On June 16, 2021 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs and Gustave Roussy, the leading cancer center in Europe, reported that the European Patent Office has issued Patent EP3613436, which is directed to Kimozo, the first pediatric, ready-to-use and taste-masked oral suspension of temozolomide(Press release, ORPHELIA Pharma, JUN 16, 2021, http://www.orphelia-pharma.eu/news/european-patent-covering-kimozo/ [SID1234584045]). Kimozo results from the collaboration between the pharmacists and clinicians from Gustave Roussy and ORPHELIA Pharma.
"Temozolomide is an essential oncology drug used to treat relapsed or refractory neuroblastoma, a disease that unfortunately affects very young children. We are working in close collaboration with European clinicians and our goal is to make this pediatric form of temozolomide available as early as 2021 through early access programs"; commented Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma.
"We have developed a hospital compounded liquid preparation of temozolomide in 2015 to address the needs of young patients treated at our center", explain Maxime Annereau, pharmacist and Samuel Abbou, pediatric oncologist at Gustave Roussy, both at the origin of this project. "This hospital formulation was suitable for children but did not exhibit the physico-chemical and stability properties compatible with an industrialized product. This product was therefore not available to all patients. Three years of research and development between Gustave Roussy and ORPHELIA Pharma were necessary in order to achieve the targeted specifications: a highly concentrated, taste-masked and stable formulation".
"Our research efforts led to the development of Kimozo, the first drinkable formulation of temozolomide. The innovation is based on the discovery of a key excipient involved in the stability and the control of the rheological properties of the suspension, an invention that has been patented", concludes Jeremy Bastid.
The grant of Patent EP3613436 entitled "oral suspension of temozolomide" and co-owned by ORPHELIA Pharma and Gustave Roussy has been published in the European Patent Bulletin. Based on the filing date of the application, the patent protection is expected to last until 2038.