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Aradigm

 

AERx Drug Delivery System

Liposomal Formulations

Intellectual Property

The Power Behind Effective Pulmonary Drug Delivery

Aradigm's innovative AERx pulmonary drug delivery platform demonstrated performance that is highly efficient and precise compared to other inhalation systems. The performance of the AERx platform is due to its unique fine mist aerosol generation systems combined with patented breath control technology. For each therapeutic application, the AERx platform can be customized to deliver drugs and biologics to treat lung diseases topically or to transport therapeutics through the lung and into the bloodstream.

AERx First-Generation Hand-Held Delivery Devices
AERx first-generation inhalation delivery systems are sophisticated electromechanical devices that were designed to achieve superior efficiency and precision required for applications such as Type 1 and Type 2 diabetes management with inhaled insulin, represented by the product AERx iDMS previously licensed to our partner Novo Nordisk. The first-generation devices include the two examples shown below. The first device is for diabetes management. It features dose titration capability to one unit, inhaled air temperature and flow control as well as electronic disease management capabilities. The second device has similar features to the AERx iDMS but is for pain management. Next to the device, the photograph shows the user and prescriber electronic keys to prevent misuse and abuse of controlled drug substances.

 
strip detail nozzle detail
Diabetes Management Pain Management 

  AERx Second-Generation Delivery Device: AERx Essence®
AERx Essence is a small, palm-size all-mechanical device. The AERx Essence system offers a level of performance (efficiency and reproducibility) close to the first generation AERx system, but in a small, light and low-cost package, yet retaining the high durability of the first generation systems.

 
Click on the image for a brief video depicting AERx Essence dosing
AERx Essence device Read about AERx Capabilities

Efficient, Precise Aerosol Generation
Aradigm's AERx pulmonary drug delivery technology provides performance that is at the leading edge in terms of efficiency of delivery to the lung and reproducibility of dosing - not just in the laboratory but also as determined in many human clinical trials.

This method of delivery also often provides more rapid onset of action than pills or patches because molecules are more immediately absorbed into the bloodstream and avoid becoming compromised by gastrointestinal degradation and metabolism. In fact, several biologics that could not be delivered by oral administration have been delivered effectively using the AERx system.

Advanced Breath-Control Technology
Studies have shown that even well trained patients tend to develop improper inhalation techniques over time, resulting in less effective therapy. To ensure more consistent dosing and lasting beneficial effects, Aradigm's AERx delivery system employs powerful breath control methods and technologies to guide patients into proper breathing maneuvers. This feature can also be customized for different patient groups, such as young children or others with small lung volumes.

Additional Advantages of the AERx System
• Small hand-held devices
• Adequate dose typically in one or two breaths
• Liquid formulation - applicable to many valuable biologics and drugs
• Very short administration time (typically 1-2 breaths)
• Highly efficient, precise aerosol delivery
• Breath control to ensure reliable drug delivery to lung
• Outstanding reproducibility in humans
• Simple to use
• Dose titration capabilities
• Eliminates needle-phobia issues and potential for needle-stick injury

Promising Applications
AERx pulmonary delivery systems successfully delivered 15 different drugs and biologics in human clinical trials.

AERx Strip® Technology
The single-use nozzle contained in each disposable AERx Strip dosage form is created with a laser-machined array.  Nozzle hole exits are approximately 1 micron in diameter with a uniform shape, to provide consistent, fine-particles drug delivery.

 
strip detail nozzle detail
AERx Strip dosage form Detail Nozzle Detail

Scientific Publications
ARADIGM scientists have published extensively on aerosol formulation and pulmonary drug delivery. Following are citations from some of those works.

Gonda, I. et al.: "Inhalation Delivery Systems with Compliance and Disease Management Capabilities" Journal of Controlled Release 1998; 53:269-274.

Schuster, J. et al.: "The AERx Aerosol Delivery System" Pharmaceutical Research 1997;14(3):354-357.

Farr, S.J. et al. "AERx - Development of a Novel Liquid Aerosol Delivery System" Respiratory Drug Delivery V. Dalby, R.N. et al. (eds.) Interpharm Press Inc., Buffalo Grove, Illinois. 1996, pp. 175-184.

Desphande D. et al. "Aerosolization of Lipoplexes Using AERx® Pulmonary Delivery System" AAPS Pharmaceutical Sciences 2002. 4(3): 1-10.

 

Sep 7, 2010  

San Diego's Zogenix Files for $90M IPO to Expand Development of Needle-Free Injector and Pain Drugs 

 

FDA Decision Pending For 7/15/09 for Zegonix (DosePro)

APPROVED!

 

DosePro Video Link

 

DosePro needle-free drug delivery system to treat migraine and cluster headache. SUMAVEL DOSEPRO is a fast-acting, easy-to-use therapy that patients can self-administer. SUMAVEL DOSEPRO is a pre-filled, single-use disposable, needle-free drug delivery system designed to deliver 6 mg of sumatriptan in 0.5mL of sterile liquid.

Aradigm is entitled to a $4 million milestone payment upon first commercial sale, and royalty payments upon any sales of products in the U.S. and other countries, including the European Union, which may be developed and sold using the DosePro technology.

Zogenix Licenses European Development

and Commercial Rights for sumatriptan DosePro(TM)...LINK

 

 

Below is a list of proprietary programs and their respective stages of development. In addition to these current programs, Aradigm continues to apply its expertise and intellectual property to other potential therapeutic applications that may benefit from the Company's novel formulations and drug delivery technology.

Proprietary Programs
  Product /
  Indication
Research Preclinical Phase 1 Phase 2 Phase 3 New Drug Application FDA
Approved
ARD-3100   Cystic Fibrosis (CF)
Liposomal



       
Ciprofloxacin              

ARD-3150   Bronchiectasis (BE)
Liposomal



       
Ciprofloxacin              

ARD-1100   Inhalation Anthrax (1)
Liposomal

         
Ciprofloxacin              

ARD-1600   Smoking Cessation
Nicotine


 

 

"We are Fulfilling Unmet Needs in Pulmonary Medicine."

Aradigm is an emerging specialty pharmaceutical company developing and commercializing a portfolio of drugs delivered by inhalation for the treatment of severe respiratory disease.

Bolstered by its depth of expertise in pulmonary drug delivery and an extensive intellectual property portfolio, the Company is uniquely positioned to fulfill unmet needs in pulmonary medicine. Our corporate strategy includes the following:

• Continued development of proprietary respiratory disease therapies

• Pursue regulatory pathways that reduce the time, costs and risks associated with product development

• Conservation of capital for proprietary product development through the outsourcing of late stage clinical and commercial scale manufacturing

• Deployment of a specialized sales and marketing force to meet the unique needs of pulmonologists in the United States

• Out-licensing technology and intellectual property assets for applications that lie outside the company's strategic interests and core expertise

http://www.aradigm.com/

Investor Relations http://investor.aradigm.com/

 

Zogenix Royalties ( from May/12/09 10-Q)

In August 2006, the Company sold all of its 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 DosePro tm ). The Company received a $4.0 million initial payment from Zogenix, and it will be entitled to a milestone payment upon initial commercialization, and royalty payments upon commercialization of DosePro products. 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 ("Sumavel tm 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.

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Here is the Sumavel DosePro that was developed by Aradigm and sold to Zogenix.  Zogenix has now teamed up with Japan's 2nd Largest pharma company (Astellas)  to market this product and ARDM will get Royalties from tese sales!

 

 

Manufacturing
SUMAVEL® DosePro™

Sumavel DosePro Manufacturing Video Thumbnail

 

 

SUMAVEL® DosePro™


$3.5B Market Acute Migraines and Cluster Headaches


Aradigm Corporation Logo

SUMAVEL DosePro Receives Marketing Approval in Germany and the United Kingdom

  Aradigm to Earn 3% Royalty on Net Sales 

 HAYWARD, Calif.--(BUSINESS WIRE)-- Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced that Zogenix, Inc. ("Zogenix", Nasdaq:ZGNX) and Desitin Pharmaceuticals GmbH ("Desitin") were granted approval of the Marketing Authorization Application ("MAA") for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache by the Federal Institute for Drugs and Medical Devices of Germany (BrArM) and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA). The approvals were received five weeks after receipt of the first European Union ("E.U.") approval for SUMAVEL DosePro in Denmark. According to Zogenix, Germany and the United Kingdom are two of the largest pharmaceutical markets in Europe. Aradigm is entitled to 3% royalty on net sales of SUMAVEL DosePro in all territories, including the US where this product is marketed by Zogenix and Astellas Pharma US, Inc.

Desitin is awaiting additional E.U. marketing authorizations and plans to launch SUMAVEL DosePro in Denmark and Germany in early 2011, and then follow with its U.K. launch. Germany is the reference member state for the SUMAVEL DosePro MAA through the E.U. Decentralized Procedure.

SUMAVEL DosePro offers fast acting, easy-to-use, needle-free subcutaneous administration of sumatriptan as a potential treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. According to Zogenix, these unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraines and migraines with vomiting.

In August 2006, Aradigm sold all of its assets related to the needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to Zogenix. Aradigm is entitled to royalties from the sale of all products based on this technology platform.

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, inhaled bioterrorism infections and smoking cessation.

More information about Aradigm can be found at www.aradigm.com.

Forward-Looking Statements

Except for the historical information contained herein, this news release contains forward-looking statements, including, but not limited to, statements regarding our future plans and expectations related to receipt of royalty payments from Zogenix and further European approvals of SUMAVEL DosePro. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated therein, including, but not limited to, the receipt of royalty payments from Zogenix, as well as the other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 24, 2010, and the Company's Quarterly Reports on Form 10-Q.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.

SUMAVEL is a registered trademark and DosePro is a trademark of Zogenix, Inc.

For Aradigm Corporation
Nancy Pecota, 510-265-9370
Chief Financial Officer
  

Source: Aradigm Corporation

News Provided by Acquire Media

http://investor.aradigm.com/releasedetail.cfm?releaseid=542968


 

 

 

 

(MORE UPDATES COMING... INCLUDING CHARTS, NEWS and OPINIONS)
 

CHART link below!

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=55772665&txt2find=ardm

 


*** LifeSci Advisors Announces Investment Opinion on Aradigm Corporation ***

http://www.lifesciadvisors.com/clientinfo/aradigm/Aradigm__LSA_Initiation_2-17-11__clientinfo.pdf


NEW YORK, NY--(Marketwired - Oct 29, 2013)

"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications." 

http://www.marketwired.com/press-release/lifesci-advisors-initiates-coverage-of-aradigm-corporation-otcbb-ardm-1845844.htm 

Phase III Program in Bronchiectasis Planned to Launch in 2014; Recent Partnership With Grifols Worth Up to $90 Million Plus Tiered Royalties;

 


ALBANY, New YorkFebruary 25, 2014 /PRNewswire/ 
Pulmonary Drug Delivery Systems Market Expected to Reach USD 28.7 Billion Globally in 2019: Transparency Market Research
According to a new market report published by Transparency Market Research "Pulmonary Drug Delivery Systems Market(Products- Metered Dose Inhalers, Dry Powder Inhalers and Nebulizers; Applications- Asthma, COPD and Cystic Fibrosis) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019," the global pulmonary drug delivery systems market was valued at USD 21.03billion in 2012 and is expected to grow at a CAGR of4.5% from 2013 to 2019, to reach an estimated value of USD 28.70billion in 2019.
http://www.prnewswire.com/news-releases/pulmonary-drug-delivery-systems-market-expected-to-reach-usd-287-billion-globally-in-2019-transparency-market-research-247046411.html


HYATTSVILLE, Maryland Tue Apr 1, 2014 7:49pm EDT
U.S. FDA advisers back MannKind's inhaled diabetes drug Afrezza
http://www.reuters.com/article/2014/04/01/us-mannkind-fda-diabetes-idUSBREA301Z620140401
ARDM has huge potential with AERx iDMS (inhalable insulin) right now.
The drug was in the last lap of clinical trials before halting by Novo Nordisk in past.
http://www.aradigm.com/products_iDMS.html
http://www.aradigm.com/products_1700.html


April 15, 2014 07:00 AM Eastern Daylight Time
Results from Non-Tuberculous Mycobacteria (NTM) Study Using Aradigm's Liposomal Ciprofloxacin to be Presented at the American Thoracic Society 2014 International Conference
http://www.businesswire.com/news/home/20140415005071/en/Results-Non-Tuberculous-Mycobacteria-NTM-Study-Aradigm%E2%80%99s-Liposomal#.U00dfvl_vfg
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=840192


April 30, 2014 07:00 AM Eastern Daylight Time
Aradigm Corporation Announces the Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=843923


Tuesday, 20 May 2014 07:00am EDT 
FDA Grants QIDP Designation to Aradigm's Inhaled Antibiotic
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=848931
http://www.oindpnews.com/2014/05/aradigms-pulmaquin-gets-qidp-status/
 


HAYWARD, Calif., Jun 03, 2014 (BUSINESS WIRE)
Aradigm Receives $5 Million Milestone For Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=852036


June 23, 2014 07:00 AM Eastern Daylight Tim
Aradigm Corporation Announces the Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=855907

DRUG DELIVERY TECHNOLOGIES MARKET FORECAST 2014-2024

Opportunities for Leading Companies

Leading companies and potential for market growth
Overall world revenue for drug delivery technologies will reach $138.1bn in 2014, our work forecasts. We predict steady growth from 2014 to 2024. Our work shows you what organisations hold greatest potential. See profiles of 18 leading companies, including these:
• 3M
Aradigm Corporation
• Vectura Group
• Applied Pharma Research
• Catalent Pharma Solutions
• Emisphere Technologies
• Ethypharm
• Glycologic
• Alkermes
• Antares Pharma
• Bioject Medical Technologies
• Pacira Pharmaceuticals
• Nanopass Technologies
• Noven Pharmaceuticals
• CIMA Labs
• Columbia Laboratories
• Generex Biotechnology Corporation
• pSivida

https://www.visiongain.com/Report/1252/Drug-Delivery-Technologies-Market-Forecast-2014-2024
 


SEC Company Filings - Aradigm Corporation
https://searchwww.sec.gov/EDGARFSClient/jsp/EDGAR_MainAccess.jsp?search_text=*&sort=Date&formType=1&isAdv=true&stemming=true&numResults=10&queryCo=Aradigm&numResults=10

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ARDM
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#1362   Does somebody know the reason? rikic 12/08/16 10:21:16 AM
#1361   Insider acquired 40900 shares (SEC Form 4) rikic 12/08/16 05:57:11 AM
#1360   STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP rikic 12/07/16 02:06:49 AM
#1359   Aradigm to Present at the Stifel 2016 Healthcare rikic 11/15/16 06:21:09 AM
#1358   Multi-million Dollar DTRA Funding for Biodefense Research with rikic 10/18/16 11:11:25 AM
#1357   Aradigm Announces Australian Research Council Funding to Develop rikic 10/09/16 10:40:52 AM
#1356   Aradigm Announces Last Patient Dosing Visit in ORBIT-3 rikic 09/22/16 11:03:11 AM
#1355   Aradigm (ARDM) Shares March Higher, Can It Continue? rikic 09/21/16 08:51:28 AM
#1354   Aradigm to Host Analyst Meeting and Webcast on rikic 09/21/16 08:48:04 AM
#1353   Will ARDM Bounce Last Just a Few Days? rikic 09/20/16 02:27:43 AM
#1352   bullish signal batteryman 04/28/16 07:38:31 AM
#1351   Today ARDM can fly over 6 $$ ( batteryman 04/26/16 09:27:17 AM
#1350   Today will be a great day. batteryman 04/22/16 09:51:45 AM
#1349   Positive Stock Sentiment batteryman 04/21/16 09:21:14 AM
#1348   nice chart. batteryman 04/20/16 11:36:10 AM
#1347   Excelent news: batteryman 03/17/16 07:54:55 AM
#1346   Its going higher and higher but its still BioSpecialist 03/16/16 09:43:45 AM
#1345   They have a long history of failure to drugmanrx 03/14/16 01:23:48 PM
#1344   Undiscovered ARDM is one of the cheapest Biotechs BioSpecialist 03/14/16 12:37:05 PM
#1343   Aradigm to Present at the Ladenburg Thalmann 2015 rikic 09/23/15 09:46:28 AM
#1342   Aradigm Corporation Completes Enrollment in Phase III Study rikic 09/22/15 07:37:03 AM
#1341   Results from Pulmonary Non-Tuberculous Mycobacteria (PNTM) Study Using rikic 09/10/15 09:25:37 AM
#1340   Brokerages Set $26.00 Price Target for Aradigm (NASDAQ:ARDM) rikic 09/03/15 03:28:15 AM
#1339   Phase 3 Study With Dual Release Ciprofloxacin for rikic 08/19/15 05:10:20 AM
#1338   Golden Cross Puig 08/06/15 01:08:04 PM
#1337   Golden Croos THIS WEEK !! Puig 08/06/15 01:06:07 PM
#1336   Back in,trading activity looks interesting.hopefully we'll get some straycat 06/11/15 03:28:30 PM
#1335   Prices below $7 per share was great opportunity rikic 06/10/15 08:41:50 AM
#1334   why is this halted this morning???????? KeaneO 05/21/15 10:00:03 AM
#1333   Results from Pulmonary Non-Tuberculous Mycobacteria (PNTM) Study Using rikic 05/12/15 10:58:43 AM
#1332   I believe in continuous growth of this stock. rikic 04/24/15 10:31:03 AM
#1331   Aradigm Announces Appointment of Dr. Robert A. Reed rikic 04/21/15 08:00:25 AM
#1330   Aradigm to Host Key Opinion Leader Breakfast and rikic 04/17/15 07:27:03 AM
#1329   Looking very good Goldmind 04/08/15 09:55:49 AM
#1328   Francisella Tularensis Infections - Pipeline Review, H1 2015 rikic 04/03/15 02:09:06 AM
#1327   Plague - Pipeline Review, H1 2015 rikic 04/03/15 02:08:08 AM
#1326   You are right. "...an Investigation Involving Possible Breaches..." :) rikic 04/03/15 02:07:14 AM
#1325   What.. Did they take to many shares for themselves... dingocub 03/22/15 01:10:36 PM
#1324   Here's the live radio show Igor Did last week.. dingocub 03/04/15 03:11:26 AM
#1323   Aradigm Corporation President & CEO Dr. Igor Gonda, rikic 02/27/15 07:43:38 AM
#1322   Strong Buy PT $26 (AnalystsReview.com) rikic 02/27/15 07:39:15 AM
#1321   Just bought in chulo8211 02/23/15 10:57:39 AM
#1320   INSIDERS STOCK BUYING FORM-4(5) rikic 02/17/15 06:00:01 AM
#1319   Aradigm Corp. PT $100 within 2-5 years. It rikic 02/13/15 10:06:22 AM
#1318   CEO Igor just bought some shares at $7.70 dingocub 01/27/15 04:03:36 PM
#1317   Aradigm Granted Key Composition of Matter Patents for rikic 01/15/15 11:28:03 AM
#1316   Looks like UP is the new direction (Anyone Anyone...) dingocub 01/12/15 11:37:32 AM
#1315   easily possible,wouldn't take much to move this micro straycat 01/08/15 10:41:20 PM
#1314   My Magic Ball sees $11 price by Jan 21st dingocub 01/08/15 11:53:43 AM
#1313   http://investor.aradigm.com/releasedetail.cfm?releaseid=882332 rikic 01/08/15 10:31:57 AM
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