So there are many approaches that are being developed right now, many in earlier stages, lots of devices, surgical approaches, and a handful of therapeutics in the late stage, and a few in the earlier stages.
And I think so far chronic disease in general has been a difficult area to really get a handle on and to create a care system than can tackle chronic disease. We’ve done a reasonable job with this dyslipidemia, hypertension, diabetes, where the therapeutic approaches have become integrated into primary care, at least in the United States.
But even in those settings, there could be a lot more effective therapy compliance, persistence, and integration of care. So when we started with the obesity therapeutic, we thought how do we not only develop an effective therapeutic that can help a lot of people, but let’s think longer term when we commercialize this product with our partner, North America Takeda, and we are seeking a partnership for the rest of the world. How do we integrate the therapeutic into a robust, chronic care maintenance program?
And so that’s something to keep in mind, and I’ll talk a little bit about a program that we’re piloting that we call Weight Mate, where we’ve got the weight loss pill, Contrave, plus a program that, together, in a hand in glove manner, can deliver a much more effective and long term change program.The therapeutics that I’ve seen so far, including Contrave, I think enable a higher level of success if a patient is committed to change, enter into some diet and exercise program, whether it’s personal or a commercial program, the therapies enable much higher levels of success. And so that’s the approach that we’re taking. Now, we submitted our Phase III data and our program data to the FDA for approval in early 2010. We had a positive advisory panel, the first positive panel in 13 years, but the FDA had concerns around drugs for cardiovascular safety after the results of the sibutramine large outcomes trial, which turned out negative, about a 16% increase in risk.