Biotech Values

[mcbio]

XNPT @ Wedbush (8/16/11)

1. Regarding sNDA for Horizant against PHN, XNPT/GSK are seeking approval of a total 1200mg/day dose (600mg BID). The gabapentin exposure for 1200mg/day total of Horizant is 40% lower than an 1800mg/day dose of oral gabapentin (it's important to stay under the exposure of oral gabapentin for purposes of a 505(b)(2) approval). The evidence of efficacy for this dose of Horizant was from a 13-week double-blind placebo controlled study before where Horizant showed a reduction from baseline pain score of negative 2.17 compared to negative 1.27 for placebo. Also, the percent of patients with 50% reduction in pain score was 36% for Horizant 1200mg/day vs. 16% for placebo. The most common AEs for this dose were comparable to placebo as well.

2. XNPT is due $10M from Astellas upon approval of Horizant in Japan. XNPT is also due mid-teen royalties on net sales.

3. Regarding 829, more buzz about being in talks with potential partners with a statement that there could be a partnership in the "near future." Later in the presentation there was discussion about the merit of partnering now or after Phase 1 results or perhaps a little later after the potential GI safety benefit compared to BIIB's drug is proven in the clinic. Without giving a firm commitment on the specific approach, it was stated that XNPT does not expect to enter Phase 3 for 829 without a partner.