Cell Therapeutics Makes Pixantrone Available in EU, NDA Filing Completion on Target for End of 2Q
May 5, 2009 at 6:34 am EST | Tags: Deals & Alliances, Filings & Approvals, Gossip & Rumors
Cell Therapeutics (CTIC) said that pixantrone will now be available on a named-patient basis in Europe. IDIS will be supplying the drug for patients with NHL who have failed previous therapies or have relapsed.
The news has already caused CTIC to jump 23% in pre-market trading, from 47 cents to 58 cents. The news follows the shareholder excitement which has been brewing in anticipation of an NDA filing completion and potential licensing deal with NVS, or possible other third party, the latter of which we profiled this past weekend.
CTIC president Craig Philips said this about the news:
“CTI has worked hard to make pixantrone available in Europe at the prescriber’s request as it provides an option for these difficult to treat aggressive NHL patients. We continue to work toward potential approval of pixantrone at the end of 2009 in the United States and expect to complete the submission of the New Drug Application to the Food & Drug Administration this quarter.”
Here is what Dr, Pier Luigi Zinzani, M.D. from Institute of Hematology and Oncology, University of Bologna said about his experience with Pix and the news release:
“Our experience with pixantrone has been positive with patients achieving a complete response where such a result was not achievable with other treatments. I am pleased that it is now available on a named-patient basis as it has the potential to address a significant unmet need in this heavily pretreated patient population.”
Stay tuned…
Image from celltherapeutics
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