Ardm

[axelvento]

.23


Aradigm

PHASE II Aradigm

preclinical Aradigm

preclinical Aradigm


Form 5 / CEO Igor Gonda Acquires further 166.666 shares. He now holds 1,610,666 shares.

Aradigm - Annual Statement of Changes in Beneficial Ownership

[axelvento]

Aradigm Waits For FDA Clearance For Phase III Clinical Trial Of Inhaled Liposomal Ciprofloxacin To Treat Bronchiectasis.

I expect ARDM will receive FDA clearance in the first quarter of 2011.


________________________________________ ____________________



Zogenix Reports Fourth Quarter and Full Year 2010 Financial Results

Net product revenue on sales of SUMAVEL DosePro for the fourth quarter 2010 was $7.2 million, up 27% from $5.7 million in the third quarter 2010. Net product revenue for the full-year was $19.1 million, consisting of $18.7 million in SUMAVEL DosePro prescriptions dispensed to patients in the U.S. and $0.4 million in sales to Zogenix’s E.U. commercialization partner Desitin.

2011 Financial Guidance
For the full-year 2011, the Company anticipates total revenue in the range of $46 million to $52 million which includes $6 million of contract revenue from the Astellas co-promotion agreement.

Press Release

More than double royalties for Aradigm in 2011 = cca $1.2 million to $1.38 million!!!

[axelvento]

Strut:

O/s 173m
float 77m


Aradigm - Quarterly Report


rumor
news this week very BIG contract comming

[axelvento]

Da ricordare che stiamo parlando di una scommessa
con tutti i suoi rischi.....

Hanno sempre bisogno di soldi per finanziare phase III

[playars]

articolo vecchio
ma molto interessante

https://www.investalink.com/docs/mar...igm%20ARDM.pdf

[axelvento]

Time & Sales
Price Size Exch Time
0.23 10000 OBB 03/10
0.23 183368 OBB 03/10 buy
0.23 17500 OBB 03/10
0.228 2000 OBB 03/10
0.23 2500 OBB 03/10
0.228 49132 OBB 03/10
0.23 5000 OBB 03/10
0.23 234399 OBB 03/10 buy
0.229 11500 OBB 03/10
0.23 650 OBB 03/10
0.23 8000 OBB 03/10
0.23 1350 OBB 03/10
0.2275 2200 OBB 03/10
0.2275 4101 OBB 03/10
0.2261 6000 OBB 03/10
0.23 3650 OBB 03/10
0.2261 10000 OBB 03/10
0.2261 10000 OBB 03/10
0.2261 5000 OBB 03/10

[playars]

Originalmente inviato da axelvento

Time & Sales
Price Size Exch Time
0.23 10000 OBB 03/10
0.23 183368 OBB 03/10 buy
0.23 17500 OBB 03/10
0.228 2000 OBB 03/10
0.23 2500 OBB 03/10
0.228 49132 OBB 03/10
0.23 5000 OBB 03/10
0.23 234399 OBB 03/10 buy
0.229 11500 OBB 03/10
0.23 650 OBB 03/10
0.23 8000 OBB 03/10
0.23 1350 OBB 03/10
0.2275 2200 OBB 03/10
0.2275 4101 OBB 03/10
0.2261 6000 OBB 03/10
0.23 3650 OBB 03/10
0.2261 10000 OBB 03/10
0.2261 10000 OBB 03/10
0.2261 5000 OBB 03/10

non sono noccioline....
$$$$$$$$$$$$$$$$$$$$$$$$$

qualcuno carica la legna

[axelvento]

Originalmente inviato da playars

non sono noccioline....
$$$$$$$$$$$$$$$$$$$$$$$$$

qualcuno carica la legna

t 0.23 723 OBB 16:02:31
t 0.23 1448 OBB 16:00:24
t 0.23 250 OBB 16:00:08
0.23 25000 OBB 15:57:15
0.2291 10000 OBB 15:57:12
0.23 25000 OBB 15:56:41
0.23 400 OBB 15:49:03
0.23 293600 OBB 15:49:00
0.23 6000 OBB 15:48:56
0.23 6027 OBB 15:48:00
0.2291 4600 OBB 15:45:21
0.2291 400 OBB 15:45:20
0.23 23700 OBB 14:30:18
0.23 10000 OBB 14:30:09
0.2291 10000 OBB 13:34:54
0.2291 2764 OBB 13:25:03
0.23 13350 OBB 12:39:37
0.23 4000 OBB 12:08:18
0.23 9700 OBB 11:59:52
0.23 50000 OBB 11:56:14
0.23 350 OBB 11:31:25
0.23 50000 OBB 11:28:52
0.23 50000 OBB 11:28:31
0.23 25000 OBB 11:19:50
0.23 23000 OBB 11:19:18
0.23 2000 OBB 11:19:18
0.2251 2000 OBB 10:50:39
0.23 500 OBB 10:32:38
0.23 4900 OBB 10:30:34
0.23 5000 OBB 09:30:08

[Virgilio]

Quanto hanno in cassa?

[playars]

Aradigm Completes Enrollment in Phase 2b Study of Inhaled Ciprofloxacin for the Management of Respiratory Infections in Bronchiectasis



announced the last patient was enrolled in a Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (CFI, ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE), a severe progressive respiratory disease for which there is currently no approved treatment in the U.S.



BE is an orphan disease that afflicts approximately 110,000 patients in the U.S. and another roughly 210,000 in Western Europe.



The Phase 2b trial, designated ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) is an international, double-blind, placebo-controlled study which randomized 101 patients and is being conducted under a U.S. Food and Drug Administration IND. The ORBIT-1 study design calls for four weeks of once-daily inhaled doses of the active drug or once-daily inhaled placebo. Two doses of the active drug are included in the study - 100 or 150 mg ciprofloxacin delivered by inhalation as 2 or 3 mL of liposomal dispersion, respectively.



The primary efficacy endpoint is a standard measure of antibacterial activity - the change from baseline in sputum Pseudomonas aeruginosa colony forming units (CFUs). Secondary endpoints include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes are being monitored for safety.



Earlier Study: Significant Impact on Lung Infections, Excellent Safety



The Company previously announced results from the 6-month Phase 2b study (ORBIT-2) with Aradigm’s once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with BE. The study resulted in an unprecedented success for the long term use of inhaled antibiotics in BE patients and demonstrated a significant impact on lung infections coupled with excellent safety and tolerability. Importantly, the Kaplan-Meier analysis showed that the median time to first pulmonary exacerbation in the per protocol evaluation increased from 58 days in the placebo group to 134 days in the active treatment group and was statistically significant (p<0.05, log rank test). DRCFI also had a superior pulmonary safety profile reflected in the number and severity of pulmonary adverse events. Furthermore, there was a statistically significant lower need to initiate antibiotics in the active group versus the placebo group to treat respiratory infections.



The results from each of these trials will produce an extensive database of information from which to select the optimum product and the most appropriate endpoints to test in Phase 3.



About bronchiectasis



Bronchiectasis (BE) is a progressive lung disease in which the airway walls are chronically inflamed. This is often the result of a vicious cycle of bacterial infection, in which damage to the lungs further predisposes the lung to more infections. The body repairs the damaged lung tissue by forming tough, fibrous material, which leads to changes that impair normal lung structure and function. Recurrent lung infections reduce the patient’s quality of life and progressive respiratory insufficiency is the most common cause of death. The colonization of the lung with the microorganism Pseudomonas aeruginosa is associated with the severity of BE. Exacerbations in this patient population often require hospitalization and administration of intravenous antibiotics. BE is frequently observed in patients with cystic fibrosis (CF), however, it is a condition that affects about 110,000 people without CF in the United States and many more in other countries. There is currently no drug specifically approved for the treatment of this condition in the U.S.



About liposomal ciprofloxacin



Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF patients. The Company’s once-a-day novel inhaled formulations of ciprofloxacin are encapsulated in liposomes, allowing for a sustained release of the drug within the lung and improving airway tolerability. The formulations are to be used for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. The Company previously reported positive results from its 6-month Phase 2b study (ORBIT-2) with Aradigm’s once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) and other Phase 2a studies of 22 CF patients and 36 BE patients who received ciprofloxacin for inhalation (CFI, ARD-3100) once-a-day for 2 (CF) or 4 (BE) weeks, respectively. The Company is also developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia.



About Aradigm



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. The Company has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation anthrax and tularemia infections, and smoking cessation.



More information about Aradigm can be found at Aradigm.