Monsanto's Orbofiban Heart Drug Trial Raises Concerns Over Mortality Rates

Monsanto Co.'s announcement that it would stop enrolling patients in its test of the heart drug orbofiban, which prevents blood clots, sent the company's stock plummeting by 10.5 percent, losing $4.44 a share and closing at $38 a share. The decision came after an unexpected excess of early mortality was detected among patients who took the drug for 30 days or less. Although most patients already in the test will continue to be treated with the drug, the news has raised questions about the viability of the product and Monsanto's financial prospects.

Key Takeaways:

• The study will continue for patients who have used the drug for more than 30 days, but the fate of the product remains uncertain due to the high rate of deaths among patients who took the drug for 30 days or less.
• Monsanto has stopped enrolling patients in the test due to "an unexpected excess of early mortality" among the 2,000 patients who had been enrolled in recent weeks, although the exact number of deaths was not disclosed.
• The drug has been designed as long-term relief for people who have suffered heart attacks, unstable angina, and chest pains associated with heart disease, but its future is now in question.
• The announcement has also exacerbated concerns about Monsanto's financial prospects, particularly in light of the company's decision to call off a merger with American Home Products Corp. last month.
• Analysts believe that the setback may make companies nervous about signing a deal with Searle, a subsidiary of Monsanto, and may impact the company's ability to find marketing partners for other products.
• The study uses three groups: patients receiving aspirin and a placebo, patients taking aspirin plus orbofiban for six months, and patients receiving aspirin plus orbofiban for 30 days.

Statistics:

• The company's stock fell by 10.5 percent, losing $4.44 a share and closing at $38 a share.
• Trading volume was about triple the average daily trade for the past two weeks.
• The study has been conducted at 800 sites in 30 countries and was designed to enroll 12,400 patients, each of whom would be treated for six months.
• 10,200 patients had been accepted for the study, including 8,000 who had used the drug for more than 30 days.
• The study is expected to be completed in mid-1999, and the exact number of deaths among patients who took the drug for 30 days or less has not been disclosed.

Sources:

• "Monsanto said Wednesday it had stopped accepting patients for tests of a heart drug because of higher than expected deaths among one group."
• "The news sent Monsanto's stock plunging by 10.5 percent, losing $4.44 a share and closing at $38 a share."
• "The company said it stopped enrollments in its tests because of 'an unexpected excess of early mortality' among patients who took the drug for 30 days or less."
• "Spokesmen for Monsanto and its drug subsidiary, G.D. Searle & Co., said the deaths may have been caused by other factors, but they said researchers won't know until the study is completed in mid-1999."
• "It's a setback," said William Fiala, who follows Monsanto for the Edward Jones brokerage. "We don't know how viable the product will be going forward, but the outlook is clearly diminished."