Sanofi-Aventis Rebates Aim To Accelerate Switch To Ambien CR
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm is offering concessions to U.S. healthcare providers to switch patients to the extended-release formulation.
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Sanofi-Aventis is offering deeper rebates to accelerate substitution from its sleep aid Ambien (zolpidem) to its extended-release formulation Ambien CR , CFO Jean-Claude Leroy said during a second quarter earnings call Aug. 2. "In some respects, we make concessions to accelerate substitutions....The healthcare providers have, of course, been a bit reluctant to treat Ambien CR the same way they have been handling Ambien IR before we have put the necessary strategies in place," Leroy explained. "We are approaching a situation where Ambien CR is more or less treated the same way as Ambien IR has been treated and this is the desired effect." Global sales of the firm's sleep aids ( Stilnox /Ambien/Ambien CR) increased 5.9% in the second quarter to €467 mil. ($598.2 mil.) compared to the first quarter. Second quarter U.S. sales were up 6.3% from the first quarter to €2.49 bil. ($3.19 bil.). The extended-release formulation of Ambien, which cleared FDA in September, does not carry limitations on duration of use attached to the immediate-release formulation (1 (Also see "Ambien CR Gets FDA Approval; Launch Expected In Mid-September" - Pink Sheet, 6 Sep, 2005.)). The immediate-release formulation loses patent expiration in October. FDA's "Orange Book" lists two patents for Ambien CR, the last of which expires Dec. 1, 2019. Exclusivity for the drug expires Sept. 2, 2008 (2 (Also see "Ambien CR, Razadyne ER Paragraph IV Certifications Filed" - Pink Sheet, 19 May, 2006.)). Sanofi has had to manage negative publicity this year surrounding potential sleepwalking and sleep eating side effects associated with Ambien (3 (Also see "Ambien Publicity Sets The Whole Class On Snooze, Sanofi Says" - Pink Sheet, 5 May, 2006.)). -Mary Bruce |