BioWatch: VIVUS & Orexigen Looking More FDA-Favorable (VVUS, OREX, ARNA)

Patients taking QNEXA with mean percentage weight loss after 108 weeks was -9.3% at mid-dose and -10.5% at top dose versus -1.8% for the placebo group.

QNEXA patients also showed a significant reduction in the number of antihypertensive medications required to be taken versus placebo.  Patients with hypertension at the start of the study at mid-dose was down by -9.8% and and down by -18.9% at the top dose; patients taking a placebo showed a net increase of +4.2%.

Dyslipidemic patients at baseline treated with the mid-dose and top dose of QNEXA saw triglycerides drops of -25.9% at the mid-dose and -26.3% at the top dose versus -14.3% for the placebo group.  Dyslipidemic patients saw improvements in HDL-C at the mid-dose of 11.4% and gains of 16.7% at the top dose of QNEXA versus gains of 9.1% for the placebo group.

Orexigen Therapeutics, Inc. (NASDAQ: OREX) is also trading higher on Phase III Contrave data.  The company announced in additional study data that overweight and obese patients treated with Contrave maintained normal 24-hour circadian patterns over one year of treatment.  Its shares are up 13.5% at $3.27 in pre-market trading versus a 52-week range of $2.47 to $11.15.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) is up marginally as it is the other of the three seeking approval for its weight loss drug.  Keep in mind that it has recently announced a $35.5 million financing package.  At $1.40, its 52-week range is $1.26 to $8.00.

So, what does all this mean?  VIVUS still trades as though it will get FDA approval for QNEXA.  There are some safety profile issues in side-effects, but that may be mostly toward women who are pregnant.  VIVUS seems to have the goods here and it is our belief that QNEXA will get approval for weight loss and that it will have a Black Box warning against use by women who are pregnant and maybe those which may seek to become pregnant.

Right before the open, VIVUS shares are up about 12% at $7.07 on more than 1 million shares versus a 52-week range of $4.69 to $13.68.

JON C. OGG