Lung Rx and ImmuneWorks Announce Collaboration in Idiopathic Pulmonary Fibrosis and Primary Graft Dysfunction

Ten years ago when I was diagnosed with Idiopathic Pulmonary Fibrosis (IPF) there was no cure for the disease other than a lung transplant. Existing therapeutic treatments such as prednisone and clinical trials with experimental drugs had no effect on slowing progression of the scarring of lung tissue that eventually leads to respiratory failure and inevitable death if a transplant is not an option or available. So this new research is very welcome and offers a glimmer of hope for the future.

SILVER SPRING, Md., and INDIANAPOLIS, Feb. 10 /PRNewswire-FirstCall/ -- Lung Rx, LLC, a wholly-owned subsidiary of United Therapeutics Corporation (Nasdaq: UTHR), announced today that it has entered into a Development Agreement with ImmuneWorks, Inc. to pursue development of ImmuneWorks' lead compound, IW001, a purified bovine Type V Collagen oral solution for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and Primary Graft Dysfunction (PGD) in patients receiving lung transplant. The parties expect to commence human clinical testing in 2010. In November 2009, the U.S. Food and Drug Administration granted orphan drug exclusivity to IW001.

"We are delighted to form this alliance with ImmuneWorks in these areas of high unmet medical need," said Lung Rx President and CEO Martine Rothblatt, Ph.D. "This development program further solidifies our commitment to clinical research in diseases with few, if any, approved therapeutic options."

In addition to funding the development program, Lung Rx has been granted an option to acquire all of the issued and outstanding capital stock of ImmuneWorks. Financial terms of the transaction were not disclosed.

"We are extremely pleased to align with Lung Rx and United Therapeutics, companies that share our commitment to bringing novel treatments to patients suffering from incurable lung diseases such as idiopathic pulmonary fibrosis and those undergoing lung transplantation," said Wade A. Lange, President & CEO of ImmuneWorks. "We strongly believe that the coupling of United Therapeutics' track record of innovation and our novel therapeutic approach is a powerful combination to bring potentially life-saving treatments to patients."

About IPF

Idiopathic Pulmonary Fibrosis is a progressive, usually fatal disease that afflicts in excess of 100,000 persons in the United States alone. According to the Coalition of Pulmonary Fibrosis, approximately 48,000 new patients are diagnosed with this devastating disease annually with 40,000 deaths from the disease each year -- about the same number of deaths as from breast cancer. Within five years of diagnosis, progression of IPF leads to death in approximately 70% of patients. There are currently no FDA-approved options for patients suffering from this life-threatening condition.

About PGD

Primary Graft Dysfunction is a leading cause of morbidity and mortality in patients following lung transplant surgery. This complication that may affect up to 10%-25% of lung transplant patients. PGD is also a significant risk factor for development of bronchiolitis obliterans syndrome, a chronic, scarring process that affects the small airways of the lungs and is a leading cause of death in lung transplant patients.

About Lung Rx and United Therapeutics

Lung Rx LLC, a wholly-owned subsidiary of United Therapeutics Corporation, is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products. United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. [uthr-g]

About ImmuneWorks

Founded in 2006, ImmuneWorks, Inc. is a biotechnology company committed to developing safe and effective immune tolerance treatments for patients with serious autoimmune diseases. ImmuneWorks' work on antigen-specific autoimmunity has supported several publications and forms the basis for development of its lead program, IW001.

SOURCE United Therapeutics Corporation

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