Javelin Pharmaceuticals Inc (JAV)

[Bio_pete]

1. Why did the company chose to start with the EU/UK mkt for Dyloject instead of going US-first? What is the timetable for a possible US approval (are they running a different p-3 study)?

Voltarol is the injectable form of diclofenac marketed in EU. Problems with Voltarol include pain on injection and a slow rate of administration. No injectable form of diclofenac is approved in the US so it made sense to go after the EU market first.

JAV announced last month that they had started the second Phase III trial for Dyloject in the U.S. NDA planned for 2008, Market in U.S. 2009.

The safety of short-term use of diclofenac, which is a nonselective NSAID, has been reaffirmed in recent white papers issued in 2005 by European and U.S. regulatory agencies.

2. What is the mkt potential in EU for Dyloject? ditto for the US?

Management gave some figures during the most recent CC of over $250 million market opportunity ($75 G5 and $175 US.) Dyloject is trying to replace Toradol in the US which has received a block box warnings for gastrointestinal/ulcer risk. If Dylojects profile shows that it does not inhibit platelet function to the same degree as Toradol then it will be a big drug in the US.

JAV should also have nasal ketamine on the US market by 2009 which is also a $250 million drug.