This Saturday, October 24 is the “pre-meeting” day which means it is outside the constraints of the Continuing Medical Education limitations on corporate participation. Most participants head right for the Pharmacology update section. This section involves presentations by mainly pharmaceutical company researchers as to where their compounds are on the tortuous path to approval by the Food and Drug Administration (FDA). To researchers, it is a tip-off as to where their research should be going; to competitors, it is an indication of how their compounds may fare. There are not a few investment advisors in the audience looking to where their clients should place bets as to which company’s products may get approved or not.
A cautionary note: This Saturday show is not unlike the paddock at the Kentucky Derby. Some horses look just beautiful; some are not so handsome but have great records; some are nags but just keep moving along. Over the next few days, more details on these compounds eke out in oral and poster presentations. Sometimes the beautiful horses stumble; sometimes the nags win. It’s a horse race.
Today, however, presentations by three pharmaceutical companies and one researcher for a device manufacturer focused on their products in Phase II or Phase III of development. The companies were Arena, Vivus, Orexigen and Amylin. The one device company was represented on the platform by Lee Kaplan of Harvard, commenting on GI Dynamics’s EndoBarrier system.
I was seated among several highly experienced, knowledgeable obesity researchers and, frankly, keyed off their reactions. The Arena information was impressive but not inspiring. The Vivus presentation showed real promise and indicated a good bet for approval. The Orexigen data was impressive but not overwhelming. Amylin’s products were at an earlier stage of development and should not be compared with those at later stages of development. However, they seem to have a good track on products which may not have the side effects of the other compounds. The GI Dynamics data involved a new surgical intervention which, while promising, had a number of issues around delivering the product.
In short, a lot more needs to be discussed about these compounds. However, these presentations were inspiring to the audience of researchers and clinicians that a new generation of therapies are closer than we think. The Devil is, alas, in the details and over the next few days more details on these and other products will emerge. Stay tuned.