Bayer bolsters campaign for PAH drug riociguat with positive long-term data

Bayer has a new set of upbeat results from its long-term extension study of riociguat, a major new player in a busy field of competitors angling for a share of the market for pulmonary arterial hypertension. 

Investigators say they tracked further improvements in the 6-minute walking distance test with continued riociguat treatment. After an additional 12 weeks of treatment in PATENT-2, the 6MWD had increased further in former riociguat patients compared with baseline of the pivotal PATENT-1 trial. The former placebo patients also improved to a similar extent. Functional class also improved further with continued riociguat treatment, with sustained effects in a group of patients that reached the one-year mark for treatment. Bayer plans to gather one-year results on all the patients.

The outcomes will help Bayer make a case for riociguat with the FDA, which has provided priority review status for the drug. The pharma company has been developing this treatment while United Therapeutics ($UTHR) and Actelion ($ATLN) were busy working on next-gen versions of PAH drugs. United, though, recently picked up its second CRL from the FDA for an oral version of Remodulin. Actelion, however, believes it is well positioned to pick up an approval on macitentan--an absolutely essential product needed to safeguard its blockbuster PAH franchise.

Thomson Reuters Pharma says that analysts have projected average sales of $679 million for riociguat by 2017. If they are right, Bayer will continue to rack up some impressive gains on the pharma side of the business. The pharma company--which has a $4 billion R&D budget--markets Nexavar with Onyx Pharmaceuticals ($ONXX), recently obtained an approval for Stivarga and added an OK for Xofigo for advanced prostate cancer just days ago. 

"Despite the availability and advantages of several approved PAH therapies, the prognosis for patients remains poor and mortality remains high. The interim results of PATENT-2 support the benefits of riociguat that were seen in the PATENT-1 trial. We are confident that, together, these results reinforce the role of riociguat, if approved, as a new treatment in the armamentarium against PAH," said Kemal Malik, head of global development at Bayer. 

- here's the press release
- read the Reuters report