RAPAFLO improves urinary symptoms: Watson Pharma Phase 2 study

RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, maximizes target organ activity by binding with high affinity to the alpha (1A) receptors concentrated in the prostate.

The double-blind, 12-week, placebo-controlled Phase 2 study evaluated the safety and efficacy of RAPAFLO in patients with moderate to severe non-bacterial CP/CPPS who previously had not received alpha-blockers for the condition.

The primary measure of efficacy was improvement in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score.

Secondary end points evaluated were: safety; change from baseline in NIH-CPSI pain, urinary, and quality of life scores; and change from baseline in Medical Outcomes Study Short Form 12 (SF-12) physical and mental component scores.

Kingston General Hospital urologist, Queen's University in Kingston, Ontario, Canada Urology professor and lead author of the study J Curtis Nickel said RAPAFLO has demonstrated significantly improved outcomes in men suffering from CP/CPPS.

"Importantly, twice as many men treated with RAPAFLO 4 mg once daily versus placebo reported feeling a moderate to marked improvement in their condition, showing that the statistically significant findings also were clinically meaningful for the patients, Nickel said.

Originally developed by Kissei Pharmaceutical in Japan, RAPAFLO is licensed to Watson for the US, Canada and Mexico markets.

C3 Research Associates - Clinical Research Development and Management Group C3 Research Associates is a quality-focused clinical research development and management group supporting innovative biotechnology, medical device and pharmaceutical organizations, stewarding therapeutics from preclinical through phase IV drug development and successful market life cycle. GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity.

Len Bogner: Rexahn Pharmaceuticals (RNN) Update May 9, 2011 | CP ...

President, Bogner Business Associates LLC

6-12 Month Target:  $2.50-$3.00

Upside Potential:  $7.50-$10.00

RATING:  SPECULATIVE BUY

We Reiterate Speculative Buy Rating and Raise Our

6-12 Month Price Target

Our favorable investment case for Rexahn Pharmaceuticals (RNN) has been highlighted by two key assumptions:  (a) the Company will be able to finance clinical trials for its three core compounds—Archexin (cancer treatment), Serdaxin (depression and Parkinson’s disease), and Zoraxel (sexual dysfunction)—and receive funding from Teva Pharmaceuticals for its leading pre-clinical anti-cancer compound (RX-3117); and (b) the Company will meet a drug-development timeline we’ve presented that could result in substantial royalty and milestone payments “in the not to distant future.”

To date, RNN has “hit and missed” on these two investment variables and seen some classical startup company “peaks and troughs” in its stock price during the last few years.

We have remained “muted” in our financial models, basically focusing our projections on the operating losses (and cash needs) the Company would likely sustain during 2009-2012, before moving to last-stage clinical trials, and, ultimately, commercialization of its products.

We think the Company has made considerable progress in implementing the research and development phases of its strategic plan: the major candidates are, or should, begin critical Phase II clinical trials this year, and RX-3117 is moving toward Phase I trials in early 2012.

Consequently, we are now presenting our revised earnings model for 2011-2013, which incorporates our estimates of new revenue streams, which we believe will be sufficient to move RNN “into the black” next year and foreseeable future.  This would mark the first time in the Company’s history that it has generated a profit.  Our numbers more appropriately depict the “directional” trend in revenue generation and not the absolute level of sales that could be achieved in 2012 and beyond.

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