Urigen Pharmaceuticals, Inc. (URGP-OTC: BB)

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March 19, 2010 Issue

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With The Last Drug Approved For Painful Bladder Syndrome/Interstitial Cystitis Thirteen Years Ago Often Taking 6 Months To Provide A Benefit, Urigen Pharmaceuticals, Inc. Is Bringing Hope With Their URG101 That Provides Initial Relief In A Matter Of Minutes Now In Phase II Clinical Studies

Company Profile:

Urigen Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for urological disorders. Urigen's two lead programs target what management believes to be significant unmet medical needs and major market opportunities in urology. Urigen's URG101, a proprietary combination of approved drugs that is instilled into the bladder, targets painful bladder syndrome, which affects approximately 10.5 million men and women in North America. Urigen's URG301, a proprietary dosage form of an approved drug that is locally delivered to control urinary urgency, targets acute urgency in females diagnosed with an overactive bladder, in what management believes to be another major unmet need that is insufficiently managed by presently available overactive bladder drugs.

Dr. William J. Garner M.D.
President and CEO
William J. Garner, M.D., has served as President and Chief Executive Officer of Urigen since December 2005. Dr. Garner is an experienced entrepreneur. Prior to founding Urigen, Dr. Garner had been the founder and managing director of EGB Advisors, LLC, a pharmaceutical commercialization boutique. Through this entity, Dr. Garner worked on a number of biopharmaceutical business transactions and has raised financing for another company that he founded called Inverseon, Inc., developing a novel therapy for asthma. Before this, Dr. Garner worked in medical affairs at Hoffmann LaRoche in oncology. Prior to Roche, Dr. Garner was in the venture capital department at Paramount Capital Investments in New York City. Dr. Garner has a Master of Public Health from Harvard and received his M.D. degree from New York Medical College. Dr. Garner did residency training in Anatomic Pathology at Columbia-Presbyterian and is currently a licensed physician in the State of New York.

Healthcare
Biotechnology
(URGP-OTC: BB)

Urigen Pharmaceuticals, Inc.
27 Maiden Lane, Suite 595
San Francisco, CA 94108
Phone: 415-781-0350
 

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published – March 19, 2010

CEOCFO: Dr. Garner, what attracted you to Urigen Pharmaceuticals?

Dr. Garner: It is an interesting story. I saw patients being treated experimentally by our scientific founder, and saw them responding to the drug in minutes, so he and I co-founded the company with some other people. That product we now term URG101 for Painful Bladder Syndrome (PBS).

CEOCFO: Would you tell us about you products and the general scope of the industry and opportunity?

Dr. Garner: Well a little bit about the term Painful Bladder Syndrome/Interstitial Cystitis which is sort of a mouthful. Painful Bladder Syndrome/Interstitial Cystitis is actually not a small population of people afflicted, it is actually quite a large number and when we started the company it was a little bit difficult to estimate. We had estimated that there were 10 ½ million men and women in the US and Canada, but historically there have been some smaller numbers circulating. Then last year the Rand Corporation announced that with a pretty tight definition, and just looking at women that they believe there were minimally 3 to 8 million American women that have Interstitial Cystitis. In addition, we think of Interstitial Cystitis as a more rigid definition underneath the umbrella term of Painful Bladder Syndrome. So it is quite a significant opportunity for our URG101.

CEOCFO: How has painful bladder syndrome been treated in the past?

Dr. Garner: Actually, the last pharmaceutical innovation for Painful Bladder Syndrome/Interstitial Cystitis was innovated by our scientific founder, which is important to the Urigen story. He developed a drug, which now sells about $175 million that is marketed in the US by a division of Johnson & Johnson, and co-promoted by Bayer Corporation as well. However, it was approved in late 1996.  So since then in those thirteen or fourteen years we haven’t had a new innovation, and that is the standard of care. With that drug, you have to take it three times per day generally for six months, and you can imagine waiting for six months for a response to your pain, which may not come. So that gives you an idea of the opportunity for URG101, which actually works in a matter of minutes during an office visit. So it is truly a paradigm-shifting product potentially and that is what I saw meeting patients in Dr. Parsons’ clinic in 2003 at the University of California San Diego.

CEOCFO: What does URG101 do?

Dr. Garner: URG101 is a proprietary combination drug of buffered lidocaine and Heparin that is instilled into the bladder for an exposure of about 30 minutes. URG101 has an anesthetic that treats pain and heparin provides bladder coating.  It is addressing the underlying defect in the lining of the bladder associated with Painful Bladder Syndrome. This science has been worked out over three plus decades by Dr. Parsons, some in his lab and some in his clinic and in the past has resulted in publications in Science magazine. So there is real science behind this and that work led to the development of a pharmaceutical and now this pharmaceutical, URG101 in development, which we think is going to be a very important treatment option for people with Painful Bladder Syndrome.

CEOCFO: Where are you in this process?

Dr. Garner: We have completed a double-blind placebo controlled multi-center Phase II study in the United States, and we achieved statistical significance with respect to our primary end point, which is a pain end point and actually all three of the secondary end points, which we are either looking at a pain or urinary urgency or a combination of those two. So we believe we have some very important unambiguous Phase II data, and this product needs further development. In the coming months, we are going to be requesting a meeting with the FDA and our plan is to meet with them to discuss what will be required to get the product approved in the US.

CEOCFO: Is the medical community paying attention?

Dr. Garner: There is probably not enough attention paid to it because historically there was a lot of confusion and people have been misdiagnosed. Women are frequently told they have endometriosis and they actually have in many cases Painful Bladder Syndrome. Painful Bladder Syndrome/Interstitial Cystitis afflicts more women than men, the ratio is approximately up to four women for every man who is afflicted. However, the medical community has recognized this is a difficult population to treat. They have been considered very difficult patients and sometimes practitioners didn’t want to see them because they couldn’t offer them too much. But, assuming we are successful with an FDA approval we believe that URG101 will truly shift the treatment paradigm. This group includes a lot of people that have been treated for endometriosis and non-specific prostatitis. It also includes a lot of what are believed to be urinary tract infections, which are treated with billions of dollars of antibiotics, but many of those people actually have Painful Bladder Syndrome. There is right now some tremendous opportunity in the marketplace that may be addressed with a product like URG101.

CEOCFO: What else are you working on at Urigen?

Dr. Garner: Urigen also has an URG300 platform, the first product we call URG301. It is a low-dose lidocaine female urethral suppository, so it is again like URG101 in that it is applying established molecules, in this case lidocaine, locally to the urinary system for the treatment of important diseases. So, for example, you can have a painful urethra associated with your painful bladder syndrome and for some people who need to undergo instrumentation of their bladder or their urethra, it is difficult to apply a local anesthetic to that part of the body because the gel won’t stay put, in the female urethra. This product will melt over a matter of minutes and will deliver the drug locally. Also potentially, you can use this for people who have failed therapies for something called ‘overactive’ bladder, which is Painful Bladder Syndrome minus the pain. It consists of urinary urgency and frequency. $3 billion plus of those drugs are sold worldwide, but most people don’t stay on those drugs due to lack of efficacy and side-effects. So we would like to provide sort of a salvage therapy for people, another treatment option later for them after they fail their oral therapy. Therefore, we are not competing with the players in that area, but we would like to provide an important treatment option for them with URG301. We can also put other active ingredients into the 300 platform going forward.

CEOCFO: Is there much competition in this area?

Dr. Garner: The short answer is people are recognizing the market and the market potential. There have been a lot of failures in Phase II and even in Phase III with systemic agents by large companies. It is not that we are any smarter than they are, but we believe that for a lot of these patients you really need a regional therapy. You need to deliver drugs so they can get very good access to the bladder where you have this damage to the urothelium or the lining of the bladder. So there is recognition of this and there have been other intravesical therapies for smaller diseases developed in urology. In addition, hundreds of millions of dollars of drugs are delivered as our drug is delivered directly into the bladder with a catheter. Now that sounds invasive, but if you have tremendous pain, pain that is associated in some people with suicide, you can imagine that a brief catheterization and a thirty-minute exposure of drugs is potentially going to give you life-changing pain relief and it would be something that would be very important.

CEOCFO: Is this difficult for physicians to diagnose?
Dr. Garner: It is something that has been difficult for physicians to diagnose and unless they really have experience with this as twenty years ago they may have sent you to a psychiatrist, but it turns out that it is very real. It is just that we didn’t understand it when I went to medical school and it is a fundamental paradigm shift that should happen and that we believe is going to happen, if and when this product gets approved. Dr. Parsons really is the point of reference in this area. He really developed the only pharmaceutical that has been innovated in the past 15 years. Prior to that people would use an industrial solvent that they would put in the bladder to try and kill the nerves. The amazing thing is that we talk to a company that has 10 or 20 people, sometimes even 5 people and inevitably someone will say, ‘may I speak with Dr. Parsons privately?’ It is incredibly prevalent and that is something that the Rand Corporation has helped somewhat address, but some of the Urigen story is that this seems too good to be true, could it really be this big, could you really be helping these people this much? The reality is that when they look at Dr. Parsons has done; he is real deal as he has done this before.

CEOCFO: What is the timetable?

Dr. Garner: We are a public company, what investors will see is Urigen applying for an FDA meeting around the data that I mentioned in Phase II. It is going to be a number of years on the order of 2 ½ to 3 years at least before we are able to, assuming we have a full partnership in place, complete the remainder of the clinical trials.

CEOCFO: What is Urigen’s financial picture today?

Dr. Garner: We are a .17 cent stock. We went public in 2007 by a reverse merger. We are traded on the bulletin board, and we have a market cap less than $20 million. We are a story that doesn’t have analyst coverage that we think is under appreciated, so we certainly appreciate any visibility that CEOCFO can provide us.

CEOCFO: Address potential investors, why should they pay attention to Urigen Pharmaceuticals?

Dr. Garner: The reason to pay attention is that we have established some important safety information. Think about it, you are delivering the drug just locally for thirty minutes, and you are not providing systemic exposure. So the next question is does it work? Well we achieved statistical significance with respect to all of the end point in a double-blind placebo controlled, multi-center U.S. study and you protect it with a patent. The key patent issued in the United States is good until at least July of 2026 and we believe it provides relatively broad protection. Number four, I mentioned the Rand Corporation survey over 100,000 households and they believe that they are undercounting it, but you’ve got just women just by a strict definition of 3 to 8 million people afflicted. We think it is story that yes, it has risk because we are in the development stage, but we have de-risked it in meaningful ways with respect to safety, intellectual property, activity of URG101, and market size.

CEOCFO: Final thoughts, what should people remember most about the Urigen story?

Dr. Garner: People should remember that stock price does not necessarily correlate to the quality of the work that is being done. We would also ask them to read up on our website about Dr. Parsons and what he has done as he actually developed the drug in this area before. So we ask them to watch for our coming progress with URG101.

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Actually, the last pharmaceutical innovation for Painful Bladder Syndrome/Interstitial Cystitis was innovated by our scientific founder, which is important to the Urigen story. He developed a drug, which now sells about $175 million that is marketed in the US by a division of Johnson & Johnson, and co-promoted by Bayer Corporation as well. However, it was approved in late 1996.  So since then in those thirteen or fourteen years we haven’t had a new innovation, and that is the standard of care. With that drug, you have to take it three times per day generally for six months, and you can imagine waiting for six months for a response to your pain, which may not come. So that gives you an idea of the opportunity for URG101, which actually works in a matter of minutes during an office visit. So it is truly a paradigm-shifting product potentially and that is what I saw meeting patients in Dr. Parsons’ clinic in 2003 at the University of California San Diego. - Dr. William J. Garner M.D.

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