goldman sachs: lani blockbuster-potential , page-2

LANI was submitted for a Japanese NDA 9 weeks ago.
Perimivir took only 9 weeks to gain approval, so Im expecting an announcement shortly. When approved, LANI is available for immediate sale. The northern flu ends in May and a third wave of infections appears to be playing out in the US. Expect it to be the same in Japan, where pH1N1 now appears to be 100% tamiflu resistant. An early approval could see LANI sales (+ royalty payments to BTA) much sooner than expected. LANI will be snapped up by retail or the Govt stockpile, and sales will be constrained only by DS production.

DS has previously flagged production of 3-4 million [doses] of LANI for 2010, and 10 million for 2011. The royalty and milestone production payments from DS to BTA are secret, but we should know their value shortly.

On the clinical front, Biota/DS/GSK should be able to complete Phase III Trials in May for (1) Prophylactic LANI, and (2) IV Relenza.

The prophylactic LANI market will be large! Antivirals have traditionally been used for treatment. Preventative use creates a new market, its hard to predict how big itll be. I think iv relenza could be a good little earner for BTA/GSK. For example, if iv relenza was sold for treatment of ICU patients during the current pandemic than orders of 10-20,000 doses per country (x60 countries) could have been expected. Perimivir is sold at $2225 USD a pop.

Its going to be an interesting couple of months for BTA. Good luck all,
MS