| 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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| To: Tadsamillionaire who wrote (245) | 7/12/2006 10:07:53 PM | | From: Tadsamillionaire | | | | )--Jul 5, 2006 -- Aradigm Corporation (Nasdaq:ARDM - News) today announced the execution of an agreement further developing the strategic partnership with Novo Nordisk. The agreement is designed to strengthen Novo Nordisk's patent position within the area of inhaled insulin as related products progress towards commercialization and has resulted in a non-dilutive cash infusion to Aradigm of $27.5 million. The Novo Nordisk inhaled insulin program is currently in Phase 3 clinical trials. This agreement is comprised of an intellectual property assignment, a royalty prepayment and an eight-year promissory note. The promissory note is secured by the royalty payments on the AERx Diabetes Management System (iDMS) sold under the Aradigm license.
The key features to the restructuring and cash infusion include:
-- Aradigm's receipt of $12 million in exchange for transferring to Novo
Nordisk the ownership of a select number of patents that are especially
important for inhaled insulin. Aradigm will retain exclusive, royalty-free
control of these patents outside the field of glucose control and will
continue to be entitled to royalties in respect to any inhaled insulin
products marketed by Novo Nordisk.
-- The receipt by Aradigm of $8 million in exchange for a 100 basis point
or 1% reduction on its average royalty rate set forth by the commercialized
AERx iDMS product. This will result in Aradigm receiving royalty rates that
will rise to an average of 5% or higher by the fifth year after
commercialization.
-- Finally, Novo Nordisk has paid Aradigm $7.5 million in a 5%, eight-
year note that is payable in three equal payments commencing in six years,
and is secured by the royalty payments to Aradigm upon the
commercialization of the AERx iDMS product.
Message 22596651 |
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| From: Tadsamillionaire | 8/4/2006 10:22:36 PM | | | | | | Aradigm Corporation Second Quarter 2006 Earnings and Conference Call Notification
Aradigm Corporation (NASDAQ: ARDM) will announce its second quarter 2006 financial results on Thursday, August 10, 2006, after the close of the U.S. financial markets. The Company will host a live webcast and conference call at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time that same day.
Date: Thursday, August 10, 2006
Time: 4:30 p.m. Eastern, 1:30 p.m. Pacific
Internet: The live webcast can be accessed at www.aradigm.com
Telephone: 1 (877) 788-8790
International callers, dial +1 (706) 679-7281
Passcode: 3423978 or mention Dr. Bryan Lawlis as moderator
For those unable to listen to the live broadcast, a replay will be available under the Investors section of the company website or by dialing 1 (800) 642-1687 (U.S. domestic) or +1 (706) 645-9291 (international) and entering in the conference ID # 3423978 beginning approximately one hour after the completion of the call.
Aradigm combines its non-invasive delivery systems with novel formulations to create products that enable patients to comfortably self-administer biopharmaceuticals and small molecule drugs. The company's advanced AERx® pulmonary and Intraject® needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs and priorities focus on the development of specific products, including partnered and self-initiated programs in the areas of respiratory conditions, neurological disorders, heart disorders, and smoking cessation. In addition, Aradigm and its partner, Novo Nordisk, are in Phase 3 clinical trials of the AERx Diabetes Management System for the treatment of Type 1 and Type 2 diabetes. More information about Aradigm can be found at www.aradigm.com.
Aradigm, AERx and Intraject are registered trademarks of Aradigm. |
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| From: Tadsamillionaire | 10/26/2006 7:54:19 PM | | | | | | Aradigm to Request Hearing Regarding Its Continued Listing on Nasdaq Capital Markets
Aradigm Corporation (NASDAQ: ARDM) has requested a hearing before a NASDAQ Listing Qualifications Panel to discuss its continued listing on the NASDAQ Capital Market. This hearing is being requested as a result of preliminary financial results, which indicate that for the third quarter ended September 30, 2006, the company's shareholder equity may be below the minimum requirements of $2.5 million set forth by NASDAQ. If granted a hearing, the company will outline its near-term plans for regaining and maintaining compliance.
"Our third quarter operating results remain on track, and we have sufficient cash for the near-term operations of the company. With our current plans, we anticipate being able to create a sustainable common shareholder equity position," said Thomas Chesterman, Aradigm's Chief Financial Officer. "I would caution our investors, though, we may not be granted a hearing and may be delisted immediately from the Nasdaq Capital Market or, even if granted a hearing, we may not succeed in convincing Nasdaq to allow us to maintain our listing. If we are delisted from the Nasdaq Capital Market, we will likely be traded on the Pink Sheets or the Over-The-Counter Bulletin Board, which will further reduce the liquidity or our common stock and may cause our stock price to drop."
The company plans to announce full financial results for the third quarter on November 10, 2006.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, pulmonary hypertension, asthma, inhalation anthrax infections and smoking cessation. |
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| From: Tadsamillionaire | 11/24/2006 12:37:26 PM | | | | | | Aradigm Announces the Results of the AERx HCQ Asthma Phase 2a Study
Aradigm Corporation (PINKSHEETS: ARDM) today announced that the results of the Phase 2a clinical trial program of inhaled hydroxychloroquine (HCQ) as treatment for patients with moderate-persistent asthma, conducted on behalf of and funded by APT Pharmaceuticals ("APT"), did not meet the pre-specified clinical efficacy endpoints. No serious adverse events were reported either related to the drug or Aradigm's AERx delivery system.
Both APT and Aradigm will be continuing the data analysis, in order to decide whether they will pursue additional investigations with inhaled HCQ.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, pulmonary hypertension, asthma, inhalation anthrax infections and smoking cessation.
In addition, Aradigm's AERx insulin Diabetes Management System (iDMS), which has been licensed to Novo Nordisk for development and commercialization in return for royalties, is in Phase 3 testing for Type 1 and Type 2 diabetes. Under the agreements with Novo Nordisk, Novo Nordisk is responsible for all further clinical, manufacturing and commercial development, while Aradigm and Novo Nordisk continue to cooperate and share in technology development, as well as intellectual property development and defense. Novo Nordisk also remains a substantial shareholder and investor in Aradigm. |
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