Saturday, November 26, 2011

The challenges in drug repositioning -- and application of B.E.A.M.S

In my weekend series of posts on drug repositioning, let's look at a number of challenges for companies repositioning drugs.  Some are unique to this process and others common to any form of drug development. 

In the development of a drug for a completely new indication, drug repositioning cannot avoid the potential risk that the drug will not be effective in late-stage clinical trials -- especially if it has not previously moved further forward than preclinical development.

Drug repositioning can be based on marketed drugs that are off patent. This means that the active ingredients are easily available. However, if the dose required is similar to the dose used for an existing indication, physicians may simply choose to use the generic form, which is likely to be cheaper than the newly available, and possibly higher cost, branded repositioned drug.
“Because of this, it is important for a repositioned drug to have a difference in presentation. This may be a difference in delivery system or formulation, or a significant difference in dose — for example, Merck & Co launched the 5-alpha reductase inhibitor finasteride as Proscar for benign prostatic hyperplasia and then relaunched it as Propecia, at a significantly reduced dose and under a new patent, for male pattern baldness,” says one major company executive.

Access to data can have an impact on drug repositioning timelines. Companies that are developing a compound that they have not originated will need access to a competitor’s data or will have to rely on public domain data. This dependence on publicly available data can have its pitfalls. “If the company relies wholly on using public databases for their in silico screening, then there is a risk that their discovery may be found simultaneously by others,” adds another industry expert.

It may be harder for drug repositioning companies to get funding, as some investors have been burned by project failures, and others may be more familiar with traditional drug development and so are unsure how to value repositioning projects, especially as existing financial models don’t work.
Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at
When I have consulted with Bioscience Bridge, LLC, we worked with clients to classify and prioritize existing technology assets through the use of our proven process in the evaluation of a university’s bioscience IP portfolio.

The B.E.A.M.S. Evaluation Tool measures a technology’s:
  • Breakthrough potential
  • Ease of development
  • Advantages over competitive technologies
  • Marketability
  • Sampling or prototyping for evaluation

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