The Merck analyst meeting is over for 2005! Dr. Peter Kim, who runs R&D, had the most interesting discussion, on the R&D front. Compared to BMS' annual meeting, they did focus more on diabetes and give more detail on diabetes:
- As has been the case with Big Pharma in the last couple of years, diabetes and obesity are now two raging areas of major (and separate) focus (2 of 9 in this case).
- Merck didn't appear to give any info on obesity, besides it being a major quote unquote area of focus. Management did say Merck's pipeline in atherosclerosis, cardiovascular, diabetes and obesity is an example of prioritization.
- MK-0364 is in Phase IIb for obesity. We don't believe this compound has ever been discussed (not in ADA database 03-05, etc). As we understand it, the compound currently in a two-year trial, with people with BMIs of 30-43 - that's a lower BMI floor. Hard to figure the N, but it's randomized, double-blind, placebo controlled across the US, Europe, Israel, etc. so it must be sizable. See some info at clinicaltrials.com. http://www.clinicaltrials.gov/ct/show/NCT00131391 One red flag - similar to acomplia, there is exclusion criteria for psychiatric disorders. It's 18 and up and other exclusion criteria are lipid related. Timing unclear - it is in enrollment.
- MK 431, their DPP-IV, is in Phase III. It has a new proposed name, Januvia. They run through the efficacy results - they aren't particularly impressive results - we saw them at ADA. They ran through specs for new investors - once daily, and hypoglycemia, weight gain, and adverse events "similar to placebo" - the drug characterized as "generally well tolerated." They showed the A1C drop by A1C cohort. On average, below 7, the drop was 0.3; from 7 to 8.5, the drop was 0.6, and over 8.5%, the drop was 1.1%. They say "substantial drop in A1C." One confusing note was the statement that "It was highest in patients with the highest baseline A1C" - as if that was unexpected. This was a 12-week trial.
- On Januvia - they discusssed body weight being neutral and having no hypoglycemia - we assume this is in monotherapy, but they didn't go through trial details.
- They show a slide showing "restoration of pancreatic islet b cells in mice" - looking at diabetic mice, diabetic mice plus dppIV, and lean control mice - showing of course more beta cells in the dppIV treated mice. "Might actually lead to disease modification over time, which we are very interested in studying in humans."
- Phase III on target, set for 2006 filing, submitting more data to ADA for Washington meeting.
- Merck is also working on a Januvia plus metformin drug - phase III initiated in 2005, and they will submit in 2007. This is discussed as MK-431A and said that Metformin has a well-established tolerability (?), efficacy, and safety profile. Glucose control through two mechanisms - they note that fasting plasma levels were notably reduced and this will probably be a key message vs Byetta.
- No reference to Pargluva whatsoever - enough said.