The Race Is On
The neck and neck race that we see developing here may not hold the glitz and glamour of a Kentucky Derby or Indianapolis 500 but the stakes are much higher. This race is for the coveted first to market title for the latest and greatest anti-obesity drug carrying the FDA seal of approval. And what is waiting at the finish line for those who make it? A share of the estimated $30 billion spent on weight loss each year. With only $200 million currently spent on prescription drugs, the pay off could be huge. The ride hasn’t always been smooth for the three front runners, Orexigen Therapeutics, Arena Pharmaceuticals Inc. and the current leader, Vivus as they head into the apparent home stretch.
Hurdles that must be overcome by pharmaceutical companies in the area of weight loss include: at least a 5 percentage point difference between trial subjects that are taking the drug and a control group taking a placebo, minimizing side effects such as heart disease and psychiatric episodes and showing an improvement in co-morbidities (related diseases such as diabetes, high cholesterol and high blood pressure) to encourage insurance companies to pay for treatments.
Sanofi-Aventis SA, Pfizer Inc. and Merck & Co. are just a few of the past hopefuls that dropped out of the race due to one or more of the above reasons.
Orexigen’s Contrave, a combination of two older drugs, Neltrexone a drug currently used to fight opioid and alcohol addictions and bupropion an antidepressant, Arena’s Lorcaserin which is similar to but chemically different from fenfluramine, one of the ingredients in the banned fen-phen diet pill of the 1990’s, and Vivus’ Qnexa using a combination of a generic version of the other fen-phen ingredient, phentermine, an anticonvulsant drug topiramate have all apparently satisfied the FDA’s requirements for safety and efficacy by showing at least twice the number of subjects loosing over 5% of their body weight as compared to a placebo group. All three companies hope to apply for FDA approval late this year or early next year. As a side note, Arena has bounced back after an earlier set back this year when trial data fell short of the required 5% weight loss requirement and subsequently laid off 130 workers. New trials obviously met those requirements. Also, Orexigen has a back up drug Empatic, in phase II trials that will be waiting in the wings as an alternative if patients do not respond to any of the other three treatments.
What does all this mean in the real world? Well, if you do the math and you currently weigh 250 pounds and loose 5% of your body weight in a year, you will have lost a whopping 12.5 pounds in a year! A pound a month? A pound of fat is 3500 calories, divided by 30 days, means that all you have to do is cut out or burn 120 calories a day to achieve these results on your own. While a 5% positive result doesn’t impress me all that much (and not everyone achieves that), you make your own decision when these products hit the market, probably in 2011, and maybe you will get better results. As usual, these trials are not conducted on children so any promise for Childhood Obesity will either be from a doctor’s off label use or dependant on approval for that indication further in the future. In the mean time, we will certainly be watching and waiting for any good news from the pharmaceutical front.
P.S. possibly the best approach right now might be investing in any or all of the top three’s stock as they have skyrocketed lately.
Tags: childhood obesity, diet pills, obesity, weightloss
