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European Biopharmaceutical Review

Fit for Repurpose




EBR: In terms of discovering new medications for rare diseases, how successful has drug repurposing been so far?

Dr Hermann Mucke: It has just started but is quite successful already. The successes have not been widely popularised outside the rare disease community, but they are beautiful examples of drug repurposing, especially for the mechanism-centred strategy, where you exploit known pharmacological effects of an approved drug – even side effects that may cause adverse events in the original indication – for a substantially different indication. The advanced clinical studies that are ongoing carry huge promises. Of course, some of these late-stage projects will fail, just as it is the case in new chemical entities, but the momentum is there and guarantees that repurposed drugs will serve a broader swath of the rare disease space within the next few years.

What can be said for the financial implications of drug repurposing?

That depends on what stage of the drug development process you are focusing on, and it also depends on whether you look only at out-of-pocket savings or do a full calculation with overhead cost, set-asides for failure risk, capital cost, and so on. Direct savings will be greatest for companies aiming at partnering or out-licensing their candidate after a successful proof-of-concept trial; they will save the entire cost of lead optimisation and initial preclinical safety. In most cases, they will already know that the compound is safe in man at the plasma levels they intend to use – at least in healthy volunteers. Knowledge concerning the basic pharmacokinetic, pharmacodynamic, and side effect behaviour essentially eliminates a huge part of the early-stage risk, which is a major factor if you do a full assessment. Time savings are also crucially important. However, some costs are still incurred: you need a complete freedom-to-operate analysis, and if you are repurposing a generic drug, you will likely develop a new formulation (perhaps with a different route of administration) to guard against crossprescription – which will require at least a pharmacokinetic bridging study. If you look only at advanced clinical development, out-of-pocket savings or acceleration of development will not be all that large because a full Phase III programme will be required regardless of whether you have a known drug or a new chemical entity. However, a de-risking advantage in terms of safety and tolerability will be maintained, and that can make the full cost calculation significantly more favourable. Derisking of development is the central operational term in drug repurposing.

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Dr Hermann Mucke owns and manages H. M. Pharma Consultancy (established in 2000), a globally acting provider of consulting services to the life science industry with headquarters in Vienna, Austria. His company’s focus areas are strategic patenting, design of earlystage drug development projects, and assistance with regulatory affairs – all with a particular emphasis on drug repurposing. Hermann, a biochemist and molecular biologist by training, had a strong hand in repurposing galantamine for Alzheimer’s disease before he founded his consultancy. He is Senior Editor at the Pharmaceutical Patent Analyst, and Drug Repurposing Editor at ASSAY and Drug Development Technologies.
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Dr Hermann Mucke
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