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Biotech / Medical : ARADIGM CORP. ARDM -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (234)2/6/2005 4:46:32 PM
From: keokalani'nui  Respond to of 255
If anyone gets the paper, I'd be interested in knowing how many puffs it takes to administer, say, 10 units.

To: tuck who wrote (234)2/11/2005 11:06:59 AM
From: keokalani'nui  Read Replies (1) | Respond to of 255
This from Yahoo. I listened to the call and brh has it pretty much right. But the comments about the fda and approving for t2 but not t1 were more or less oblique and roundabout in that novo said in at least one conversation with the fda about insulin-affecting drugs--not specifically attributable, but inferred, to pulmonary--it wants to approve a drug not a regimen suggesting that if pulmonary insulin is not safe and effective for all insulin dependent diabetics then this could be a hurdle to approval. I don't know if I feel the same. How is approval for t2 a regimen and approval for t1 and t2 not a regimen?

More interesting were the comments about pharmacoeconomics. Novo says basal insulin will never be delivered to lungs so if you are insulin dependent and getting at least one shot, what government coverage is going to pay 5x for pulmonary pre-prandial where there is no clinical improvement? He said this is especially a concern in EU where novo is getting plenty of heat on its analogues, priced 30% higher than human, which are demonstrably superior. Suggested more potential in US on this issue; 'but ask why our competition has not yet filed.'

Bottom line, this thing looks dead. So to me it appears the only reason for buying it was to lock away all the data from competitors and hibernate the project until perhaps some "ah-ha" moment arrives unlooked for.

Novo comments on ardm insulin
by: brheavy 02/10/05 06:10 pm
Msg: 24814 of 24845

from the webcast today. Novo's comments were

1. that it doesn't appear appropriate for type I diabetics.

2. that the costs don't look good for Europe where they even have a trouble getting a 30% premium for superior insulin analogs.

3. that they are just as far from a product today as when they started!!!

4. that the conversations with the fda indicate they would not approve a filing that did not cover both type I and type II ... (so remember number 1 above) Yikes...

One last comment. Novo's findings suggest T1s are not an appropriate population because, even though it is absorbed as insulin, it works in T1s as an intermediate. Lars continued to say that leaves T2, 'where an intermediate-acting would be appropriate' (presumably for the early stage patient requiring exogenous insulin, but not one with total dependency) but the economics don't look so good.

This is why ardm has lost 20% last 2 days.

To: tuck who wrote (234)6/14/2005 4:46:54 PM
From: keokalani'nui  Read Replies (1) | Respond to of 255
Aradigm Announces Novo Nordisk Presentation of Data of AERx Insulin Diabetes Management System at the American Diabetes Association Annual Meeting
Tuesday June 14, 4:00 pm ET

HAYWARD, Calif., June 14 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) announced that at a session today at the Annual Meeting of the American Diabetes Association (ADA) its partner, Novo Nordisk, gave an oral presentation of clinical data from a recent pharmacokinetic/pharmacodynamic trial of the AERx insulin Diabetes Management System. Novo Nordisk previously discussed results from this trial during their first quarter financial conference call on April 28, 2005. The presentation is entitled "Onset of Action of Inhaled Insulin Via the AERx® iDMS Was Faster Than Subcutaneous Human Regular Insulin and Similar to That of Subcutaneous Insulin Aspart" and summarizes the findings from the trial. The abstract is available below and at the ADA website

The purpose of this single-center, open-labeled, three-period cross-over trial was to compare the onset of action and duration of action of inhaled insulin via the AERx® insulin Diabetes Management System (iDMS) to that of subcutaneously (s.c.) administered insulin aspart and s.c. human regular insulin.

In total, 15 non-smoking people with type1 diabetes (34 +/- 10 years (meanSD), BMI 24.3 +/- 2.3 kg/m2, duration of diabetes 7.5 +/- 0.9 years) were randomized to receive a dose (0.3 AERx U/kg, U/kg or IU/kg) of inhaled insulin via the AERx® iDMS (AERx), insulin aspart s.c.(IAsp) and human regular insulin s.c. (HI) on three different dosing days in randomized order. The study was carried out by means of 10 hour isoglycemic glucose clamp (clamp level of 7.2mM) and the glucose infusion rate (GIR) recorded for 10-hours post dosing.

The onset of action (defined as time to 10% of AUC GIR(0-10h)) was faster for AERx (72 [62;82] min (LSMeans [95%CI])) compared to HI (89 [79;100] min, P=0.01), and not different from IAsp (66 [56;76] min, NS). Duration of action (defined as time interval from t 10%AUCGIR(0-10h) to t 90%AUCGIR(0-10h)) for AERx was longer (291 [264;318] min) than IAsp (209 [182;235] min, P<0.01), but not different to that of HI (297 [270;323] min, NS). The time to maximum GIR (t GIRmax) did not differ between AERx (142 [106;178] min) and IAsp (136 [101;171] min, NS), while t GIRmax for AERx was faster than HI (202 [167;237] min, P=0.01). No safety issues were raised in this trial; adverse events were few and mild.

In conclusion, inhaled insulin via the AERx® iDMS has an onset of action not significantly different to subcutaneous insulin aspart, but significantly faster than human regular insulin, while the duration of action is not significantly different to human regular insulin, but significantly longer than insulin aspart. These characteristics make inhaled insulin via the AERx® iDMS suitable as a meal-time insulin.