Wellesley Pharmaceuticals, LLC
January 20, 2014 Issue
The Most Powerful Name In Corporate News and Information
Patented Drug for Nocturia Treatment
David A. Dill
Pharmaceuticals, headquartered in Newtown, PA is developing an innovative,
patented drug for treating nocturia (frequent urination at night), which
affects about 2.2 billion people worldwide. Currently there are no drugs on
the market focused on nocturia and Wellesley plans to be first to market in
the space. We believe that our proprietary safe drug, Paxerol™, positions us
to be the industry leader, addressing a massive unmet medical need. Paxerol
offers significant advancement in terms of mechanism of action relative to
existing indirect treatments of nocturia and should allow us to provide
relief to hundreds of millions of people.
3 Valley View Drive
Newtown, PA 18940
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 20, 2014
Mr. Dill: We have developed a very safe drug that in low doses will greatly reduce the occurrence of nocturia, which is a frequent need to urinate at night. It affects over two billion people, so it is a very big unmet need because there is no drug on the market today focused on this problem.
CEOCFO: Is that because people have not tried, considered it not important enough or it has just been difficult to find a solution?
Mr. Dill: Nocturia has been a very difficult problem to solve. There are overactive bladder drugs on the market today, but their efficacy is in the 10% - 15% range in terms of reduction in trips to the bathroom on a weekly basis, and they have significant side effects for many people which cause something like 80% of people who try it to give up on it after a few months. We have essentially no side effects, and efficacy in the 33% - 100% range, but only for an eight hour period. It does not work for a 24 hour period, but it protects during the most important eight hours, we believe.
CEOCFO: Is there more than one cause of nocturia?
Mr. Dill: Our medical experts tell us that there are probably about twenty underlying causes of nocturia, but a great many of them have one key factor in common, which is excess prostaglandin production. People who suffer from nocturia or overactive blander, and even children who wet their beds tend to have significantly elevated levels of prostaglandins in their urine, and prostaglandins irritate the bladder and can make a bladder that is only 20% full feel like it is about to burst. What we do is we inhibit the production of prostaglandins very significantly which effectively increases the comfortable bladder capacity, thereby delaying the need to urinate so frequently.
CEOCFO: In layman's terms, what is actually happening that is limiting the production?
Mr. Dill: It is a complex chemical process, and the drugs have three different ways of interfering with this multi-step process of the creating prostaglandins. It is like you have a hose that is leaking and you cover the three leaking places, and that way the prostaglandins cannot get out. That just an analogy; that is not the way it really works, but it is essentially in three different ways controlling or inhibiting the production of prostaglandins. A world famous scientist, Frank Rauscher, III, deputy director of The Wistar Institute, figured out the mechanisms of action that make Paxerol so effective. He has a much more accurate and complex explanation about how this works.
CEOCFO: What are prostaglandins?
Mr. Dill: They are lipid compounds, and they occur not just in the bladder but throughout the body. Pain medicines used for other areas on a much more massive basis can help relieve pain and can relieve the production of prostaglandins, but in the bladder it is a much more subtle process so low doses can be very effective.
CEOCFO: Where are you in the development process?
Mr. Dill: The product is 100% developed, except for the extended release platform. If you just chop up the drugs and take them as currently available with their immediate release profile, it only works for about five hours. People generally want to sleep more like eight hours, so we are going to have an extended release platform which gives a significant amount of the drug in the beginning right before you go to sleep, and then slowly releases some additional milligrams of the drug throughout the night.
CEOCFO: Do you anticipate challenges in the extended release or is it just that you have not gotten there yet?
Mr. Dill: There are at least 200 different formulations that provide extended release, and we have been reluctant to choose one because our ultimate game plan is to license the product out to a big pharmaceutical company. Each one of them has its own favorites in terms of extended release, so we figured our odds of picking the one that they would prefer the most are pretty low. On the other hand, we may have the opportunity to, before getting Food and Drug Administration (FDA) approval, sell the product through a third party that will release it as a prescription drug special or even to sell it directly online or through pharmacy chains in North America. This is possible because of the very safe drug components we are using. Therefore, we may have to spend some money to at least come up with one extended release formulation for that purpose. Again, our future licensee may choose a different extended release formulation, but there are many that could work for this purpose.
CEOCFO: Would it be called Paxerol in Europe or Asia as well?
Mr. Dill: That is possibly true. When this ultimately gets to market, I assume our licensee will come up with a more clever name, but that is just the name my wife came up with, and we like it.
CEOCFO: What are the next steps for Wellesley Pharmaceuticals?
Mr. Dill: There are two basic next steps. One is launching the product in Europe or North America on a relatively small scale, which we hopefully will get completed around the third quarter of this year. Then the big step is finalizing a phase 2 trial for FDA approval purposes here in the US, which will hopefully be the basis for our getting a big pharmaceutical company licensing deal early in 2015.
CEOCFO: Is the medical community aware of Paxerol or is it way too early?
Mr. Dill: Well, some members of the medical community are aware. I have a urologist on my team, I have a nephrologist on my team, and I have the world's leading expert on acetaminophen on my team. There are certain other people who are aware of it as well, including the 38 people who have informally tested it (78% reported good results). I discussed it with leading urologists at Johns Hopkins and elsewhere, so there are some people who are aware. Of course, anyone who wants to read my 4 issued patents could become aware, but it is not common knowledge certainly.
CEOCFO: Are you funded for the continued development?
Mr. Dill: We cannot proceed much further without raising money. We need $3 million to complete the Phase 2 trial that should allow us to license our product to a big pharma company early in 2015. Once that is completed, we will earn large milestone payments and be cash flow positive thereafter. A 15% license fee on Paxerol sales to tens or hundreds of millions of customers will provide massive earnings for our stockholders once our licensee gets the product approved by the FDA and launched around the world. If that funding is not available soon enough, then we will just launch the product on a more modest basis ourselves either in the US or Europe. That way we can earn the money we need to complete the trial and get it licensed out to the right partner. The third option would be to go down both paths. If we raise $3.5 - $4 million, we could launch the product and conduct the trial in parallel, thereby generating revenue on a modest basis while we await the launch by a big pharma partner that can turn Paxerol into the blockbuster drug we know it can be.
CEOCFO: Are the medical and investment community showing interest in nocturia at the point in time?
Mr. Dill: There certainly seems to be an interest among the pharmaceutical companies, because it is a completely unmet need at this point. There are lots of drugs for other purposes, such as overactive bladder or attacking cancer or cholesterol or other conditions, but there is no drug on the market today for nocturia. It affects over 2 billion people and is associated with higher rates of heart disease, stroke and deadly falls. My father-in-law got up at 2 AM and fell down and broke his hip. He was dead within ten weeks and that is a very common story. It is certainly also a quality of life problem. It leads to insomnia, fatigue, depression, and traffic accidents from people falling asleep. A published estimate quoted over $60 billion a year just in terms of the cost of nocturia for lost work time in the US alone. It is a huge problem with no solution on the market. You talk to any urologist and they will say that that is the most common complaint of their customers. The only sure way to avoid nocturia long-term is to die young. By the time you get to age 80, 80% of the people suffer from it, so it is just a matter of time.
The problem is the venture capital companies look at this and they say, “You only need $3 million, but I never invest less than $10 million.” What they should be saying is, “If I invest $3 million and get 100 times my money back, then maybe that is much better than investing $10 million and getting 5 or 10 times my money back.” Of course, any bureaucracy needs general guidelines to help it sort through massive amounts of data, so their rules probably work well in general. It just means that they occasionally will miss huge opportunities.
Other VCs have said that it is not an area of therapeutic interest for them. I guess somehow the fact that it is 2 billion people in need with no solution available is not sexy enough as opposed to some other malady. There are lots of important problems, but some problems affect 100,000 people and some problems affect 2 million people, but there are not too many problems that affect 2 billion people. Likewise, there are not too many medical problems that have zero drugs on the market to address them. A recent study tracked the nocturia experiences of 16,000 people over a 12 year period. Among the women ages 65-90, 68% of those who had no nocturia symptoms survived at least 12 years. Among those who had 3 or more nightly nocturia episodes, only 22% survived at least 12 years. I can only conclude that those VCs who say it is not an area of therapeutic interest must all be orphans.
CEOCFO: Have you been in discussion with the pharmaceutical companies?
Mr. Dill: We have talked to virtually all of the major pharmaceutical companies, and some have given us feedback on our trial protocol, and a number have said get me the Phase 2 trial data, and then we can talk about a license. We just need to get this one trial done and then I think we will be in good shape.
CEOCFO: How else are you reaching out to let the world know what you are working on or do you want to keep it somewhat under wraps?
Mr. Dill: We have 4 patents already issued, so we have no big need to keep this a secret. We are slowly spreading the news among urologists, all of whom see this problem regularly. Mostly through our licensing agent we are just keeping the pharma companies informed about our progress, since they will be the key audience that will ultimately make our product a huge success.
CEOCFO: Would you tell me a little bit about your background that was helpful in developing Wellesley Pharmaceuticals?
Mr. Dill: My background is one of being a CFO managing large projects and dozens and hundreds of people. I have managed finance, research, HR, legal, and operations teams, so I have a lot of management experience. I do not a lot of pharmaceutical experience since I have only involved in this area for the last three years, but I have an excellent team. I have a world class licensing agent, a world famous scientist, a leading urologist and a leading nephrologist both in the Philadelphia area, and the world’s leading expert on acetaminophen, which is one of our drug’s components. I have an excellent team with very deep experience.
CEOCFO: What have you learned over the last three years that is going to help you as you go forward with the company?
Mr. Dill: Mostly what I have learned is that getting a drug approved is a complex process, and it is critical to have the right expertise on the team. It is obviously something that takes time and money to get done right, but I now have people on my team with decades of experience in the pharmaceutical industry, and we have the three key leaders we need. We need to continue the patent work and for that I have Dr. Ping Wang, one of the leading patent attorneys in the world working with me. We need to get the trial completely successfully and I have Dr. Tony DelConte, the fellow who took a leading overactive bladder drug through clinical trials for Novartis International AG. Then I have Dr. Joy Barton from Marquant Partners who is a world class licensing agent that the team at AstraZeneca introduced me to. I have the right leadership for each of the key tasks facing us.
CEOCFO: Why pay attention to Wellesley Pharmaceuticals and Paxerol?
The key is that we have a very capital-efficient solution to a huge unmet
need. Since over 2 billion people have the problem and there is no drug on
the market to treat it, nocturia is perhaps the biggest unmet medical need
in the world and there is essentially no competition out there right now. We
have a very safe drug that should be able to go through clinical trials very
quickly because the FDA has already confirmed that we can follow a 505(b)(2)
regulatory path, which means that do not need Phase 1 safety testing.
Therefore, we should have a very quick path through the FDA and a drug that
should be extremely popular because it works very effectively starting on
the first night and 78% of the people who have tried it so far have reported
good results so we know that it works. You do not have to wait months for
efficacy, you do not have to worry about side effects, and it should not
need a high price because the underlying cost is going to be less than 2¢ a
dose. For all of these reasons, it should be something that sells very well.
If our licensee gives away a sample of seven safe immediately effective
patented Paxerol pills to someone suffering from nocturia, they will be
hooked for life, so it should be a very compelling product. With no
competitive drug available, they should grow the customer base very quickly.
For each 1% of the nocturia sufferers our big pharma licensee gains as
customers, we will earn over $150 million in licensing fee net income each
year. After just a single $3 million investment, our company will be cash
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