Replies to post #116131 on Biotech Values

[Ecomike]

First thought that comes to my mind is synergistic effects, and possibility that a higher dose of a blend may be Ok'd. But since it is the FDA, who knows. I lost all faith in the FDA ages ago.

Any idea how big a deal this may be for NVS?

[genisi]

This might reflect on GSK/THRX relovair as it also has a qd LABA component (vilanterol trifenatate).

[DewDiligence]

NVS’ QAB149 hits primary endpoint in COPD phase-3 studies as adjunct to Spiriva:

http://www.novartis.com/newsroom/media-releases/en/2011/1515988.shtml

The INTRUST 1 and 2 studies met their primary endpoints by demonstrating significant improvements in lung function of 130 and 120 mL respectively for Onbrez Breezhaler (150 mcg) plus tiotropium (18 mcg) compared to tiotropium alone after 12 weeks (both p<0.001). Both therapies were given once-daily. Lung function was assessed by measuring patients' forced expiratory volume of breath in one second (FEV1) averaged over eight hours (i.e. FEV1 AUC5 min-8h).

Onbrez Breezhaler plus tiotropium also performed significantly better than tiotropium in improving trough FEV1 (i.e. mean of 23 hrs 10 mins and 23 hrs 45 mins post-dose) at week 12, with the two studies showing differences of 80 and 70 mL compared to tiotropium alone (both p<0.001). The changes in trough FEV1 from baseline at week 12 were 230 mL and 190 mL for indacaterol plus tiotropium, and 150 mL and 110 mL for tiotropium alone. In both studies the reduction in use of rescue medication (albuterol) was numerically greater with Onbrez Breezhaler plus tiotropium than with tiotropium alone.

Onbrez Breezhaler and indacaterol are alternate names for QAB149.

The PDUFA date for QAB149 monotherapy is 7/31/11 (#msg-61247314). See the prologue of #msg-60733567 and #msg-60523825 for additional info on QAB149 and the QVA149 (QAB149 + NVA237) combination product.