The Fight Against Diabesity: How Will San Diego Adapt in the Era of Tough FDA Scrutiny?

Xconomy San Diego — 

Two out of three Americans are now said to be overweight or obese, and about 25 million people have chronic Type 2 diabetes that’s often caused by unhealthy diets and a lack of exercise. Taken together, these two related conditions are sometimes called “diabesity,” a rising public health scourge. Anyone who develops drugs to safely help people lose weight and control blood sugar can clearly tap into a vast potential market, and save the health system billions of dollars.

San Diego is one of the world’s leading hubs of pharmaceutical R&D in this field. That’s why I’m really excited today to announce that Xconomy’s first major national event of 2011 will turn the spotlight on this work in San Diego, and confront the challenges all drug developers are now facing from an increasingly tough-to-satisfy FDA.

This event, called “San Diego’s Fight Against Diabesity,” will feature a highly interactive panel discussion including two well-known executives from the San Diego scene: Dan Bradbury, the CEO of Amylin Pharmaceuticals (NASDAQ: AMLN); and Jack Lief, the CEO of Arena Pharmaceuticals (NASDAQ: ARNA). To add a little extra perspective from outside the region, we’ve invited Kurt Graves, executive chairman of Hayward, CA-based Intarcia Therapeutics, and former commercial head at Vertex Pharmaceuticals and Novartis. And Bob More, a general partner with Frazier Healthcare Ventures in Menlo Park, CA, who’s well-known to many in the San Diego life sciences scene, has graciously agreed to moderate this conversation.

This is not a rah-rah moment for anyone in the business. The cost of developing diabetes and obesity drugs has been skyrocketing lately, as the FDA has raised the bar ever higher for new drug approvals in the wake of high-profile safety controversies with GlaxoSmithKline’s Avandia and Abbott Laboratories’ Meridia. We broke the news recently on how one of San Diego’s former biotech highfliers, Phenomix, went out of business after it couldn’t find a partner to carry on a Phase 3 development program when it suddenly started to look too expensive. Both Amylin and Arena have been dealt well-publicized setbacks this fall from the FDA. The next San Diego company to face FDA scrutiny is Orexigen Therapeutics (NASDAQ: OREX), which will take its obesity drug before an FDA advisory panel on Dec. 7.

So if you’d like to join the conversation, mark your calendars for the evening of January 27. Registration starts at 5:15 pm, and the program will run from 6 pm to 7 pm, followed by an hour of networking. The event will be held at Amylin’s offices in San Diego. You can see all the details on how to register by clicking here.

This event is being modeled after the hit gathering we organized in San Diego back in March, which examined at the 20-year outlook for the local life sciences industry. I’m personally flying in from my base in Seattle and looking forward to meeting, as always, with our readers and helping you pose your questions to the panel. See you there on January 27.