Wednesday September 19, 6:00 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Receives FDA Approval for Transfer of Actimmune(R) Manufacture To Boehringer Ingelheim
Facility to Support up to $500 Million in Annual Actimmune(R) Sales
BRISBANE, Calif., Sept. 19 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) announced today that the United States Food and Drug Administration (FDA) has approved the transfer of manufacturing of InterMune's lead product, Actimmune® (Interferon gamma-1b) from Genentech, Inc. to Boehringer Ingelheim Austria GmbH in Vienna, Austria, part of the Boehringer Ingelheim group of companies headquartered in Ingelheim, Germany.
``Boehringer Ingelheim is a world-class manufacturer of biopharmaceuticals and we are extremely pleased that the FDA has approved their facility for the manufacture of Actimmune®,'' said Peter VanVlasselaer, Ph.D., Senior Vice President of Technical Operations for InterMune. ``With the improved manufacturing capacity, InterMune will have the ability to meet the growing demand for Actimmune®. We are pleased to be working with Boehringer Ingelheim on both the manufacture of interferon gamma as well as the development and commercialization of this product around the world.''
Boehringer Ingelheim currently manufactures InterMune's clinical supply of Actimmune® and manufactures European commercial supply of interferon gamma-1b under Boehringer Ingelheim's trade name, Imukin®. The first commercial shipments of Actimmune® produced by Boehringer Ingelheim will be received by InterMune in the fourth quarter of 2001.
On March 26, 2001, InterMune and Boehringer Ingelheim formed an international strategic partnership to develop and commercialize interferon gamma-1b under Boehringer Ingelheim's trade name, Imukin®, in all countries outside of the United States, Canada and Japan. InterMune assumes responsibility for the clinical and regulatory development of interferon gamma-1b, and Boehringer Ingelheim retains an option to exclusively promote interferon gamma-1b under Boehringer Ingelheim's trade name, Imukin®, in all countries outside of the United States, Canada and Japan. InterMune may opt to promote the product where Boehringer Ingelheim does not do so. Indications included under the agreement are idiopathic pulmonary fibrosis (IPF), tuberculosis, systemic fungal infections, chronic granulomatous disease (CGD) and osteopetrosis.
InterMune is developing and commercializing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune markets its lead product, Actimmune®, for the treatment of CGD and severe, malignant osteopetrosis. InterMune is currently conducting a Phase III clinical trial with Actimmune® for the treatment of IPF. InterMune is also conducting or planning clinical trials of Actimmune® for the treatment of multidrug-resistant tuberculosis (MDR TB), atypical mycobacterial infections, ovarian cancer, cryptococcal meningitis, cystic fibrosis, liver fibrosis and non-Hodgkin's lymphoma. InterMune recently acquired rights to Infergen®, which is marketed in the United States and Canada for the treatment of chronic hepatitis C infections. InterMune also markets Amphotec® worldwide for the treatment of invasive aspergillosis.
Boehringer Ingelheim offers the entire production technology chain at its biopharmaceutical manufacturing facilities in Vienna (Austria), Biberach (Germany) and St. Joseph/ Missouri (USA) with additional fill-and-finish capacities in Bedford/ Ohio (USA). It has the world's largest capacities for contract manufacture of mammalian cell culture and fill-and-finish for biopharmaceuticals and is Europe's leading manufacturer of biopharmaceuticals.
The Boehringer Ingelheim group of companies, one of the 20 leading pharmaceutical corporations in the world, has some 140 affiliated companies worldwide and focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95% of sales, is comprised of prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers. In 2000, Boehringer Ingelheim posted revenues of more than EUR 6 billion and spent almost EUR 1.0 billion on R&D, equivalent to 16% of net sales. Fixed asset investment totaled a record EUR 497 million. For more information on Boehringer Ingelheim, please visit www.boehringer-ingelheim.com.
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