Highlights include Arena Pharmaceuticals, Inc. (
ARNA), Vivus, Inc. (
VVUS), Orexigen Therapeutics, Inc. (
OREX) Merck & Co., Inc. (
MRK) and Johnson & Johnson (
JNJ).
Arena's Lorcaserin Approvable, But No Blockbuster
On March 30, 2009,
Arena Pharmaceuticals (
ARNA) released the much-anticipated results of the 2-year BLOOM clinical trial studying 10mg BID lorcaserin vs. placebo. Full data will be presented at the
American Diabetes Association (ADA) meeting in early June 2009.
The results are mixed, in our view. To put things in perspective, we will analyze the data stand-alone based on the FDA's guidelines for approvability.
FDA guidelines say that one of the below two endpoints must be met:
1) The drug must demonstrate a mean categorical weight loss of 5% in greater than 35% of the study participants, and these results must be twice that of the placebo group.
The BLOOM clearly passes this required endpoint. After one year, 47.5% of the patients taking lorcaserin lost at least 5% of their body weight vs. only 20.3% for the placebo. The results were also statistically significant and clinically meaningful at the 10% hurdle, 22.6% vs. 7.7%.
2) The drug must demonstrate a placebo-adjusted weight loss for the entire study population greater than 5%.
The BLOOM data unfortunately fails this endpoint. Data from BLOOM show that patients taking lorcaserin lost a statistically significant amount of weight (ITT) vs. placebo, 12.7 lbs (5.8%) vs. 4.7 lbs (2.2%), respectively, but the placebo adjusted total of 8.0 lbs (3.6%) did not eclipse the 5% hurdle.
Therefore, based on the FDA guidelines and the data from BLOOM, we believe lorcaserin is a drug that is clearly approvable.
