EUR 850.00 For Business Accounts Only

Morningstar | Maintaining Our Plasma FVEs Following Encouraging Grifols Alzheimer's Data for Plasma Exchange

Grifols presented phase 2b/3 AMBAR data at Clinical Trials on Alzheimer's Disease (CTAD) in Barcelona on Oct. 27 that indicated a positive effect of plasma exchange on disease progression in patients with Alzheimer's, with a particularly strong effect in the subgroup of patients with moderate disease. While the analysis is not complete and several questions are still outstanding, we expect this to drive a limited amount of off-label demand for albumin (and potentially immunoglobulin) from plasma players including Grifols, Shire, and CSL in the near term. Once the analysis is complete and data is published, support from the American Society for Apheresis (ASFA) for the use of plasmapheresis as a treatment for Alzheimer's could further boost demand and potentially pricing power for albumin. However, we think financial impact is limited by constrained supply of plasma, and it will take years for Grifols to not only verify these results in larger studies but also for industry players to build enough collection and fractionation capacity to attempt to meet potential demand. Therefore, we're not making any changes to our fair value estimates in the industry based on this news. We continue to view Grifols and Shire (acquisition pending by Takeda) as holding narrow economic moats. Large plasma industry players see significant cost advantages that allow strong profitability, and the long-term demand outlook appears steady despite innovation that could compete with certain niches of the plasma protein market.

In the overall study, after 14 months of treatment, Grifols saw a 66% reduction in disease progression on ADAS-Cog (not significant) for treated patients compared with placebo, and a significant 52% reduction in decline in ADCS-ADL. In the subset of patients with moderate disease (161 patients), there was a significant 61% reduction in progression each measure, while a trend to a benefit was seen in mild patients. The data was not divided by treatment arm, so it is unclear how patients benefited by treatment type (three experimental arms included high dose albumin plus immunoglobulin, low dose albumin plus immunoglobulin, or low dose albumin alone).

The mechanism of albumin's efficacy could be via a peripheral sink mechanism (attaching to circulating amyloid and helping to flush free amyloid from the brain), but also could be due to albumin's immune-modulatory and anti-inflammatory properties. Immunoglobulin was included in the treatment protocol to help support patient immune systems during treatment, and we believe albumin is more central to the efficacy seen in trials.