12/14/09
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Ladenburg Thalmann analyst Juan Sanchez
Sanchez said the drug has the potential to become a $250 million to $450 million product in the U.S. and a $450 million to $600 million product worldwide, before considering off-label uses and potential approvals for other indications.
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NEW YORK (Dow Jones)--Shares of PSivida Corp. (PSDV) jumped as much as 15% Monday as investors eagerly awaited data from a Phase III trial of Iluvien.
The company has said in the past that it expects to report safety and efficacy data from the trial by the end of December for the drug treating diabetic macular edema, a potentially blinding eye disease affecting over 1 million people in the U.S. There currently are no drugs approved by the Food and Drug Administration for DME, the company said.
PSivida spokeswoman Beverly Jedynak said Monday the company hasn't released data yet, but that it has said it expects to by the end of the year.
"People trade on expectations, and I think people are expecting something [to be released soon]," she said.
In recent trading, shares jumped 13% to $4 on more than double the normal daily volume. They earlier traded as high as $4.09. Shares have more than quadrupled year-to-date, trading sharply higher than their 52-week low of 60 cents from March.
In September, the company reported positive 18-month interim results from the study. And it said last month during its fiscal first-quarter results that if the data are positive, its partner Alimera Sciences Inc. will file a new drug application with the FDA in the second quarter of calendar 2010 and request priority view.
Ladenburg Thalmann analyst Juan Sanchez said in a note last week that he continues to expect positive results for the data.
He said there is "ample evidence intravitreal steroids are effective in the treatment of DME," and he believes both doses of Iluvien maintain sufficient steroid levels in the back of the eye. Iluvien is inserted into the eye in this course of treatment.
"In essence, we believe Iluvien is the safest way to conveniently and continuously deliver steroid to the back of the eye compared to current treatment and view both dose groups favorably," Sanchez noted last month.
He added he believes it will become the treatment of choice for DME, with off-label usage for other indications. Sanchez said the drug has the potential to become a $250 million to $450 million product in the U.S. and a $450 million to $600 million product worldwide, before considering off-label uses and potential approvals for other indications.
-By Shara Tibken, Dow Jones Newswires; 212-416-2189; shara.tibken@dowjones.com;
online.wsj.com
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