Aradigm Corporation And United Therapeutics Corporation Sign Development and Commercialization Agreement Targeting Pulmonary Hypertension | ...
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`Aradigm Corporation And United
`Therapeutics Corporation Sign
`Development and
`Commercialization Agreement
`Targeting Pulmonary Hypertension
`
`Published: Oct 24, 2005
`
`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
`
`https://www.biospace.com/article/releases/aradigm-corporation-and-united-therapeutics-corporation-sign-development-and-commercialization-agreement-targeting-...
`
`Liquidia's Exhibit 1057
`Page 1
`
`

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`Aradigm Corporation And United Therapeutics Corporation Sign Development and Commercialization Agreement Targeting Pulmonary Hypertension | ...
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`Page 2 of 3
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`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
`.
`
`https://www.biospace.com/article/releases/aradigm-corporation-and-united-therapeutics-corporation-sign-development-and-commercialization-agreement-targeting-...
`
`Liquidia's Exhibit 1057
`Page 2
`
`

`

`Aradigm Corporation And United Therapeutics Corporation Sign Development and Commercialization Agreement Targeting Pulmonary Hypertension | ...
`
`Page 3 of 3
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`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/
`
`✉ F T L (cid:64) r
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`https://www.biospace.com/article/releases/aradigm-corporation-and-united-therapeutics-corporation-sign-development-and-commercialization-agreement-targeting-...
`
`Liquidia's Exhibit 1057
`Page 3
`
`