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Biotech / Medical ARADIGM CORP. ARDM

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To: tuck who wrote (219)	9/28/2004 10:59:49 PM
From: keokalani'nui	of 255

I would not have expected this. Novo Nordisk Expands Licensing Rights to AERx(R) iDMS Inhaled Insulin Program From Aradigm and Obtains Full Development and Manufacturing Rights Tuesday September 28, 7:00 pm ET BAGSVAERD, Denmark and HAYWARD, Calif., Sept. 28 /PRNewswire-FirstCall/ -- Novo Nordisk (NYSE: NVO - News) and Aradigm Corporation (Nasdaq: ARDM - News) today announced an agreement giving Novo Nordisk full development and manufacturing rights to the AERx® insulin Diabetes Management System (iDMS) program. Under the agreement, Novo Nordisk will purchase manufacturing equipment and leasehold improvements currently utilized by Aradigm in the AERx® iDMS program for an estimated cash payment of USD 55 million. Novo Nordisk will assume all further responsibilities for AERx® iDMS development and funding. Aradigm will maintain a long-term interest in the program through an adjusted royalty on future AERx® iDMS net sales. As a result of the expanded licensing agreement, Novo Nordisk has formed a new affiliate, Novo Nordisk Delivery Technologies, Inc. based in Hayward, California, which will assume the leases and operational overhead on two of Aradigm's current three buildings, and will offer employment to approximately 130 Aradigm employees who have been dedicated to iDMS. The companies have the option to continue collaborating in specific areas such as next-generation AERx® technologies. If needed, Novo Nordisk will provide certain contract manufacturing services to support other AERx® programs for up to three years. "Novo Nordisk remains committed to the development of inhaled insulin. The AERx® iDMS is an excellent fit within our portfolio of insulin delivery systems," stated Lars Rebien Sorensen, president and chief executive officer of Novo Nordisk. "We are confident that the transition will be smooth, and that both companies will benefit from the new structure." "We are pleased that Novo Nordisk has assumed a greater role in completing the development of the AERx® iDMS system," added Dr Bryan Lawlis, Aradigm's president and chief executive officer. "This agreement establishes two key components for Aradigm's future success: it confirms Novo Nordisk's commitment to the AERx® iDMS program, and it provides Aradigm the financial flexibility to accelerate the development of additional AERx® and Intraject® applications. In addition to the cash payment at closing, Aradigm will no longer be responsible for the expenditures associated with commercial scale-up and manufacturing of AERx® iDMS." Finalization of the agreement is subject to customary closing conditions, including approvals from regulatory authorities, as well as approval from Aradigm common and preferred shareholders, which is expected at a special shareholder's meeting to be held later in 2004. The agreement is expected to close by the end of 2004. The transaction does not change Novo Nordisk's expectations for the financial results for 2004.

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To: keokalani'nui who wrote (220)	9/28/2004 11:41:48 PM
From: rkrw	of 255

What will ardm invest in now?

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To: keokalani'nui who wrote (220)	9/28/2004 11:54:20 PM
From: scaram(o)uche	of 255

Wow. All sorts of strange and good news of late, strange developments. Fun.

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To: keokalani'nui who wrote (220)	10/13/2004 2:49:58 PM
From: tuck	of 255

>>HAYWARD, Calif., Oct. 13 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) today announced positive results from the Clinical Performance Verification (CPV) Trial of its Intraject needle-free delivery system. Results from the trial showed that the study met its primary endpoint of demonstration of successful injection performance with Intraject with an excellent reliability profile. The trial demonstrated acceptable performance and delivery consistency of the selected configuration in 194 healthy subjects who were each given multiple injections of saline via Intraject. In total, there were 1152 injections with no occurrence of injection-related adverse events and no reliability issues such as glass breakage or malfunctions. Subjects rated their injections as causing little or no pain sensation, a result in line with numerous other studies previously conducted with Intraject. In addition, the majority of subjects responded that they preferred the use of the Intraject device to a standard needle injection. "This trial was the final stage of technical development for Intraject and clearly demonstrates that the technological and design issues that faced the system prior to our acquisition of the Intraject technology have been fully addressed," said Dr. Bryan Lawlis, President and Chief Executive Officer of Aradigm. "The CPV data and extensive reliability testing conducted on the final Intraject configuration in parallel with this study exceed the performance requirements for Intraject. In addition, we have made excellent progress with our contract manufacturers towards process scale-up for registration and commercial manufacturing. This strong technical foundation lets us initiate the partnering of the platform to companies for use with their drugs, as well as allowing us to commence clinical trials using Intraject with a drug of our own choosing. We expect to complete and announce the selection of the drug by the end of the year with the objective of commencing pivotal trials for regulatory submissions in the second half of next year."<< snip Cheers, Tuck

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To: rkrw who wrote (218)	11/10/2004 11:44:12 AM
From: tuck	of 255

>>VALENCIA, Calif., Nov. 10 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) today announced at the CIBC World Markets Fifteenth Annual Healthcare Conference that it recently held an "End of Phase 2" meeting with U.S. Food and Drug Administration (FDA) officials to discuss the Company's Technosphere® Insulin System, which is under development to administer insulin by inhalation for the treatment of diabetes mellitus. Dr. Wendell Cheatham, Corporate Vice President and Chief Medical Officer of MannKind Corporation, said he was pleased with the FDA meeting, commenting that "the discussions focused on our plans for pivotal Phase 3 clinical development of the Technosphere® Insulin System, which is expected to include two years of safety data from a subset of trial patients with type 1 and with type 2 diabetes at the time of submission of a new drug application." "MannKind completed its current U.S. Phase 2b study in October and we will present the final efficacy and safety data from that study to the FDA in the coming weeks. We plan to begin a series of Phase 3 and special population studies in Europe and in the United States. The first ex-U.S. Phase 3 trial is planned to begin by year-end, and the first U.S.-based Phase 3 study is planned to begin by mid-2005," Dr. Cheatham added.<< snip Cheers, Tuck

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To: tuck who wrote (224)	12/1/2004 6:06:25 PM
From: Tadsamillionaire	of 255

Aradigm Announces Results From Clinical Study of Intraject Needle-Free System With Sumatriptan Wednesday November 17, 8:01 am ET HAYWARD, Calif., Nov. 17 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) today announced positive results from a pilot pharmacokinetic study in which sumatriptan delivered via its needle-free Intraject® system was compared to the currently marketed subcutaneous needle-injected sumatriptan product. Sumatriptan is indicated for the acute treatment of migraine headache. Results from the study showed that sumatriptan administered via the Intraject system met all bioequivalence criteria and demonstrated statistically equivalent pharmacokinetics to the marketed injectable product. "This study provides the final validation of Intraject as the system successfully delivered active drug," said Dr. Bryan Lawlis, Aradigm's President and Chief Executive Officer. "We have funded this program to date in order to demonstrate conclusively that Intraject needle-free delivery is a viable replacement for conventional subcutaneous injection, and to accelerate our path to first product launch. In the first half of 2005, we anticipate manufacturing registration lots and preparing for pivotal bioequivalence trials in the second half of the year. We are encouraged that our rapid progress is generating attractive partnering prospects for this product, as well as for other products that are currently marketed or being developed for subcutaneous delivery." The trial was a randomized, open-label, single-dose, crossover study evaluating the pharmacokinetics of sumatriptan at three injection sites in 18 healthy adult male and female volunteers. Subjects were randomized to receive sumatriptan both by Intraject and by the currently marketed subcutaneous needle-injected sumatriptan product into the abdomen, thigh, and arm. The comparability of Intraject to the subcutaneous needle-injected sumatriptan product was established at all three injection sites using standard bioequivalence criteria of peak concentration achieved in blood plasma (Cmax), and total drug concentration in blood plasma achieved over time (AUC). Other pharmacokinetic measures were similar between Intraject and the needle-injected product, and there was no significant difference in blood levels between the two products. "This positive data means that Intraject has the potential to be competitively positioned in the $2 billion triptan market," said Dr. Stephen Farr, Senior Vice President and Chief Scientific Officer of Aradigm. "Rapid absorption is important for achieving rapid relief in the treatment of migraine attacks. To date, the performance of injected sumatriptan has not been equaled by any oral triptan. We expect that patients seeking faster pain relief will be pleased to have an effective option that does not involve a needle." Aradigm develops non-invasive delivery systems to enable patients to comfortably self-administer biopharmaceuticals and small molecules that would otherwise be given by injection. The company's advanced AERx® pulmonary and Intraject® needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs focus on neurological disorders, heart disease, respiratory conditions and cancer. More information about Aradigm can be found at www.aradigm.com. Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including clinical results, the timely availability and acceptance of new products, the impact of competitive products and pricing, and the management of growth, as well as the other risks detailed from time to time in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including the company's Annual Report on Form 10-K, and quarterly reports on Form 10-Q. NOTE: AERx and Intraject are registered trademarks of Aradigm.

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To: keokalani'nui who wrote (220)	12/2/2004 11:25:44 AM
From: Tadsamillionaire	of 255

--Aradigm Corporation (NASDAQ: ARDM) announced today that Dr. Bryan Lawlis, President and Chief Executive Officer will present at the Robins Small-Cap Life Sciences Investor Conference in New York on December 7, 2004. Dr. Lawlis is scheduled to present at 1:15 p.m. EST at the Lotus Club, located at 5 East 66th Street. This conference presentation is being webcast and can be accessed at: catalystresearch.com. The Robins Small-Cap Life Sciences Conference will feature small-cap life sciences companies expected to perform well in 2005. Bradley Pharmaceuticals, Inc. kicks off the conference at 9:00 a.m. EST. Other presenting companies include Cardiotech International, Inc., LifePoint, Inc., and Curon Medical, Inc.. The conference is open, free of charge, to the professional investment community and will be moderated by Marc Robins, CFA, founder of The Robins Group (an Institutional Broker Dealer) and Robins Media. About Robins Media: Marc Robins has over 25 years of experience in the small-cap arena, including a regularly featured column in Forbes, contributing articles in the AAII Journal and his frequent quotes found in various financial media. The conference is part of a series of events hosted by Robins Media. These events showcase undervalued, under-followed small-cap companies. About Aradigm Corporation Aradigm develops non-invasive delivery systems to enable patients to comfortably self-administer biopharmaceuticals and small molecules that would otherwise be given by injection. The company's advanced AERx(R) pulmonary and Intraject(R) needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs focus on neurological disorders, heart disease, respiratory conditions and cancer. More information about Aradigm can be found at www.aradigm.com. cobrand.knobias.com

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To: rkrw who wrote (221)	12/13/2004 5:42:58 PM
From: tuck	of 255

>>What will ardm invest in now?<< >>HAYWARD, Calif., Dec. 13 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) today announced that it has entered into an agreement with Defence R&D Canada for the aerosolized delivery of liposomal-encapsulated ciprofloxacin to develop a treatment and prophylaxis for serious respiratory infections, including, but not limited to, bioterror-related inhalation anthrax. The drug will be delivered by Aradigm's AERx® technology platform. Under the terms of the contract, Defence R&D Canada (DRDC) is funding Aradigm's product and formulation development work and initial pre-clinical studies, with work scheduled to begin in January 2005. Stemming from this agreement, Aradigm will hold the intellectual property associated with the inhalation of liposomal ciprofloxacin, an anti-infective agent used in multiple disease states. "We are pleased to be in partnership with DRDC and that they recognize the delivery benefits of the AERx System in this area of great international importance," said Dr. Bryan Lawlis, President and Chief Executive Officer of Aradigm. "This agreement is intended to build upon the proof-of-principle work already completed successfully by DRDC. The goal of DRDC and Aradigm is to complete pre-clinical studies next year and move as rapidly as possible into human safety studies. With these agreements, Aradigm now owns a proprietary and potentially efficacious formulation of an anti-infective for the treatment of a wide range of respiratory diseases with significant commercial potential." In addition to the DRDC contract, Aradigm has been granted an exclusive worldwide license by Inex Pharmaceuticals Corporation to their intellectual property relating to the manufacturing of liposomal ciprofloxacin. "Encapsulation of ciprofloxacin in liposomes results in a liquid formulation that can be readily aerosolized and delivered efficiently to the lung as well as dramatically increasing the residence time of the ciprofloxacin within the lung," said Dr. Stephen Farr, Aradigm's Chief Scientific Officer. "For local infections of the lung, our goal is to develop liposomes that release the ciprofloxacin at a sustained rate to enhance the killing of pathogens. Beyond the initial technical development, the contract enables Aradigm to evaluate the efficacy of inhaled liposomal ciprofloxacin in established animal models of respiratory infections. Data from these studies may provide the opportunity to proceed into human studies for the treatment of respiratory infections such as those prevalent in patients with cystic fibrosis."<< snip Cheers, Tuck

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To: tuck who wrote (227)	12/14/2004 7:52:55 AM
From: Tadsamillionaire	of 255

I see this as a good thing."With these agreements, Aradigm now owns a proprietary and potentially efficacious formulation of an anti-infective for the treatment of a wide range of respiratory diseases with significant commercial potential." "Aradigm will hold the intellectual property associated with the inhalation of liposomal ciprofloxacin, an anti-infective agent used in multiple disease states."

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To: scaram(o)uche who wrote (222)	12/14/2004 7:59:04 AM
From: Tadsamillionaire	of 255

In addition to the DRDC contract, Aradigm has been granted an exclusive worldwide license by Inex Pharmaceuticals Corporation to their intellectual property relating to the manufacturing of liposomal ciprofloxacin.

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