Schering-Plough and partner Johnson & Johnson found cause to celebrate FDA's approval of Simponi (golimumab) April 24, even as Schering waits to find out whether J&J will try to challenge ownership of the anti-TNF drug as a result of Schering's planned merger with Merck.

That's because a so-called change of control clause originally crafted in 1998 applies to both Simponi, and its predecessor, Remicade (infliximab). If J&J believes that Schering has changed hands, it could decide it has the rights to market the two anti-TNF medicines outside the U.S.

FDA cleared Simponi, the first monthly subcutaneous TNF blocker, for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis a week after Canadian regulators gave their marketing go-ahead to the compound in the same indications. European approval is expected in the first half of this year, too.Meanwhile, onlookers are still guessing what shape J&J's opposition to a proposed $41.1 billion merger by Schering with Merck might take, if it comes (¹ Also see "Will Johnson & Johnson Undercut Merck’s Bid to Buy Schering-Plough?" - Pink Sheet, 9 March, 2009.).

The reverse-takeover approach taken by the parties probably won't let the pair entirely dodge change-of-control provisions built into the Schering/J&J arrangement, but J&J likely does not relish trying to find a European partner for the TNF blockers that can match the clout of Schering.

Together the Remicade and Simponi assets are projected to be worth as much as $8 billion. J&J, which made $3.7 billion from Remicade sales in 2008, has not tipped its hand, although investors are clearly wondering what the diversified drug maker will do.

In response to a question posed at J&J's annual shareholder meeting, the drug maker's chief executive officer William Weldon tried to pacify investors. "We are analyzing the situation and I can't disclose any of the discussions we're having," he said, according to a Wall Street Journal report. "Rest assured, we're not sitting back and doing nothing."

Simponi's appeal is more commercial than clinical, since it allows patients to take injections rather than sit for bothersome and time-consuming infusions. This ease of use is expected to push sales beyond those of Remicade in fairly short order. The new compound will compete with Amgen's Enbrel (etanercept) and Abbott's Humira (adalimumab).

Whatever J&J decides to do with regard to the Merck deal, Schering needs the Simponi juice. Net sales dipped 6 percent in the first quarter of this year, to $4.4 billion, due largely to foreign-exchange rates and worse performance of its Vytorin and Zetia cholesterol joint venture with Merck (² Also see "Schering Looks Ahead To Simponi Launch In Canada, Europe After Sluggish Q1" - Pink Sheet, 21 April, 2009.).

- Randall Osborne (r.osborne@elsevier.com)

J&amp;J Celebrates Simponi Approval With Schering – For Now

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J&J Celebrates Simponi Approval With Schering – For Now