RAC (ASX) Q. Bisantrene is not new. How can RAC monetise if it is out of patent?

Originally posted by RaceOncology: ↑

A very good question. While bisantrene the molecule is out of patent, our new RC220 formulation (i.e. the drug product) is not. What we have been able to do is reformulate bisantrene so that the problem of crystallisation in the blood that caused it to be abandoned by the original developer (Lederle), has been solved.

This process is very similar to what Abraxis did with Taxol to create Abraxane - they reformulated Taxol to solve the solubility issues with the original formulation and went on to sell billion of dollars worth of Abraxane over the past couple of decades. Reformulation to solve drug problems can be very profitable if done intelligently. Here is a link to some of the history of Abraxane.

https://stabiopharma.com/where-it-all-began-how-007-became-abraxane/

The obvious follow up question is won't someone just start selling the old formulation once our new formulation of bisantrene is approved? The answer is no for two reasons:

1. The old formulation is not FDA or EMA approved. Any developer of the old formulation would have to spend tens of millions dollars to bring the old formulation to market, but as soon as they brought it to market the generic drug manufacturers could start selling the own version of the old formulation and the price would immediately fall to that of a generic drug. No company will invest all the money required to develop the original formulation of bisantrene if they will face immediate generic competition.

2. Even if some company is crazy enough to spend all the money required to get the old formulation of bisantrene approved, no doctors or patients are going to participate in any of the trials need for approval. You can’t run a clinical trial of a worse version of an approved drug that offers no benefit to the patient - it would be unlikely that you could even get ethics approval to run such a trial.

This same priniciple applies to a different formulation of bisantrene. Unless this new formulation offered some significant clinical benefit over our RC220 formulation then it can’t be trialed and hence approved. This is exactly what happened with Abraxane which did not face any direct competition until the original formulation patents ended and the generic manufacturers could start making it.

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makes sense, it would hardly be worthwhile getting approval for the old formulation, may as well just license or acquire the new formulation.

raises a couple of questions regarding the upcoming allcomers trial (CPACS - Cardio protective anti cancer synergy).

1. Is trial design targeting a tumour agnostic approval for CPACS RC220 (new formulation)?

2. As the CPACS trial is in combo with Doxorubicin (largest anthracycline combo opportunity), if approved would this allow Bisantrene be used off-label with other anthracyclines?

3. Does the new combination therapy of Bis + Dox allow for a combo patent?

4. Does a combo patent allow for reimbursement of Dox treatment at patent protected pricing rather than generic pricing?

5. If Bisantrene protects the heart and provides anti cancer synergy, will the lifetime Dox limit in combo allow to be increased?

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