Monday January 7, 6:01 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Receives Fast Track Designation From FDA for Actimmune In the Treatment of Idiopathic Pulmonary Fibrosis
- Phase III IPF Study Maintains Strong Patient Retention -
BRISBANE, Calif., Jan. 7 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for Actimmune® (Interferon gamma-1b) injection for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and usually fatal disease for which there is no effective therapy.
Fast Track programs are designed to facilitate the development and review of new drugs that are intended to treat life-threatening conditions and reflect the potential to address significant unmet medical needs. The FDA stated, in part, in its letter to InterMune, that `` ... we are designating as a Fast Track development program the investigation of Interferon gamma-1b for its effects on progression free survival in patients with idiopathic pulmonary fibrosis who are unresponsive to steroids.''
``Actimmune is the first and only drug to receive Fast Track designation for IPF,'' said W. Scott Harkonen, MD, President and Chief Executive Officer of InterMune. ``Official Fast Track status for this indication will help accelerate review and approval of this potentially important treatment for patients suffering from this life-threatening condition.
``We look forward to announcing the results of the Phase III trial for IPF by November 2002 and plan to work closely with the agency as we submit our marketing application at the end of the year,'' added Dr. Harkonen.
In addition, the Company reported that in its ongoing Phase III trial for IPF, approximately 60% of the trial is complete in terms of patient treatment days. Furthermore, less than 5% of patients have withdrawn from the study prior to meeting the primary endpoint. This retention rate is well within the assumptions underlying the statistical power and sample size of the 330-patient trial.
Dr. Harkonen also stated, ``We are very pleased with this high level of patient retention as of January and expect that patient retention going forward will continue to be strong. We would like to thank all participating investigators, coordinators and patients for their tremendous commitment and dedication to this trial.''
IPF is characterized by progressive scarring, or fibrosis of the lungs, which ultimately leads to respiratory failure. The prognosis is poor for patients with IPF and the median life span is three to five years from the time of diagnosis. There are approximately 50,000 patients in the United States suffering from IPF, which occurs primarily in persons 40 to 70 years old. Actimmune is the first and only drug to have shown promise as a treatment for IPF in a Phase II clinical trial.
About Actimmune
Actimmune is an approved product on the market for the treatment of two rare congenital diseases, chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. InterMune is conducting or planning to conduct multiple Phase II and three Phase III clinical studies with Actimmune, including the Phase III clinical trial for the treatment of IPF.
InterMune recently reported positive results from a Phase II clinical trial examining the use of Actimmune in combination with amphotericin B for the treatment of cryptococcal meningitis, a difficult-to-treat and life-threatening fungal infection. The Company plans to initiate a Phase III trial of Actimmune for the treatment of ovarian cancer. Studies are also ongoing with Actimmune for the treatment of cystic fibrosis and atypical mycobacterial infections.
About InterMune
InterMune is a commercial-stage biotechnology company dedicated to developing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune has three marketed products, growing product revenues and advanced-stage clinical programs addressing a range of diseases with attractive commercial markets. For additional information about InterMune, please visit www.intermune.com. |
