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Post by dudley on Jun 9, 2015 13:17:09 GMT -5
The key thing to recognize when looking at Afrezza Rx data is the timing delays inherent in the process. Although these delays will doubtlessly decrease in the future as the spirometry issue is whittled down and the insurance stuff is smoothed out - for now it is safe to assume there is still somewhere in the 2-3 month range before a patient actually gets a script that gets tallied in Symphony. With that in mind the Symphony data we see today is anywhere from 2 to 3 months BEHIND the actual demand curve. I.E someone beginning the "script journey" in April would STILL not have a prescription in hand today that would be captured in Symphony with this sort of inherent delay. By default the current script counts CANNOT be comprised of much more than the February group of adopters with some March patients as well. Probably a sprinkling of others in there that may have gotten some expedited treatment but in my mind the biggest part of the April-May-June demand is in the pipeline. As that wave of demand eventually hits the actual Symphony script count data I think there will be some very significant percentage increases. It's a pretty simple concept once you walk through the logic but everybody seems to be ignoring it and focusing on the Symphony data as pertinent when it simply is not yet a relevant measure. It WILL be relevant once at a minimum the April and May patient groups get assimilated into the data but for now it is pretty much an inaccurate portrayal - mainly comprised of February and some March adopters - of what the Real demand curve is - at least in my opinion.
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Post by bobw on Jun 9, 2015 15:35:07 GMT -5
From the Afrezza slide: New data from the AFFINITY 1 study ● No increase in hypoglycemia risk resulting from a supplemental dose of Afrezza® 90 min post-meal(1) Here is a link to the abstract: www.reddit.com/r/afrezza/comments/36088z/late_breaking_abstracts_submitted_to_the_aace/Late Breaking Abstracts submitted to the AACE: (afrezza reduces hypoglycemic incidents) Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 1. Ochsner Medical Center, 2. Sanofi US, Inc., 3. Sanofi Canada, 4. Atlanta Diabetes Associates Objective: Conduct a post hoc analysis of hypoglycemia rates from a 24-week, phase 3 randomized study of prandial Technosphere Insulin Inhalation Powder (TI; N=172) versus insulin aspart (IA; N=167) added to basal insulin in pts with T1DM (NCT01445951). Methods: Annualized hypoglycemia event rates were determined in the overall study population, pts taking ≥1 postmeal supplemental dose (TI n=111; IA n=91), and pts not taking a supplemental dose (TI n=61; IA n=76). Hypoglycemia rates during study weeks 0-12 (dose adjustment) and 12-24 (stable dosing) were assessed. Hypoglycemia was defined as total (all events), confirmed (blood glucose <49 mg/dL), nocturnal (0:00−6:00 AM), and severe (assistance required). Data were adjusted for baseline A1C level. Results: There was no significant difference in the mean number of supplemental doses taken between the TI and IA arms (34.1 vs 26.6, respectively; P=0.1907). Significantly higher hypoglycemia rates (events per pt/year) were seen for IA versus TI in the overall population (total 81.1 vs 55.2; confirmed 15.0 vs 9.0; nocturnal 8.8 vs 5.9; severe 0.9 vs 0.5; all P<0.05) and pts taking ≥1 supplemental dose (total 96.3 vs 60.9; confirmed 18.6 vs 9.8; nocturnal 11.5 vs 6.5; and severe 1.1 vs 0.6; all P<0.05). In pts not taking a supplemental dose, a significantly higher total hypoglycemia rate was seen with IA versus TI (64.9 vs 46.0 events per pt/year; P=0.0160). Within each arm there was a trend for higher total hypoglycemia rates ≥1 hour after supplemental dosing (events per pt/year) in pts with a higher supplemental dose frequency (TI vs IA: 0.4 vs 0.4; 1.7 vs 2.2; 4.9 vs 6.6 for pts receiving 1-5, 6-20, and 21-60 supplemental doses during the study); there was no significant difference between the TI and IA arms. In the overall study population, within both treatments arms there was a trend for a higher rate of all types of hypoglycemia during weeks 0-12 (titration) versus 12-24 (stable dosing). In pts taking a supplemental dose, a similar trend was seen in the IA arm only. In pts not taking a supplemental dose, there was a trend for higher total, confirmed, and nocturnal hypoglycemia rates during weeks 0-12 versus 12-24 for IA; and total, confirmed, and severe hypoglycemia for TI. Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk. Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdf Page 12
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Post by peppy on Jun 12, 2015 12:26:38 GMT -5
Sanofi CC transcript news.yahoo.com/edited-transcript-san-pa-conference-060956393.htmlAnd talking about Afrezza, let me take just a few minutes and one slide to give you an update on the Afrezza launch to date, and starting off with a focus on the headline and make it clear that we've implemented as a strategy a moderately targeted US launch, where, starting in February, in order to ensure that the specialists and high diabetes-treating physicians were appropriately aware, educated and have the capability to prescribe Afrezza, we targeted physicians who represent roughly 50% of the branded diabetes market in the US. As I say, that launch started in February, bringing Afrezza, this new option, to either initiate or intensify insulin to the market, with a very distinct PK/PD profile that you see depicted on the right, this peak action in approximately 15 minutes and the rapid diminution of the insulin activity, which is certainly very much appreciated by customers who understand insulin pharmacokinetics. We're currently working diligently to improve the market access position, where, going into the launch, we understood that this would largely be a third-tier benefit. And that's proving to be the case. And we need to ensure that it is third-tier benefit without restrictions. And as I say, we're having some good success already with a number of plans where we have completed contract discussions and have secured third-tier -- tier-three access for the product. There will be additional activities in the second half of the year, having waited the respectful period to ensure that we're educating and informing physicians about the product, we'll be launching print and DTC promotion in a matter of weeks. Also the implementation, which has already begun, of our patient support program, the Afrezza COACH program. Over the last four to six weeks we've been able to accomplish, post OPDP comments, the training of a speaker bureau on this product and now substantial execution of peer-to-peer education programs. And you will have seen that the FDA recently approved the 12-unit cartridge. And we plan to launch that early in the -- late in the third quarter.
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Post by EveningOfTheDay on Jun 12, 2015 14:53:56 GMT -5
After reading Sanofy's comments I think one could make a pretty good case that the remaining production milestone will be achieved when a certain number 12u cartridges is produced, similar to when MNKD had produced enough 4u and 8u cartridges previous to the February launch. Therefore, I would say it is pretty safe to expect another 25 million milestone sometime in the next quarter. My opinion, of course.
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