| To: tuck who wrote (234) | 2/11/2005 11:06:59 AM | | From: keokalani'nui | | | | 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...
wsw.com
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 | | | | 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.
forbes.com |
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| From: Tadsamillionaire | 2/15/2005 7:38:19 AM | | | | | | 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 | | | | 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 www.diabetes.org.
Results:
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: Tadsamillionaire | 1/12/2006 4:34:14 PM | | | | | | Promising events now that the reverse split has taken place...
Wednesday December 21, 8:00 am ET
Supply Chain Qualified and Commercial Manufacturing Line Fully Operational
HAYWARD, CA--(MARKET WIRE)--Dec 21, 2005 -- Aradigm Corporation (NasdaqNM:ARDM - News) today announced the completion of manufacturing of pivotal and clinical batches of its Intraject Sumatriptan product on its commercial-scale manufacturing line. With the successful transfer of technology and analytical methods to the company's Contract-Manufacturing Partners, final product release testing is currently underway and, pending partnering of the product, would be available for a pivotal bioequivalence trial in 2006.
biz.yahoo.com
Thursday January 5, 8:15 am ET
HAYWARD, CA--(MARKET WIRE)--Jan 5, 2006 -- Aradigm Corporation (NasdaqNM:ARDMD - News) today announced that it has filed a request for orphan drug designation with the United States Food and Drug Administration (FDA) for its liposomal ciprofloxacin product for the management of cystic fibrosis (CF).
biz.yahoo.com
Such designation provides a company with seven years of marketing exclusivity for a selected drug approved by the FDA along with regulatory assistance, reduced filing fees and possible tax credits. |
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| To: tuck who wrote (230) | 2/15/2006 10:55:43 AM | | From: Tadsamillionaire | | | | Aradigm Corporation Fourth Quarter and Full Year 2005 Earnings and Conference Call Notification
Wednesday February 15, 9:30 am ET
HAYWARD, CA--(MARKET WIRE)--Feb 15, 2006 -- Aradigm Corporation (NasdaqNM:ARDM - News) will announce its fourth quarter and full year 2005 financial results on Wednesday February 22, 2006, after the close of the U.S. financial markets. The Company will host a conference call via webcast to discuss the results of the quarter at 1:30 p.m. Pacific Time that same day. Dr. Bryan Lawlis, President and Chief Executive Officer and Thomas Chesterman, Senior Vice President and Chief Financial Officer will host the conference call.
Date: Wednesday, February 22, 2006
Time: 4:30 pm Eastern, 1:30 pm Pacific
Internet: The live webcast can be accessed at aradigm.com
Telephone: 1 (877) 788-8790
International callers, dial +1 (706) 679-7281
Passcode: 5291277 or mention Dr. Bryan Lawlis as moderator
biz.yahoo.com |
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| From: Tadsamillionaire | 7/12/2006 10:01:59 PM | | | | | | Aradigm shares jump on inhaled-insulin deal
Associated Press
NEW YORK - Aradigm Corp. shares surged 29 percent Wednesday after the developer of drug-delivery systems negotiated a restructured deal with Danish drug maker Novo Nordisk to develop inhaled insulin.
Aradigm, based in Hayward, Calif., said it will receive a cash infusion of $27.5 million from Novo Nordisk, a leading maker of diabetes-care products.
Aradigm's stock rose 40 cents to close at $1.80 on the Nasdaq Stock Market.
Novo Nordisk will pay Aradigm $12 million to assume ownership of a group of patents related to inhaled insulin, which is in late-stage clinical testing. Aradigm, in turn, will receive royalties on any inhaled insulin sold by Novo Nordisk.
Aradigm, in turn, agreed to a 1 percent reduction in its average royalty rate inhaled insulin product, in exchange for $8 million. The transaction will result in Aradigm having an average royalty rate of 5 percent or higher, five years after the product's launch.
In addition, Novo Nordisk has paid Aradigm $7.5 million in the form of a 5 percent, eight-year note. The note is secured by future royalty payments.
Aradigm Chief Executive Bryan Lawlis said the company now has more than $35 million in cash.
Earlier this year, the Food and Drug Administration approved the first inhaled insulin product in the U.S., Exubera. Co-developed by Pfizer Inc. and Nektar Therapeutics, it will be launched mid-July.
Diabetes-drug heavyweight Eli Lilly & Co. and partner Alkermes Inc. also are working on inhaled insulin, as is Mannkind Corp.
mercurynews.com |
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