Granted Fast Track and Breakthrough Therapy Designation by the FDA
Completed NDA to FDA and MAA to EMA : PEDMARK (US) / PEDMARQSI (EU) is proposed to be indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic solid tumors.
Priority review granted upon acceptance by FDA.
FDA assigned PDUFA target action date of November 27, 2021. Prior FDA issued CRL was based on deficiencies with the facility of the drug product manufacturer identified during pre-approval inspection. No clinical or safety issues were identified.
Potential for 7.5 YEARS US market exclusivity with Pediatric Orphan Drug Designation
Patent protection in the US until 2039 for the for the unique anhydrous form of the active ingredient in Fennec’s PEDMARK product, as well as related methods of synthesis
EU regulatory milestones achieved
EMA validation received for MAA
Positive opinion on PIP received by PDCO at EMA
Potential for 10 YEARS EU market exclusivity with Pediatric-use Marketing Authorization (PUMA), if granted
PEDMARK has the potential to be the first and only therapy indicated in this area of significant high unmet medical need
Collaboration with Oregon Health and Science University (OHSU)
Fennec Pharma licensed 1 US and 9 foreign patents from OHSU for STS. The STS methods of use patents expire in Europe and Japan in 2021 and are currently pending in the US
Patent Protection was recently granted in the US until 2038 for method of use for children <5 years of age
References: 1. Cisplatin Injection [prescribing information ]. WG Critical Care, LLC., Paramus, NJ; February 2019. 2. Breglio AM, Rusheen AE, Shide ED, Fernandez KA, Spielbauer KK, McLachlin KM, et al. Cisplatin is retained in the cochlea indefinitely following chemotherapy. Nat Commun. 2017;8(1):1654. 3. Landier W. Ototoxicity and cancer therapy. Cancer. 2016;122(11):1647-1658. 4. Langer T, am Zehnhoff-Dinnesen A, Radtka S, Meitert J, Zolk O. Understanding platinum-induced ototoxicity. Trends Pharmacol Sci. 2013;34(8):458-469. 5. Data on file, Fennec Pharmaceuticals 2020.
PEDMARK™ is a registered trademark of Fennec Pharmaceuticals Inc.