dleb see:http://www.biota.com.au/uploaded/154/1021512_75investorpresentation-im.pdf - see p22
BTA have been decidedly obscure about LANI, but here's the reality: LANI has completed one phase III study in Asia and all going well, D-S will likely file for a limited (for "treatment" not "prevention") registration in Japan during 2010, which means a possible launch in Japan in 2011, which means no substantial royalties for BTA until a couple of years later - and because BTA only gets half royalties on the deal with D-S, the stream from this one country may be limited compared with Relenza. As for the rest of Asia, D-S will probably look for licensing partners and if successful will launch in Korea, Taiwan (the two largest pharma markets outside Japan) by 2012-13.
So, the real payoff for LANI is in US and Europe (3/4 of the world pharma market in $) where the seasonal flu market is potentially large and the pandemic stockpiling market is already huge at around $1-2B pa. The problem is that in these markets the drug is only in phase I studies (!) and the Japanese trials won't do. So (1) BTA needs to find a licensing partner; (2) that partner (or BTA) will have to conduct phase II trials in EU or US before (3) going into any multicentre phase III trials in EU and US, before (4) filing for registration and waiting 18 months. So a launch in...say 2014-15? Again half royalties for BTA.
I love this stock but let's be careful of the hype on LANI. It's a great opportunity but the major payoff is in 5-10 years after Relenza is long gone.
BTA Price at posting:
$1.30 Sentiment: None Disclosure: Held
