The FDA has granted its fast-track status to Actelion's Phase III drug for C. difficile-related diarrhea, promising a shorter path to approval for the antibiotic treatment.
In an interview with Bloomberg, COO John Milligan says the big biotech outfit--which is expected to generate megablockbuster revenue from the newly approved Sovaldi for hep C--is pondering a head-to-head study to determine whether Letairis is better or worse than Actelion's recently approved lung drug Opsumit.
The Swiss drugmaker said in a statement that the EC approved the drug for use by itself or in concert with another PAH drug. Actelion intends to begin selling it in Europe in February, with Germany first in line to get it.
Drugmakers have often been accused of trying to thwart competition with arrangements like pay-for-delay deals or aggressive patent litigation to protect their key drugs. But Swiss drugmaker Actelion went even further than that, a court ruled, buying out a drug company and then canceling a development deal in an effort to protect its only significant product at the time, PAH drug Tracleer.
The EU on Friday recommended approval of Actelion's Opsumit, following FDA approval the week before, and by today the takeover talk was in full swing. With regulators giving thumbs up to a drug projected to be a blockbuster, analysts say any number of companies may want to do a deal and add the assured revenue to their own top lines.
Actelion has been anxiously awaiting FDA approval of its new pulmonary arterial hypertension treatment Opsumit, a follow-up to its only significant product, Tracleer, which goes off patent in 2015. Friday it got it.
Late on Friday the FDA came through with an approval for Actelion's pulmonary arterial hypertension drug Opsumit (macitentan), its next-gen successor to the franchise drug Tracleer.
In its third-quarter earnings report, Abbott surprised investors with a sizable dividend boost, while Actelion assured shareholders it can deliver new profit streams before blockbuster Tracleer goes off patent in 2015. Baxter's report was a little less rosy, with earnings falling on acquisition costs.
Ceptaris Therapeutics won FDA approval for its topical treatment for mycosis fungoides, the most common form of cutaneous T-cell lymphoma. The gel delivers the chemotherapeutic agent mechlorethamine, previously only approved for intravenous treatment.
Bayer garnered support from FDA staff for its submission for approval of riociguat for two forms of pulmonary hypertension, though reviewers recommended clearing the experimental drug at a lower dose than the company sought.