Continue reading below, and find historical context and info here.
Also be sure to check out coverage of Cubist by Jason Chew at Chimera Research.
As we begin Q3, we are, as planned, increasing our call universe for ENTEREG to a significantly larger percentage of the hospitals for clinical business managers [50-100% higher call universe each] call-on in the U.S. [with] some adjustments we are making to incorporate key learnings in the first 6 months of the relaunch [based on the 600 hospitals that had been ordering already].
The first 6 months of revenues for ENTEREG this year are up 22% compared with Adolor's product revenues in the first half of last year when ENTEREG was co-promoted by Adolor and GSK.
Our clinical business managers continue to report considerable enthusiasm amongst surgeons and others based on the ENTEREG clinical profile and the drug's success in helping patients achieve an earlier discharge from the hospital following its use. However, getting ENTEREG used routinely for appropriate bowel resection surgeries, ideally by having it added to orders, requires interaction with multiple stakeholders and this takes time. The stakeholders involved can vary quite a bit from institution to institution. We are rapidly sharing learning on proven path to success with ENTEREG so that the selling time involved is manageable and does not infringe on time needed to support CUBICIN and DIFICID. "It's going to take a lot of time to connect the dots...to convert the demand"
For ENTEREG, we are making good progress in preparations for our radical cystectomy supplemental NDA filing, and are on track to file the sNDA by year-end.
It's certainly -- as hard as we thought it would be, we didn't think it would be easy, but we still remain committed to our $100 million top line objective and committed to the success of the product.
On the ENTEREG launch, can you maybe just talk a little bit about the fact that some hospitals seem to be trying to institutionalize decreased postsurgical opioid use to try to improve discharge times? And if that's kind of one of the headwinds that you guys feel like you might be running into as you relaunch this product?
Well, actually I don't see that as a headwind. I see that really, as almost a tailwind if you will. Because ENTEREG is -- I think can be part of that strategy. What you're trying to do, you want to have this drug on board so that you can ultimately impact this disease before it becomes a big problem. And that basically is what hospitals are trying to do. So I don't see it as a major issue. We're not having a problem convincing people that there's a need for ENTEREG. As a matter of fact, every time I talk to a sales representative, they're overwhelmed by the amount of surgeons and nurses who see the need and want to use it. But where the challenge comes is there's so many steps along the way that have to be coordinated. And I guess you could say that the surgeons aren't so enthralled that they are willing to go through the extra effort to break down all those barriers. So that's what we have to do. So I'm not concerned about the demand per se, I'm concerned about converting the demand.
You actually see a lot of scripts being written for patients that are on either reduced opioids or I guess no opioids at all?
No. If that's your point, that one of the ways to reduce POIs, that they're trying to reduce opioid use, then that's different. But I don't think -- we're not seeing significant changes in opioid use across the U.S. I mean, I know that it's been an area of focus for a long time. But we haven't seen major changes in the uses of opioids. In the U.S., opioids are very well entrenched, and we obviously watch that in terms of our pain pipeline as well.
Phase 3 program to start by year-end 2012 - CBST would not reveal the cost of the program. Partnering discussions ongoing, no commitment regarding whether to partner before or after seeing phase 3 data.
"Second, we are actively seeking a commercial partner for our opioid-induced constipation therapy candidate, CB-5945. As you know, the market opportunity for OIC therapy is mostly in primary care. As we engage in conversations, we will be weighing the relative advantages of out-licensing the rights before or after we see Phase III data."
"Since our last call, top line Phase II data on 2 potential OIC competitors has been announced. We remain optimistic that 5945 has the potential to be the best-in-class OIC therapy because of its differentiated profile, which balances the efficacy needed for success with the tolerability that physicians and patients are seeking."
Question re competitors in OIC: I guess I'll just be interested if there's any additional color, how do you see your potential to differentiate? I know, one, put theirs on the shelf because they didn't think it was necessarily best in class. And I think the other looked better than what we had seen last time. The efficacy still looked pretty good, and it looked like one of the key tolerability issues have been addressed
"I think it's really a combination of both of those aspects, Tom. I think that it is a large market. There's many, many prescriptions written, as you know, in the U.S. for various opioids for chronic pain. But we also, based on the Phase II data, think that 5945 is delivering as strong an efficacy signal as any of them, really second to none, but at a tolerability level that looks a heck of a lot closer to placebo than what we've seen in the other Phase II studies that have been presented to date....what you see in the other products is different strategies to try to get both efficacy and tolerability, sometimes they have to use higher doses to get efficacy. But when they do that, they lose some of the tolerability that they're looking for. I think what you see in 5945, we hope, if the Phase II data are replicated, is the perfect balance, which is a drug that will give you a normalized bowel function, but will have tolerability that is close to placebo. So we've seen nothing yet from a competitor that has shown that it can achieve both those objectives."