
updated: 11/2/2009 3:46:37 PM
Indianapolis-based biotech company ImmuneWorks Inc. says the U.S. Food and Drug Administration has designated one of its drugs for use in populations smaller than 200,000. The drug treats a progressive lung disease that is generally fatal. The Orphan Drug Designation also gives ImmuneWorks a seven year market exclusivity period for its idiopathic pulmonary fibrosis treatment.
Source: Inside INdiana Business

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Press Release
ImmuneWorks announces that the U.S. Food and Drug Administration (FDA) recently designated IW001 (bovine Type V Collagen oral solution) as an Orphan Drug. Orphan drugs are those drugs that are intended to be used in populations smaller than 200,000 patients in the United States.
“The seven years of market exclusivity granted under the Orphan Drug Designation is important for companies such as ours that are developing drugs for small markets because it creates certainty around our market and intellectual property,” said Wade A. Lange, president and chief executive officer of ImmuneWorks.
ImmuneWorks also announced that it has been selected to present to investors attending the MidAmerica Healthcare Venture Forum to be held in Madison, Wisconsin. President & CEO Lange will present at 11:15am on November 12.
About idiopathic pulmonary fibrosis: IPF is a devastating lung disease that is progressive and generally fatal. There are an estimated 128,000 persons in the United States who suffer from IPF with 48,000 new persons diagnosed with this devastating disease annually and 40,000 patients dying from the disease each year (source: Coalition for Pulmonary Fibrosis). The number of deaths annually is the same as breast cancer and greater than other cancers such as multiple myeloma.
About ImmuneWorks:
ImmuneWorks, Inc is a biotechnology company developing novel therapeutics and complementary diagnostic tests for patients with serious lung diseases. The company is initially developing treatments for idiopathic pulmonary fibrosis and prevention of lung transplant rejection. ImmuneWorks’ expertise is their understanding of the convergence of pulmonary and autoimmune diseases to create therapeutics that will make a difference in the lives of patients.
Source: ImmuneWorks