Recently, Endo Pharmaceuticals (ENDP) and partner Bioniche Life Sciences Inc. announced the initiation of a second late-stage study of their cancer candidate, Urocidin. The randomized, open-label, multi-center study (n~450) will compare Urocidin with mitomycin C for treating patients suffering from non-muscle-invasive bladder cancer.
This form of bladder cancer affects the surface of the bladder and is treated by urologists using surgical resection and therapy based on intravesical infusion. Urocidin is administered into the bladder through a trans-urethral catheter. The study is expected to be conducted in 120 sites across the globe.
We believe that if Urocidin is successfully developed and commercialized the top line at Endo Pharma would be boosted significantly. Moreover, if Urocidin hits the market then it would provide an additional option for treating patients suffering from bladder cancer. Bladder cancer is highly prevalent in North America, being the fourth most common cancer form to affect men and the fifth overall between both men and women.
The non-muscle-invasive form of bladder cancer affects approximately 70% patients suffering from bladder cancer patients. Approximately 350,000 patients affected with non-muscle-invasive bladder cancer patients are either newly diagnosed or have a recurrence every 12 months in the US, Europe and Japan (combined).
The bladder cancer market, dominated by generic drugs, has a huge unmet need. Apart from Endo Pharma’s Urocidin, Spectrum Pharma’s (SPPI) EoQuin and Javolor (already available in the UK) developed by France’s Pierre Fabre group will also target the bladder cancer market.
Our Recommendation
Currently, we have a ‘Neutral’ stance on Endo Pharma in the long-run, which is supported by the Zacks #3 Rank (short-term ‘Hold’ recommendation) carried by the company.
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