Aradigm Completes Study of Inhaled Treprostinil with AERx Inhaler
HAYWARD, Calif.--(BUSINESS WIRE)--Nov 10, 2008 - Aradigm Corporation (OTCBB:ARDM) today announced the results of a clinical trial of inhaled treprostinil in Aradigm's palm-size AERx Essence(R) inhaler and receipt of $2.75 million, which includes the first milestone of $2 million and development costs. The cross-over study in 14 healthy volunteers conducted in the United Kingdom compared aerosol delivery and distribution using gamma scintigraphy, as well as pharmacokinetics and safety of inhaled aqueous solution of treprostinil delivered via the AERx Essence inhaler, versus the Nebu-Tec OPTINEB(a)ir nebulizer. OPTINEB was used by Lung Rx, Inc. ("Lung Rx"), a wholly owned subsidiary of United Therapeutics Corporation ("United Therapeutics") in its Phase 3 TRIUMPH (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension) study of inhaled treprostinil, which is included in the New Drug Application submitted by Lung Rx to the US Food and Drug Administration for the treatment of pulmonary arterial hypertension (PAH).
Data from the study showed that the AERx Essence inhaler efficiently delivered aerosolized treprostinil deeper into the lung than delivery by the OPTINEB nebulizer. Inhaled treprostinil was well tolerated from both delivery systems, and no serious adverse events were reported in the study. The AERx Essence inhaler is an easy to use inhalation device that is expected to deliver medication to the patient in 2 to 4 breaths, significantly reducing the burden of therapy for PAH patients.
"We believe that the convenience and directed lung delivery with the AERx inhaler could be very attractive for many pulmonary arterial hypertension patients," said Martine Rothblatt, Ph.D., Chairman and CEO of Lung Rx and United Therapeutics. "We will take steps on the clinical, manufacturing and regulatory fronts toward the approval and launch of this product."
Lung Rx will be responsible for funding the remainder of the development of treprostinil in the AERx inhaler through registration and commercial launch. Aradigm will receive full reimbursement of its expenses for activities on this program conducted for Lung Rx.
"I am very pleased that once again we have been able to produce data demonstrating the outstanding performance of our AERx technology in the delivery of valuable drugs to the lung. We will now work with Lung Rx to advance the technology transfer to enable them to provide PAH patients with our AERx technology as rapidly as possible," said Igor Gonda, Ph.D., President and CEO of Aradigm.
As previously announced, Dr. Gonda will be presenting at the Rodman & Renshaw 10th Annual Healthcare Conference on Tuesday, November 11, at 5:20 Eastern, at the Palace Hotel in New York City. The presentation can be accessed from the Company's website at www.aradigm.com.
About Lung Rx
Lung Rx, Inc. is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products.
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. Current activities include partnered and self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, pulmonary hypertension, bronchitis, inhalation anthrax 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 that involve risk and uncertainties, including statements relating to future program development, approval and commercialization, as well as the other risks detailed in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including the Company's Annual Report on Form 10-K, and quarterly reports on Form 10-Q.
Aradigm, AERx, AERx Essence and the Aradigm logo are registered trademarks of Aradigm Corporation.
(a) Other names and brands may be claimed as the property of others.
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Posted: November 2008