Indevus Reports Positive Data From Phase III NEBIDO Trial ( Compound Achieves All Key Endpoints for...)

Indevus Reports Positive Data From Phase III NEBIDO Trial

Compound Achieves All Key Endpoints for Both Efficacy and Safety

LEXINGTON, Mass., June 07, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced final results from its Phase III pharmacokinetic trial for NEBIDO (testosterone undecanoate), a long- acting injectable testosterone therapy under development for the treatment of male hypogonadism which the Company licensed from Bayer Schering Pharma AG, Germany. The data from the recently completed 48-week trial showed that NEBIDO met its primary endpoints, a responder analysis based on average testosterone concentrations during the steady state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady state dosing interval. In addition, the drug was well tolerated. The Company will host a conference call and webcast today at 9:00 a.m. eastern time (details follow below).

"I am extremely pleased to report the successful completion of our NEBIDO study and we are looking forward to the submission of our NDA later this summer," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The market opportunity for NEBIDO is substantial. The results of our trial demonstrate the potential of NEBIDO, the only once every three month treatment for male hypogonadism, to dramatically improve the treatment options for men who suffer from this condition."

Study Design

The study was designed to supplement the European clinical trial database (originally generated by Bayer Schering Pharma AG, Germany), which has formed the basis for the approval of NEBIDO in over 75 countries to date. Specifically, the purpose of the completed Phase III trial was to evaluate NEBIDO under U.S. Food and Drug Administration (FDA) pharmacokinetic guidelines for the approval of testosterone therapy products for male hypogonadism.

The Phase III pharmacokinetic trial was a randomized op
'"/>

Page: 1 2 3 4 5 6
Related medicine technology :

1. Indevus Announces Presentation of Pagoclone Data at 47th Annual New Clinical Drug Evaluation Unit Meeting
2. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
3. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
4. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
5. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
6. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
7. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
8. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
9. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
10. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
11. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS

Post Your Comments:

( Compound Achieves All Key Endpoints for...)Indevus Reports Positive Data From Phase III NEBIDO Trial,Health