Biotech Values

[ghmm]

Actelion:

Selexipag meets primary endpoint in pivotal Phase III GRIPHON outcome study in patients with pulmonary arterial hypertension

http://www1.actelion.com/en/journalists/latest-news/griphon-results.page?

Selexipag decreased the risk of a morbidity/mortality event versus placebo by 39% (p<0.0001). Efficacy observed was consistent across the key subgroups; age, gender, WHO Functional Class, PAH etiology and background PAH therapy. Patients were treated for up to 4.3 years. The overall tolerability profile of selexipag in GRIPHON was consistent with prostacyclin therapies.

I suspect they missed on 6MW and Borg dyspnea but cudous to them for being smart enough to run the trial UTHR should have ran with their oral. Now they'll likely get approved as add-on while Oral Remodulin is not. I think it was a safe bet if they got enough Prostacylin they would meet the primary given the history of Prostacylin's. The line

tolerability profile of selexipag in GRIPHON was consistent with prostacyclin therapies

actually implies they may have had a high drop/dose reduction rate so it'll be worth listening to see if they give more details on what they DID NOT release in the PR.


They will have a conference call 8am EST tomorrow available from the above link.

Here is the clinicaltrials.gov entry
http://clinicaltrials.gov/ct2/show/NCT01106014