I don't know if there are enough dialysis patients with hyperphosphatemia, high levels of phosphorus in the blood, to propel Keryx Biopharmaceuticals'
Keryx's shares opened up just 7% on the news, but the fairly muted response is likely because of the stellar run the stock has already had this year; shares are more than double where they were at the beginning of the year.
In the trial, patients taking six or eight pills a day were able to reduce their phosphorous levels by 25% to 28.8% after taking the drug for 28 days. The trial was conducted under a Special Protocol Assessment (SPA) with the Food and Drug Administration, so the agency shouldn't have any problems with trial design.
Six or eight pills a day may seem like a lot, but Genzyme's
The more convenient dosing should help Keryx take market share away from Renagel and Renvela, which racked up just over $700 million in sales last year. But investors are going to have to wait awhile to see the revenue coming in. Keryx still needs to complete a long-term safety trial that isn't fully enrolled yet. The trial requires a year of dosing, so it'll be 2012 before Keryx will be able to submit a marketing application to the FDA.
At least it should be easier to sign up those patients now that we know the drug works.
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