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The development of a TPM®/Propofol injection had unique challenges – none less than
the need for the formulation to support acute injection as well as 24hr infusion. This is the first time
that this TPM® based injectable formulation (or in fact TPM® alone) will be tested at such high dose
over such a long exposure period in formal toxicology studies. Formulation design and agreement on
the exact test protocols have lengthened the program and extended the toxicology program timeline.
However, we believe that a suitable program is now designed and the testing pathway can now
continue.
Ensuring the right toxicological program for TPM®/Propofol injectable formulation is important as it
potentially has wide reaching implications for all of the TPM® injectable program. It is expected that
positive results will provide data that can support and potentially reduce the toxicological testing
requirements of all future TPM® injectables. We also believe that these results will play a role in the
direction that Terumo decides to take this relationship in the future.
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