Mar. 16--Eli Lilly and Co., which found success with its erectile-dysfunction drug Cialis, is taking steps that could lead to the launch of another men's health product.
The Indianapolis drug maker said Monday it has signed an exclusive worldwide license agreement to sell Axiron, an experimental drug now under federal review for treatment of testosterone deficiency in older men.
An underarm applicator would put the drug "over a small and discreet area of the body," the company said. It was developed by Acrux, an Australian biotech that specializes in medicines administered through the skin. Treatments now use gels and patches to spread the medicine over large areas of the torso or arms.
The drug was submitted last month for Food and Drug Administration review. Assuming a normal review, a response is expected by early next year, said Lilly spokesman Mark Taylor.
Under the pact, Lilly will give Acrux $50 million upfront, $87 million upon FDA marketing authorization and up to $195 million for potential commercialization milestones, as well as royalty payments. Lilly said it expects to incur a charge to earnings in the first quarter of 2010 of about 3 cents a share.
Global sales of testosterone therapies have grown to more than $1 billion a year, with sales of testosterone gels in the U.S. of $700 million, the companies said.
Testosterone deficiency is marked by lethargy, depression, reduced libido and decreases in muscle mass and bone density. It is estimated that up to 39 percent of men 45 and older could have low testosterone levels.
Lilly made its mark in the field by launching Cialis in 2003 with its former partner, ICOS. Cialis rang up sales last year of $1.6 billion. Lilly also is testing a drug for treatment of enlarged prostate.
Call Star reporter John Russell at (317) 444-6283.
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