Coming in from Capetown ...It's a zoo here! There are three of us here from Close Concerns, and we are busy every single second and we continue to lament we couldn't bring more - there are always ten sessions going on, four of which we REALLY want to see. So SERENADE was the big news today. You have likely seen the results if you are following the market closely - we felt the efficacy was slightly better than we would have thought - this drug really does work on a bunch of different defects, and we love that can help from multiple angles (glycemia, lipids, weight). While it is not ALL that potent, we'll have to watch it over time - seems a drug destined for combination therapy. Sanofi seems to be pushing it as an add-on to Metformin, which is smart, since we think convincing payors to reimburse for two new drugs (say, DPP4 inhibitors and rimonabant) will be tough. The tolerability is impressive.
Also, this solved a mystery for me - it now seems pretty clear Sanofi was waiting for SERENADE to finish before it submitted the final response from the approvable letter to FDA. Turns out this trial DID accept people who were depressed, so this is a good way to see how those people did. The psychotic element of this trial doesn't seem so reassuring - and actually we're more concerned that this drug is kind of an "anti-happy" drug from what we hear - but clearly, it has to get out into the real world to assess. Just as clearly, it does reduce various risk factors pretty cleaning - that's certainly a positive. Our question now is whether FDA just approves it but gives the depression element a black box, or if it is more worried that that. We think they'll probably have to approve it, we can't think that would be strong enough data to keep it from the market. And then, how much doctors are worried about the depression is another question. It's likely not at the top of the worried list - THAT said, a lot a lot a lot of association already exists with diabetes and obesity, so this won't be a small group that's excluded, if it comes to that.
Exhibits are much smaller here and poster space is one millionth of ADA. The meeting is also healthier - no one but NO ONE walks the halls munching potato chips, that is for sure.
One word on obesity - Nick Finer, MD (Cambridge University, UK) said in a session on the topic that there is a huge prejudice against anti-obesity drugs. Diabetes drugs can claim weight loss on their label and do not have to show that effects on glycemia are independent of weight loss; are not required to be discontinued after use for the duration of the longest clinical trial, and there is no expectation that their benefits are maintained after drug withdrawal. In contrast, obesity drugs can only claim secondary benefits if those are weight independent, their labels require discontinuation after one to two years, and at the same time those labels often explicitly state that the effects are not maintained after withdrawal.
A session later, Dr. Cooney gave a list of what classes of compounds various companies are working on (i.e. have published, presented, or patented) in obesity - we didn't catch them all, but here goes....
• AMPK activators: Abbott
• ACC inhibitors: Pfizer (ACC1, ACC2), Ajinomoto, Teijin (patents)
• DGAT-1 inhibitors: BMS (published), Bayer, Otsuka, Sankyo, Amgen, AstraZeneca (patents)
• DGAT-1 antisense RNA: ISIS Pharmaceuticals (abstract)
• SCD-1 inhibitors: Xenon Pharmaceuticals, Novartis (patents)
• SCD-1 antisense RNA: ISIS Pharmaceuticals & Merck (published)
One of the sessions we were quite excited about was THE CLINICAL REALITIES OF LONG TERM COMPLICATIONS: WHAT SHOULD WE TELL OUR PATIENTS? Overall, although it is very valuable, we didn’t find this session so scintillating but there wasn’t much we didn’t know from DCCT – it all comes back to control, control, control. That said, there were some high points – the realization, for example, that a bit of retinopathy, if screened early, can be addressed, but a bit of foot neuropathy can in many cases not be reversed (patients might think the opposite).
Over and out for now - more to follow.