Pharmaceutical company Race Oncology (ASX: RAC) has taken a formidable step towards commercialising its leading oncology drug candidate Bisantrene, used to treat acute myeloid leukaemia (AML), courtesy of the company’s non-executive director Dr John Cullity.
Dr Cullity is a former consultant to the World Health Organisation (WHO) and World Bank having served at the upper echelons of the biotech industry in both the public and private sectors for over 20 years.
One of his most notable stints was working as a senior executive in the pharmaceutical industry, as Director of Health Economics and Strategic Pricing at Schering-Plough, and a seven-year period at Sanofi-Aventis in oncology pricing and business development.
Race has said that it has executed a services agreement with Biosynergy Partners to pursue licensing and other deals for Bisantrene with the assistance of transaction consulting business Biosynergy, a company owned by Dr Cullity.
Race has confirmed that Dr Cullity will continue to fulfil his responsibilities as a non-executive director of Race as well as carrying out his designated duties as stipulated by Biosynergy.
Licensing deal terms
Under the terms of the agreement, potential transactions going forward are set to include “any sale, license, partnership, collaborative venture or another arrangement, whereby an interest in Bisantrene is transferred to a third party,” according to Race.
The agreement announced today will not include a retainer although transaction fees have been set at 6% of the total consideration of up to US$25 million (A$35.3 million), and 3% of the total consideration over US$25 million.
Race has said that Dr Cullity will work with Race’s management team to prepare licensing presentations and due diligence materials for prospective partners, as well as identifying and engaging with potential partners. Furthermore, he is expected to structure, negotiate and close a potential commercial transaction that will see Bisantrene commercialised.
“We are particularly interested in exploring licensing deals, where the partner carries the cost of the proposed AML registration trial. We would also like to see upfront license fees paid that would represent non-dilutive funding for Race,” said Peter Molloy, CEO of Race Oncology.
Dr Cullity has said that BioSynergy will work with Race to “bring the Bisantrene value proposition before global oncology companies,” although Race has also grounded expectations by saying that there is no guarantee that its agreement with BioSynergy will lead to an acceptable licensing or other deal.
Redevelopment business strategy
Race’s business model is to pursue later-stage drug assets in the cancer field that have been overlooked by top-tier pharmaceutical companies, often distracted by blockbuster new drugs that carry huge development costs and several years spent in research and development.
Race’s first asset under its business model is Bisantrene which the company has successfully manufactured in order to complete the necessary development required to gain FDA approval, while also making the drug available as an unlicensed medication under named patient programs outside the US.
Earlier this year, Bisantrene was granted a rare paediatric disease designation for the treatment of childhood AML by the FDA which meant Race was in with a chance of fast-tracking the drug under an accelerated 6-month review by the FDA.
Bisantrene is a chemotherapy drug that was tested in more than 40 clinical studies before it was “lost” in a series of pharmaceutical mergers during the 1990s. The pharmaceutical junior listed on the ASX in 2016 with the aim of rediscovering a chemotherapy drug, aiming to treat various cancers including leukaemia.