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Bayer submits oral PAH drug riociguat for approval

Set to challenge Actelion and Gilead

Bayer

Bayer has filed for approval of its pulmonary arterial hypertension (PAH) drug riociguat in the US and EU, setting up an assault on a $3.5bn market currently dominated by drugs from Actelion and Gilead.

Riociguat is the first in a new class of PAH drugs known as soluble guanylate cyclase (sGC) stimulators, and in trials has been shown to be effective in treating both PAH and a related form of pulmonary hypertension known as chronic thromboembolic pulmonary hypertension (CTEPH).

It is one of a stable of five new pipeline products that Bayer has said could provide peak sales of around $7bn over the next few years. Last year, the company indicated that riociguat was a "€500m-plus opportunity", helped by the fact that it is the only drug to have clinical efficacy data in CTEPH.

Currently CTEPH patients' only option is surgery, but a sizeable proportion of patients are unsuitable for this type of intervention.

"These regulatory submissions for two distinct forms of pulmonary hypertension … fuel our hope to bring this much-needed new treatment option for these serious and potentially fatal diseases to patients and doctors soon," commented Bayer's head of global development Kemal Malik.

Actelion's endothelin antagonist Tracleer (bosentan) is the leading player in the PAH category at present, with sales of around $1.2bn in the first nine months of 2012. Coming up the rankings fast is Gilead's Letairis (ambrisentan) - sold outside the US by GlaxoSmithKline as Volubris - which reached about $625m in revenues for 2012 as a whole.

Bayer's drug has been shown to be effective versus placebo in increasing the distance patients with PAH and CTEPH can walk, both when used on its own and when added to Tracleer therapy.

Tracleer's success has come despite a risk of liver damage with the drug, which Actelion is hoping to reduce with its new-generation endothelin antagonist Opsumit (macitentan) which has been filed for approval in the US and EU.

Meanwhile, the PAH market as a whole is expected to grow significantly over the coming years - despite the loss of patent protection for Tracleer in 2015 and generic competition to smaller PAH drugs such as United Therapeutics' Remodulin (treprostinil), Actelion's Ventavis (iloprost) and Pfizer's Revatio (sildenafil).

Driving the growth will be a steady stream of new candidates coming through the pipeline which will try to address the significant unmet need in PAH therapy, including drugs which can reverse pulmonary vascular remodelling, improve survival rates, and delay disease progression.

Market research published by GlobalData last year suggested that in 2020 the three leading drugs in the major PAH therapeutics market will be riociguat, macitentan and United Therapeutics' already-marketed Tyvaso (treprostinil) with estimated sales of $700m, $438m and $421m, respectively.

12th February 2013

From: Sales

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