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Norgine, APR, Labtec sign Setofilm licensing deal

Norgine and APR Applied Pharma Research (APR), with its joint venture partner Labtec, have signed an exclusive licensing agreement under which Norgine will sell and distribute Setofilm Ondansetron Oral Dispersible Film (ODF) in Europe and selected non-European countries in Middle East, Africa and Australasia.

Developed by APR and Labtec in partnership with Monosol RX, Setofilm is the first prescription product developed as an ‘orodispersible film’ form to be registered in Europe.

Setofilm is designed to prevent and treat Chemotherapy and Radiotherapy Induced Nausea and Vomiting (CINV and RINV) in adults as well as children aged equal or above 6 months, and also to treat Post-Operative Nausea and Vomiting (PONV) in adults and children aged equal or above 4 years.

Setofilm ODF, comprising of a very thin polymeric film strip containing Ondansetron, relies on a novel and proprietary oral drug delivery technology platform.

The formulation has the size of 3cm² and 6cm² for the 4mg and 8mg dosage, respectively, and is specifically useful for patients who have difficulties swallowing, such as children or elderly patients.

APR CEO Paolo Galfetti said they hope that Setofilm appropriately fits with Norgine’s therapeutic focus in supportive care and provide patients with a unique product to help them in managing the debilitating conditions.