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