roberto Tascione, CEO of Zambon.

The oral film formulation of riluzole consists of strips that dissolve when placed over the tongue without the need for water. It uses Aquestive’s PharmFilm technology, which combines permeation enhancers, stabilizers, and polymer blends to ensure steady delivery of the therapy throughout the lining of the mouth.

Riluzole oral film was designed to facilitate intake of medications by ALS patients who have difficulty swallowing.

The U.S. Food and Drug Administration (FDA) is currently reviewing the new drug application of riluzole oral film, under the brand name Exservan. A decision as to whether  the formulation will be approved for sale is expected Nov. 30.

“Once approved, we believe that riluzole, via our orally administered dosage form, can bring meaningful and positive change for the care of patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication,” Kendall said.

Previous patient studies showed that riluzole oral film can be taken safely twice a day and that it has a pharmacokinetics profile — absorption, availability, distribution, metabolism, and elimination by the body — equivalent to that of the capsule formulation, Rilutek.

Riluzole was the first treatment approved to treat ALS. It belongs to a class of medications called benzothiazoles and acts by changing the activity of natural substances produced by the body that can damage nerve cells. In ALS, the treatment slows symptom progression and prolongs survival.

This compound is currently approved under two formulation, as tablets, under the brand name Rilutek, and as an oral liquid solution, under the brand name Tiglutik.