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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM)

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From: Icebrg	5/23/2007 2:21:43 AM
	of 3044

Ortho Biotech: extended Doxil approval unlikely to significantly boost sales 22nd May 2007 By Tom Gray Combination of Doxil and Velcade approved in the US for second-line treatment of multiple myeloma. Ortho Biotech's drug combination has received FDA approval having shown significant clinical benefit compared to the current standard treatment for relapsed or refractory multiple myeloma patients. Although there could be appreciable physician enthusiasm surrounding this drug combination, this may only have a limited impact on the overall market share of Doxil. 'Content The FDA have approved the use of Ortho Biotech's Doxil (liposomal doxorubicin) in combination with Millennium Pharmaceuticals/Ortho Biotech's Velcade (bortezomib) for the treatment of relapsed or refractory multiple myeloma patients who have not previously received Velcade. Ortho Biotech's Supplemental New Drug Application (sNDA) for this drug combination had been accepted by the FDA in January 2007, and was approved under the agency's Priority Review program. Doxil is a liposome-encapsulated formulation of doxorubicin, a DNA polymerase inhibitor and topoisomerase II inhibitor. This formulation shows a more favorable safety profile in comparison to doxorubicin, particularly in terms of cardiac toxicity. FDA approvals have already been granted for Doxil as a treatment for AIDS-related Kaposi's sarcoma patients intolerant to or having progressed following prior combination chemotherapy, and for ovarian carcinoma patients whose disease has progressed or recurred following treatment with platinum-based chemotherapy. The drug is developed and marketed in the US by Ortho Biotech, a subsidiary of Johnson & Johnson. In 1996, Schering-Plough was granted worldwide marketing rights for Doxil outside the US, excluding Japan and certain other countries. Sales of Doxil in 2005 were reported by Johnson & Johnson/Schering Plough to be $533 million. Approval of Ortho Biotech's sNDA was based on data from a Phase III trial involving 646 patients, which compared the combination of Doxil and Velcade to Velcade alone. A statistically significant improvement of the median time to progression (MTTP) was observed for the combination of Doxil and Velcade (MTTP = 9.3 months) compared to Velcade alone (MTTP = 6.5 months). In view of the significant clinical benefit conferred by the combination of Doxil and Velcade in comparison to Velcade alone, it is likely that physician enthusiasm for the drug combination will be high. Coupled with the fact that Velcade and Doxil are both marketed by Johnson & Johnson in the US, Doxil could show significant market penetration in this setting. Given the relatively low incidence of multiple myeloma, however, sales of Doxil for this indication are unlikely to make a significant impact on the overall market share of the drug. pharmaceutical-business-review.com

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