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Biotech / Medical : ARADIGM CORP. ARDM -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (196)	4/30/2004 1:03:11 PM
From: keokalani'nui	Read Replies (2) \| Respond to of 255

Having listened to novo's and ardm's cc: 1. Both companies believe it is not the device, nor is it membrane-permeability related. 2. The 'present consensus' is that the antibodies are not neutralizing. 3. The antibody formation is significant and it will be a primary focus of the coming analysis. 4. There is precedence in early insulin replacement studies (80s) that antibodies, though not neutralizing, can over the course of a study have a modifying effect on insulin. So they will be studing samples for the insulin profiles and whether there is progression of this unfavorable BG outcome. I believe this is the first suspect. 5. Could be that this is limited to T1, as they have susbstantially more circulating abs at baseline. However, the T2 study originally planned to start this year will be delayed until they figure this out. 6. Novo says in the August cc they ought to have an answer. 7. No one knows if exubera has the same issue, as no daytime bg data has been released. 8. This was all very unexpected. A good question is how long was the T1 P2? EDIT: sold the hot shares for a .04 loss.

To: rkrw who wrote (196)	6/9/2004 3:21:01 PM
From: tuck	Read Replies (1) \| Respond to of 255

It would appear that night time glucose levels, which derailed AERx, weren't measured in Exubera long term safety studies. From this year's ADA meeting: >>Sustained Long-Term Efficacy and Safety of Inhaled Insulin during 4 Years of Continuous Therapy Abstract Information Abstract Number: 486-P Authors: JAY SKYLER, FOR THE EXUBERA® PHASE II STUDY GROUP Institution: Miami, FL Results: Inhaled insulin has shown encouraging efficacy and safety data in short-term clinical trials. This study examined whether these favorable results are maintained in the long term. Continued open-label inhaled insulin therapy was offered to patients with diabetes who had completed any of three 3-month, randomized, controlled clinical trials (type 1, insulin-treated type 2 or type 2 diabetes uncontrolled on oral agents [OAs]). A total of 204 patients entered the extension, with 159 electing to stay on inhaled insulin (INH) or switch from comparator treatments and 89 patients having received at least 4 years of INH therapy. A small group of patients (n=23) on OAs or subcutaneous insulin was followed for up to 2 years as well. Mean (± SD) HbAì1cí was 8.23 ± 1.21% after 4 years in INH patients compared with 8.71 ± 1.49% at the start of INH treatment. Inhaled insulin dose increased slightly from 0.15 mg/kg after 3 months of treatment to 0.18 mg/kg after 4 years. The rate of overall hypoglycemia decreased from 2.58 episodes/subject month (first 4 weeks of INH treatment) to 1.50 after 4 years (final 6 months). Annualized changes in the lung function parameters FEVì1í and DLìCOí (mean ± SE) in INH patients over 4 years were -0.057 ± 0.004 L/yr and -0.376 ± 0.067 mL/min/mmHg/yr, respectively. Corresponding declines in non-INH patients (based on 2-year data only) were -0.071 ± 0.023 L/yr and -0.673 ± 0.423 mL/min/mmHg/yr, respectively. In conclusion, glycemic control and pulmonary function are well maintained during long-term continuous inhaled insulin therapy.<< So my question is, why has ARDM/Novo made this measurement while NKTR and partners have not? Will the FDA want this parameter? I would think that if the former thought it was appropriate to delay development while investigating this issue, that the FDA would surely want to look at it from all comers. I wonder what others are thinking. FBR downgraded NKTR today, but I can't find the rationale. The results appear pretty good, absent the above measurement. Thanks for any thoughts from anyone on this. Cheers, Tuck

To: rkrw who wrote (196)	8/10/2004 3:28:44 PM
From: tuck	Respond to of 255

>>CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 10, 2004--Alkermes, Inc. (Nasdaq: ALKS - News) 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. About Diabetes Diabetes is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. According to the American Diabetes Association ("ADA"), diabetes can be associated with serious complications and premature death, but people with diabetes can take steps to control the disease and lower the risk of complications (Source ADA). Additionally, the World Health Organization ("WHO") lists diabetes as one of the leading causes of mortality worldwide. Approximately 193 million people around the world have diabetes, and this number is expected to double to 330 million by the year 2025 (Source International Diabetes Federation). << There is no thread for Alkermes, according to the lame SI search engine. NKTR recently got creamed by EMEA "not licensable" letter a few days ago. Not sure what the specific concerns were, but one wonders if the antibody issue is haunting them, too. Will Lilly and Alkermes really escape? NKTR is up 10%, ALKS 20% . . . and ARDM is still in its hospital bed. Cheers, Tuck