Biotech Values

[DewDiligence]

BLUE updates BT data from NORTHSTAR study:

http://finance.yahoo.com/news/bluebird-bio-reports-beta-thalassemia-123500227.html

The Northstar Study is an ongoing, open-label, single-dose, international, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of LentiGlobin BB305 drug product for the treatment of subjects with beta-thalassemia major. As of October 28, 2015, 13 subjects with beta-thalassemia major have undergone infusion with LentiGlobin BB305 product candidate. As of October 28, 2015, nine of these subjects had at least six months follow up

Results in these patients as of October 28, 2015 include:

• Median HbAT87Q production at six months follow up was 4.9 g/dL among patients of all genotypes (n=9), 4.9 g/dL among patients with non-ß0/ß0 genotypes (n=5) and 5.0 g/dL among patients with the ß0/ß0 genotype (n=4).

• All of the patients with non-ß0/ß0 genotypes with at least six months follow up (n=5) have achieved sustained transfusion independence as of the data cut-off, ranging from 7.1 to 16.4 months of ongoing transfusion independence; total hemoglobin at last follow up for these patients ranged from 9.1 to 12.2 g/dL.

• Patients with the ß0/ß0 genotype (n=4) demonstrated a reduction in transfusion volume ranging from 33 percent to 100 percent.

• The safety profile was consistent with autologous transplantation. No Grade 3 or higher drug-product related adverse events have been observed, and there is no evidence of clonal dominance.

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