- ADLR made a webcast presentation at the Wedbush conference on 8/16/11.
- To access webcast link, as well as link to my notes from ADLR 2q11 earnings conference call in July, visit the Past Events & Notes page.
- Complete stock research notes for the company can be found on the ADLR page.
- My notes from the presentation are below:
- We think we have the makings of a best in class compound in opioid inducd constipation (OIC), and this program will be the center of our comments today [I personally am not that excited by the data, program, or chances for a lucrative partnership to fund phase 3 development]
- We were thrilled to have the GSK transaction come together
- Entereg is the first and only approve product in its space and has long IP protection thru 2020
- Entereg sales run rate is currently in the low to mid $30's millions
- "We think we can grow topline revenues"
- Two trials only differed in dosing regimen
- Spontaneous bowel movement - definition requires no rescue laxative use in past 24 hrs
- 94% of patients completed treatment
- On average, subjects were obese based on BMI, had high baseline opiod use, and most common primary pain conditon was back pain
- 0.1 mg dose did not achieve statistically significant improvement
- 0.25mg once daily dose - significant increase of 1.18 SBM per week...responder analysis was not significant, but trial not sized for this endpoint
- 25 mg twice daily dose yielded increase of 2 SBM, near doubling of response rate. Clinically significant, as Number Needed to Treat (NNT) =3
- Patient-reported data has been collected, still being analyzed. We will validate the instrument before end of phase 2 meeting with FDA
- most common adverse event (AE) - 10% abdonomial pain in both placebo and treated
- The data support development of 0.25mg dosed twice daily
- In summary, we are exactly where we wanted to be at the end of the summer...though not the best choice of broader market condtions in which to have good news
- preference for phase 3...partner vs go alone? We have options, for now will keep them open. We have been maintaining dialogue with a number of parties over the course of phase 2, we will share data with them shortly and see where discussions take us. We are focused operationally so we can start phase 3 as early as possible in 2012. We will have more to say in the near term about how to finance that. It will not be an inexpensive program, cost in range of $60m.
- Comparison to other programs in the OIC space? We were very pelased with efficacy, pleasantly surprised on the tolerability side, which is very important in this population. We like what we see in comparison to competitors. Of course phase 3 data for us and others will be the key.
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