ARDM.OB... Interessanter Cashwert - 500 Beiträge pro Seite

[BrauchGeld]

Hab spontan 10000st in F zu 0,129 € gekauft .Ich denke hier geht was !

Marktkap : 14,02 Mio US$
Cash : 19,8 Mio US$
Kurs : 0,14 US$


Pipeline :
http://www.aradigm.com/products_pipeline.html



Recent Highlights


November 10, 2008: announced the receipt of $2.75 million from Lung Rx, Inc. ("Lung Rx"), a wholly-owned subsidiary of United Therapeutics Corporation, following the completion of a clinical trial of inhaled treprostinil comparing the Company's AERx Essence(R) inhaler and the OPTINEB nebulizer, which was used by Lung Rx in its Phase 3 study of inhaled treprostinil. The AERx Essence inhaler is an easy-to-use and maintain palm-size inhaler that is expected to deliver medication to the patient in 2 to 4 breaths, potentially significantly reducing the burden of therapy for pulmonary arterial hypertension patients.
January 21, 2009: announced positive top-line results from an open-label, four week treatment study of efficacy, safety and tolerability with ARD-3150 once-daily inhaled liposomal ciprofloxacin hydrochloride in patients with non-cystic fibrosis bronchiectasis. This orphan drug condition is a chronic severe respiratory disease and there is currently no drug specifically approved for its treatment in the US.
February 26, 2009: closed a "registered direct" offering selling approximately 44.7 million shares of common stock at a negotiated purchase price of $0.10 per share for gross proceeds of approximately $4.5 million. The investors in the offering were all current Aradigm shareholders.

"Last year, we completed two successful Phase 2a studies with our lead product candidate, inhaled liposomal ciprofloxacin, for the treatment of infections associated with cystic fibrosis and bronchiectasis," said Igor Gonda, Ph.D., the Company's President and CEO. "In our collaboration with Lung Rx, we completed a clinical trial of inhaled treprostinil in our AERx Essence inhaler and received the first milestone payment of $2 million and development costs. As a result of the intensive cost control efforts and the additional financing from our existing investors in February, we will be able to advance our lead product candidate for infections associated with severe respiratory diseases."

[BrauchGeld]

Wenn die Hyänen von Amis die Aktie entdecken werden wir weitaus höhere Kurse sehen !

[BrauchGeld]

We recommend investors to take advantage of the current price weakness to purchase ARDM. At a market cap of $11 million and $22 million in cash as of February 2009, we do not believe the value for Aradigm’s pipeline including ILC or the inhaled Remodulin partnership is at all reflected in the current valuation. We strongly reiterate our BUY rating. The reduction of our price target to $3.30 from $6.00 is largely a function of the significant increase in the number of shares outstanding to 95 million from 54 million as a result of the recent 40 million share financing which was priced at $0.10 per share. Our price target is based on a 25x multiple of our 2012 fully-diluted EPS of $0.28 discounted back at 35% (see Table 2 below for details).

[Popeye82]

Antwort auf Beitrag Nr.: 37.362.712 von BrauchGeld am 10.06.09 13:35:20

Hi Brauch Geld(dann sollte man sich in anlagetechnischen Sachen vielleicht lieber nicht an Dir orientieren? ),

Vielleicht ist das eine interessante Sache, kann ich nicht abschätzen. Aber das Rating ist doch "echt gewagt" -3,30 -6$, mit einem KGV von 25, basierend auf einem angenommenen EPS in 3Jahren(bei einem Biotech!!) +kleiner Abschlag.

Sorry, aber das ist selbst für pushen unprofessionell. Wer sich an solche "Analysten" hält, der hat von Anfang an verloren.

Gruß,
Popeye

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.365.363 von Popeye82 am 10.06.09 17:35:14

@Popeye

Ich bin mein eigener Analyst und ich denke die Aktie wird sich gut in meinem Depot machen ..

Hab diese analyse einfach nur mal so reingestellt !

Schau zu und lerne ....

[Popeye82]

Antwort auf Beitrag Nr.: 37.365.474 von BrauchGeld am 10.06.09 17:46:03

Habe mich ausschlieslich auf die Herleitung der "Analyse" bezogen, die m.A. nach vollkommener Schwachsinn ist.

Ansonsten -I will do.

Gruß,
Popeye

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.365.588 von Popeye82 am 10.06.09 17:57:20

Bevor ich was kaufe mach ich immer meine eigene DD .

Hier die komplette Analyse ..

Aradigm reports 4Q 2008 results with a lower loss than expected. The Company reported a net loss of ($5.3) million, or ($0.10) per share which was $2.2 million lower than our estimate for a net loss of ($7.5) million, or ($0.14) per share. Aradigm reported $19.4 million in cash as of December 31, 2008, and with the recent completion of a financing in February with net proceeds of roughly $4.0 million, we estimate a February 2009 pro-forma cash of approximately $22 million ($0.23 per share). With a current monthly burn rate of approximately $1.5 million, we project it is enough cash to achieve significant developmental catalysts including a potential partnership for the ARD-3100 (inhaled liposomal ciprofloxacin-ILC), potential bronchiectasis or CF Phase IIb data

by 2010 and more progress with the AERx treprostinil program.

• In February, Aradigm reported top-line Phase II trial results indicate treatment of

bronchiectasis patients with its ILC was safe and well tolerated and resulted in a

statistically significant reduction in the level of bacterial infection in the lungs of these patients following 28-days of treatment. The positive top-line Phase II data reported from a 28- day open label study designed to examine the safety and efficacy of two dose strengths of ILC in 36 bronchiectasis patients indicate the treatment is safe and well-tolerated and it results in a highly statistically significant reduction in the bacterial load in these patients. Overall, we are impressed with the results reported as they confirmed the positive results with respect to safety and bacterial load reductions observed in the CF trial reported last year.

We recommend investors to take advantage of the current price weakness to purchase ARDM. At a market cap of $11 million and $22 million in cash as of February 2009, we do not believe the value for Aradigm’s pipeline including ILC or the inhaled Remodulin partnership is at all reflected in the current valuation. We strongly reiterate our BUY rating. The reduction of our price target to $3.30 from $6.00 is largely a function of the significant increase in the number of shares outstanding to 95 million from 54 million as a result of the recent 40 million share financing which was priced at $0.10 per share. Our price target is based on a 25x multiple of our 2012 fully-diluted EPS of $0.28 discounted back at 35% (see Table 2 below for details).

[Silberpfeil1]

Wie ging der Spruch? 3 Leser, 5 verschiedene Lesearten (oder so ähnlich)?

Ich lese die "Analyse" so:

We recommend investors to take advantage of the current price weakness to purchase ARDM. At a market cap of $11 million and $22 million in cash as of February 2009, we do not believe the value for Aradigm’s pipeline including ILC or the inhaled Remodulin partnership is at all reflected in the current valuation. We strongly reiterate our BUY rating. The reduction of our price target to $3.30 from $6.00 is largely a function of the significant increase in the number of shares outstanding to 95 million from 54 million as a result of the recent 40 million share financing which was priced at $0.10 per share. Our price target is based on a 25x multiple of our 2012 fully-diluted EPS of $0.28 discounted back at 35% (see Table 2 below for details).

Also -> 10 Cent bezahlt, für 14 Cent weitergereicht.

Gruß

Silberpfeil

[BrauchGeld]

ARDM ist für mich nur was Kurzfristiges .

Zulassung am 15 Juli 2009 davon könnte auch Aradigm profitieren !!!

In August 2006, we sold all of our assets related to the Intraject needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to Zogenix, Inc., a private company. Zogenix is responsible for further development and commercialization efforts of Intraject (now rebranded under the name DoseProtm). We received a $4.0 million initial payment from Zogenix, and we will be entitled to a milestone payment upon initial commercialization, and royalty payments upon any commercialization of products in the U.S. and other countries, including the European Union, that may be developed and sold using the DosePro technology. In December 2007, Zogenix submitted a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for the migraine drug sumatriptan using the needle-free injector DosePro ("Sumaveltm DosePro"). The NDA was accepted for filing by the FDA in March 2008. The same month, Zogenix entered into a license agreement to grant exclusive rights in the European Union to Desitin Pharmaceuticals, GmbH to develop and commercialize Sumavel DosePro in the European Union. On October 31, 2008, Zogenix received a Complete Response Letter from the FDA on its NDA. On February 18, 2009, Zogenix disclosed that the Complete Response letter from the FDA cited the need for a single additional in vitro test to be conducted and that Zogenix recently submitted the requested information to the FDA. The FDA accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009. Zogenix stated that it is their intention to launch Sumavel DosePro following FDA approval in the second half of 2009.

[BrauchGeld]

Hab ein gutes gefühl auch diese Aktie mit profit loszuwerden


Aradigm Presents Phase 1 and Phase 2 Data on Inhaled Liposomal Ciprofloxacin in Healthy Volunteers and Cystic Fibrosis Patients at the 32nd European Cystic Fibrosis Conference

Both Studies Demonstrated Pharmacokinetics Supporting Once-Daily Dosing, with Significant Reduction in Bacterial Infection in Cystic Fibrosis Patients

* On Thursday June 11, 2009, 7:00 am EDT

http://finance.yahoo.com/news/Aradigm-Presents-Phase-1-and-b…

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.371.387 von BrauchGeld am 11.06.09 13:05:50

Bam Capital (Dendreon´s TopAktionär) und Deerfield sind bei ARDM neu eingestiegen !

http://www.nasdaq.com/asp/holdings.asp?symbol=ARDM&selected=…

[BrauchGeld]

PARTYYYYYYYYYY ....Schade das ich nur 10000st habe

[BrauchGeld]

Hier geht aber die Post bald könnt ihr meine Aktie haben für sagen wir mal min. 0,50€

[BrauchGeld]

Rekordvolumen und über 40% plus das sieht hervorragend aus !

[Popeye82]

Hi BrauchGeld,

Nur mal interessehalber -was würdest Du hierzu sagen(hab mal ein paar Passagen hervorgehoben, die sich doch recht beachtlich anhören) ...??


Lipoxen is filled to the brim with blockbuster drug potential - Proactive Investors - Jun 11, 2009

- by Ian Mclelland -
www.proactiveinvestors.co.uk/companies/news/6096/lipoxen-is-…

"Virtually every week investors are reminded of the high risks of investing in start up pharmaceutical and biotechnology companies who rely solely on the capital markets to fund their drug development programs. The sector has been decimated in the past twelve months by the rapid contraction in finance available which has resulted in a number of AIM companies either delisting to conserve cash, diluting existing shareholders into oblivion to stay afloat, or effectively putting the company up for sale. It has not been pretty.

There are some positive outcomes from all this turmoil however - investors quickly learn which companies are build to last. There are a handful of characteristics that any junior pharmaceutical company requires, but there are three qualities that really deliver the litmus test. First, and most obvious, the company has to have a solid portfolio of intellectual property and drug candidates at various stages of development. Second, it requires a loyal shareholder base, willing to support the company irrespective of wider market turmoil. Third, and equally important, it requires sound management. This combination of management, excellent prospects and strong shareholder support is actually quite a rare combination in the junior pharmaceutical sector, let alone across the entire market.

They do exist however, and one of those companies is Lipoxen (AIM: LPX), who successfully raised £2.9 million last week ensuring it is funded through to 2010.

Lipoxen has arguably the most impressive range of company making technologies of any pharmaceutical company on AIM under £50 million – perhaps £100 million. It arrived on shareholder’s radar in January 2006, and since then has announced a dizzying array of research collaborations, pre-clinical and clinical trials and licensing agreements for some of its novel technology platforms. If Lipoxen is accused of anything, it would be that it has so many applications in development that investors struggle to see the company’s potential.

Lipoxen in the simplest of terms, can be viewed as a company targeting three specific areas – biological, vaccines and oncology drugs. It has three novel platforms to do this – PolyXen®, ImuXen® and VesicAll®. The key focus of the company is the first two platforms.

The PolyXen® platform is a versatile protein drug delivery technology. The technology is essentially based on a polymer of sialic acid which is naturally found in the body. The polymer is attached to a drug, which generates several positive attributes. Firstly, as the polymer is a natural substance, it effectively hides the drug from the body’s immune system. Second, the polymer acts like a tail on the drug, substantially increasing its life once administered. This means the drug dose frequency required is greatly reduced as the drug is released over a longer time frame. PolyXen® polymers also improve the stability and water solubility.

Rather than focus solely on effectively reengineering drugs on its own, Lipoxen has opted to partner with major pharmaceutical companies who already have blockbuster drugs in the market, but are nearing the end of their patent protection. Lipoxen offers them a novel solution. By taking an established drug and adding its polymer, the new drug gains all of the improved characteristics of the polymer, and as a reformulation, can reapply for a new patent. This is clearly an opportunity many pharmaceuticals would not like to miss, and Lipoxen has already signed a string of agreements with large players to develop reengineered version of their own products.

One of those is SuliXen®, an improved formulation of insulin for diabetics. Another is ErepoXen®, which recently received positive Phase I clinical trial results for both efficacy and toxicity. ErepoXen® is being developed as a long-acting form of EPO, a product with annual sales of US$9bn, for the treatment of anaemia in cancer and renal disease patients.

Lipoxen’s other major technology platform is ImuXen®, which is also a naturally derived application that is based around liposome. Liposome is widely accepted as an effective medium for delivering drugs for cancers and other diseases. Lipoxen’s technology is designed to improve the deliverability of a wide range of potential products, but they key driver the company is focusing on is vaccines.

ImuXen® uses a proprietary liposomal formulation method to deliver vaccine materials to the immune system, in a manner which is designed to emulate the response of a natural encounter with the infectious agent. “The key benefit of ImuXen® technology is that it gives rise to strong immunological responses, akin to that achieved by live attenuated vaccines, while avoiding completely the risk of infection as a result of vaccination which is a rare but
significant consequence of some live attenuated vaccines,” the company states – and clearly some people agree…

There is a plethora of agreements already in place testing the ImuXen platform on a wide variety of vaccines, including Hepatitis and pneumococcal vaccines plus a range of chemotherapy drugs including Paclitaxel. It is certainly worth noting that one of the largest vaccine manufacturers in the world, the Serum Institute of India Limited, is the second largest shareholder in Lipoxen, after subscribing in a placing in 2007 followed by several share purchases in the market. It is furthermore worth noting that Lipoxen has already signed a world-wide licence agreement with InterVet - one of the largest animal health company’s in the world, and a subsidiary of Schering-Plough Corporation (NYSE: SGP). Just one more point to take note of, Lipoxen has agreements in place already with some very big players including Baxter (NYSE: BAX), Amgen (NYSE: AMGN), Genzyme (NYSE: GENZ) and Genentech (NYSE: DNA)! Baxter in particular appears so impressed it subscribed to Lipoxen’s recent placing (Lipoxen has an exclusive worldwide development and licence agreement with a subsidiary of Baxter International to develop improved, longer-acting forms of blood-clotting factors.)


A recent pre-clinical study into Lipoxen’s vaccine candidate for the prevention of Hepatitis-E outlines the potential quite nicely. The trial combined Lipoxen’s ImuXen® formulation technology with the Serum Institute manufacturing capability to produce a liposomal vaccine. The vaccine, after administration, produced a “very strong antibody response” and after vaccination there was “complete” protection from liver disease. A similarly positive pre-clinical result was recently announced for a flu vaccine, which caught the attention of the UK press reporting on Swine Flu.

There are many other ongoing preclinical and research collaborations ongoing where Lipoxen’s technology is involved. Partners include Cambridge Biostability, University of Cambridge and the Health Protection Agency, University of Nottingham, and have received funding from a wide range of groups, including the PATH Malaria Vaccine Initiative.

It is amazing to think that all of this is occurring in just one small company listed on AIM with a market capitalisation of £15 million. One would be wrong to assume that cash burn rates are high – quite the opposite. Compared to many of its peers, Lipoxen is burning through a comparatively modest amount of money, thanks largely due to a frugal financial director, who shares a small office with the CEO, and the fact that many of the company’s product developments are being funded by its partners – Lipoxen only has 24 employees.

Lipoxen shares its non-executive chairman, Brian Richards, with Alizyme plc, while most of the non-executive directors are top heavy from the research and development field. Lipoxen’s board is balanced out with CEO Scott Maguire, a US investment banker with a few decades of experience in the life science and health care investment banking sector.

This all blends into a rather potent cocktail at Lipoxen. The CEO brings in a wealth of experience in the healthcare investment banking industry, the company’s three platform technologies have a impressive array of possible applications and routes to commercialisation and the shareholder register looks as solid as rock.

This makes Lipoxen stand out from the crowd, and it certainly warrants considerable due diligence from serious investors with a long term view.

Profile
Lipoxen Plc is a United Kingdom-based holding company. The Company, along with its subsidiaries, is engaged in the development of drug and vaccine delivery systems and products in the fields of protein drugs, vaccines and oncology. The Company’s three delivery technologies include PolyXen, ImuXen and VesicALL. PolyXen technology uses the biopolymer polysialic acid to prolong the active life and improve the pharmacokinetics of therapeutic peptides and proteins. ImuXen technology uses liposome-based constructs to enhance the effectiveness of deoxyribonucleic acid (DNA), protein and polysaccharide vaccines. VesicALL technology is a technology that enables the formulation of anti-cancer treatments and other drugs using liposomal entrapment. "


um das mal professionell zusammenzufassen: ich hab keine Ahnung von Deren Produkten -ansonsten hört es sich aber wirklich großartig an.


Grüße,
Popeye

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.376.480 von Popeye82 am 11.06.09 21:54:15

Hallo Popeye ich kenne LPX die Aktie ist durchaus interessant ich sehe auch gerade das der riese Baxter mit knapp 5% in LPX eingestiegen ist aber Pipeline befindet sich noch im frühen Stadium deshalb für mich persönlich nicht so interessant .


http://www.iii.co.uk/investment/detail?code=cotn:LPX.L&displ…

[BrauchGeld]

Die Ampeln stehen auf grün für ARDM

Laut Allotc ist jetzt Aradigm ein Strong buy gestern noch nur Buy ..
http://www.allotcbb.com/quote.php?symbol=ardm

[koronis]

Antwort auf Beitrag Nr.: 37.376.799 von BrauchGeld am 11.06.09 22:32:03

ich weiß, es hat nicht viel zu sagen, aber die aktie stand mal bei 250 US$. Volumen außergewöhnlich hoch. Käufer überwiegen deutlich. Das sieht nach einer guten Zündung aus.

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.376.890 von koronis am 11.06.09 22:48:55

Ich glaube heute wird wieder ein guter Tag für ARDM !

[BrauchGeld]

[BrauchGeld]

http://www.rallymonkey.com/oldvideo.php

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.382.141 von BrauchGeld am 12.06.09 16:07:43

Hab meine in F gekauften Aktien umgewandelt !

http://quote.barchart.com/texpert.asp?sym=ARDM

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.395.553 von BrauchGeld am 15.06.09 17:39:49

Gute chancen das wir diese Woche noch über 30cent gehen werden !

[koronis]

Antwort auf Beitrag Nr.: 37.395.951 von BrauchGeld am 15.06.09 18:24:34

scheint so, als würden wir heute schon die 30 in angriff nehmen. unser Baby steigt und steigt und (noch) keiner merkt es

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.396.320 von koronis am 15.06.09 19:10:36

Könnte was werden heute wenn die 25cent geknackt wird !!

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.405.051 von BrauchGeld am 16.06.09 19:21:42

Hab ein gutes Gefühl das es heute über die 25cent geht !

[BrauchGeld]

Am 15 juli ist die US-Zulassung wenn se die erhalten sehe ich einen hype bis 1$ oder gar mehr !

[BrauchGeld]

Die Party geht weiter die 30cent ist in sichtweite !

[BrauchGeld]

Jetzt 100% plus seit Thread eröffnung und das ist noch gar nichts !

[koronis]

Antwort auf Beitrag Nr.: 37.414.878 von BrauchGeld am 17.06.09 22:11:23

damits kein monolog wird schreib ich auch noch mal was ich denke jetzt gehts erst mal kontinuierlich bergauf, bis zum 15 Juli.

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.415.131 von koronis am 17.06.09 22:49:38

Wow jeden tag im grünen bereich

[BrauchGeld]

[koronis]

Antwort auf Beitrag Nr.: 37.420.622 von BrauchGeld am 18.06.09 17:22:42

das geht in immer größeren Schritten bergauf. seher wir heute noch die 40?

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.421.212 von koronis am 18.06.09 18:16:00

Ein paar Minuten vor Börsenschluß kam dieser artikel das mit hoher sicherheit in der nächsten Woche für weiteren Kursanstieg sorgen wird !
Mein Finger ist bereit den Verkaufsknopf zudrücken spätestens am 15.Juli ist es soweit !

http://seekingalpha.com/article/144288-aradigm-hard-to-value…

Aradigm Corp (ARDM.OB) is a difficult company to value. We like the product pipeline, specifically the inhaled Cipro product (ILCH) for BE and CF, but more visibility is needed before we can recommend investment in the name.

Plus, Aradigm continues to post operating losses and unless the company can sign a development and commercialization partner for ILCH in 2010, the company is going to have to raise additional cash. We already witnessed an 82% dilutive offering in February 2009. At this point we think that management is going to have to raise as much as $30 - 40 million over the next 3+ years in order to get to cash flow positive operations and positive EPS in 2013.

Hopefully the bulk of this will come in the form of an upfront payment on ARD-3100/3150. Other potential non-dilutive cash raising opportunities exists from Zogenix, the anthrax program, or through partnering ARD-1600 or ARD-iDMS.

The company’s AERx Essence technology is among the best we have seen in the market. The technology compares well with other inhaled platforms we have seen including Alexza’s (ALXA) Staccato platform, Mannkind’s (MNKD) Technosphere, and Alkermes' (ALKS) AIR technology.

AERx Essence alone is probably worth a market value of $50 million to a company looking to develop next-generation inhalable drugs. The platform is broadly applicable and allows for the development of treatments for a host of diseases, including diabetes, cystic fibrosis, anthrax, asthma, COPD and pulmonary arterial hypertension.

The best near-term catalyst on the horizon is the initiation of a phase IIb program with the inhaled liposomal ciprofloxacin hydrochloride (ILCH) candidate in non-CF bronchiactisis (BE). Assuming this trial starts in the third quarter 2009, data should be available before the end of the year.

If positive, it could allow management to form a development and commercialization partnership in 2010. As such, Aradigm might be an excellent purchase for the high-risk tolerant biotech investor. Although we are hesitant to recommend the purchase of a volatile OTC traded name with limited daily trading volume, the upside is significant. Our near-term target is $0.50.

[BrauchGeld]

Im moment macht ARDM eine kleine pause aber der nächste Angriff wird schon vorbereitet bis zum 15.Juli ist es nicht mehr weit ...

[koronis]

Antwort auf Beitrag Nr.: 37.480.135 von BrauchGeld am 27.06.09 16:57:09

bin ich ganz deiner meinung. jetzt holt sie luft. ich denke bis 0.40 wird der 2. Ausschlag mindestens gehen. Volumen hat lehrbuchmäßig nachgelassen und der Kurs steigt langsam wieder an. ich überlege, ob ich bisschen nachlege

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.480.849 von koronis am 27.06.09 21:21:08

Aradigm´s partner Zogenix hat die Zulassung erhalten , Aktie ist gut bin aber trotzdem raus um mehr Bioniche zukaufen .

http://www.zogenix.com/index.php/news/

[Ventrikel]

Antwort auf Beitrag Nr.: 37.587.757 von BrauchGeld am 16.07.09 19:13:18

Kann bitte jemand den RT-chart reinstellen, bin leider in Arbeit und hab keinen entsprechenden Zugang.

Danke im voraus!!

[koronis]

Ich glaube heute startet die Rakete...

NEWS

ARDM,

Aradigm Receives Orphan Drug Designation for Inhaled Liposomal Ciprofloxacin to Treat Cystic Fibrosis in Europe

* Press Release
* Source: Aradigm Corporation
* On Wednesday August 5, 2009, 4:05 pm EDT


HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTCBB:ARDM - News) (the “Company”) today announced that the European Medicines Agency (EMEA) granted Orphan Drug Designation to the Company’s inhaled liposomal ciprofloxacin drug product candidate for the treatment of lung infections associated with cystic fibrosis (“CF”).
Related Quotes
Symbol Price Change
ARDM.OB 0.2395 -0.0055
Chart for ARADIGM CORP
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Under European guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is the first product candidate for the indication approved for marketing in the European Union. Orphan drug designation also allows the candidate's sponsor to seek assistance from the EMEA in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the Commission as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant.

“We are very pleased that the EMEA granted our liposomal ciprofloxacin Orphan Drug Designation for the treatment of cystic fibrosis,” said Dr. Igor Gonda, the Company’s CEO and President. “This designation is an important step in our development of a new chronic treatment for management of respiratory infections commonly experienced by CF patients. Our once-a-day dosing has the potential to significantly decrease the burden of therapy for these patients.”

Ciprofloxacin is a widely prescribed antibiotic in the form of oral and intravenous formulations to treat acute exacerbations of infections of the lung frequently experienced by cystic fibrosis patients. It is often preferred because of its broad-spectrum anti-bacterial action. The Company’s once-a-day novel inhaled formulation of ciprofloxacin delivered in liposomes is to be used for chronic maintenance therapy as it is expected to achieve high antibiotic concentration for efficacy at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects.

The Company was granted previously orphan drug designations by the U.S. Food and Drug Administration for inhaled liposomal ciprofloxacin for the management of CF and for non-cystic fibrosis bronchiectasis. The Company is also developing inhaled liposomal ciprofloxacin as a potential treatment for prevention and treatment of bioterrorism infections such as inhaled anthrax.

About cystic fibrosis

Cystic fibrosis is a genetic disease that causes thick, sticky mucus to form in the lungs, pancreas and other organs. In the lungs, the mucus tends to block the airways, causing lung damage and making these patients highly susceptible to lung infections. According to the Cystic Fibrosis Foundation, CF affects roughly 30,000 children and adults in the United States and roughly 70,000 children and adults worldwide. According to the American Lung Association, the direct medical care costs for an individual with CF are currently estimated to be in excess of $40,000 per year.

About Aradigm

The Company 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. Current activities include self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, inhalation anthrax infections and smoking cessation.

More information about the Company can be found at www.aradigm.com.

[dottore]

Antwort auf Beitrag Nr.: 37.720.708 von koronis am 06.08.09 07:23:36

diese Tage berät die FDA über die Zulassung des Inhalat mit Ciprofloxacin. Die Resultate sind so umwerfend gut, dass von einer raschen Zulassung ausgegangen werden darf.
Zogenix ist eine 100%ige Tochter der Aradigm und im Biotechherzen der USA - in San Diego- angesiedelt.