Schering-Plough expects to initiate a new clinical trial this year for the anesthesia injection Bridion (sugammadex) to address FDA's concerns about hypersensitivity, the company reported during its fourth quarter sales and earnings call Feb. 3.

Bridion, which was approved by European regulators, hit a roadblock with FDA in August, when the agency deemed the drug "not approvable" (¹ Also see "Schering Plough’s Bridion Faces FDA Setback" - Pink Sheet, 1 August, 2008.). The company is seeking approval of Bridion to reverse muscle relaxant effects after anesthesia, but the agency is concerned that it causes hypersensitivity.

Following a meeting with FDA in December, the company now has a strategy for addressing the agency's issues about Bridion in the U.S., Schering-Plough Research Institute President Tom Koestler said.

"The path forward will involve a small study in normal healthy volunteers in a few hundred subjects," Koestler said. The study protocol has yet to be finalized and submitted to FDA. The trial will likely run about 12 weeks and could be enrolled in an eight to 10 week timeframe, he said.

The drug, which Schering gained through the November 2007 acquisition of Organon Biosiences, has launched in about 10 countries outside the U.S., Schering reported.

"In every country that we've had a chance to launch into, we get excellent feedback from the physicians who've had an opportunity to use the product," Global Pharmaceutical Business President Carrie Cox said.

Bridion is one of five R&D "stars" that Schering management highlighted during a pipeline update in November. The company is projecting that the drug will have peak sales of $750 million to $1 billion (² Also see "Schering Telescope Points To 5 R&D “Stars,” But TRA Shines Brightest" - Pink Sheet, 1 December, 2008. p. 3).

Firm creating psychiatry sales force ahead of Saphris launch

Another star, the schizophrenia and bipolar disorder drug Saphris (asenapine) was the subject of an FDA complete response letter in January (³ Also see "Schering-Plough's Saphris Hits FDA Roadblock With "Complete Response"" - Pink Sheet, 14 January, 2009.). Schering has said FDA did not require additional studies for Saphris, however, and that it plans to respond to the letter this quarter.

The company plans to establish its own psychiatry sales force ahead of the launch, CEO Fred Hassan noted during the call.

"It can be done very carefully and sequentially, first penetrating the high [return on investment] space, which are the psychs, and then expanding to the high ROI primary care doctors and finally taking it to the broader audience," he said.

Schering reported fourth quarter sales of $4.3 billion, up 17 percent versus a year ago, due to the inclusion of a full quarter of Organon sales, compared to a partial quarter in 2007. Sales growth came from inflammatory disease medication Remicade , brain cancer treatment Temodar and corticosteroid Nasonex . However, net sales from Schering's cholesterol joint venture with Merck, which includes Vytorin and Zetia , declined 26 percent to $1.1 billion. Schering recorded $426 million from the venture in the fourth quarter, versus $566 million in the fourth quarter 2007.

-Jessica Merrill (j.merrill@elsevier.com)

Schering Plans Bridion Clinical Trial To Address FDA’s Hypersensitivity Concerns

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