Emisphere Halts Development of Oral Heparin, Citing Insufficient Efficacy
10:43 GMT-04:00 Tuesday, May 14, 2002
Dow Jones Newswires
NEW YORK -- Emisphere Technologies Inc. (EMIS) Chairman and Chief Executive Michael M. Goldberg said the company would no longer develop the oral, liquid version of the blood-thinning drug heparin, which wasn't more effective in Phase III clinical testing than Aventis SA's (AVE) Lovenox.
The news sent shares of Emisphere plummeting $6.87, or 58, to $5.05 in midmorning trading on the Nasdaq Stock Market. On Monday, the shares closed at $ 11.92, down 66 cents.
Mr. Goldberg contended Tuesday during a conference call with analysts and investors that Emisphere's formulation of heparin didn't miss the efficacy mark by much, and suggested the late-stage tests may not have been properly administered, although he stressed that view was based only on anecdotal evidence.
Patients inject Lovenox, the most commonly prescribed version of heparin, for two to three weeks after leaving the hospital. Some industry watchers had speculated that patients would adopt oral heparin as an alternative to Lovenox because of its convenience.
Despite the disappointing trial, Emisphere believes that its technology for turning traditionally injected drugs into an oral form is sound, Mr. Goldberg said. The firm will now focus on a solid formulation of heparin, which also would be taken orally, as well as oral forms of other drugs.
As the firm shifts its focus, Mr. Goldberg said the firm will reduce its staff and cost structure, and will provide updated financial forecasts to investors in about a month.
The CEO didn't give further details, though he did note that he expects the cost cuts to save Emisphere "tens of millions of dollars," and that the the end of liquid-heparin testing and development will significantly reduce Emisphere's cash burn rate.
Because Emisphere remains confident that its technique for turning injected drugs into an oral form is sound, Mr. Goldberg said Emisphere expects existing and anticipated development partners will give the firm additional funding.
Mr. Goldberg added that the oral, liquid form of heparin was safe, but missed efficacy requirements by a slim margin.
Additionally, he said that it's "crystal clear" that not all hip-replacement patients enrolled in the late-stage trial took all doses as instructed. He also suggested that some patients involved in the trial took other anticoagulants, such as aspirin, which may have skewed the results.
In light of patients' alleged noncompliance in taking the liquid form of heparin, Mr. Goldberg said "a bad tasting liquid may not be better than injection in some patients' minds."
Mr. Goldberg said Emisphere takes this message to heart and now will only develop treatments in pill, not liquid, form. "We've taken valuable lessons from this study," he said.
All of Emisphere's other experimental treatments, including insulin- replacement therapy, are in pill form, the CEO added.
Another Emisphere executive suggested that if the patients enrolled in the study had remained in the hospital during the trial, Emisphere's experimental treatment may have been as effective as Lovenox.
-By Nick Baker |
