19: Withdrawal of the medicine Xigris from the market
October 26 2011
Announcement no. 19
Withdrawal of the medicine Xigris from the market
Eli Lilly has announced that the medicine Xigris is being withdrawn from the market because a study conducted showed that, after treatment with Xigris, no statistically significant reduction in mortality among patients with severe septicemia was noted.
Xigris is still the only medicine approved for the treatment of severe septicemia. The recently concluded study was launched by Eli Lilly in 2008 and sought to help improve the selection of patients with severe septicemia for treatment with Xigris; this was not achievable, possibly due to the selection method used. We are not aware of any use of BioPorto's selection method (the APC-PCI assay) in the study conducted by Eli Lilly.
The results of the published study, and the withdrawal of Xigris from the market, show there is a very great need for a selection method to select patients with severe septicemia for treatment. BioPorto's APC-PCI (Activated Protein C/Protein C Inhibitor) test, which in a smaller study was demonstrated to be suitable for the selection of septicemia patients for treatment, will therefore be even more relevant for the correct selection of patients with severe septicemia, either in terms of bringing Xigris back to the market or with a view to developing new methods for the treatment of severe septicemia. Several noteworthy studies are currently in progress with a view to developing new treatments of severe septicemia, and accurate patient selection will be decisive in connection with the development of new therapies.
The studies BioPorto has launched to validate the APC-PCI assay with a view to using it for measuring Protein C activation both in patients with severe septicemia and in patients with thrombotic (blood-clot forming) conditions could be affected by the withdrawal of Xigris because it is to be expected that only patients in the first part of the study will be treated with Xigris. The initial results from these studies are still expected to be available in 2011.
With reference to BioPorto's announcement no. 18 dated October 24, 2011 regarding the US patent authorities' approval of the issuance of BioPorto's patent concerning the diagnostic use of the APC-PCI biomarker for selecting patients with severe septicemia for special treatment, it should be noted that the patent is not specifically oriented towards treatment with Xigris.
For further information, please contact:
Frank Harder, CFO
Thea Olesen, CEO
Telephone +45 4529 0000, e-mail firstname.lastname@example.org