patient enrolment begins april 2010

If you thought that Neuren's price chart was like watching paint dry only more stressful, sentiment could be about to change. The 2009 Annual Report (2009AR) which was released 31 March 2010 advises that "patient enrolment [for NNZ-2566] is now expected to begin in April 2010." The Neuren equivalent of D-Day has arrived.

Lets recap. NNZ-2566 has been the subject of a collaborative R&D development agreement with the US Walter Reed Army Institute.

During 2009, Neuren and army scientists published four peer-reviewed papers reporting on the performance of NNZ-2566 in experimental models of traumatic brain injury (TBI) - excerpt 2009AR. Within the context of a deep well of experimental data, the US Army have awarded a grant for the Phase 2 trial of $US14.2m (on top of earlier grants of $US4m).

In pre-clinical studies conducted by the US Army, NNZ-2566 showed significant effects in attentuating so-called non-convulsive seizures that can occur following TBI - excerpt 2009AR. It is important to reflect upon the significance of this disclosure. The US Army have already reached preliminary affirmative conclusions on the efficacy of NNZ-2566 in an area which is a major focus of the Army's TBI research program.

On the back of the 2009 developments, Neuren have secured new funding of up to $AUD7.6m through private placements and a convertible debt facility. Neuren's current R&D program is funded through to the end of 2011. Further, the Neuren Board has been strengthened through the November 2009 appointment of Dr John Holaday. Holaday has built five public and private biopharmacetual companies and raised more than $US450m in capital. Bear in mind that Holaday was the founder of the Neuropharmacology Branch of the Walter Reed Army Institute. The relationship between Neuren and the Army Institute has deep roots and each have a huge vested interest in the success of NNZ-2566.

If the Phase 2 trials are succesful, we know that the FDA will fasttrack the drug through regulatory approval processes. Yes, its a big if but at least we have arrived at the point of knowing. The economics of success will be stunning for a biotech company with a current market cap of approximately $15m. Neuren has estimated that the total sales of NNZ-2566 within the first 10 years following approval will be $US2B (thats billion not million). Sale estimates are only for the US market. Currently there are no drugs available for TBI.

Exciting! You bet.