From: MLD38 | 4/13/2007 12:11:54 PM | | | | ARDM.OB : Michael Shulman, ChangeWave Biotech promo
Michael Shulman, ChangeWave Biotech Investor wrote in the promo: ..."I want you to look ahead to all the new opportunities we can share together. In fact, I've just created a new Video Alert on another little biotech that could double in a flash, on the way to another 5-bagger. It's yours FREE to watch by clicking here now: iplacereports.com
****************************************************************** Some of the written material on the webpage with the video:
..."The next stock to double in a flash -- Guaranteed? Of course not – this is what I call a “bleeding edge” biotech…a company – like Dendreon when I first recommended it – that still has challenges ahead of it. Yet, interestingly, this company is also a fairly mature company in many ways – and that takes a lot of the risk out of your investment now. Especially at today’s price. Every share you buy today costs about a buck-and-a-half. So you get a lot of leverage for just a small investment now. My target? $6.50 a share – a very nice move from here. When I say the company is fairly mature, here’s what I mean: They’ve raised a lot of cash through the years. And their science and technology is great. That’s the good news. The bad news is old news. Management fumbled the ball for years. And frankly, Wall Street lost patience, especially as the company recapitalized – as they actually eliminated many of their old problems in the process. Recently, the stock is acting better, so you want to establish your position now. While I consider this company a mid-to long-term hold – playing out over the next couple years – this stock has the potential, like Dendreon, to suddenly jump out fast. If that happens, our long-term investment will become a trade instead, as we double, or triple, our money virtually overnight."...
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NOTE: I do not subscribe to Michael Schulman's ChangeWave BioTech newsletter, but I think ARDM.OB was the unnamed stock he discussed in the promo video. I do not know what the recommendations say ( ie buy, sell, hold, or short ... or at what share price, etc. ), but here are the titles of some of his recent BioTech alerts, etc.
04/12/2007 Catching Up With Spectrum and Nektar Biotech 04/05/2007 Speculation versus Investing Biotech 04/04/2007 New Buy Recommendation: Aradigm (ARDM) Biotech
ARDM had increased price and volume around April 4 - April 13 bigcharts.marketwatch.com
Stock quotes for ARDM.OB, NKTR, SPPI finance.yahoo.com
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Insiders: finance.yahoo.com
Insiders: SEC Form 4 secform4.com
Also: 01/25/07 is the Date of Event Requiring Statement of Tang's Initial Statement of Beneficial Ownership of Securities Form 3 secinfo.com Tang Capital Partners, LP. Kevin C. Tang is the sole manager of Tang Capital Management, LLC, which is the general partner of Tang Capital Partners, LP. filed
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Aradigm aradigm.com ...products are being developed for the treatment of a variety of diseases such as diabetes, cystic fibrosis, inhalation anthrax and pulmonary arterial hypertension. The company is also investigating the use of its technologies for other important therapeutic applications.... Aradigm : Novo Nordisk ...Aradigm is partnered with Novo Nordisk as well as several other biotechnology and pharmaceutical companies in the delivery of compounds via the AERx technology.... ...contract manufacturing agreement with Novo Nordisk Delivery Technologies, Aradigm has access to manufacturing capacities that include over 200,000 square feet dedicated to commercial scale production and houses equipment such as the AERx Strip line (left). This single facility, when complete, will have the capacity to manufacture up to 750 million dosage forms a year.... Mgmt, directors, advisors: aradigm.com
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Financials: phx.corporate-ir.net ...net loss for the year ended December 31, 2006 was $13.0 million, or $0.89 per share, compared with a net loss of $29.2 million, or $2.01 per share, for the same period in 2005. The year-over-year reduction in net loss was driven primarily by the recognition of an $8 million gain on sale of royalty interest and a $12 million gain on sale of patents, both transactions with Novo Nordisk, a related party.... Dr. Igor Gonda, Aradigm's President and CEO: ..."Our cash burn for the fourth quarter, and as we move into 2007, was below $2 million per month. With the proceeds of our recent public offering, we are in a strong financial position to support our new strategic initiatives aimed at becoming a 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."... |
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To: keokalani'nui who wrote (240) | 4/19/2007 4:47:51 PM | From: keokalani'nui | | | SEATTLE--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced detailed results of its Phase III AIR-CF2 study evaluating aztreonam lysine for inhalation, an antibiotic, in patients with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In the study, a 28-day treatment course of aztreonam lysine significantly improved the time to need for inhaled or intravenous (IV) antibiotics versus placebo. All patients received an initial 28 days of treatment with tobramycin inhalation solution prior to receiving study drug. Aztreonam lysine for inhalation was well tolerated and patients also experienced significant improvements in pulmonary function and respiratory symptoms. The data were presented by Karen S. McCoy, MD, Chief of the Division of Pediatric Pulmonology and Associate Professor of Pediatrics at The Ohio State University College of Medicine and Chief of the Section of Pulmonology at Columbus Children's Hospital, at this year's Cystic Fibrosis Therapeutics Development Network conference in Seattle, Washington. Topline results from this study were previously announced on December 19, 2006. AIR-CF2 was a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine for inhalation following a 28-day treatment course of tobramycin inhalation solution in people with CF who have pulmonary P. aeruginosa. Patients were randomized to receive 28 days of treatment with 75 mg of aztreonam lysine or volume-matched placebo each administered twice (BID) or three times (TID) daily by the eFlow® Electronic Nebulizer. Patients were followed for an overall study period of 126 days, with 56 days of observation after receiving aztreonam lysine for inhalation therapy or placebo.
Two hundred and forty-six patients were enrolled in the study and of those 211 were randomized to receive aztreonam lysine for inhalation or placebo. The mean age of patients treated with blinded study drug in the trial was 26.2 years. Participants had received more than five courses of tobramycin inhalation solution, on average, in the previous year (mean value = 5.33 courses). More than 85 percent of patients were taking medication (dornase alfa) to thin mucus secretions in the lungs and nearly 70 percent were taking oral azithromycin. At baseline, the mean percent predicted forced expiratory volume in one second (FEV1), a measure of lung function, was 55.7 percent overall, and 37 percent of patients had a predicted FEV1 less than or equal to 50 percent, indicating severe impairment of lung function.
"Pulmonary pseudomonal infection remains the leading cause of sickness and death in people with CF," said Dr. McCoy. "Data from the AIR-CF2 study indicate that aztreonam lysine for inhalation may provide broad clinical benefit, which is particularly significant given that most patients in the study had relatively long-standing CF, a history of frequent antibiotic use and impairment of lung function at the start of the study."
Two hundred and forty-six patients were enrolled in the study and of those 211 were randomized to receive aztreonam lysine for inhalation or placebo. The mean age of patients treated with blinded study drug in the trial was 26.2 years. Participants had received more than five courses of tobramycin inhalation solution, on average, in the previous year (mean value = 5.33 courses). More than 85 percent of patients were taking medication (dornase alfa) to thin mucus secretions in the lungs and nearly 70 percent were taking oral azithromycin. At baseline, the mean percent predicted forced expiratory volume in one second (FEV1), a measure of lung function, was 55.7 percent overall, and 37 percent of patients had a predicted FEV1 less than or equal to 50 percent, indicating severe impairment of lung function.
"Pulmonary pseudomonal infection remains the leading cause of sickness and death in people with CF," said Dr. McCoy. "Data from the AIR-CF2 study indicate that aztreonam lysine for inhalation may provide broad clinical benefit, which is particularly significant given that most patients in the study had relatively long-standing CF, a history of frequent antibiotic use and impairment of lung function at the start of the study."
Study Results
During the 28-day run in treatment course of tobramycin inhalation solution, patients had an average increase in improvement in FEV1 of less than 1 percent and no improvement in respiratory symptoms as measured by the respiratory domain of the cystic fibrosis questionnaire-revised (CFQ-R), a patient-reported tool used to measure health-related quality of life for people with CF.
Treatment with aztreonam lysine for inhalation lengthened the time to the need for inhaled or IV antibiotics -- the primary endpoint of the study -- by a median of greater than or equal to 21 days compared to placebo (pooled p-value=0.0070 by log rank test). Physicians determined the need for antibiotics based on the presence of decreased ability to exercise, increased coughing, increased production of mucus in the lungs and/or decreased appetite, all of which are signs of exacerbation.
Aztreonam lysine-treated patients also experienced significant improvements from baseline in respiratory function, as measured by relative improvement of FEV1, with an absolute difference of 6.3 percent versus placebo (p=0.0012). These results were consistent across age groups (less than 18 years of age and greater than or equal to 18 years of age; p=0.0378 and p=0.0132, respectively).
In addition, aztreonam lysine-treated patients experienced significantly greater improvements in respiratory symptoms, as measured by the respiratory domain of the CFQ-R, than placebo-treated patients. Approximately 52 percent of aztreonam lysine for inhalation-treated patients experienced improvements exceeding the minimal clinically important difference in respiratory symptoms compared to 37 percent of placebo-treated patients (p=0.0196). AIR-CF2 is the first randomized, controlled study of an aerosolized antibiotic to include and show improvements in respiratory symptoms using the CFQ-R questionnaire.
Aztreonam lysine for inhalation was also associated with significantly greater reductions in P. aeruginosa colony forming units (a measure of the amount of bacteria present in the lungs) at 28 days compared with placebo. Pseudomonas sensitivity as measured by minimum inhibitory concentrations did not significantly change from baseline to the end of therapy in aztreonam lysine for inhalation-treated patients after 28 days of therapy.
The safety profile observed in AIR-CF2 was consistent with expected symptoms of underlying CF lung disease. The most common treatment-emergent adverse events were cough, productive cough, nasal congestion, respiratory tract congestion and wheezing. The overall rates of adverse events, drug-related adverse events and serious adverse events were similar among patients treated with aztreonam lysine for inhalation and those treated with placebo. |
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From: fred hayes | 1/14/2008 10:04:22 PM | | | | Down to one insulin inhaler project -- ALKS LLY device. -------------------------------------------------- UPDATE 1-Novo Nordisk halts work on AERx inhaled insulin Mon Jan 14, 2008 5:36pm EST (Adds details on Novo plans, Lilly product)
NEW YORK, Jan 14 (Reuters) - Danish drugmaker Novo Nordisk (NOVOb.CO: Quote, Profile, Research)(NVO.N: Quote, Profile, Research) said on Monday it was halting development of its AERx inhaled insulin product and will lay off most of the approximately 300 company employees working on the product.
The company said it decided the product, meant to deliver inhaled droplets of liquid insulin, did not have adequate commercial potential given the recent failure to attract patients of Pfizer Inc's (PFE.N: Quote, Profile, Research) own inhaled insulin drug, called Exubera.
Pfizer in October abandoned its involvement with Exubera, which delivered inhaled insulin powder through a bulky device, because of dismal sales.
"In simply looking at the market and the convenience of our device, we decided it is not really there," Novo Nordisk spokesman Christian Qvist Frandsen said.
Frandsen said Novo Nordisk plans to lay off the majority of its 300-person team developing the product, based primarily in Hayward, California.
"We will continue to research inhaled insulin powder and inhaled liquid insulin, but starting from scratch," Frandsen said.
Novo Nordisk is one of the world's biggest sellers of insulin drugs, which are taken by injection several times a day to control excessive amounts of sugar in the bloodstream.
Novo Nordisk had licensed rights to the AERx product from Aradigm Corp (ARDM.OB: Quote, Profile, Research), a tiny biotechnology company.
"We will have to negotiate to give the rights back to Aradigm," said Frandsen.
Frandsen said Aradigm would have received a "small single-digit royalty" on sales of AERx if Novo Nordisk had brought the product to market.
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From: Area51 | 9/21/2017 4:47:16 PM | | | | What up?
2:56 pm ET | *Shares Of Penny Stock Aradigm Up 40% On ~10x Avg. Volume On No Apparent News
| Benzinga |
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