INTERMUNE/BOEHRINGER TO COMMERCIALIZE INTERFERON/GAMMA-1B.InterMune (Nasdaq: ITMN), Burlingame, Calif. and Boehringer Ingelheim International GmbH, Germany, have formed an international strategic partnership to develop and commercialize interferon gamma-1b interferon gamma-1b Actimmune Pharmacologic class: Biological response modifier Therapeutic class: Antineoplastic Pregnancy risk category C Actionunder Boehringer Ingelheim's trade name, Imukin(R), in all countries outside of the United States, Canada and Japan. Indications to be developed include idiopathic pulmonary fibrosis idiopathic pulmonary fibrosis Idiopathic interstitial fibrosis of lung Pulmonology An idiopathic condition characterized by scarring and fibrosis of alveolar septae more common in middle-aged men, possibly related to collagen vascular disease, with positive (IPF (Itanium Processor Family) See Itanium. ), tuberculosis, systemic fungal infections, chronic granulomatous disease Chronic Granulomatous Disease DefinitionChronic granulomatous disease (CGD) is an inherited disorder in which white blood cells lose their ability to destroy certain bacteria and fungi. (CGD CGD Chronic granulomatous disease, see there ) and osteopetrosis, as well as additional indications to be agreed upon later. This strategic alliance adds worldwide scope to InterMune's existing rights to develop and commercialize interferon gamma-1b under the trade name ACTIMMUNE(R) in the United States, Canada, and Japan. Under the agreement, InterMune will fund and manage clinical and regulatory development of interferon gamma-1b for all indications. Boehringer Ingelheim has an option to exclusively promote Imukin(R) and InterMune may opt to promote the product where Boehringer Ingelheim does not do so. Furthermore, the two companies will share in the profits from commercializing interferon gamma-1b through a specified royalty schedule. "This partnership allows InterMune to participate in up to approximately $2.5 billion in additional revenue opportunities, bringing our worldwide market opportunity in these indications for interferon gamma-1b to approximately $6.0 billion," said W. Scott Harkonen, M.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of InterMune. "This partnership also provides us with the opportunity to leverage our existing clinical programs, many of which are being conducted internationally, to access these very significant markets outside of the United States. We have a strong relationship with Boehringer Ingelheim through our existing manufacturing arrangement, and look forward to building upon that relationship with this very exciting partnership. It is really a win-win for both companies." "The cooperation with InterMune will enable us to determine the efficacy of Imukin in patients suffering from serious diseases such as tuberculosis and idiopathic pulmonary fibrosis and to make the product widely available for the treatment of these patients if the results are positive," said Dr. Andreas Barner, member of the board of managing directors of Boehringer Ingelheim responsible for Research, Development and Medicine. Prior to receiving regulatory approvals for IPF, tuberculosis, or systemic fungal infections, the agreement provides InterMune with royalties on Imukin(R) net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight above current levels. Imukin(R) is currently approved and marketed for CGD in 36 countries. Boehringer Ingelheim and InterMune plan to immediately seek expedited EU approvals for Imukin(R) for the treatment of severe, malignant osteopetrosis, an indication for which ACTIMMUNE(R) is already approved in the United States. InterMune also plans to expand its Phase III clinical development programs to target approvals in the expanded international markets. InterMune is a biotechnology company dedicated to the development and commercialization of innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune currently markets ACTIMMUNE(R) (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis and is in Phase III clinical trials for the treatment of idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis (MDR MDR, n See multidrug resistance. MDR, n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration. TB). The company also markets Amphotec(R), an FDA-approved lipid-complexed form of amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. for the treatment of invasive aspergillosis Aspergillosis Definition Aspergillosis refers to several forms of disease caused by a fungus in the genus Aspergillus. Aspergillosis fungal infections can occur in the ear canal, eyes, nose, sinus cavities, and lungs. , a life-threatening fungal infection fungal infection, infection caused by a fungus (see Fungi), some affecting animals, others plants. Fungal Infections of Human and Animals . For more information about InterMune and ACTIMMUNE(R), please visit InterMune's web sites at www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com. The Boehringer Ingelheim group of companies, with headquarters in Ingelheim, Germany, is one of the 20 leading pharmaceutical companies in the world. In 1999, it posted revenues of almost DM 10 billion. Boehringer Ingelheim has some 140 affiliated companies Affiliated Companies A situation that occurs when one company owns a minority interest (less than 50%) in another company. Also refers to companies that are related to each other in some way. Notes: An affiliated company is sometimes referred to as a subsidiary. worldwide. The focus is on the human pharmaceutical and animal health businesses. The human pharmaceutical business, which accounts for 92% of sales, mainly includes prescription medicines and products for consumer health care but also products for industrial customers (chemicals and biopharmaceuticals). Substantial research and development, production, and distribution facilities are located around the globe. In 1999, Boehringer Ingelheim spent DM 1.6 billion on R&D, equivalent to 16% of net sales. For more information on Boehringer Ingelheim, please see the Internet website http://www.boehringer-ingelheim.com. For more information, call 650-409-2028 or 415-433-5381. |
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