To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Tobi (Tobramycin) Receives Patent In Europe For Lung Infections In Cystic Fibrosis Patients URL: http://www.pslgroup.com/dg/1D427A.htm Doctor's Guide May 31, 2000
SEATTLE, WA -- May 31, 2000 -- PathoGenesis Corp. announced it has been granted a European patent for all seventeen European countries for TOBI® (tobramycin solution for inhalation), its inhaled antibiotic for management of cystic fibrosis patients with Pseudomonas aeruginosa lung infections. Tobi has been patented in the U.S. and Australia, and patent applications are pending in Canada and Japan. In addition, PathoGenesis expects to begin receiving additional regulatory approvals of Tobi in various European Union countries in the fourth quarter of 2000. Tobi was approved by the U.K. Department of Health last December. Achieving this milestone was particularly noteworthy because the U.K. is the lead country for seeking regulatory approval of Tobi in the E.U. The remaining E.U. countries have been asked to approve the inhaled drug through a mutual recognition process. The European regulatory agencies accepted the company's Tobi application earlier this month. This means the regulators are expected to review the Tobi dossier and respond to PathoGenesis with questions, if any, in the third quarter. This step is required before Tobi can be approved for sale in the various countries. In anticipation of these expected additional regulatory approvals, PathoGenesis has made significant progress toward building a commercial infrastructure in Europe. PathoGenesis has established companies in the U.K., France and the Netherlands, and finalized distribution agreements with leading organizations in other key countries. On the market in the U.S. since 1998, Tobi also has been approved for sale in the U.K., Canada, Australia, Israel and Argentina. "The European patent is part of our ongoing effort to enhance our competitive position in the E.U. once we receive regulatory approvals," said Wilbur H. Gantz, chairman and chief executive officer. "This patent protection is particularly important given the significant benefits that Tobi provides to cystic fibrosis patients. The results of our clinical trials have been so encouraging that we plan to conduct additional clinical trials of Tobi -- not only for cystic fibrosis patients, but for other people with difficult-to-treat lung infections. Next month, we expect to report the results of a clinical trial comparing Tobi and another drug that is sometimes used in Europe to treat lung infections." Seattle-based PathoGenesis Corp. develops and commercializes drugs to treat chronic infectious diseases - particularly serious lung infections, including those common in cystic fibrosis, bronchiectasis and ventilator patients. PathoGenesis' stock is traded on the Nasdaq National Market System under the symbol PGNS. Related Links: TOBI (tobramycin) and PathoGenesis Corp. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.