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   Biotech / MedicalARADIGM CORP. ARDM


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To: tuck who wrote (191)3/30/2004 11:52:26 AM
From: idler
   of 255
 
This may or may not mean anything - I mentioned inhalable insulin to my family physician, and he is very skeptical it will ever be brought to market - he thinks it's too hard to precisely regulate the dosage by inhalation (e.g., if someone has a cold and can't breath properly) and injection isn't such a hardship or inconvenience. I don't know what to make of it - not being an expert.

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To: idler who wrote (192)4/2/2004 9:22:45 AM
From: Tadsamillionaire
   of 255
 
I spoke with our family D.O. and he was really impressed. Thought it was a novel idea. He wanted to know the company name and said that inhalers for diseases such as diabeties should perform well. I know it would beat the injections...JMHO

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To: tuck who wrote (191)4/30/2004 8:40:14 AM
From: rkrw
   of 255
 
Was todays ardm announcement good news or bad news?

Here's yet another inhaled insulin company. Isn't Mankind the name of a world wrestler? No doubt named after someone named Mann. Add it to the list of cheesy biotech names :-)

Reuters
UPDATE - Biopharmaceutical firm MannKind files for IPO
Friday April 30, 8:34 am ET

(Adds details)
WASHINGTON, April 30 (Reuters) - MannKind Corp., a biopharmaceutical firm focused on treatments for diabetes, cancer and autoimmune diseases, on Friday filed with the U.S. Securities and Exchange Commission (News - Websites) to go public.

The Valencia, California-based company filed a preliminary offering document for as much as $86.25 million in common stock but did not specify the number of shares or the price for the IPO, as those details are expected in future filings.

UBS Investment Bank, Piper Jaffray, Wachovia Securities, Jefferies & Co. Inc. and Harris Nesbitt Gerard are listed in the prospectus as the underwriters.

It is seeking a Nasdaq listing under the symbol "MNKD."

The company said it plans to use the proceeds from the IPO for developing its dry powder insulin that is inhaled, working capital and other general corporate purposes.

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To: rkrw who wrote (194)4/30/2004 9:59:59 AM
From: tuck
   of 255
 
Better for Nektar or Aerogen, I guess.

>>HAYWARD, Calif., April 30 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) today announced safety and efficacy results from the 12-month interim analysis of the first Phase 3 trial of the AERx® iDMS pulmonary insulin product. The trial met its primary safety endpoints with no change in pulmonary function tests and no adverse effects reported from examinations of chest x-rays. Antibody production, while expected to increase in the AERx group due to the new pulmonary route of administration, was not associated with any adverse clinical outcomes. In addition, the main efficacy endpoint of the trial, HbA1c levels, was statistically the same in the AERx and subcutaneous groups.

Although earlier phase 2 data had indicated good mealtime glucose profiles in type 2 patients, the current interim analysis showed delayed post-meal plasma glucose suppression in type 1 diabetics. In the immediate post-meal period, plasma glucose levels were higher, and during the nighttime, plasma glucose levels were lower in the AERx iDMS group compared to the subcutaneous group. Patients in the subcutaneous group received a newer, faster acting insulin (insulin aspart), while AERx patients received a formulation of regular human insulin. Because of the unexpected nature of these observations, Novo Nordisk has decided to amend the current trial protocol to conclude the study in the next few weeks, with approximately 19 months of maximum patient exposure, instead of the planned 24 months patient exposure.

"It is clear that the post-meal glucose effects seen in this study are not caused by the method of insulin delivery. All analysis shows that the AERx System is performing as expected," said Richard Thompson, Chairman and Chief Executive Officer of Aradigm. "We will be working closely with Novo Nordisk to further understand the ramifications of the mealtime results and decide on the next steps for the product."

Bryan Lawlis, Aradigm President and COO added: "Novo Nordisk has committed to maintaining their current level of support for the AERx iDMS project. While we are disappointed that the efficacy outcome was not optimal for type 1 patients, we believe that the market potential in type 2 patients is likely to remain a significant opportunity, especially considering the recent change in diagnostic criteria that has classified 41 million Americans at risk in addition to the more than 16 million with type 2 diabetes."

Conference Call

Aradigm will discuss the details contained in this release in a conference call today at 9:00 am Eastern Time, 6:00 am Pacific Time. Dial toll-free +1-866-406-3487 to access the call. International callers dial +1-630-691-2771. The event webcast can be found under the investor relations section of: www.aradigm.com. The webcast and audio replay of the conference call will be available following the call, which can be accessed on www.aradigm.com or by dialing toll-free +1-888-843-8996. International callers should dial +1-630-652-3044. The replay passcode is 8940393.<<

snip

Looks like they'll have to start over with a newer insulin formulation? Wonder why these post-meal signals didn't show up in PII; I guess they weren't measuring these things in the earlier trial. If the safety data had been bad, this would be a penny stock. Sigh.

Cheers, Tuck

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To: tuck who wrote (195)4/30/2004 10:16:06 AM
From: rkrw
   of 255
 
Bummer. I still think ardm may have a better mousetrap than nktr. But ardm can't seem to catch a break.

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To: tuck who wrote (195)4/30/2004 11:21:31 AM
From: keokalani'nui
   of 255
 
>>during the nighttime, plasma glucose levels were lower in the AERx iDMS group compared to the subcutaneous group<<

It was probably this finding, not the post-prandial elevation, that killed the trial.

Wonder why they couldn't continue the trial for the T2 diabetics.

Antibodies also.

Just bought a couple ardm tickets at $1.2, some alth too, but no gnta.

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To: rkrw who wrote (196)4/30/2004 1:03:11 PM
From: keokalani'nui
   of 255
 
Having listened to novo's and ardm's cc:

1. Both companies believe it is not the device, nor is it membrane-permeability related.

2. The 'present consensus' is that the antibodies are not neutralizing.

3. The antibody formation is significant and it will be a primary focus of the coming analysis.

4. There is precedence in early insulin replacement studies (80s) that antibodies, though not neutralizing, can over the course of a study have a modifying effect on insulin. So they will be studing samples for the insulin profiles and whether there is progression of this unfavorable BG outcome. I believe this is the first suspect.

5. Could be that this is limited to T1, as they have susbstantially more circulating abs at baseline. However, the T2 study originally planned to start this year will be delayed until they figure this out.

6. Novo says in the August cc they ought to have an answer.

7. No one knows if exubera has the same issue, as no daytime bg data has been released.

8. This was all very unexpected. A good question is how long was the T1 P2?

EDIT: sold the hot shares for a .04 loss.

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To: keokalani'nui who wrote (198)5/2/2004 6:42:25 PM
From: tuck
   of 255
 
[Impact of particle size and aerosolization time on the metabolic effect of an inhaled insulin aerosol.]

Thanks for the CC notes, Wilder. This just out:

>>Diabetes Technol Ther. 2004 Apr;6(2):119-27.

Impact of particle size and aerosolization time on the metabolic effect of an inhaled insulin aerosol.

Kapitza C, Heise T, Fishman RS, Shapiro DA, Gopalakrishnan V, Rave K, Bott S, Perera AD, Heinemann L.

Profil Institute for Metabolic Research, Neuss, Germany.

The effects were compared of varying aerosol particle size and aerosolization time within each breath on the metabolic effect elicited by inhalation of a liquid insulin aerosol in comparison with that after subcutaneous injection (s.c.) of regular insulin. In this single-center, open-label euglycemic glucose clamp study, 13 healthy non-smoking subjects received five administrations of insulin in randomized order on separate study days, once by s.c. (0.15 U/kg of regular insulin) and four times by inhalation. Subjects inhaled 1.5 U/kg of liquid insulin aerosol administered by the Aerodose(R) Insulin Inhaler (Aerogen Inc., Mountain View, CA) configured to deliver two aerosol particle sizes - fine [F, 4.4 +/- 0.3 microm (mean +/- SD)] or very fine (VF, 3.5 +/- 0.2 microm) - and two aerosolization times (aerosol released for the first 2 or 4 s after the start of each 5-s inhalation). Glucose infusion rate (GIR) values necessary to keep blood glucose concentrations constant at 5.0 mmol/L were determined over a 6-h period following insulin administration. After inhalation of insulin, the onset of action was substantially more rapid on all four inhalation study days than after s.c. insulin, and the time to maximal action [t(GIRmax) (min)] was reached earlier: F/2 s, 127 +/- 54; F/4 s, 128 +/- 55; VF/2 s, 158 +/- 91; VF/4 s, 132 +/- 72; s.c., 175 +/- 69 (P < 0.0001). The longer aerosolization time (4 vs. 2 s) resulted in higher maximal metabolic action [GIR(max) (mg/kg/min), F/4 s 8.1 +/- 3.6, VF/4 s 8.4 +/- 2.7 vs. F/2 s 6.6 +/- 2.4, VF/2 s 7.2 +/- 2.4 (P = 0.01 for 4 s vs. 2 s, grouped data)], total metabolic activity [area under the curve of GIR 0-6 h (g/kg), F/4 s 1.97 +/- 0.92, VF/4 s 2.14 +/- 0.86 vs. F/2 s 1.56 +/- 0.68, VF/2 s 1.78 +/- 0.60 (P = 0.01)], and relative biopotency [F/4 s 10.6 +/- 4.0%, VF/4 s 11.7% +/- 4.1% vs. F/2 s 8.5 +/- 3.2%, VF/2 s 9.7 +/- 2.4% (P = 0.01)]. None of these summary measures was significantly affected by particle size. No drug- or device-related adverse events were observed. This study shows that aerosolization time, but not particle size, in the ranges studied, had an impact on the metabolic effect elicited by inhaled insulin, allowing rational selection of delivery parameters for further clinical testing. Based on the observed biopotency and the rapid onset of action, inhalation of a liquid insulin aerosol generated by the Aerodose Insulin Inhaler shows promise for covering prandial insulin requirements.<<

Don't know if it relates. Could aerosolization time be a factor in ARDM/Novo's trial? This might not be comparable; I gather these were not diabetics with abs circulating.

Say, how was that Russell Creek Chardonnay, anyhow? It must be a local exclusive; I've not seen it down here.

Cheers, Tuck

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To: tuck who wrote (199)5/2/2004 7:20:28 PM
From: keokalani'nui
   of 255
 
Ardm also found in its early studies that the aerosolized insulin was more fast acting than sc. That is why they didn’t formulate today’s newer faster acting insulin, novolog—and used instead POI (plain old insulin). What novo will look at is whether the longer period of repeated dosing somehow produces a moiety that tweaks the insulin in a way so as not to neutralize it but to cause a delay in effectiveness. If they do find it, it is a dead program, imo. I just can’t believe there is some circulating Ab in T1s only that causes this phenomena.

>>Russell Creek Chardonnay<<

It was the 2001 merlot, which took 1st overall at the tri-cities tasting. I hosted a blind tasting of nouveaux 2001 Washington reds. It won, but everyone probably wanted to brush their teeth after. My friends will drink anything anyway so I’m not sure that tells you anything. The wine could use a couple years laying down. Pretty label, cool name.

russellcreek-winery.com

No, you won’t see it down there. Just about all the Yakima/Columbia wineries worth a sh*t are direct ship small fry. If you want a couple up and comers, try the 2001 Cab from patit creek, its first ever and just released (yes, I think it is good but it's just a baby), or the 2002 Ciel (have not tasted) from JM Winery (likely to be v. good).

jmcellars.com

patitcreekcellars.com

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To: keokalani'nui who wrote (198)5/5/2004 6:36:13 PM
From: Area51
   of 255
 
<<Could be that this is limited to T1, as they have substantially more circulating abs at baseline. However, the T2 study originally planned to start this year will be delayed until they figure this out.>>

I gather this is the critical question. Since the market has cut ARDM price in half it seems to say that there is a 50% chance that the product is still marketable to type 2 diabetics (which are more than 90% of all diabetics or so I understand).

Since you sold I guess you think that there is less than a 50% chance that the product will be marketable to type 2 diabetics?

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