Biotech Values

[DewDiligence]

More details on Gammagard’s failure in AD (from the same PR):

Topline analyses from the randomized, double-blind, placebo-controlled, multi-center trial found that after 18 months of treatment, patients with mild to moderate Alzheimer's disease taking Baxter's IG treatment at either the 400 mg/kg or the 200 mg/kg dose did not demonstrate a statistically significant difference in the rate of cognitive decline as compared to placebo (mean 7.4 in the 400 mg/kg group, 8.9 in the 200 mg/kg group, and 8.4 in the placebo group). Results also did not indicate a statistically significant change in functional ability as compared to placebo (mean -11.4 in the 400 mg/kg group, -12.4 in the 200 mg/kg group, and -11.4 in the placebo group).

[Let the subgroup analysis begin!]: While the study was not powered to show statistical significance among the sub-groups, in the pre-specified sub-group analysis, the 400mg/kg treatment arm showed a positive, numerical difference in change from baseline versus placebo in cognition as measured by the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) and Modified Mini-Mental State (3MS) Examination among both moderate patients and carriers of the ApoE4 genetic marker. These differences ranged between 16 percent and 29 percent. A data table is available at: www.baxter.com/gap/baxter_gap_study_data_table.pdf .

…Based on these results, Baxter will reconsider its current approach for its Alzheimer’s program and will determine next steps after full data analyses. The current Baxter studies [plural] of IG in mild to moderate Alzheimer’s disease will be discontinued. [I.e. the second phase-3 trial of Gammagard in AD, which was partially enrolled, will be dropped.]

This was always considered a high-risk program, so most investors probably aren’t surprised by the failure.

I would expect other IVIG players, such as GRFS and CSL Behring, to drop their own AD trials in progress.

BAX CC today at 8am ET.