Urology Product Preview

May 1, 2011

Urology drugs and devices that are in the pipeline from Astellas Pharma, Inc., Teva Pharmaceutical Industries Ltd., Medivation, Inc., Nymox Pharmaceutical Corp., and TARIS Biomedical.

Phase III trial results of OAB compound are promising

Astellas Pharma Inc. recently announced positive results from two phase III trials of mirabegron (YM178), the first in a new class of compounds in development for the treatment of overactive bladder. Study results showed that mirabegron improves OAB symptoms, including urinary incontinence and frequency of micturition.

After 12 weeks of treatment, once-daily mirabegron demonstrated significant improvements from baseline in the co-primary endpoints of incontinence episodes and micturitions over a 24-hour period.

Astellas expects to submit a market authorization application for mirabegron to the FDA later this year.

New drug application accepted for testosterone gel

The FDA has accepted for filing a new drug application by a subsidiary of Teva Pharmaceutical Industries Ltd. for a testosterone gel (Bio-T-Gel). The gel is intended for the treatment of male hypogonadism.

The FDA has assigned a PDUFA date, the target date for the FDA to review the NDA, of Nov. 14, 2011.

Teva is responsible for all Bio-T-Gel regulatory and marketing activities. The gel was initially developed by BioSante Pharmaceuticals.

Phase II trial of advanced prostate Ca agent launched

Medivation, Inc. and Astellas Pharma Inc. recently announced the treatment of the first patient in a phase II trial comparison study of prostate cancer treatments.

The study will compare an investigational triple-acting oral androgen receptor antagonist known as MDV3100 and the anti-androgen bicalutamide (Casodex) in the treatment of prostate cancer patients who have progressed while on LHRH analog therapy or following surgical castration.

The phase II study is expected to enroll 370 patients overall. The primary endpoint is progression-free survival.

7-year study of BPH agent yields positive results

Nymox Pharmaceutical Corp. recently announced positive results from a 7-year outcome study of NX-1207, a treatment for BPH.

The study evaluated symptomatic change and treatment status of patients involved in studies begun in 2003. Study data indicate that a significant percentage of patients given a single treatment of NX-1207 have shown sustained improvement of their symptoms without other treatment for more than 7 years.

The treatment is injected in a urologist's office and requires a single administration. Other follow-up trials have provided information regarding the safety of NX-1207 as well, Nymox said. The treatment has now entered its phase III development program.

Clinical study builds on early trial of IC drug

TARIS Biomedical has initiated a phase IB clinical study of its product candidate LiRIS in patients with interstitial cystitis.

The study will evaluate the safety and tolerability of LiRIS in patients suffering from moderate to severe IC. The therapy is designed to continuously deliver lidocaine over an extended period directly to the bladder to decrease symptoms associated with IC.

The phase IB study builds on a previously completed phase IA study in which TARIS said it established proof of concept by demonstrating the tolerability and retention of the TARIS delivery device.