Elan, the Irish drugs company, reported today that total revenue increased by 18% to $352.1 million in the first half of 2008, compared to the same period in 2007 and the net loss fell by 44% to $159.4 million.
Total in-market sales of the MS (multiple sclerosis) Tysabri drug were $359.7 million in the first half of 2008, an increase of 199% over the $120.5 million recorded for the same period of 2007, reflecting strong patient demand across global markets. At the end of June 2008, approximately 31,800 patients were on therapy worldwide, comprising approximately 31,200 on commercial therapy and approximately 600 in MS clinical trials, representing an increase of 127% over the 14,000 patients who were on therapy at the same time in 2007.
Elan CEO Kelly Martin commented:"Our operating discipline, focus on execution, and commitment to deliver tangible and measurable results continue to serve as our core principles from which we drive the leadership and management of our company. During the first half of 2008, we continued to make solid operating progress. Tysabri recorded in-market sales of $359.7 million, an increase of almost 200% over the $120.5 million recorded in the same period of 2007. At the end of June 2008, approximately 31,800 patients were on therapy worldwide, an increase of 127% over the 14,000 who were on therapy at the same time in 2007. We are encouraged by the results from the Phase 2 trial of bapineuzumab, which enhances our knowledge base and continues to validate our immunotherapeutic approach to Alzheimer's disease.
The recent volatility in our stock price is a result of the markets' interpretation of two specific events.
The first event was the presentation of the Phase 2 detailed data for bapineuzumab (AAB-001) on July 29th at the International Conference on Alzheimer's Disease (ICAD) meeting in Chicago. The data were presented by Dr. Sid Gilman, who is the William J. Herdman Distinguished Professor of Neurology and Director of the Michigan Alzheimer's Disease Research Center with the University of Michigan, as well as the Chairman of the Bapineuzumab Safety Monitoring Committee (the Safety Monitoring Committee).
The primary focus of the trial was safety; a secondary purpose of the trial was to determine if there was any efficacy (or biological signal) against cognitive, functional or biomarker endpoints.
In relation to the primary focus, the Safety Monitoring Committee concluded that AAB-001 is "generally well tolerated and safe."
As previously announced on June 17, 2008, the Phase 2 study did not meet its pre-specified efficacy endpoints which utilized the ADAS-cog and DAD measures. Post-hoc analysis of the data allowed us to better understand "what the drug is doing" and provided invaluable insights. As Dr. Gilman presented at the oral session, we observed statistical significance for all "completer" patients (i.e. in patients who had all six scheduled infusions and an efficacy assessment at week 78) in three of four efficacy endpoints (ADAS-cog, NTB, and DAD) and observed a positive directional movement on a fourth efficacy endpoint (CDR-sb).
Analyses of patients sub-grouped by genotype provided additional valuable insights into this potential immunotherapeutic approach to the treatment of mild to moderate Alzheimer's disease. Within the ApoE4 carrier subgroup, there were favorable directional changes. Among the ApoE4 non-carrier subgroup, we observed statistically significant and clinically meaningful effects across cognition, function and biomarker measures.
We believe both the safety and efficacy findings support the design of and decision to initiate the bapineuzumab Phase 3 studies that are currently underway."
Results detail
