Urology Product Preview

July 1, 2012

Urology drugs and devices in the pipeline from Janssen Research and Development, LLC; Auxilium Pharmaceuticals, Inc.; Tengion Inc.; Ampio Pharmaceuticals, Inc.; Tokai Pharmaceuticals, ImaginAb, Inc.; BZL Biologics, LLC; Agensys, Inc.; and Seattle Genetics, Inc.

Supplemental applications submitted for advanced PCa therapy

Janssen Research & Development, LLC has submitted a supplemental new drug application to the FDA for abiraterone acetate (ZYTIGA) intended to extend the use of abiraterone administered with prednisone to include the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy. Simultaneously, Janssen-Cilag International NV submitted a similar type II variation to the European Medicines Agency.

Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international phase III, randomized, double-blind, placebo-controlled COU-AA-302 clinical study, in which abiraterone plus prednisone produced a statistically significant improvement in radiographic progression-free survival and a trend for increased overall survival.

Auxilium Pharmaceuticals, Inc. recently announced positive top-line results from its phase III IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials that assessed collagenase clostridium histolyticum ([CCH] XIAFLEX), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease. Both trials' co-primary endpoints (mean reduction in penile curvature deformity and improvement in the Peyronie's Disease Questionnaire bother domain) met statistical significance, and the agent was well tolerated, according to the company.

Patient enrollment continues for phase I trial of urinary conduit

Tengion Inc. reported continued clinical progress in the phase I trial of the company's Neo-Urinary Conduit for use in bladder cancer patients requiring a urinary diversion following cystectomy. The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients.

The Neo-Urinary Conduit is a combination of a patient's own cells and bioabsorbable scaffold that is intended to catalyze regeneration of a native-like urinary tissue conduit, passively transporting urine from the ureters through a stoma into a standard ostomy bag.

Tengion recently announced the implantation of the trial's fifth patient, with the objective of implanting up to 10 patients by the end of 2012.

Phase III data: Advanced PCa agent significantly increases survival

The investigational drug radium-223 dichloride (Alpharadin) significantly increased overall survival (HR=0.695, p=.00007) in patients with castration-resistant prostate cancer and symptomatic bone metastases, according to updated data from the phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. In addition, the median overall survival benefit in patients given radium-223 dichloride increased from 2.8 months at the time of the pre-planned interim analysis in June 2011 to 3.6 months. Results from the trial were presented at the American Society of Clinical Oncology annual meeting in Chicago.