Allos Therapeutics Inc. (ALTH) announced the Food and Drug
Administration has granted orphan-drug designation to one of its
products for treating a form of bladder cancer.
Shares rose 7.9% premarket to $7.80. The stock was up just 11%
the past 12 months through Monday.
Pralatrexate is being investigated for use in advanced or
metastatic transitional cell carcinoma of the urinary bladder.
Allos has pralatrexate in a Phase II study with patients with
advanced or metastatic relapsed TCC of the urinary bladder.
Advanced or metastatic TCC of the urinary bladder is a
life-threatening condition. According to the American Cancer
Society, an estimated 70,980 new cases of bladder cancer were
expected to be diagnosed in the U.S. last year. TCC accounts for
nearly all bladder cancers.
The Orphan Drug Act provides incentives to create therapies for
so-called orphan diseases--those that affect fewer than 200,000
Americans. There are about 7,000 such maladies, most of them
serious, that have few or no drugs to treat them. Getting an
orphan-drug designation opens the door to incentives once the FDA
approves a medicine for sale in the U.S., including seven years'
marketing exclusivity and tax breaks.
The small biopharmaceutical company has yet to become profitable
as it works on research and development.
-By Kevin Kingsbury, Dow Jones Newswires; 212-416-2354; kevin.kingsbury@dowjones.com