Actelion boosted by trial success
pharmafile | April 30, 2012 | News story | Research and Development, Sales and Marketing | Actelion, Tracleer, almorexant, macitentan
Actelion’s pulmonary arterial hypertension drug macitentan has met its primary endpoint in a Phase III trial.
The news comes after a torrid 18 months for the firm, which has seen a series of late-stage failures decimate its pipeline.
This includes the failure of its sleeping treatment almorexant, tipped as the company’s next major product, which was dropped in 2011 after it hit safety problems in Phase III trials.
This led to aggressive takeover talks, and it looked as if the writing was on the wall for the firm.
But these new results have rallied its share price – surging by 18% today – and could represent the great white hope for the company.
The Swiss biotech said that its SERAPHIN Phase III study showed that pulmonary arterial hypertension (PAH) patients treated with macitentan, decreased the risk of a morbidity/mortality event over three and a half years versus placebo.
This risk was reduced by 45% in the 10 mg dose group and 30% at the 3 mg dose, meaning the study met its primary endpoint.
The firm is hoping that the drug will be a successor to its established PAH treatment Tracleer, which made CHF 1.52 billion ($1.67 billion) last year, but will start to go off patent in 2015.
Jean-Paul Clozel, chief executive of Actelion, said: “I am extremely pleased with the outstanding SERAPHIN results.
“We are committed to working with the health authorities to bring this potentially important advancement in PAH to patients as soon as possible.”
Clozel added that he expected the drug to be submitted for regulatory review around the globe by the end of the year.
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual.
Macitentan is a dual endothelin receptor antagonist that resulted from a tailored drug discovery process.
The drug is also being studied currently in a pivotal Phase III programme in patients with ischemic digital ulcers associated with systemic sclerosis, initiated in December 2011.
The drug is also being investigated in a Phase I/Ib open-label study in patients with recurring glioblastoma.
Ben Adams
Related Content
Beyond Batten Disease Foundation partners with Actelion on development of combination treatment
Beyond Batten Disease Foundation (BBDF) has partnered with Actelion Pharmaceuticals, a Janssen company, to provide …
Pharmafile.com’s top ten stories of 2017
After a packed year that has flown by, we’ve reached the final top ten of …
Actelion spin-off hit by blow shortly before buyout
Idorsia, the spin-off R&D company of Actelion, has been hit a blow even before it …
