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All right, good afternoon. My name is Steve Byrne. I cover the small and mid-cap (inaudible) stocks in the States. It’s my pleasure to introduce the Orexigen team. We’re graced with three of their managers here – Mike Narachi, CEO, we have Mark Booth, Chief Commercial Officer, and Jay Hagan, CFO, so we’ve got quite a team here. So it’s all yours, Mike.
Yeah, thanks for inviting us and thanks for your interest in Orexigen, and probably if you’re interested in Orexigen you’re interested in the obesity space. It’s evolving rapidly over the last year or so, and I think the pace of new information and are we meeting or beating expectations is going to continue here over the next couple of years.
I’ll be making forward-looking statements today, and if you don’t mind I’ll sit so I can use my glasses and see the screen. I won’t try and read this – obviously lots of forward-looking statements. Things materially change in the future, and all of our documents are on file on our website and with the SEC.
In general, we have two late-stage obesity therapeutics. One’s been reviewed by the FDA and we got a complete response that asked us to rule out cardiovascular risk. The other has completed Phase IIb. We raised the capital, we started our large cardiovascular outcome safety trial, and we’re getting ready now to resubmit in the U.S. and submit in Europe and synchronize those approval processes so that we can then cascade into global approvals. We have a North American commercial partner in Takeda that’s committed to heavy resourcing of a blockbuster primary care launch when the approval comes, and we’re in the process of seeking a rest-of-the-world partner to commercialize Contrave. And our second product, Empatic, we have to make some strategic business decisions on how best to develop that, but our default position would be to put that into a rest-of-the-world partnership agreement and use some of those partner dollars to fund the development and probably not start Phase III development of that second product until rest-of-the-world commercialization partners are brought on board. We would expect that partnership to come together in the highest value-creating way for Orexigen around the same time that we have data from the cardiovascular outcomes trial.