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Actelion Braces For Tracleer Patent Cliff With New Drugs, New Data Standards

Executive Summary

Actelion is preparing for the patent loss on its leading PAH drug not simply with a new product, but by setting a new efficacy standard across the entire PAH community.

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Opsumit Label And Pricing Suggest Actelion’s Gamble Ready To Pay Off

Actlelion is banking on labeling advantages and strategic pricing to propel sales of its new drug for pulmonary arterial hypertension, Opsumit, even after its best-selling PAH drug, Tracleer, goes generic.

Optimal Labeling For Opsumit Allows Actelion To Drop Promotion Of Tracleer

With a ‘clean’ label that differentiates macitentan from current standard of care, Actelion’s got what it wanted from FDA: a newly approved next-generation drug with a long patent life that can expand its presence in the pulmonary arterial hypertension market, and, importantly, protect its core franchise from upcoming generic competition.

Actelion, Under Pressure To Diversify, Eyes Rare Disease Start-Up Ceptaris

Actelion is paying a $25 million upfront for an option to acquire Ceptaris Therapeutics, contingent upon the latter’s receiving FDA approval for its only asset, Valchlor, which faces an August PDUFA date. If the deal closes, Ceptaris will receive another $225 million plus milestones from the Swiss-based biotech.

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