LifeCycle shares soar after low-dose organ rejection drug edges Prograf in Ph3

In a head-to-head study with a market leading treatment designed to prevent kidney transplant rejection, Denmark's LifeCycle Pharma says that its once-daily experimental drug edged out Astellas's twice daily Prograf. And investors quickly bid up the biotech's shares by 40 percent once word of the success of the non-inferiority trial spread.

Investigators say that after 12 months data on LifeCycle's LCP-Tacro demonstrated a rejection rate of 2.5 percent compared to 4.9 percent for Prograf. The similarities aren't too surprising. Both use a chemical called tacrilimus to tamp down on the immune response that can trigger organ rejection. But LifeCycle's lower dosage requirement should give it an edge over the generic competitors to Prograf that have been popping up after the older drug lost patent protection.

LifeCycle added that it will wait for another round of trial data before it files for an approval in the U.S. and Europe in early 2013.

"The results we have seen in this large Phase III study demonstrate that LCP-Tacro allows for patients to be successfully converted from Prograf to LCP-Tacro at a lower dose and with once-daily convenient  dosing," said Dr. Suphamai Bunnapradist, M.D., a professor at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA. "These data suggest that LCP-Tacro may potentially offer an improvement in outcomes, as well as improved convenience for our transplant patients due to the once-a-day dosing."

- check out the LifeCycle release
- here's the story from Bloomberg

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