| IRBS Submits Compound for FDA Orphan Drug Designation |
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| By Staff and Wire Reports | |
| Thursday, 04 March 2010 09:46 | |
 ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTC.BB:IRBS), today announced the submission of an application for Orphan Drug Product Designation for the company's lead compound, Homspera®, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments.
The United States Orphan Drug Act was created in 1983 to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, a waiver of user fees, the potential for grant funding, and tax benefits for clinical trials. Many orphan products receive expedited review or accelerated approval because they are for serious or life-threatening diseases.
ImmuneRegen continues to advance the development of its Homspera drug candidate for the treatment of Idiopathic Pulmonary Fibrosis in collaboration with Dr. Jacob Finkelstein at the University of Rochester and several Contract Research Organizations. "ImmuneRegen is excited to be pursuing the indication of Idiopathic Pulmonary Fibrosis most aggressively, as this disease is still without an effective licensed treatment in the U.S., although many expect InterMune's pirfenidone to eventually be approved. The relative lethality yet low prevalence of IPF confers Orphan Drug Status and Fast Track eligibility for many potential therapeutics, and most analysts believe IPF therapies will have a multi-billion dollar commercial market. Leveraging the support of our industry and academia partners will allow us to expedite the development of Homspera for this indication, and will expand opportunities for more rapid development in the other areas we are and or expect to pursue, such as neutropenia, Influenza and Melanoma," explained ImmuneRegen CEO Michael Wilhelm. "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites            |
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