Race Oncology receives key FDA designation for its Bisantrene drug

Race Oncology ASX RAC FDA Bisantrene drug AML acute myeloid leukaemia
Race Oncology's Bisantrene drug receives ‘rare paediatric disease’ designation from the FDA.

Speciality pharmaceutical company Race Oncology (ASX: RAC) has received positive news regarding its flagship acute myeloid leukaemia (AML) drug, Bisantrene.

The drug has been granted a rare paediatric disease designation for the treatment of childhood AML by the FDA and means Race Oncology could potentially see its drug fast-tracked 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.

According to Race Oncology, it is looking to obtain a ‘priority review voucher’ (PRV) from the FDA in order to formalise the fast-tracking of Bisantrene. To be awarded the PRV, Race will need to conduct a clinical trial into Bisantrene’s effects on childhood leukaemia under an ‘Investigational New Drug’ (IND) application.

As it stands, Race says that it cannot confirm a commencement date, duration, size or estimated cost of the trial, until it has held further discussions with the FDA.

Racing towards progress

Aside from the potential value of the PRV itself, the FDA designation serves as an important affirmation of the potential clinical value of Bisantrene.

“This is a game-changing outcome for Race that adds substantial value to the company,” said Race Oncology CEO, Peter Molloy.

“To date, we have focused our clinical development plan on adult AML, which is the largest population of AML patients,” said Mr Molloy. Now, in parallel to the adult program, we plan to expedite a paediatric program directed towards securing the PRV.”

Once awarded, a PRV can be used to progress a particular drug candidate or can be sold to another pharmaceutical company for use with another drug and indication. The accelerated review conferred by the PRV can have very substantial value to some companies and accordingly there is an active secondary market for PRVs.

The market for PRVs has quickly become a substantial and significant market in and of itself: since 2016, PRVs have been selling in the range of US$110-130 million each (A$150-175 million).

To date, Race has indicated that it intends to sell the PRV if awarded.

“Selling the PRV does not affect the overall value of Bisantrene,” says Mr Molloy.

“Bisantrene could still be launched, licensed or sold as a treatment for adult and paediatric AML, without any significant diminution of its value as a result of the PRV transaction.”

Today’s FDA news helped Race Oncology shares to jump as high as $0.22 per share in the morning trading session, up around 42%.

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