Bayer hands off FDA app as pulmonary hypertension drug race heats up

Bayer has raced to the FDA with its application for riociguat, a promising candidate for pulmonary hypertension and a key player in the pharma giant's plans for a blockbuster year in 2013 as it sets the stage for a high-profile market battle with two big competitors. 

In two late-stage studies the oral treatment significantly improved the walking distance of pulmonary hypertension patients after 16 weeks of therapy. Bayer says that the data on inoperable chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension should warrant an OK in the key U.S. market, where the treatment will square off against some high profile competitors. 

"These regulatory submissions for two distinct forms of pulmonary hypertension not only represent important progress in our cardiovascular pipeline but also fuel our hope to bring this much-needed new treatment option for these serious and potentially fatal diseases to patients and doctors soon," said Kemal Malik, Bayer's head of global development.

Riociguat was one of the chief exhibits in an unusual presentation by Bayer's Marijn Dekkers last November. Added with a new approval for Stivarga, good prospects for radium-223 dichloride (Alpharadin, in-licensed from Algeta), along with high hopes for Xarelto and Eylea, Bayer was anticipating $7 billion in new sales growth. That's a solid return for a company that spends about $4 billion a year on R&D. Thomson Reuters notes that the average peak sales forecast for riociguat is $480 million.    

The market for PAH drugs has undergone some rapid fire changes in recent months. While Bayer was touting its upbeat Phase III last fall Actelion was boasting about success with macitentan, its successor to Tracleer. Actelion's ($ATLN) application was accepted in December and both therapies are now being prepped for battle against Gilead's ($GILD) Letairis while the FDA recently sent United Therapeutics ($UTHR) packing with a CRL for treprostinil.

- here's the press release

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