Anadys gets FDA nod on hepatitis C drug study

August 1, 2009

UPDATE 1-Anadys gets FDA nod on hepatitis C drug study, shrs up

Thu Jul 30, 2009

* Gets FDA clearance on mid-stage hepatitis C study

* Q2 loss/shr 21 cents vs est loss/shr 28 cents

* Shares up 22 pct

July 30 (Reuters) - Anadys Pharmaceuticals Inc (ANDS.O) said U.S. health

regulators cleared the parameters for a mid-stage study of its hepatitis C drug,

sending its shares up 22 percent.

The drug, ANA598, is the company's key product candidate and has faced safety

concerns earlier this year after three patients dropped out of a safety study as

they developed a rash.

Anadys said the U.S. Food and Drug Administration cleared the study protocol and

patient dosing is expected to commence within the next several weeks.

Ninety patients are planned to be enrolled in the study, with 30 patients

receiving the drug, ANA598, and 15 receiving a dummy drug at each dose level.

The study would test 200 mg and 400 mg doses of the drug.

The company, which has two other drugs in the pipeline for hepatitis C and

cancer, also posted a narrower-than-expected quarterly loss and said its cash

reserves are expected to fund operations into 2011.

For the second quarter, the company posted a net loss of $6.5 million, or 21

cents a share, compared with a net loss of $7.1 million, or 25 cents a share, a

year ago.

Research and development expenses fell 16 percent to $4.6 million, while general

and administrative expenses rose 28 percent.

As of June 30, the company's cash, cash equivalents and securities

available-for-sale totaled $30.6 million, Anadys said in a statement.

Shares of the company were up 17 percent at $2.10 in trading after the bell.

They closed at $1.80 Thursday on Nasdaq. (Reporting by Esha Dey in Bangalore;

Editing by Vinu Pilakkott)

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