Elan and partner Transition Therapeutics have announced that Phase II Alzheimer's drug candidate ELND005 did not meet cognitive and functional endpoints in an 18-month study. While our sales forecast for this drug is too small to drive our fair value estimate of Elan, we're concerned about the study's implications for the amyloid-beta theory of the disease, and we think detailed data (to be published at a later date) could give more insight into the potential of Elan's Alzheimer's research platform. The fact that the study did not meet its primary endpoints was not a surprise; the Phase II study was small (351 patients), and two of the three dose groups for ELND005 were discontinued in December due to a higher number of serious adverse events, including nine deaths among roughly 180 patients. Serious adverse events were also elevated in the low-dose group, at 21.6% of patients versus 13.3% in the placebo arm. Elan did see a biological effect on amyloid beta in the cerebrospinal fluid of a subset of patients (only 20 patients in the placebo and low-dose groups provided samples), but management is not willing to disclose prior to the study's publication whether there was a trend toward better cognition and function in the low-dose group. Elan and Transition plan to move the drug into a Phase III trial and simultaneously begin searching for another partner to further spread out the risk and reward. As an oral Alzheimer's drug candidate, ELND005 could tap into multi-billion-dollar potential if successful, but we're not boosting our 30% probability of approval or our sales estimates based on this mediocre top-line Phase II data.
Elan also announced that it no longer plans to sell Elan Drug Technologies, as market conditions would prevent the firm from obtaining a fair value for the asset. However, Elan still hopes to move forward with reducing its debt levels; by repurchasing $300 million in 2011 debt and refinancing $190 million of 2013 debt, Elan plans to reduce its total debt to $1.24 billion and extend its maturity. Given the recent $206 million legal settlement reserve and Elan's failure to shore up some additional liquidity by selling Elan Drug Technologies, we're considering lowering our credit rating for Elan.