On July 2, 2019 ORPHELIA Pharma, a biopharmaceutical company whose mission is to develop and market pediatric medicines in the fields of neurology and oncology, reported that it has signed a collaboration and licensing agreement with Gustave Roussy, a leading cancer center in Europe, to develop Kimozo, the first pediatric formulation of temozolomide (Press release, ORPHELIA Pharma, JUL 2, 2019, View Source [SID1234538116]).
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Temozolomide is an essential anti-cancer drug for the treatment of malignant gliomas in children. Unfortunately, there is no suitable pediatric formulation, which forces caregivers to open the adult capsules and disperse their contents into a food to administer the treatment to the children. The medical need has been underlined by the European Medicines Agency (EMA), in its document "Draft Inventory of paediatric therapeutic needs – EMA / 381728/2014".
"Temozolomide is one of the cancer drugs for which the need for a formulation for children is the strongest," says Professor Gilles Vassal, Director of Clinical Research Gustave Roussy. "This need has been recognized by the international pediatric oncology community and has led us to develop innovative, child-friendly hospital care."
Kimozo was developed on the basis of the hospital preparation developed by Gustave Roussy. The first pediatric formulation of temozolomide, Kimozo comes in the form of an oral suspension with taste masking, in a sealed bottle. Five oral syringes (for a 5-day course) will allow the drug to be administered effectively and safely. Kimozo is being industrialized by ORPHELIA Pharma.
"When the adult capsule is used, children may regurgitate the product, the dose administered is not precisely known, and finally, the family and caregivers may be exposed to this cytotoxic agent during pregnancy. preparation. Gustave Roussy has developed a hospital preparation that is extremely useful for children and on which we rely for Kimozo ", commented Jérémy Bastid, ORPHELIA Pharma’s Development Director.
"There is a significant medical need in pediatrics," says Hugues Bienayme, Founder and CEO of ORPHELIA Pharma. "In addition to malignant gliomas, temozolomide is prescribed in several rare solid cancers of the child. The uses of Kimozo will therefore be multiple. "