A key Bisantrene patent has received “Notice of Allowance” in the United States, which extends the commercial exclusivity period for the drug in the American market.
The patent titled, “Combinatorial Methods to Improve the Therapeutic Benefit of Bisantrene and Analogs and Derivatives Thereof,” is one of two Bisantrene patents filed in the US, Europe and five other key countries.
The US is the first jurisdiction to allow the patent. The second Bisantrene patent is still under examination with the US Patent Office.
In a significant boost for Race, the patent provides commercial protection for all uses of Bisantrene currently contemplated by Race in the US through to 2034.
“We already have Orphan Drug Designation in the US, which provides seven years of commercial exclusivity for Bisantrene from US FDA approval,” said Mr Molloy.
“This patent potentially doubles that exclusivity period in the US.”
The patent protects the use of Bisantrene in patients with refractory or relapsed cancers, including AML and related leukaemia (MDS, ALL, CLL), as well as breast cancer, lymphoma and other cancers.