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   Biotech / MedicalARADIGM CORP. ARDM

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To: tuck who wrote (230)12/31/2004 12:08:57 PM
From: keokalani'nui
   of 255
Anybody know how many puffs req'd to deliver a unit?

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To: tuck who wrote (230)1/7/2005 11:20:43 AM
From: rkrw
   of 255
I think the differentiator is going to be the device. If the first asthma albuterol device was a ntkr inhaler (looks like a bong but I don't think could work as a dual purpose device :-) and the next one out was a standard MDI puffer, which would win? So I think in the long run nktr will need a small device to compete. And the ardm device may not be much better, long run. alks/lly could be a darkhorse--very small device supposedly. I also wouldn't ignore mnkd, their ceo is a diabetes legend (founded Minimed). So call it a long term, 5 year type of prediction.

Alkermes Announces Lilly Decision to Proceed with Late-Stage Clinical Development Program for Inhaled Insulin
Tuesday, August 10, 2004
-- Cambridge, MA, August 10, 2004 -- Alkermes, Inc. (Nasdaq: ALKS) announced today that Eli Lilly and Company (“Lilly”) has made a positive product decision and will proceed with significant investment for the further development of an inhaled formulation of insulin. The decision follows the successful execution of several critical steps: the completion and analysis of data from a Phase 2 study; the achievement of commercial manufacturing powder production scale-up; and the development and testing of the commercial pulmonary insulin inhaler system. Development activities will include both clinical trials and additional manufacturing activities for the inhaler system and the production facility.

A recently completed Phase 2 clinical trial for inhaled insulin using Alkermes’ AIR® technology showed that patients with type 1 diabetes achieved glycemic control levels similar to injected insulin. The trial was a multi-center, cross-over design study with 120 patients with type 1 diabetes receiving an inhaled formulation of insulin using AIR technology for a three-month period. Inhaled insulin had a rapid onset of action and was well tolerated with adverse events similar in both treatment arms.

“We’re delighted that the strength of the clinical data and our achievement of commercialization milestones provided the basis of the decision by Lilly to move forward with further development for inhaled insulin,” said Elliot Ehrich, M.D., Chief Medical Officer at Alkermes. “We look forward to initiating additional clinical studies that will bring us another step closer to developing an important new treatment for the growing number of people living with diabetes.”

The inhaled insulin delivery system is based on Alkermes’ AIR pulmonary drug delivery technology, which uses a small, easy-to-use, inhaler designed to provide drug delivery for a wide range of drug doses. Alkermes and Lilly have collaborated on the inhaled insulin program since 2001 to develop an innovative treatment option for people with diabetes.

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To: rkrw who wrote (233)2/6/2005 2:20:24 AM
From: tuck
   of 255
[Compliance with inhaled insulin treatment using the AERx]

>>Diabetes Technol Ther. 2004 Dec;6(6):800-7.

Compliance with inhaled insulin treatment using the AERx iDMS Insulin Diabetes Management System.

Cramer JA, Okikawa J, Bellaire S, Clauson P.

Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut 06516-2770, USA.

OBJECTIVE: The AERx Insulin Diabetes Management System [AERx iDMS, jointly developed by Novo Nordisk (Bagsvaerd, Denmark) and Aradigm Corp. (Hayward, CA)] provides insulin by pulmonary administration. This investigation was designed as a pilot trial to demonstrate the ability of patients to use the electronic device to deliver mealtime inhaled insulin doses and explore the impact on compliance. METHODS: AERx iDMS was evaluated in a substudy of a 12-week, multicenter open trial by adult patients with type 2 diabetes previously on any insulin regimen. The device was used for dosing fast-acting human insulin immediately before main meals, in combination with bedtime NPH insulin. The AERx iDMS device recorded the date and time of each insulin inhalation, insulin units used, and inhalation technique during aerosol delivery. Compliance was defined as the percentage of prescribed doses taken during the treatment period, dose timing, and the efficiency of dosing technique. RESULTS: Insulin dosing for 49 patients (age 59.1 +/- 7.7 years) using AERx iDMS was monitored for 78.9 +/- 10 days (range, 41-94 days) with 226 +/- 35 doses (range, 122-272 doses). Patients inhaled on average 2.9 +/- 0.3 doses of insulin daily, taking an average of 11.8 +/- 5.6 units per dose. Compliance with the prescribed regimen was 94.3 +/- 9.1% (range, 45-100%). Overall, 4.2 +/- 9.5% of prescribed doses were omitted. Hemoglobin A1c decreased 0.77 +/- 0.96% from baseline to the end of the study. Inhalation technique was excellent, with 97% of patients experiencing fewer than five inadequate doses. CONCLUSIONS: Excellent compliance with AERx iDMS dosing, timing, and inhalation technique showed that the device was well accepted by patients. The electronic monitoring feature could be used as an educational tool to help patients and clinicians manage insulin dosing.<<

I think we've seen similar data in the past, so big sarcastic whoop, I guess, especially considering the events of the past year. Wonder what Novo has found? One almost wonders if they bought the program to bury the embarrassment. They had said the expected to be finished with their analysis of the stopped trial months ago, but I've seen nada . . .

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

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To: tuck who wrote (234)2/11/2005 11:06:59 AM
From: keokalani'nui
   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.

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To: keokalani'nui who wrote (236)2/15/2005 7:28:08 AM
From: Tadsamillionaire
   of 255
From the Forbes article...a while back

My view is that the FDA is going to set a very high bar for approving inhaled insulin. The FDA sees delivering drugs through the pulmonary route as a different dosing form. In the FDA's view, the benefit is primarily convenience. In other words, the regulators seem to discount the fact that convenience promotes compliance, which leads to better health outcomes. Therefore, the agency will be extra-cautious in making sure inhaled insulin is safe. For example, the FDA requires two years of safety data, while other forms of injected insulin have been approved on one-year or even six-month data.

Exubera, a dry powder, is inhaled into the lungs before meals. Needles aren't used, and the drug is quickly absorbed into the bloodstream. Nektar scientists took the product through phase I clinical trials and then licensed the technology for further development and commercialization to Pfizer and Aventis. Pfizer and Aventis have a global agreement to co-develop, co-promote and co-manufacture inhaled insulin. Nektar is responsible for manufacturing the fine-insulin powders and supplying the inhalers.

Exubera is awaiting European approval. The companies are planning to file with the FDA for U.S. approval of Exubera by mid-2005. In its deal with Pfizer, Nektar will get 15 percent of all revenue from the product.

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From: Tadsamillionaire2/15/2005 7:33:28 AM
   of 255
Why does Punk,Ziegel & Co have Market perform rating, upgrade on this stock? eom.

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From: Tadsamillionaire2/15/2005 7:38:19 AM
   of 255
Aradigm Corp (ARDM) Mkt On Open Sell Imbalance: Shrs 54400

09:28 Thursday, February 03, 2005
(END) Dow Jones Newswires

Novo Nordisk Sees 05 Op Pft +5% In DKK

02:12 Friday, January 28, 2005
(MORE) Dow Jones Newswires

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To: tuck who wrote (234)6/14/2005 4:46:54 PM
From: keokalani'nui
   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.

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From: Tadsamillionaire8/8/2005 11:06:41 AM
   of 255
New Star Analyst Rankings for ARADIGM 5 star!

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