Novartis Shows Off Once-Daily COPD Combo Data At European Meeting
A superiority claim based on the ILLUMINATE data will become a valuable marketing defense against a generic of GlaxoSmithKline’s Advair, should one become available.
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Novartis released results from “an unprecedented package of data” to be filed with European regulators for its novel once-daily dual bronchodilator combination of the LABA indacaterol and the LAMA NVA237 (glycopyrronium) for COPD at the European Respiratory Society Congress, but FDA has already made clear that it wants to see trials with once- and twice-daily dosing at lower strengths than those tried in the European program, and those studies have yet to launch.
In its first investor meeting in four years, Mylan lays out plans to barge over the generics industry’s post-2013 so-called ‘reverse patent cliff’ by focusing on high-barrier-to-entry products – including generic Advair – and portfolio and geographic diversification.
Commercialization of the fixed-dose combo buys lifecycle management for Forest and should support future drug development for partner Adamas, the originator of the technology behind the combination.