MediGene AG (DX:MDG) Successfully Completes Pivotal Clinical Phase III Trials Of Polyphenon® E Ointment For The Treatment Of Genital Warts
10/19/2005 5:12:25 PM
The German-American biotech company MediGene AG (Frankfurt, Prime Standard: MDG) announces the successful closure of the Americas phase III trial of Polyphenon® E Ointment* for the treatment of anogenital and perianal warts, thus fulfilling the clinical requirements for filing an marketing application (NDA). The outcome of this statistically significant trial with more than 500 patients demonstrates significant efficacy of the ointment compared to placebo as well as good tolerability. The data obtained surpass the positive results MediGene had received in the comparable European phase III trial on more than 500 patients, completed in March 2004. The company plans to submit an NDA in the US, in mid 2005, followed by submission in Europe.