ORPHELIA Pharma Selects Tanner Pharma Group to Initiate Named Patient Program for KIMOZO® (temozolomide) in European Countries
18 Apr 2023
License out/inDrug Approval
PARIS & CHARLOTTE, N.C.--(BUSINESS WIRE)-- ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan medicines, and Tanner Pharma Group, a global provider of integrated specialty access solutions, have signed an exclusive agreement to manage the supply and distribution of Ped-TMZ, also known as KIMOZO® (temozolomide 40 mg/ml, oral suspension), to meet the special demands which may come from physicians for this unapproved pediatric form of temozolomide.
Temozolomide is an anti-cancer drug approved as capsules or IV formulation in Europe for certain brain tumors. It is also used in treatment protocols for other rare cancer indications that mainly affect very young children, including refractory or relapsed neuroblastoma. In young children, an oral suspension of temozolomide is age-appropriate to ensure correct medication administration.
Under the terms of the agreement, Tanner Pharma will provide access to KIMOZO® via a named patient program in European countries, in particular countries where KIMOZO® has already been used as an investigational medication in the context of ORPHELIA Pharma's now fully enrolled TEMOkids clinical trial. A named patient program is a mechanism through which physicians can legally and ethically prescribe investigational or approved drugs for patients prior to their commercial availability. The access to unapproved drugs is strictly regulated and adherence to national regulations is mandatory.
Tanner Pharma will manage all elements of the supply including healthcare practitioner enquiry management, national regulatory oversight, liaison with national authorities, and logistics. The agreement currently covers all European territories but France.
Healthcare professionals can obtain details about the program by contacting: kimozo@tannerpharma.com.
About KIMOZO® 40 mg/ml
KIMOZO® 40 mg/ml is a liquid, taste-masked and ready-to-use drinkable formulation of temozolomide developed in collaboration between the pharmacists and clinicians of Gustave Roussy hospital and the development team of ORPHELIA Pharma. KIMOZO® is being developed for the treatment of refractory and relapsed neuroblastoma, a childhood cancer of dismal prognosis.
KIMOZO® was granted Early Access Authorisation (Autorisation d’Accès Précoce) by the French authorities in March 2022.
The formulation of KIMOZO® is covered by a patent application in Europe and in the US.
For more information about ORPHELIA Pharma, visit .
For more information about Tanner Pharma Group, visit .
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Contacts
ORPHELIA Pharma
Magali Rosbif
Tel: +33 (0)1 42 77 08 18
orphelia@orphelia-pharma.eu
Source: Tanner Pharma Group
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