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Vivus, Onyx, Amarin Await Key Dates in July


Vivus expects word on potential US approval for its diet pill Qnexa, while Onyx awaits a decision on a cancer treatment. Will Amarin's fish-oil heart drug finally win approval?

MINYANVILLE ORIGINAL A summer slowdown? Not for drug and biotech investors watching new product approvals. There are several important dates investors need to circle in July.

Vivus (VVUS) may win the second US market clearance for a new diet pill this year following Arena Pharmaceuticals (ARNA) and Eisai's victory last month. (See Arena Pharmaceuticals' Diet Pill Approved for Sale in US.) Meanwhile, Onyx Pharmaceuticals (ONXX) faces a decision date for a cancer drug and Amarin (AMRN) is trying to win approval for its fish-oil heart drug.

Those are some of the story lines for this month's important dates for biotech and pharmaceutical makers. Here are some of the highlights for July. As always, some of the dates are subject to change.

July 17

Vivus awaits word from the Food and Drug Administration for possible approval of the diet pill Qnexa. The FDA pushed back its decision, which was originally expected in April. After much controversy over the past couple of years, the drug won the backing of a panel of government advisers in February. (The pill was rejected by the FDA in 2010.) Vivus shares are up almost 200% this year as investors expect the company will get US market clearance for the obesity drug. Unlike Arena, Vivus doesn't have a development partner for Qnexa. If approved, it's expected that Vivus will be required to have a plan that mitigates patient safety risks for Qnexa.

July 24

GlaxoSmithKline (GSK) faces a panel of government advisers who will weigh the use of the company's drug Tykerb with Roche's (RHHBY) Herceptin to treat advanced breast cancer. The new use would treat women who previously received Herceptin.

July 26

Amarin expects a decision on US approval for its fish-oil heart drug to treat high levels of triglycerides (a type of fat in the blood). Positive study results released last year gave investors new hope. (See Amarin Stock Surges on Heart Drug Study.) Shares of Amarin have doubled this year.

Horizon Pharma (HZNP) is supposed to hear from the FDA on possible approval of the drug Rayos, a delayed-release version of the anti-inflammatory drug prednisone for rheumatoid arthritis. Horizon's stock price has doubled this year.

Roche will go before a panel of FDA advisers who will consider the company's application to sell its eye drug Lucentis for the additional use in patients with diabetic macular edema. Lucentis is already approved for patients with the blinding disease age-related macular degeneration. The medicine competes with Regeneron's (REGN) Eylea.

July 27

Onyx should get a decision on possible US approval of its drug Kyprolis for multiple myeloma in patients who received other treatments. A panel of FDA advisers unanimously backed the treatment last month. (See Onyx Pharmaceuticals Wins US Panel's Backing for Cancer Drug.)

Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) are scheduled to hear from the FDA on an application for the expanded use of Relistor for treating patients with constipation caused by the use of opioids. The FDA delayed a decision on the drug in April.

July 30

Regeneron is expected to get a rejection from the FDA for expanded use of the medicine Arcalyst as a treatment for gout flares. In May, a panel of government advisers said the company didn't show the drug was safe and effective for that use. (See Regeneron Dips on Safety Concern Over Gout Treatment [UPDATE].)

Twitter: @brettchase

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