| To: rkrw who wrote (216) | 9/6/2004 5:29:50 PM | | From: tuck | | | | >>MUNICH, Germany, Sept. 6 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) presented scientific information today at the Annual Meeting of the European Association for the Study of Diabetes being held in Munich, Germany that described desirable features of insulin delivery and glucose control with its Technosphere®/Insulin system that are not available from currently marketed insulin or oral diabetes drug therapies. Currently in late stage Phase II clinical trials in the United States and Europe, the MannKind product is being developed to treat both type 1 and type 2 diabetes mellitus.
Dr. Wendell Cheatham, Corporate Vice President for Medical & Regulatory Affairs of MannKind Corporation and an Endocrinologist/Diabetologist, described the ability of Technosphere®/Insulin to produce a rapid increase in blood insulin level that approximates the normal early release of insulin that is observed in healthy individuals in response to a meal. Dr Cheatham noted that this early insulin signaling spike is lost in patients who suffer from both type 1 and type 2 diabetes and commented, "There is currently no marketed form of therapy for diabetes that has been able to replace or restore the signaling function of the healthy pancreas. This rapid signal is not directly involved in glucose disposal, but is needed to stop release of glucose from the liver when nutrients are being ingested in a meal. Glucose is released by the liver to fuel the body between meals, but this additive glucose is undesirable during and shortly after absorption of nutrients from a meal. Turning off the release of glucose from the liver during this meal-time period is extremely important in controlling blood sugar levels."
Dr. Cheatham presented data on the speed of absorption and pharmacological characteristics of MannKind's inhaled insulin that were similar to results seen when regular insulin was injected directly into the blood stream. In addition, the Technosphere®/Insulin system was shown to have an effect that spans the period of meal digestion and absorption. Dr. Cheatham also described a model of human glucose dynamics that MannKind developed in order to better understand why the effect of its inhaled insulin is different from that produced by insulin given via subcutaneous injection and why it is more similar to the effect of insulin given by intravenous injection. MannKind plans to present information from completed Phase II studies of its inhaled Technosphere®/Insulin to the US FDA before the end of 2004.
About MannKind Corporation
MannKind focuses on the discovery, development and commercialization of therapeutic products for diseases including diabetes, cancer, inflammatory and autoimmune diseases. The Company's lead product, the Technosphere® Insulin System, which is currently in late Phase II clinical trials for the treatment of diabetes, consists of a proprietary dry powder Technosphere® formulation of insulin that is inhaled into the deep lung using MannKind's MedTone(TM) inhaler. Early indications show MannKind's proprietary Technosphere® Insulin System's performance characteristics, convenience and ease of use have the potential to change the way diabetes is treated. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com. <<
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Cheers, Tuck |
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| To: rkrw who wrote (218) | 9/17/2004 11:01:36 AM | | From: tuck | | | | [Inhaled morphine delivered using the AERx system in patients with moderate-to-severe asthma]
>>Int J Clin Pharmacol Ther. 2004 Aug;42(8):456-62.
Safety and pharmacokinetics of inhaled morphine delivered using the AERx system in patients with moderate-to-severe asthma.
Otulana B, Okikawa J, Linn L, Morishige R, Thipphawong J.
Aradigm Corporation, Hayward, CA 94545, USA. totulana@aradigm.com
OBJECTIVE: The safety and pharmacokinetics of inhaled morphine in asthmatic subjects were investigated using the AERx System, a novel aerosol system. METHODS: Twenty subjects with asthma received inhaled placebo and inhaled morphine sulfate, 2.2 mg, 4.4 mg and 8.8 mg, on separate days in a single-blind crossover study. Six of the subjects received an additional open-label dose of 17.6 mg on a separate day. Plasma morphine concentrations and safety evaluations including pulmonary function testing were performed. RESULTS: Mean tmax values were similar following all dose groups at approximately 1-2 minutes. Mean AUC(0-->1) values showed dose proportionality for the first 3 dose groups (6.3, 12.3 and 24.3 ng x h x ml(-1)), the mean AUC(0-->1) for the 17.6 mg dose group was 1.6x that of the 8.8 mg dose group. No statistically significant differences in forced expiratory volume in 1 sec (FEV1) were found for the 2.2 mg, 4.4 mg, or 8.8 mg dose groups; at 17.6 mg, a statistically significant but not clinically meaningful reduction in mean FEV1 (-8.18%) from baseline occurred at 10 minutes compared to placebo, spontaneously returning to baseline by 60 min. Four subjects experienced significant but reversible decreases in FEV1 of > or = 20% compared to baseline and across all dose levels including after placebo, but with no associated increase in dyspnea, wheezing or other adverse events. CONCLUSIONS: Inhaled morphine using the AERx System was absorbed rapidly and demonstrated dose-dependent plasma concentrations. It was well-tolerated and did not cause clinically significant bronchoconstriction in most subjects with moderate-to-severe asthma.<<
Cheers, Tuck |
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| To: tuck who wrote (219) | 9/28/2004 10:59:49 PM | | From: keokalani'nui | | | | 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) | 10/13/2004 2:49:58 PM | | From: tuck | | | | >>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."<<
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Cheers, Tuck |
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| To: rkrw who wrote (218) | 11/10/2004 11:44:12 AM | | From: tuck | | | | >>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.<<
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Cheers, Tuck |
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| To: tuck who wrote (224) | 12/1/2004 6:06:25 PM | | From: Tadsamillionaire | | | | 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 | | | | --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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