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Bayer gets US nod for first-in-class Adempas

FDA clears drug for use in pulmonary artery hypertension
Bayer gets US nod for first-in-class Adempas style=

Bayer has made its first foray into the pulmonary artery hypertension (PAH) market after US approval for Adempas, its first-in-class soluble guanylate cyclase stimulator.

Adempas (riociguat) has been cleared by the FDA to treat adults with PAH, and also a severe subcategory of the disease known as chronic thromboembolic pulmonary hypertension (CTEPH).

It is the first and only drug to be approved for CTEPH in the US, and was fast-tracked for this indication by the FDA. It has been approved for use in patients whose condition is inoperable or does not respond to surgical treatment with a pulmonary endarterectomy.

In two pivotal trials (CHEST-1 and PATENT-1), patients PAH and CTEPH patients treated with Adempas showed improved exercise capacity, as measured by the six minute walk test (6MWT), and also demonstrated significant improvements on a range of secondary measures.

Riociguat exerts its effects in PAH by affecting the nitric oxide pathway, which is also targeted by the established PDE-5 inhibitor class represented by drugs such as Pfizer's Revatio (sildenafil).

Neither the PDE-5 inhibitors nor the two other classes of PAH drugs - endothelin antagonists and prostacyclins - have however proved particularly effective in treating CTEPH, which accounts for around 5 per cent of all PAH patients.

Actelion's endothelin antagonist Tracleer (bosentan) currently leads the PAH market with $1.6bn in sales last year. Among the prostacylin drugs, United Therapeutics' Remodulin (treprostinil) is the biggest seller, with turnover of $460m in 2012. Revatio led the PDE-5 inhibitor market for PAH with revenues of $535m, but started to feel the effects of generic competition towards the end of the year.

Riociguat is one of five drugs highlighted by Bayer as having the potential to achieve collective sales of €5.5bn over the next few years, with riociguat alone estimated to be worth upwards of €500m a year at peak.

The pharma company filed for approval of riociguat as a treatment for PAH and CTEPH in Europe in February and in Japan in May.

Bayer chief executive Wolfgang Plischke said earlier this year that the company is "excited" about Adempas as it strengthens the company's cardiology franchise with a "unique" product.

"There's no competitor around with the ability to treat PAH and CTEPH," he said.

Article by
Phil Taylor

9th October 2013

From: Sales



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