To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Canada Approves Sale Of Valtaxin (Valrubicin) For Bladder Cancer URL: http://www.pslgroup.com/dg/1D9D52.htm Doctor's Guide July 17, 2000
MONTREAL, QC -- July 17, 2000 -- Paladin Labs Inc. ("Paladin") is pleased to announce today that the Therapeutic Products Programme ("TPP") has granted Valtaxin™ a notice of compliance permitting the sale of Valtaxin in Canada. In June 1999, Paladin acquired the exclusive Canadian distribution rights for Valtaxin (valrubicin) from Anthra Pharmaceuticals, Inc. a US-based pharmaceutical company which focuses on the development of oncology therapeutics. Valtaxin is a chemotherapeutic anthracyline derivative indicated for intravesical therapy of refractory carcinoma in-situ (CIS) of the bladder. Refractory cases are those who have failed conventional first-line therapy with standard-of-care agents and are candidates for surgical removal of the bladder. In clinical trials, intravesical therapy with Valtaxin has been shown to allow one-third of patients to retain their bladders for up to four years. Bladder carcinoma is the sixth most common cancer in Canada with an incidence of 4800 cases per year. Of all patients diagnosed, approximately 15 percent are afflicted with CIS. Only 70 percent are responsive to BCG , the current gold standard of therapy. Currently, in Canada, there is no therapeutic alternative to cystectomy for patients who have failed all other modalities of treatment. In the US, Valtaxin is the only FDA-approved agent specifically indicated for intravesical treatment of CIS and has Orphan Drug designation for this purpose. Jonathan Goodman, President & CEO of Paladin stated "Valtaxin is the first approved treatment for refractory CIS patients in Canada. We are confident that Valtaxin will increase the quality of life for patients whose only other recourse is surgical removal of the bladder. We are pleased at how quickly Valtaxin navigated through the TPP having received regulatory approval in less than 6 months from our application." --------------------------------------------------------------------------------------------- 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.