Schering-Plough and Johnson & Johnson's Simponi (golimumab) received a positive nod for approval in Europe, which could make it the continent's first once-monthly subcutaneous tumor necrosis factor inhibitor. The June 26 decision also spotlights J&J's move to challenge Schering's rights to the drug, given its pending merger with Merck.

The EMEA's Committee for Medicinal Products for Human Use recommended Simponi for the treatment of moderate to severe rheumatoid arthritis, active and progressive psoriatic arthritis and severe, active ankylosing spondylitis - an inflammatory disease that typically affects the spine. Simponi gained approval for the same indications in the U.S. in April and also is approved in Canada (¹ Also see "J&J Celebrates Simponi Approval With Schering – For Now" - Pink Sheet, 24 April, 2009.).

But Schering, which largely controls rights to Simponi and its predecessor Remicade (infliximab) outside of the U.S., with the exception of Japan and some Asian markets, could see Simponi slip out of its hands. Its partner J&J, which holds U.S. rights to both drugs, filed arbitration last month, citing a "change of control" provision that J&J charges Merck and Schering are trying to avoid as part of their reverse merger agreement.

Under terms of the reverse merger, Schering will be the surviving company, renamed Merck, even though Merck is shelling out $41 billion for the deal (² Also see "Merck/Schering: The Next Wave Of Consolidation" - Pink Sheet, 16 March, 2009.).

Since the Schering/Merck deal was announced in March, there has been much speculation about whether J&J could gain ownership of the lucrative anti-TNF agents (³ Also see "J&J Not Likely To Hold Its Peace At Merck/Schering Altar" - Pink Sheet, 16 March, 2009.). But Merck has maintained that the Schering deal does not constitute a change of control because of the reverse merger set-up.

Now that an EU approval for Simponi is around the corner, the stakes are even higher for all players involved, since the drug could soon start raking in sales there. But "it will take time" for Simponi to cannibalize sales of Remicade in Europe, where physicians are less willing to change prescribing habits, Cowen analysts predict in a January 2009 report.

Remicade brought in $2.12 billion in sales for Schering last year, growing 28 percent from the year before. Wyeth's Enbrel and Abbott's Humira are significant competitors for the drug in the EU, mainly because of more convenient dosing.

UCB Pharma's PEGylated anti-TNF Cimzia (certolizumab pegol) also received a positive recommendation for approval in the EU the same day as Simponi.

-Carlene Olsen (c.olsen@elsevier.com)

Schering/J&J's Simponi Gets Positive EU Nod For Approval; J&J Seeks Full Rights To Drug

More from Archive

More from Pink Sheet