After years of anticipation by doctors, patients, and investors, Belviq was finally launched last week for treatment of obesity, type 2 diabetes and overweight patients with a weight-related health problem. Belviq is manufactured by Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) and distributed in the USA by Eisai.
Belviq is the first weight loss drug approved in 13 years by the FDA. Another drug approved bit later was Qsymia by VIVUS, Inc. (NASDAQ:VVUS). Since Qsymia is a combination of existing generics it didn’t need to go through DEA scheduling which caused a delay in the launch of Belviq. Despite high expectations set early on by several analysts, the launch of Qsymia has been, for the most part, disappointing for a variety of reasons including safety concerns, a risk mitigation and evaluation program (REMS) required by the FDA, and generic competition. Belviq has a completely different mechanism of action (see competitive advantages in the list below).
Belviq vs. Qsymia Launch
One question on the minds of many investors who are not too familiar with the obesity space is, why would Belviq’s launch be any better than Qsymia’s. Belviq’s efficacy is comparable to Qsymia’s recommended dosage, and while their trial designs were very different, there’s never been a study to compare the efficacies of the two drugs.
Belviq’s average completer weight-loss was 8.2%, and responders lost an average of around 12% in a year. Here’s a video of one gentleman who lost over 50 pounds on Belviq (click for the video). Completer and responder data are the best measure of efficacy according to some of the top obesity treatment experts.
I expect the launch of Belviq will be far better than Qsymia’s for the following reasons:
1. Belviq is a new novel new single agent available to doctors which has good efficacy and excellent safety profile, vs. Qsymia which stimulates the metabolism and is a combination of two generic drugs. In this video, Dr. Sue DeCotiis, a weight loss specialists explains why she’s excited about Belviq:
“it’s brand new type of medication… the classic weight loss medications are stimulants. They keep your hunger down by making you jittery and hyper, but a lot of patients can’t tolerate them. This works directly on the brain and it turns off that hunger impulse…”
Being a single novel agent the doors are open to combination therapies. Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) is in discussions with the FDA on such studies, e.g., in combination with phentermine.
2. Safety is the number one concern for physicians when it comes to weight loss drugs and Qsymia has an inferior safety profile compared to Belviq. Pregnant women on Qsymia have a higher risk for cleft lip birth defect. Belviq’s most common side effect is a mild, temporary headache early in treatment.
3. Not only Belviq does not stimulate the metabolism, it did not cause any heart problems in 8000 patients on whom it was tested. Thousands of echocardiograms did not show any sign of heart issues in the patients. One reason for this is the superior technology of Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) which allows Belviq to be an agonist of the serotonin 5-HT2C receptors without impacting the valvulopathy receptor, 5-HT2B. Doctors like this heart-safety aspect of Belviq because obesity drugs have traditionally not been heart-friendly.