"We estimate our service and other revenues for the year including revenues from our co-promoter Optimer’s Dificid through July this year will be about $15 million. The most notable – noticeable growth in our expenses reflects the investments in R&D this year. Our estimated range for 2013 R&D spend is between $375 million and $395 million. The biggest driver of the R&D increase is our additional spend in phase 3 trials including the ramp in enrolling for trials are already underway and the expected initiation of our phase 3 program in ventilator associated bacterial pneumonia or VAP for ceftolozane/tazobactam and our planned phase 3 efficacy study for bevanopran (CB5945)
We expect to grow revenues to a range of between $45 million and $50 million this year.
Now turning to Entereg which we added to our hospital franchise at the start of 2012, as we relaunched this product over the past year we have been very pleased with the positive reaction from prescribing surgeon both specialists who do (inaudible) surgery routinely and general surgeon for whom such surgery is a less frequent procedure. We’ve also learned that the translated the positive yield of the product value into regular use requires follow up with a number of pre and post op professionals involving care of this surgical patient.
Finally we made sure that we matched the enthusiasm that our sales for innovation has with this product ensuring we balance the extra time and attention that Entereg requires the institutionalized use but the focus we want to maintain on Cubicin and for the next several months on our co-promote of Dificid. We saw good momentum for Entereg as we ended the year with Q4 growth and carton sold of 6.1% compared with exceptionally strong Q4 of 2011, the final quarter in which (inaudible) were still promoting the product.
Overall we grew Entereg sales 41% in 2012, our first year of promoting the product. We look forward to FDA action on the sNDA filed in December seeking our label expansion to include additional types of surgeries that impact our function. We continue to expect Entereg to achieve $100 million in peak year sales. Entereg is just one of the ways we've been able to leverage our acute care infrastructure in the U.S. in recent years.
CB315 (and Optimer DIFICID co-promote)
Our two year co-promote with Optimer for the CDAD therapy Dificid in the U.S. began in July of 2011 and continue through July of this year. This has been another great opportunity to leverage the acute care infrastructure we built in the U.S. and we look forward to continuing our partnership with Optimer over the next several months.
We will continue to enrol patients throughout 2013 in the phase 3 program for surotomycin formerly known as CB-315 in clostridium difficile associated diarrhea, or CDAD.
[click here for comparison of fidaxomycin (DIFICID) vs. surotomycin (CB315) data in C. difficile]
Wondering if you could give us an update on your views on the C. diff opportunity for 315. And to what extent you are still involved with Optimer and the co-marketing and the sort of insights you are gaining from that?
Sure, while we are still involved with Optimer until July of this year we don’t expect that the relationship will continue past that. Both companies have essentially said that the partnership will likely end at that point. We’ve been very pleased with the relationship and we are continuing to promote the product through July of this year but at that point the Optimer folks will focus on Dificid and we will focus on Surotomycin (CB-315). And we do believe that the market opportunity remains healthy. That’s still a very, very large market, worldwide we estimate they are at least 30 million days of therapy in the CDAD space. And while we will have to see what the impact of Optimer’s pricing schedule will be and it’s really too early to tell what impact that will have on the market. We still believe that the market is strong and that where we have a drug that can get to the 400, 500 million worldwide peak year number.
And again, keep in mind Alan that we have complete rights to this product, that we owe no royalties and essentially the incremental commercialization costs assuming ceftolozane/tazobactam will be minimal.
Bevenopran, formerly known as CB-5945 given development as a treatment for opiod induced constipation. We began enrolling our long-term phase 3 safety trial in October 2012 and expect to initiate the three-phase three efficacy trial in the first half of 2013.
Based on our most recent dialogue with the agency, as of December 2012 we continue to believe that our overall NDA submission plan consisting of a large 1400 patients placebo controlled for long-term safety trial plus three 600 patient efficacy trials will satisfy FDA requirements for an NDA filing in OIC assuming of course the efficacy and safety data are robust. We have designed these trials including implementing a data safety monitoring board and expert adjudication of cardiovascular AEs and withdrawal events to give us the best potential for success with this program.
I was wondering just on 5945 you could talk labout where you are or how you’re viewing presently the licensing opportunity there and is there any quantification of the European cost you’re talking about for 2013 as well?
I will answer the second part of that question first. We’re not pursuing anything in Europe. So there are no costs associated with European development of 5945 in our guidance for 2013....We did have interest in 5945 but as you probably can tell we feel very strongly about this product and we felt like we have the resources and the ability to run this trial. And we didn't need to do a deal unless we like the deal. So after taking stock of what we had, we decided that it was best to go forward with the phase 3 trial ourselves and we will look at partnering opportunity when we get the data. But our sense is that this market is breaking towards us in terms of the potential competitive profile of bevenopran versus the competition and we want to make sure we are getting the right deal for the product.
If I could just get a question on pipeline you mentioned that there was some interest in the program. Can you shed some light on how much interested it was and then does it mean that you will now partner when the program is completed or is your option to potentially partner while phase 3 is still ongoing that’s still out there on the table?
So we’re open to partnering the asset at any appropriate time. We’ve had a range of parties interested but our view is that the value that this asset could bring is underappreciated. And so we are very comfortable funding the phase 3 program for the US and looking at what that data looks like before we reengage but certainly if someone is interested in engaging the four of the phase 3 data we’d be happy to entertain those conversations.