Tuesday, May 26, 2015

Merck's EU Simponi® Marketing Rights -- Likely Slightly More Valuable Now, With New (nr-axial SpA) Indication Pending

It seems that Kenilworth is likely to receive an expanded label for Simponi® -- the therapy that Merck still controls marketing rights (from J&J) for, via an arbitration settlement out of the Schering-Plough transaction -- in Europe, but not the US.

CHMP granted a thumbs up to an expanded nr-axial SpA indication, which supplements a number of existing indications in rheumatology and gastroenterology. That's some good news for Merck. From the press release then, a bit:

. . . .Merck today announced that SIMPONI (golimumab) has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI (golimumab).

The CHMP positive opinion was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with golimumab, compared with patients treated with placebo, over 16 weeks. . . .

And so -- onward we go.

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