Zambon Signs a License Agreement with Aquestive to Develop and Commercialize Riluzole Oral Film for Amyotrophic Lateral Sclerosis in EU

Zambon Signs a License Agreement with Aquestive to Develop and Commercialize Riluzole Oral Film for Amyotrophic Lateral Sclerosis in EU

Shots:

  • Aquestive to receive up front, development & commercial milestones and royalties on sales of Riluzole oral film (ROF) in EU. Zambon to get a license for the development and commercialization of ROF to treat ALS in EU
  • Zambon will be responsible for the regulatory approval and marketing of ROF in the EU while Aquestive will be responsible for the development and manufacturing of ROF. The collaboration will enhance Zambon’s portfolio & further strengthen its commitment to orphan and CNS diseases
  • Riluzole oral film utilizes PharmFilm technology, being developed to treat ALS and demonstrated bioequivalence to the reference product, Rilutek. ROF is currently under the US FDA’s review for approval with expected PDUFA date as Nov 30, 2019 and has received FDA’s ODD in Jan’2018

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Logonoid