The patent now approved in the United States expires in 2037 and covers both the Active Pharmaceutical Ingredient (arfolitixorin hemisulfate), the Drug Product and ready solution for treating cancer patients. The patent will be instrumental in supporting a future commercialization of arfolitixorin in the US market.
The Merck patent US 10,059,710 is directed towards a stable formulation of [6R]-5,10-methylenetetrahydrofolic acid and its hemisulfate salt as well as pharmaceutical compositions and uses thereof in therapy, preferably chemotherapy. The advantageous stability characteristics of the hemisulfate salt will allow the effective use of this compound in medicinal applications.
Anders Rabbe, CEO of Isofol Medical, commented: This is the most important patent to date for Isofol’s drug candidate arfolitixorin. With a patent expiry in 2037 arfolitixorin has an unusually long patent protection for the US market which substantially increases the commercial opportunity at an expected market approval. Reaching this milestone is the fruit of Isofols longtime collaboration with Merck & Cie and the patent approval also extends our supply and license agreement with the Merck Group until at least 2037.
For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB (publ)
Phone: +46 (0)707 646 500
This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person(s) set out above, on 31 August 2018, at 10:30 CET.
Arfolitixorin is a new drug candidate developed to increase the efficacy of the cytotoxic agent 5‑fluorouracil (5-FU) and as a rescue drug after high-dose methotrexate treatment. Arfolitixorin, [6R]-5,10-methylenetetrahydrofolate is the key active metabolite of the widely used folate-based drugs leucovorin and levoleucovorin. Arfolitixorin may be suitable for all patients regardless of their ability to activate folates to [6R]-5,10-methylenetetrahydrofolate, since arfolitixorin, unlike leucovorin and levoleucovorin, does not require metabolic activation to exert its effect.
About Isofol Medical AB (publ)
Isofol Medical AB (publ) is a biotech company within the field of oncology developing arfolitixorin, primarily as a treatment for advanced colorectal cancer and as a rescue drug after high-dose methotrexate treatment in osteosarcoma (bone cancer). Through a worldwide exclusive license agreement, Isofol holds the rights to develop and commercialise arfolitixorin within oncology with access to the unique patented production process and the production capabilities of Merck KGaA, Darmstadt, Germany. Isofol Medical AB is traded on the Nasdaq First North Premier. Certified Adviser is FNCA Sweden AB.