Daiichi Sankyo/Forest’s Hypertension Therapy Azor Gets FDA Nod
This article was originally published in The Pink Sheet Daily
Executive Summary
Azor will compete against Novartis’ recently approved Exforge.
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The hypertension market of combination therapies containing Pfizer's Norvasc (amlodipine) expanded Sept. 27 with the approval of Daiichi Sankyo's Azor , which contains amlodipine and Daiichi Sankyo's angiotensin receptor blocker Benicar (olmesartan). [Editor's note: An earlier version of this story mistakenly identified Forest as the originator of Benicar. The drug is co-promoted in the U.S. by Forest.] Other combination products containing amlodipine include Novartis' Lotrel (amlodipine/benazepril) and Exforge (amlodipine/valsartan); the latter was just approved in June (1 (Also see "Novartis’ Exforge To Launch By End Of June" - Pink Sheet, 21 Jun, 2007.)). Under an agreement signed in August, Japan-based Daiichi and Forest agreed to co-promote the fixed-dose hypertensive. The two companies have co-promoted Benicar since 2001, though the agreement is slated to wind down at the end of March 2008 (2 (Also see "Forest, Daiichi Partner To Promote Hypertension Combo Azor Upon Approval" - Pink Sheet, 21 Aug, 2007.)). The August agreement called for Forest to pay Daiichi $20 million upfront plus other undisclosed payments. [An exclusive interview with Daiichi Sankyo U.S. CEO Joe Pieroni ran in "The Pink Sheet" DAILY in August (3 (Also see "Daiichi Sankyo U.S. CEO Joe Pieroni: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 3 Aug, 2007.)).] Daiichi submitted Azor in November 2006 (4 (Also see "Daiichi Sankyo Submits Benicar/Amlodipine Fixed-Dose Combination To FDA" - Pink Sheet, 28 Nov, 2006.)). -Jonathan M. Block ([email protected]) [Editor's note: Additional coverage of Asian markets is provided at 5 PharmAsia News, F-D-C Reports' new beta site for Asian biotech and pharmaceutical news. To register for complimentary e-mail updates, visit 6 www.pharmasianews.com.] |