AERx Drug Delivery System
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.
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| 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.
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
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.
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| AERx Strip dosage form Detail || Nozzle Detail |
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)
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 / |
| Research || Preclinical || Phase 1 || Phase 2 || Phase 3 || New Drug Application || FDA |
| ARD-3100 Cystic Fibrosis (CF) |
| Liposomal || |
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| Ciprofloxacin || || || || || || || |
| ARD-3150 Bronchiectasis (BE) |
| Liposomal || |
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| Ciprofloxacin || || || || || || || |
| ARD-1100 Inhalation Anthrax (1) |
| Liposomal || |
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| 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
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!
$3.5B Market Acute Migraines and Cluster Headaches
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.
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.
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
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(MORE UPDATES COMING... INCLUDING CHARTS, NEWS and OPINIONS)
CHART link below!
*** LifeSci Advisors Announces Investment Opinion on Aradigm Corporation ***
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."
Phase III Program in Bronchiectasis Planned to Launch in 2014; Recent Partnership With Grifols Worth Up to $90 Million Plus Tiered Royalties;
ALBANY, New York, February 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.
U.S. FDA advisers back MannKind's inhaled diabetes drug Afrezza
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.
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
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)
FDA Grants QIDP Designation to Aradigm's Inhaled Antibiotic
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
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