| 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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| To: rkrw who wrote (221) | 12/13/2004 5:42:58 PM | | From: tuck | | | | >>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."<<
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Cheers, Tuck |
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| To: tuck who wrote (227) | 12/14/2004 7:52:55 AM | | From: Tadsamillionaire | | | | 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: Tadsamillionaire who wrote (229) | 12/23/2004 1:08:37 PM | | From: tuck | | | | >>VALENCIA, Calif., Dec. 22 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) released summary information today on results from its US-based, late Phase 2 clinical study of Technosphere® Insulin, a pulmonary insulin formulation delivered via its proprietary inhaler to patients with diabetes mellitus. The MannKind pulmonary insulin system rapidly delivers regular human insulin to the bloodstream in a manner that approximates the first phase insulin release spike by the pancreas that occurs almost immediately after the start of a meal in normal, healthy individuals but is lost in patients who develop diabetes. This spike plays an important role in glucose control by signaling the liver to stop releasing glucose into the bloodstream while glucose is being ingested from a meal.
The double-blind, placebo-controlled study was conducted at 21 sites in the United States. Patients who participated in the study were experiencing inadequate control of diabetes determined on the basis of HbA1c results (a measure of glucose control over the preceding three to four months) obtained at the time of screening. All patients received basic diabetes education and performed regular monitoring of blood glucose levels at home prior to randomization. A total of 123 patients (41 women and 82 men) were randomized into either a group that inhaled Technosphere Insulin (doses containing 6 to 48 units of insulin) or Technosphere placebo, in both cases at mealtimes. One hundred seven patients completed the full 12 weeks of treatment with blinded study agents.
Patients that constituted the primary efficacy population (n=90) had a mean HbA1c level of 7.74% at baseline with a range of 6.6% to 10.5%. As part of the study analysis plan, these patients were evaluated in two groups: those with moderately severe elevations of HbA1c levels at baseline of 8.0% and above (values identified by the American Diabetes Association as requiring definitive therapeutic intervention to minimize complications) and those with mild- to moderate elevations of HbA1c levels at baseline ranging from 6.6% to 7.9%.
Patients with moderately severe elevations of HbA1c levels at baseline (n=35; mean HbA1c 8.72%; range 8.0% to 10.5%), who were treated with Technosphere Insulin, experienced a mean reduction of 1.37 percentage points by the end of 12 weeks of treatment. The difference in reduction of HbA1c levels between the Technosphere Insulin and the placebo treatment groups was highly statistically significant (p=0.0007) in favor of Technosphere Insulin.
Patients with mild to moderate elevations of HbA1c levels at baseline (n=55; mean HbA1c 7.18%; range 6.6% to 7.9%), who were treated with Technosphere Insulin, experienced a mean reduction of 0.43 percentage points by the end of 12 weeks of treatment. The difference in reduction of HbA1c levels between the Technosphere Insulin and the placebo treatment groups was statistically significant (p=0.0447) in favor of Technosphere Insulin.
Overall, in the primary efficacy population, there was a highly statistically significant difference between the two treatment groups (in favor of the Technosphere Insulin group) with respect to the proportion of patients who achieved a reduction in HbA1c levels by the goal of at least 0.6 percentage points (chi-square; p=0.0052). Approximately four times as many patients in the Technosphere Insulin-treated group achieved a final HbA1c level of 6.5% or less as compared to the placebo-treated group.
There were no serious adverse events that were related to the use of the study drug. No episodes of severe hypoglycemia occurred in any of the patients treated with Technosphere Insulin. Pulmonary function was assessed by DLco measurements, FVC and FEV1 rates, and there was no clinically significant difference between the 12-week test results and baseline values in the patient group receiving Technosphere Insulin. Importantly, there was also no evidence of treatment-induced insulin antibodies occurring in patients treated with Technosphere Insulin.
Dr. Wendell Cheatham, Corporate Vice President and Chief Medical Officer of MannKind, commented, "This study indicates that Technosphere Insulin can effectively lower blood glucose levels in patients with type 2 diabetes who previously were experiencing inadequate control of their disease. The typical risks of frequent or severe hypoglycemia associated with insulin therapy appear to be minimal with Technosphere Insulin, giving it a potentially significant safety advantage over other therapies."
Alfred Mann, Chairman and Chief Executive Officer of MannKind, stated further, "In our earlier clinical studies, we observed that the kinetic profile of Technosphere Insulin approximates the first phase insulin release spike of normal, healthy individuals. With these latest observations of no increases in antibodies, no clinically significant changes in pulmonary function and no episodes of severe hypoglycemia in patients treated with Technosphere Insulin, we continue to be optimistic regarding the future of Technosphere Insulin. We are now preparing to submit these results to the United States Food and Drug Administration. In the meantime, we have initiated our first Phase 3 clinical trial in Europe, enrolling patients this week. We are pleased that the Company continues to achieve its intended milestones on or ahead of schedule."<<
Hmmm. No antibdies is good, beats competing inhalables; but otherwise, results are just like everyone else's, maybe even a little inferior. And this trial compares to a technosphere placebo, not to a s.c. insulin cohort. I assume they'll have to use a more robust comparison in PIII, but no details of that trial are given. Hmmm. As to pulmonary function, they deviate from using statistical significance and tlak of clinical significance. Hmmm.
Cheers, Tuck |
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| To: tuck who wrote (230) | 1/7/2005 11:20:43 AM | | From: rkrw | | | | I think the differentiator is going to be the device. If the first asthma albuterol device was a ntkr inhaler (looks like a bong but I don't think could work as a dual purpose device :-) and the next one out was a standard MDI puffer, which would win? So I think in the long run nktr will need a small device to compete. And the ardm device may not be much better, long run. alks/lly could be a darkhorse--very small device supposedly. I also wouldn't ignore mnkd, their ceo is a diabetes legend (founded Minimed). So call it a long term, 5 year type of prediction.
Alkermes Announces Lilly Decision to Proceed with Late-Stage Clinical Development Program for Inhaled Insulin
Tuesday, August 10, 2004
-- Cambridge, MA, August 10, 2004 -- Alkermes, Inc. (Nasdaq: ALKS) announced today that Eli Lilly and Company (“Lilly”) has made a positive product decision and will proceed with significant investment for the further development of an inhaled formulation of insulin. The decision follows the successful execution of several critical steps: the completion and analysis of data from a Phase 2 study; the achievement of commercial manufacturing powder production scale-up; and the development and testing of the commercial pulmonary insulin inhaler system. Development activities will include both clinical trials and additional manufacturing activities for the inhaler system and the production facility.
A recently completed Phase 2 clinical trial for inhaled insulin using Alkermes’ AIR® technology showed that patients with type 1 diabetes achieved glycemic control levels similar to injected insulin. The trial was a multi-center, cross-over design study with 120 patients with type 1 diabetes receiving an inhaled formulation of insulin using AIR technology for a three-month period. Inhaled insulin had a rapid onset of action and was well tolerated with adverse events similar in both treatment arms.
“We’re delighted that the strength of the clinical data and our achievement of commercialization milestones provided the basis of the decision by Lilly to move forward with further development for inhaled insulin,” said Elliot Ehrich, M.D., Chief Medical Officer at Alkermes. “We look forward to initiating additional clinical studies that will bring us another step closer to developing an important new treatment for the growing number of people living with diabetes.”
The inhaled insulin delivery system is based on Alkermes’ AIR pulmonary drug delivery technology, which uses a small, easy-to-use, inhaler designed to provide drug delivery for a wide range of drug doses. Alkermes and Lilly have collaborated on the inhaled insulin program since 2001 to develop an innovative treatment option for people with diabetes.
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