OBESITY DRUGS...
I'm looking to make an investment in a pharm "play." We're all aware of the great impact that obesity has on healthcare, wallstreet, and mainstreet... It's been about 10 years since a SUCCESSFUL weight loss/obesity drug has been FDA approved, and currently 3 public biopharma companies are racing to produce the newest blockbuster. This drug will address a 10+ billion dollar U.S. niche annually. The winning company will capture approximately 10-15% of this market (conservative estimate), sending shares of the winning company significantly higher.
Right now my money is on ARNA with its drug candidate Lorcaserin. Wallstreet seems to be betting against this one due to disappointing efficacy results. Wallstreet, however, isn't full of scientists and physicians... They're more like blood thirsty hounds that seem to drool over RESULTS without weighing placebo group information or side effects into the mix.
For what it's worth, I'm currently in medical school, and as a future physician I would prescribe Lorcaserin over any of the other candidates. Conservative, safest treatments come first! Physicans want safe drugs that they can prescribe chronically... I'm well versed in pharma, and I understand how the three drugs work.. I really like ARNA, but yet I haven't done much DD on the company fundamentals or pipeline. This is an area in which I am weak.
____________Some DD____________________________________________
Lorcaserin faces FDA approval on Oct 22, and is a SELECTIVE 5HT-2C R agonist... basically like fenfluramine, but does not produce vavulopathies or any heart problems because they tweaked the selectivity issue. We all know how fen-phen sales exploded but not without unfortunate health consequences due to nonselectivity. This ultimately cost Wyeth around 20B dollars... Lorcaserin is not supposed to agonize the 5HT-2B R at all. It's looking like diabetics can use this one (BLOSSOM-DM phase II trial)! Lorcaserin has a very unique profile for tolerability and safety, and it has undergone 18 clinical trials following over 8,576 patients. It also does not require a 4 week titration (Qnexa and Contrave do). This drug seems to be showing the least amount of AEs, but it is not as efficacious as the other drug candidates. It could be used as a FIRST LINE treatment. Even if not super efficacious, maybe this one could be used in combination with other drugs? Phentermine + Lorcaserin = safe fen-phen? I really like this one, but it seems wallstreet is betting against it. This is where my bet is currently....
Qnexa is a combo of phentermine and topiramate, both already FDA approved drugs. Topiramate is an anticonvulsant used to treat epilepsy. It's selective for receptors in the hypothalamus that regulate appetite. Using an antiepileptic to suppress appetite is just looking for trouble in terms of side effects... It's unique time released technology is supposed to free patients of nausea, yet this drug on it's own causes nausea. Other side effects include dry mouth, constipation, parestheis, cognitive effects etc. It's not looking as safe as Lorcaserin, but it's incredibly more efficacious (something like 18% reduction in overall body weight compared with 5-6% of Lorcaserin - Lorcaserin slides right by the FDA's min standard of 5% pts). IT faces FDUFA on Oct, 28 2010... FDA panel on July 15th. It seems that this stock, VVUS, is the one that is trading the most forward... telling me that the street may be betting on this drug as a better candidate of approval. Phentermine and Topiramate are already available in generic form. I'm thinking that this isn't beneficial to VVUS, because as a physician I would prob just prescribe two generics instead of Qnexa to future patients??? Also I'd never use an anticonvulsant to suppress appetite.
I'm still learning about Contrave, a combo of bupropion and maltrexone... Buproprion is highly contraindicated in hypertensive patients, yet doesn't HTN fit the obesity profile? Again we're seeing more adverse effects but much greater efficacy as compared to Lorcaserin. This one is my least favorite candidate so far. It doesn't face approval until early 2011.
