24.10.2012 - The competition for PAH treatments will become fierce. Actelion and Bayer both plan to market new treatments for this rare disease.
Good news for PAH (pulmonal arterial hypertension) patients: two new drugs are planned for market release. The Swiss biotech Actelion submitted a new drug application to the FDA for its Opsumit macitentan treatment. The filing is based on data from a Phase III study, which proved to be able to reduce the risk of a morbidity or mortality event compared to placebo. A low-dose of Opsumit reduced the risk by 30%, while the high dose had a 45% reduction. The compound is a tissue-targeting endothelin receptor antagonist and is thought to replace revenues from Tracleer, Actelion’s best-seller which will lose patent protection in 2015.
At the same time as Actelion announced the application, German pharma Bayer AG announced that its compound riociguat met the primary endpoint in a Phase III study. The oral soluble guanylyl cyclase (sGC) stimulator led to an improvement in a six minute walk test enhancing the patient’s walk distance to 36 meters. Bayer plans to submit regulatory filing for riociguat in the first half next year. Analysts said that macitentan might become the next first-line treatment and expected high revenues. Riociguat however might become a second line option and get additional competition from Pfizer’s Sildenafil, which is already approved for PAH and acts via the same pathway.