Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and autoimmune diseases, announced that it has received an Orphan Drug designation for oral tetrathiomolybdate (oral TTM) from the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a deadly pulmonary disease with no FDA-approved therapy.
IPF is a fatal respiratory disease characterized by progressive loss of lung function due to extensive fibrosis of lung tissues that are essential for respiration and life. According to the Coalition for Pulmonary Fibrosis, IPF affects an estimated 128,000 patients in the U.S., including 48,000 new patients per year, and results in approximately 30,000 deaths in the U.S. annually, more than the number of U.S. deaths annually from either breast or prostate cancer. Currently, there are no FDA-approved therapies for IPF. The standard of care for IPF patients is high-dose corticosteroids and immunosuppressants, which have numerous side effects that increase patient morbidity.
Steve H. Kanzer, CPA, JD, Chairman and Chief Executive Officer of Pipex stated, "Oral TTM has completed a 12 month open label phase I/II clinical trial in refractory IPF patients the results of which were reported at the May 2007 Annual Meeting of the American Thoracic Society. Provided that we elect to file an IND for oral TTM and pursue the further clinical development of oral TTM for IPF, this orphan drug designation provides additional exclusivity that supports our exclusively licensed issued U.S. Patent 6,855,340 and pending international patents covering the use of oral TTM for IPF and other high value fibrotic indications. The highly successful Orphan Drug Act of 1983 (as amended) would now provide our potential pharmaceutical partners or acquirors with a 50% tax credit for Phase III oral TTM IPF clinical trial expenses, for example, thereby reducing the after-tax cost of any such additional clinical trials to as little as 27%."
The United States Orphan Drug Act of 1983 was created 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 Orphan Drug designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, grant funding, tax benefits, and an exemption from user fees.
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