- Adolor presented at the Stifel Nicolaus Healthcare conference on 9/7/11 - click here for full schedule of biotech webcast events and links to my notes.
- Click here for detailed info on ADLR company, pipeline, partnerships.
- See my notes from the webcast below:
- Different presenters vs normal - CFO and VP of Clinical Research & Development
- 9/6 - was the first day that ADLR reps out in the field alone promoting Entereg after split with GSK
- Company is in "decent financial position" [They have been making weird comments about their "so-so", "decent", "adequate" etc financial position repeated on recent calls. I get that they will likely raise cash before phase 3 trials, but how do these comments help in any way?]
- Patients had to have minimum of 30 mg morphine equivalents per day to enter ADL5945 OIC phase 2, and their constipation had to have been entirely due to pain treatment. But average opioid intake was much higher at 177-270 mg equiv per day for chronic pain
- Patients had a mean duration of 3.4-7 years of opioid-induced constipation before entering study
- Adverse event rate was equally distributed across all study arms
- phase 3 trial will start early 2012
- Didn't mention possibiltiy of taking forward 0.25mg once daily this time [see more comment on this below]
- Entereg deal is cash flow accretive in year one.
- q2-2011 profit sharing payment to GSK calculates to $13m annualized [so ADLR is now saving this amount]
- Average Entereg course costs $550, average of ~8.5 doses. Health system savings of $2300 per patient after paying for drug, so there is some pricing flexibility. In the clinical trials, average was 11-12 doses per patient. The drug is working well so using a bit less. The marketing message hasn't changed much. We changed strategy at beginning of 2011 [I think referring to focusing less on signing up new hospitals and more on increasing penetration at current customers]
- Entereg is on formulary or availble in about 1/2 of leading hospitals.
- Typically only 1-2 of 12 surgeons use the product...now trying to increase penetration
- There is interest oin OIC drugs. NKTR deal was great. Shows the value that this indication serves to people.
- $32m cash on hand is not enough for phase 3 progam, so evalulating options. We have interest from other companies. Data became available mid-august (pharma world pretty much shut down then), so just now having some dialogue. Considering regional/global. No definitve plan
- ADL5945 - still looking at QD (daily dosing), but data was overwhelming with BID. These patients are taking multiple medicines multiple times a day. So don't feel taht BID will be a problem. Still going over QD data. We'll see which way we go
- How does the phase 2 data compare vs others? Relistor? Tolerability profile was amazing. Any other competitors' phase 2's, much worse AE profile, esp GI toxicity was in 40% range
- Sub-cutaneous relistor - goal is rapid induction of bowel movement w/in 4 hours, different approach than our compound (normalize bowel functions). Their primary endpoint is time to first bowel movement. Their drug is more like a PRN "on demand" vs normalizing bowel function with ADL5945
- FDA guidance - primary outcome is responder anaysis (was secondary endpoint in phase 2). Criteria is 3 or more bowel movements and increase of 1 vs baseline. Acute treatment would need 4 week study, Chronic would need 12 week pivotal study.
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