Vivus Offers One-Sided Story of Qnexa By Adam Feuerstein
MOUNTAIN VIEW, Calif. (TheStreet) -- Vivus(VVUS) disclosed new, positive heart-risk data from a long-term study of the weight-loss drug Qnexa while omitting negative data from the same study.
Vivus issued a press release Monday claiming that Qnexa, among other things, reduced patients' dependence on blood pressure medicines and improved cholesterol levels. Vivus shares rose by as much as 16% intraday as investors regarded the new cardiovascular data as improving the odds that U.S. regulators might one day approve the weight-loss drug.
Other data, however, painting a less flattering portrait of Qnexa's heart-safety profile were omitted from Vivus' press release, even as they were presented to attendees Sunday at the American College of Cardiology (ACC) annual meeting.
Vivus shares were up 48 cents, or 7.6% to $6.80 in recent trading.
"Our press release was meant to be an attention grabber that highlights information we regarded as relatively newsworthy," said Vivus President Peter Tam, when asked why certain Qnexa results were included or excluded from the company's press release.
Asked whether Vivus' press release on the new Qnexa data constituted selective disclosure, Tam replied, "It's a fair comment and something we'll take into consideration."
On Monday, Vivus reported that obese patients treated with mid- and high doses of Qnexa had decreases in triglycerides of 25.9% and 26.3%, respectively, compared to a 14.3% reduction for patients treated with a placebo. Results came from a two-year study of 675 obese patients known as "Sequel."
Similarly, treatment with a mid- and high dose of Qnexa yielded increases in HDL cholesterol -- so-called good cholesterol -- of 11.4% and 16.7%, respectively, compared to a 9.1% increase for placebo patients, according to Vivus' press release.
The Qnexa poster presented at the ACC meeting, however, explains that the improvements in triglyceride and HDL cholesterol levels reported by patients taking the mid-dose of Qnexa were not statistically significant compared to placebo patients. Only the high-dose of Qnexa was able to demonstrate a statistically significant benefit over placebo.
Moreover, Vivus's press release omitted data from the study showing that patients treated with both doses of Qnexa reported statistically significant higher levels of LDL cholesterol, or so-called "bad" cholesterol levels relative to placebo patients.
LDL or "bad" cholesterol levels rose 7.7% in mid-dose Qnexa patients and fell 2.2% in high-dose Qnexa patients compared to a more beneficial drop of 10.9% in placebo patients.
Treatment with Qnexa led to a reduction in the number of medicines patients required to control high blood pressure compared to placebo patients, Vivus' press release stated. However, both Qnexa and placebo patients reported similar decreases in diastolic and systolic blood pressures -- data only reported in the Qnexa poster presented at the ACC meeting.
"We are a little puzzled by the positive stock reaction to today's data, especially given the mixed data on CV [cardiovascular] biomarkers with a statistically significant increase in LDL cholesterol observed. We continue to be concerned about the approvability of Qnexa," said Jefferies analyst Thomas Wei in a research note to clients Monday.
Vivus' Tam says the overall intent of the new data was to show that previously reported cardiovascular benefits seem with Qnexa were sustained for more than two years. Vivus is performing additional analyses from the two-year study, particularly regarding Qnexa's effect on lipid levels, which the company intends to present in the future, Tam added.
The U.S. Food and Drug Administration rejected Qnexa last October. Qnexa helped patients lose a significant amount of weight compared to placebo, but regulators raised concerns about the drug's heart safety and potential to cause birth defects in women who may get pregnant while on the drug. In January, FDA asked Vivus to compile information about birth defects possibly tied to use of topiramate, one of the two drugs which make up Qnexa. Vivus said FDA has not asked for additional clinical studies to be performed.
Orexigen Therapeutics(OREX) and Arena Pharmaceuticals(ARNA) are also trying to rebound from FDA rejections of their respective weight-loss drugs.
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