Shares of Medivation ($MDVN) jumped 17% today after the drug developer confirmed some promising Phase III data on the closely-watched prostate cancer therapy MDV3100 and added some reassuring numbers on the treatment's safety profile.
Some analysts have been fretting over incidences of seizures in the study, but investigators found only a 0.6% rate in the drug arm, as TheStreet's Adam Feuerstein--a careful observer of the program--notes in his coverage. As reported earlier, men with advanced cases of prostate cancer gained a 4.8-month median average survival benefit. That's the kind of data that earns approvals. Getting a pass on safety significantly boosts their chances of success.
"MDV3100 outperformed our expectations in the AFFIRM trial by meeting the primary and secondary endpoints with strong statistical significance and demonstrating a favorable safety profile," said Howard I. Scher, M.D., chief, genitourinary oncology service at Memorial-Sloan Kettering Cancer Center and the co-principal investigator of the study. "These results, together with its convenient once-daily oral dosing regimen, should make MDV3100 a promising option for men with prostate cancer who have received prior hormones and chemotherapy."
The Wall Street Journal's coverage of the event also includes kudos for Bayer and Algeta, which have been working on their own therapy. With Zytiga newly arrived on the market, Dendreon ($DNDN) is faced with a growing number of rival treatments when it's been scrambling to right the ship on Provenge. The release also underscores just how dramatically Medivation has put its past woes with a notoriously unsuccessful Alzheimer's drug completely behind it. Not all biotechs could have made that transition intact.