Race Oncology (ASX: RAC) will launch its Bisantrene chemotherapy drug in the Middle East after signing an initial three-year distribution and sales agreement today with Israeli biopharmaceutical firm TrueMed.
The drug will be used to treat patients with acute myeloid leukaemia via the industry’s named patient program (NPP), which provides patients and doctors with access to approved medicines commercially-available in other countries but not available in their own.
Under the terms of the agreement, TrueMed will have the right to sell and distribute Bisantrene in Israel for NPP use, sourcing the drug exclusively from Race’s global distribution partner, UK-based Durbin.
In April, Race locked in a three-year agreement with Durbin to be the warehousing, invoicing, customer service and distribution focal point for Bisantrene with a view to pursuing NPP sales worldwide.
The logistics agreement covers countries throughout the UK, the Benelux Union, the Nordic region, central and eastern Europe, the AsiaPacific, the Middle East and Africa.
Before Israeli sales can commence, TrueMed must gain approval from the Israeli Ministry of Health for local NPP distribution of Bisantrene.
Race and TrueMed will profit share the value of Israeli Bisantrene NPP sales, with 60% of turnover paid to Race and 40% retained by TrueMed.
“We believe Israel could be an important contributor to future global NPP sales of Bisantrene,” said Race chief executive officer Peter Molloy.
“TrueMed has a unique approach and expertise in NPP, along with a firm belief in the opportunity for Bisantrene [to treat] acute myeloid leukaemia, based on its own market research.”
“First important asset”
Marketed as Race Oncology’s “first important asset”, Bisantrene is a small-molecule chemotherapy drug related to the anthracyclines – the most frequently-prescribed cancer drugs and first line of treatment for many cancers – but with greatly-reduced cardiac toxicity.
The drug is manufactured in vials of 10 millilitres, each of which contains 250 milligrams of the drug as a lyophilised powder.
The powder is reconstituted as a solution and injected into an intravenous bag for administering to a cancer patient.
Based on the recommended dosage over seven days, a typical adult patient with acute myeloid leukaemia may require 14 vials for a single course of treatment.
The first commercial batch of Bisantrene was produced in September 2017 in volumes large enough to treat several hundred patients under the NPP.
In July, Bisantrene was granted a Rare Paediatric Disease designation by the FDA for the treatment of childhood acute myeloid leukaemia.
At midday, shares in Race Oncology were trading 8.99% higher at $0.097.