Millennium Pharmaceuticals, Inc. (MLNM) Message Board

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

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To: tuck who wrote (2866)	6/5/2007 12:52:23 PM
From: tom pope	of 3044

ML: Seeking new angles for Velcade Wrapping up ASCO with subcu Velcade and doxil combo data Two final presentations of note at ASCO included data from a small study comparing subcutaneous to intravenous administration of Velcade, which we find intriguing, and the phase III data that recently lead to the expansion of Velcade’s label to include combination use with Doxil in relapsed/refractory multiple myeloma. Maintain estimates and Neutral. Small study compares subcutaneous to I.V. Velcade Data was presented from a 24-patient randomized trial comparing subcutaneous with intravenous administration of Velcade at 1.3 mg/m2 twice weekly. Patients received a median of 5 cycles in both arms and response rates were the same for the two groups at 42%. While PK/PD data showed the Cmax (maximum plasma concentration) higher in the subcu arm, the bioavailability (AUC, area under the curve) was comparable. After speaking with the company and investigators at ASCO, it is unclear whether subcutaneous administration will ultimately show comparable clinical benefit, but Millennium plans to confer with the FDA and quickly develop plans for a larger trial. We view the potential prospect of a more patient friendly subcu Velcade attractive, though the potential impact on physician practices and economics will also have to be considered. [abstract #8046] Velcade + Doxil phase III data with superior TTP presented Velcade’s label was recently expanded to include use in combination with Doxil (a pegylated liposomal formulation of doxorubicin), which is sold by Ortho Biotech (Millennium’s co-promote partner), for the treatment of relapsed/refractory multiple myeloma. The phase III data leading to the expanded label was presented at ASCO and showed a 43% improvement in TTP (time to progression), 9.3 months for Velcade + Doxil vs. 6.5 months for Velcade alone. Having another approved regimen for Velcade and extra incentive for Ortho Biotech in the co-marketing arrangement are positive developments, but whether they impact sales remains to be seen and we maintained our models on the label expansion. [abstract #8002].

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