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Actelion Adds to PAH Franchise with IV drug from GeneraMedix

This article was originally published in The Pink Sheet Daily

Executive Summary

Buying GeneraMedix’s IV formulation of epoprostenol allows Actelion to leverage its infrastructure and experience in PAH and strengthen its lead in this increasingly crowded market.

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Actelion Follows Innovation into GP Markets

Actelion has become Europe's most successful R&D-based biotech largely on the success of Tracleer for PAH, a specialist indication. Now, facing competition in PAH, but in line with its strategy of following innovation wherever it leads, the company's starting to build a primary care-focused commercial operation to support GP-targeted pipeline assets. That takes Actelion into a very new game, and risks destroying the laissez-faire culture seen as crucial to its unusually high R&D productivity. But Actelion reckons a well-planned, step-wise, and nimble approach to primary care marketing will allow it to retain both the maximum value from its drugs, and its biotech-ness.

Actelion Follows Innovation into GP Markets

Actelion has become Europe's most successful R&D-based biotech largely on the success of Tracleer for PAH, a specialist indication. Now, facing competition in PAH, but in line with its strategy of following innovation wherever it leads, the company's starting to build a primary care-focused commercial operation to support GP-targeted pipeline assets. That takes Actelion into a very new game, and risks destroying the laissez-faire culture seen as crucial to its unusually high R&D productivity. But Actelion reckons a well-planned, step-wise, and nimble approach to primary care marketing will allow it to retain both the maximum value from its drugs, and its biotech-ness.

Review Decision On sNDA For Actelion’s Tracleer Awaits Finalized REMS

An FDA “complete response” letter says the REMS the firm submitted in September 2008 must be finalized and approved before the agency can act on the expanded indication.

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