Moving forward:  Discussions with Terumo over potential...

Moving forward:  Discussions with Terumo over potential injectable projects continue

The return of the TPM®/Oxymorphone patch in early 2018 (due to Japanese specific

market concerns) has promoted the co-developed TPM®/Propofol injectable to flagship position in this

relationship. 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.....