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   Biotech / MedicalARADIGM CORP. ARDM


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To: Tadsamillionaire who wrote (245)7/12/2006 10:07:53 PM
From: Tadsamillionaire
   of 255
 
)--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: Tadsamillionaire8/4/2006 10:22:36 PM
   of 255
 
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: Tadsamillionaire10/26/2006 7:54:19 PM
   of 255
 
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: Tadsamillionaire11/24/2006 12:37:26 PM
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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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From: MLD384/13/2007 12:11:54 PM
   of 255
 
ARDM.OB : Michael Shulman, ChangeWave Biotech promo

Michael Shulman, ChangeWave Biotech Investor wrote in the promo:
..."I want you to look ahead to all the new opportunities we can share together. In fact, I've just created a new Video Alert on another little biotech that could double in a flash, on the way to another 5-bagger. It's yours FREE to watch by clicking here now:
iplacereports.com

******************************************************************
Some of the written material on the webpage with the video:

..."The next stock to double in a flash -- Guaranteed? Of course not – this is what I call a “bleeding edge” biotech…a company – like Dendreon when I first recommended it – that still has challenges ahead of it. Yet, interestingly, this company is also a fairly mature company in many ways – and that takes a lot of the risk out of your investment now. Especially at today’s price. Every share you buy today costs about a buck-and-a-half. So you get a lot of leverage for just a small investment now. My target? $6.50 a share – a very nice move from here. When I say the company is fairly mature, here’s what I mean: They’ve raised a lot of cash through the years. And their science and technology is great. That’s the good news. The bad news is old news. Management fumbled the ball for years. And frankly, Wall Street lost patience, especially as the company recapitalized – as they actually eliminated many of their old problems in the process. Recently, the stock is acting better, so you want to establish your position now. While I consider this company a mid-to long-term hold – playing out over the next couple years – this stock has the potential, like Dendreon, to suddenly jump out fast. If that happens, our long-term investment will become a trade instead, as we double, or triple, our money virtually overnight."...

--------------------------------------------------------------------------------

NOTE: I do not subscribe to Michael Schulman's ChangeWave BioTech newsletter, but I think ARDM.OB was the unnamed stock he discussed in the promo video. I do not know what the recommendations say ( ie buy, sell, hold, or short ... or at what share price, etc. ), but here are the titles of some of his recent BioTech alerts, etc.

04/12/2007 Catching Up With Spectrum and Nektar Biotech
04/05/2007 Speculation versus Investing Biotech
04/04/2007 New Buy Recommendation: Aradigm (ARDM) Biotech

ARDM had increased price and volume around April 4 - April 13
bigcharts.marketwatch.com

Stock quotes for ARDM.OB, NKTR, SPPI
finance.yahoo.com

--------------------------------------------------------------------------------

Insiders:
finance.yahoo.com

Insiders: SEC Form 4
secform4.com

Also:
01/25/07 is the Date of Event Requiring Statement of Tang's Initial Statement of Beneficial Ownership of Securities Form 3
secinfo.com
Tang Capital Partners, LP. Kevin C. Tang is the sole manager of Tang Capital Management, LLC, which is the general partner of Tang Capital Partners, LP. filed

--------------------------------------------------------------------------------

Aradigm
aradigm.com
...products are being developed for the treatment of a variety of diseases such as diabetes, cystic fibrosis, inhalation anthrax and pulmonary arterial hypertension. The company is also investigating the use of its technologies for other important therapeutic applications....
Aradigm : Novo Nordisk
...Aradigm is partnered with Novo Nordisk as well as several other biotechnology and pharmaceutical companies in the delivery of compounds via the AERx technology....
...contract manufacturing agreement with Novo Nordisk Delivery Technologies, Aradigm has access to manufacturing capacities that include over 200,000 square feet dedicated to commercial scale production and houses equipment such as the AERx Strip line (left). This single facility, when complete, will have the capacity to manufacture up to 750 million dosage forms a year....
Mgmt, directors, advisors:
aradigm.com

--------------------------------------------------------------------------------

Financials:
phx.corporate-ir.net
...net loss for the year ended December 31, 2006 was $13.0 million, or $0.89 per share, compared with a net loss of $29.2 million, or $2.01 per share, for the same period in 2005. The year-over-year reduction in net loss was driven primarily by the recognition of an $8 million gain on sale of royalty interest and a $12 million gain on sale of patents, both transactions with Novo Nordisk, a related party....
Dr. Igor Gonda, Aradigm's President and CEO:
..."Our cash burn for the fourth quarter, and as we move into 2007, was below $2 million per month. With the proceeds of our recent public offering, we are in a strong financial position to support our new strategic initiatives aimed at becoming a 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."...

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To: keokalani'nui who wrote (240)4/19/2007 4:47:51 PM
From: keokalani'nui
   of 255
 
SEATTLE--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced detailed results of its Phase III AIR-CF2 study evaluating aztreonam lysine for inhalation, an antibiotic, in patients with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In the study, a 28-day treatment course of aztreonam lysine significantly improved the time to need for inhaled or intravenous (IV) antibiotics versus placebo. All patients received an initial 28 days of treatment with tobramycin inhalation solution prior to receiving study drug. Aztreonam lysine for inhalation was well tolerated and patients also experienced significant improvements in pulmonary function and respiratory symptoms. The data were presented by Karen S. McCoy, MD, Chief of the Division of Pediatric Pulmonology and Associate Professor of Pediatrics at The Ohio State University College of Medicine and Chief of the Section of Pulmonology at Columbus Children's Hospital, at this year's Cystic Fibrosis Therapeutics Development Network conference in Seattle, Washington. Topline results from this study were previously announced on December 19, 2006.


AIR-CF2 was a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine for inhalation following a 28-day treatment course of tobramycin inhalation solution in people with CF who have pulmonary P. aeruginosa. Patients were randomized to receive 28 days of treatment with 75 mg of aztreonam lysine or volume-matched placebo each administered twice (BID) or three times (TID) daily by the eFlow® Electronic Nebulizer. Patients were followed for an overall study period of 126 days, with 56 days of observation after receiving aztreonam lysine for inhalation therapy or placebo.

Two hundred and forty-six patients were enrolled in the study and of those 211 were randomized to receive aztreonam lysine for inhalation or placebo. The mean age of patients treated with blinded study drug in the trial was 26.2 years. Participants had received more than five courses of tobramycin inhalation solution, on average, in the previous year (mean value = 5.33 courses). More than 85 percent of patients were taking medication (dornase alfa) to thin mucus secretions in the lungs and nearly 70 percent were taking oral azithromycin. At baseline, the mean percent predicted forced expiratory volume in one second (FEV1), a measure of lung function, was 55.7 percent overall, and 37 percent of patients had a predicted FEV1 less than or equal to 50 percent, indicating severe impairment of lung function.

"Pulmonary pseudomonal infection remains the leading cause of sickness and death in people with CF," said Dr. McCoy. "Data from the AIR-CF2 study indicate that aztreonam lysine for inhalation may provide broad clinical benefit, which is particularly significant given that most patients in the study had relatively long-standing CF, a history of frequent antibiotic use and impairment of lung function at the start of the study."

Two hundred and forty-six patients were enrolled in the study and of those 211 were randomized to receive aztreonam lysine for inhalation or placebo. The mean age of patients treated with blinded study drug in the trial was 26.2 years. Participants had received more than five courses of tobramycin inhalation solution, on average, in the previous year (mean value = 5.33 courses). More than 85 percent of patients were taking medication (dornase alfa) to thin mucus secretions in the lungs and nearly 70 percent were taking oral azithromycin. At baseline, the mean percent predicted forced expiratory volume in one second (FEV1), a measure of lung function, was 55.7 percent overall, and 37 percent of patients had a predicted FEV1 less than or equal to 50 percent, indicating severe impairment of lung function.

"Pulmonary pseudomonal infection remains the leading cause of sickness and death in people with CF," said Dr. McCoy. "Data from the AIR-CF2 study indicate that aztreonam lysine for inhalation may provide broad clinical benefit, which is particularly significant given that most patients in the study had relatively long-standing CF, a history of frequent antibiotic use and impairment of lung function at the start of the study."

Study Results

During the 28-day run in treatment course of tobramycin inhalation solution, patients had an average increase in improvement in FEV1 of less than 1 percent and no improvement in respiratory symptoms as measured by the respiratory domain of the cystic fibrosis questionnaire-revised (CFQ-R), a patient-reported tool used to measure health-related quality of life for people with CF.

Treatment with aztreonam lysine for inhalation lengthened the time to the need for inhaled or IV antibiotics -- the primary endpoint of the study -- by a median of greater than or equal to 21 days compared to placebo (pooled p-value=0.0070 by log rank test). Physicians determined the need for antibiotics based on the presence of decreased ability to exercise, increased coughing, increased production of mucus in the lungs and/or decreased appetite, all of which are signs of exacerbation.

Aztreonam lysine-treated patients also experienced significant improvements from baseline in respiratory function, as measured by relative improvement of FEV1, with an absolute difference of 6.3 percent versus placebo (p=0.0012). These results were consistent across age groups (less than 18 years of age and greater than or equal to 18 years of age; p=0.0378 and p=0.0132, respectively).

In addition, aztreonam lysine-treated patients experienced significantly greater improvements in respiratory symptoms, as measured by the respiratory domain of the CFQ-R, than placebo-treated patients. Approximately 52 percent of aztreonam lysine for inhalation-treated patients experienced improvements exceeding the minimal clinically important difference in respiratory symptoms compared to 37 percent of placebo-treated patients (p=0.0196). AIR-CF2 is the first randomized, controlled study of an aerosolized antibiotic to include and show improvements in respiratory symptoms using the CFQ-R questionnaire.

Aztreonam lysine for inhalation was also associated with significantly greater reductions in P. aeruginosa colony forming units (a measure of the amount of bacteria present in the lungs) at 28 days compared with placebo. Pseudomonas sensitivity as measured by minimum inhibitory concentrations did not significantly change from baseline to the end of therapy in aztreonam lysine for inhalation-treated patients after 28 days of therapy.

The safety profile observed in AIR-CF2 was consistent with expected symptoms of underlying CF lung disease. The most common treatment-emergent adverse events were cough, productive cough, nasal congestion, respiratory tract congestion and wheezing. The overall rates of adverse events, drug-related adverse events and serious adverse events were similar among patients treated with aztreonam lysine for inhalation and those treated with placebo.

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From: fred hayes1/14/2008 10:04:22 PM
   of 255
 
Down to one insulin inhaler project -- ALKS LLY device.
--------------------------------------------------
UPDATE 1-Novo Nordisk halts work on AERx inhaled insulin
Mon Jan 14, 2008 5:36pm EST
(Adds details on Novo plans, Lilly product)

NEW YORK, Jan 14 (Reuters) - Danish drugmaker Novo Nordisk (NOVOb.CO: Quote, Profile, Research)(NVO.N: Quote, Profile, Research) said on Monday it was halting development of its AERx inhaled insulin product and will lay off most of the approximately 300 company employees working on the product.

The company said it decided the product, meant to deliver inhaled droplets of liquid insulin, did not have adequate commercial potential given the recent failure to attract patients of Pfizer Inc's (PFE.N: Quote, Profile, Research) own inhaled insulin drug, called Exubera.

Pfizer in October abandoned its involvement with Exubera, which delivered inhaled insulin powder through a bulky device, because of dismal sales.

"In simply looking at the market and the convenience of our device, we decided it is not really there," Novo Nordisk spokesman Christian Qvist Frandsen said.

Frandsen said Novo Nordisk plans to lay off the majority of its 300-person team developing the product, based primarily in Hayward, California.

"We will continue to research inhaled insulin powder and inhaled liquid insulin, but starting from scratch," Frandsen said.

Novo Nordisk is one of the world's biggest sellers of insulin drugs, which are taken by injection several times a day to control excessive amounts of sugar in the bloodstream.

Novo Nordisk had licensed rights to the AERx product from Aradigm Corp (ARDM.OB: Quote, Profile, Research), a tiny biotechnology company.

"We will have to negotiate to give the rights back to Aradigm," said Frandsen.

Frandsen said Aradigm would have received a "small single-digit royalty" on sales of AERx if Novo Nordisk had brought the product to market.

-----------------------

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To: fred hayes who wrote (252)1/14/2008 10:13:23 PM
From: DewDiligence_on_SI
   of 255
 
Two projects counting MNKD.

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To: DewDiligence_on_SI who wrote (253)1/14/2008 10:35:27 PM
From: fred hayes
   of 255
 
You're right, I forgot that one. thanks...eom

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From: Area519/21/2017 4:47:16 PM
   of 255
 
What up?

2:56 pm ET
*Shares Of Penny Stock Aradigm Up 40% On ~10x Avg. Volume On No Apparent News
Benzinga

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