Wall Street is anxiously awaiting results from a late-stage trial of Pfizer and Bristol-Myers Squibb's next-generation blood thinner, as analysts will be looking closely for how the blockbuster hopeful, apixaban, stacks up against a wave of similar drugs that are expected to replace warfarin.
After securing European approval of the drug in May, Pfizer ($PFE) and Bristol-Myers ($BMY) are expected to report top-line data this month from a Phase III trial of the drug that is needed for U.S. marketing, Reuters reports. While the study only needs show that the experimental drug is equal to warfarin to be deemed a success, the future success of the drug in the marketplace will likely depend on whether is shows greater efficacy and lower chances of side effect associated with warfarin.
"Despite relatively high expectations reflected for the product already, any comment about a statistically significant improvement in efficacy or bleeding would be a positive catalyst for the stocks," JP Morgan analyst Chris Schott wrote in a research note, as cited by Reuters. "In the very unlikely event the study misses its primary endpoint, we would anticipate Bristol-Myers shares could be down 10%."
Apixaban is among several new blood thinners that are at various stages of hitting the U.S. market and give doctors new options for treating such conditions as atrial fibrillation and blood clots. The FDA is considering approval of Bayer and Johnson & Johnson's ($JNJ) blood clot preventer Xarelto, which already got the market green light in Europe, and Daiichi Sankyo is in late-stage development of anti-coagulant edoxaban. And U.S. regulators handed Boehringer Ingelheim an approval for Pradaxa last fall.
With Pfizer and Bristol-Myers' blood thinner likely to enter the U.S. market after at least two of those other new drugs, Sanford Bernstein analyst Timothy Anderson told Reuters that "the data need to be pretty good."
- read Reuters' report