HAYWARD, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Aradigm Corporation today announced that it has signed a development and commercialization agreement with United Therapeutics Corporation to generate a novel inhaled formulation for the treatment of pulmonary arterial hypertension (PAH). The strategic collaboration centers on the development of a novel, sustained release, liposomal formulation of treprostinil, an approved and marketed prostacyclin analogue, designed for delivery using the AERx System.
During the preliminary phase of this collaboration, Aradigm will be responsible for the development and preclinical testing of the novel liposomal treprostinil formulation to be delivered via the AERx System. By utilizing the unique features of the AERx technology, the delivery of the therapeutic compound will target the deep lung as a systemic treatment for PAH. Treprostinil is currently marketed by United Therapeutics as a continuous subcutaneous or intravenous infusion under the brand name Remodulin(R). A novel liposomal formulation of treprostinil delivered by the AERx System is expected to provide a non-invasive, sustained release therapy involving just once- or twice-daily inhalations.
The agreement contains commercial terms including development fees, milestone payments and royalties upon commercialization. The program will be fully funded by United Therapeutics.
“We believe patients affected by pulmonary hypertension will be enthusiastic about a convenient, non-invasive inhaled treatment,” said Dr. Stephen Farr, Chief Scientific Officer of Aradigm. “The combination of the accurate deep lung delivery capabilities of the AERx System and a liposomal formulation of treprostinil designed for pulmonary delivery will allow for an infrequent inhalation regimen of a proven and efficacious compound. This agreement follows a positive in vitro feasibility assessment of AERx aerosolized treprostinil, and builds on our internal experience in the development of novel liposomal formulations of proven drugs. This is another AERx program that is both partnered and in active development that, along with inhaled HCQ for the treatment of asthma and our inhaled insulin program partnered with Novo Nordisk, further validates the value of our AERx technology.”
Continued Dr. Farr: “Our AERx inhaled insulin program is in late-stage clinical trials, and well positioned towards imminent commercialization. In creating, and in the last year greatly expanding to over 300 employees, Novo Nordisk Delivery Technologies, the established division dedicated to commercializing the AERx insulin product, Novo Nordisk has made their commitment clear to moving this innovative program ahead. In addition, we believe that data from recent clinical trials provide a strong support for the AERx system in patients with diabetes.”
“We are pleased to be collaborating with Aradigm and leveraging their AERx technology and extensive formulation expertise to develop an AERx liposomal treprostinil product for once- or twice-a-day inhalation,” said Roger Jeffs, Ph.D., President and Chief Operating Officer of United Therapeutics. “We were pleased with previous evaluations of AERx to deliver treprostinil and we are excited at the potential of this product to build upon TRIUMPH, the ongoing inhalation program being developed by our subsidiary, Lung, Rx.”
According to Decision Resources, a leading market research firm, in 2003 PAH affected over 130,000 people worldwide with sales of related medical treatments, currently over $600 million per year, expected to double by 2013.
About Aradigm
Aradigm develops non-invasive delivery systems to enable patients to comfortably self-administer biopharmaceuticals and small molecules. The company’s advanced AERx(R) pulmonary and Intraject(R) needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs focus on neurological disorders, heart disease, respiratory conditions, smoking cessation, and diabetes. 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 clinical results, the timely availability and acceptance of new products, the impact of competitive products and pricing, and the management of growth, as well as the other risks detailed from time to time 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.
AERx and Intraject are registered trademarks of Aradigm. Contact: Aradigm Corporation Christopher Keenan Corporate Communications (510) 265-9370
Aradigm Corporation
CONTACT: Christopher Keenan, Corporate Communications of AradigmCorporation, +1-510-265-9370
Web site: http://www.aradigm.com/
