Editor’s note: This is the seventh in a series of Q&As profiling presenting companies for Venture 2003.Many people may not like to talk about bladder and bowel problems or sexual dysfunction. But the problems are serious, affect many people, and need to be addressed with new drug therapies.

So say the founders of Dynogen Pharmaceuticals, which is searching for more venture capital to acquire additional promising drug compounds and to strengthen its position as a research and development partner with other firms.

“Our target market consists of individuals who are affected by overactive bladder, irritable bowel syndrome, and sexual dysfunction. Currently, the number of people suffering with these diseases are staggering,” Dr. Karl Thor, one of the firm’s two co-founders, and Mark Fitzpatrick, chief financial officer, tell Local Tech Wire. “There are over 30 million people who are affected by overactive bladder and 20-40 million with irritable bowel syndrome.”

Dynogen, which is based in Durham and has an office in Boston, believes the markets for new treatments are worth well north of $2.5 billion.

Oxford Bioscience Partners, HealthCare Ventures LLC and A.M. Pappas & Associates already have seen enough promise in Dynogen to invest $13.25 million in an A round.

Dynogen is targeting genitourinary (GU) and gastrointestinal (GI) therapies, saying “current treatments are either non-existent or inadequate.”

Thor, co-founder and chief scientific officer, is an adjunct research associate professor in the Department of Surgery/Division of Urology and the Department of Obstetrics and Gynecology at Duke University Medical Center. He is also director of the Laboratory of NeuroUrology at the Veterans Affairs Medical Center, Surgical Research Services.

Dr. Lee R. Brettman, the other co-founder, is president and chief executive officer. He was entrepreneur in residence at Oxford Bioscience Partners before taking over as Dynogen’s CEO. Oxford Bioscience is one of the investors. Brettman also served as chief medical officer and senior vice president of medical and regulatory affairs at Millenninium Pharmaceuticals.

Dynogen is one of 23 companies preparing for presentations at Venture 2003, the Council for Entrepreneurial Development’s 20th annual venture capital event.

As it did a year ago, Local Tech Wire is featuring in-depth profiles of presenting firms built around a Q&A with a company executive as well as a Fact Box of important information. One profile will appear each day.

LTW put together a Q&A designed to not only produce facts about the presenters but also to give each a chance to state the case for venture capitalists to invest.

Seventh in the series is from Thor and Fitzpatrick.

Venture 2003 is set for April 22-23 in Chapel Hill.

Times are tough. If you had only one chance and one paragraph to convince an investor, how would you answer this question: “Why should an investor choose your company?”

Collectively, novel therapies for GU and GI diseases represent a multi-billion dollar market opportunity for Dynogen. Dynogen is the industry leader in understanding neuropharmacological control of the lower urinary tract and applies its predictive modeling platform to the discovery and development of genitourinary (GU) and gastrointestinal (GI) therapies for which current treatments are either non-existent or inadequate. GU and GI disorders afflict more than 60 million Americans and there are few options available to effectively treat these disorders. The Company is focused on overactive bladder, irritable bowel syndrome, and various forms of sexual dysfunction.. In addition, the Company’s management team encompasses world-class experts in the field of NeuroUrology and gastroenterology and represents over 70 years of industry experience.

What is the “pain point” (or points) you address for your customers?

Current therapies for overactive bladder (OAB) and irritable bowel syndrome (IBS) are very limited by poor efficacy and side effects and are contraindicated in major segments of these populations. Approximately 32 million Americans have some form of overactive bladder which is characterized by urinary frequency, urgency, nocturia (frequent urination episodes at night) and incontinence. Anticholinergic drugs,the market leaders for treating OAB, act on the smooth muscle of the bladder and can only be used to treat the idiopathic forms of overactive bladder, representing less than half of all patients with this disorder. Due to the side effect profile (dry mouth, dry eye, constipation) and limited efficacy, many patients avoid the use of these drugs. Anti-cholinergics are contraindicated in certain conditions which cause overactive bladder, such as BPH, a condition affecting approximately 13 million Americans. There is only one approved drug for the treatment of IBS, a disease which affects more than 20, million people in the US. It has a very restricted label because of serious side effects. Dynogen’s neurological approach to these conditions, we believe, offers substantial advantages.

What makes your company unique? Do you have a proprietary and/or a patented technology? Please explain why it is unique and what the status is of any patent filings.

Dynogen is the pharmaceutical leader in understanding neurological control of the lower urinary tract and leverages its modeling platform and scientific expertise to discover and develop neurological compounds and develop them for GU and GI disorders. The company is unique in its neurological approach to the treatment of GU and GI disorders. This approach has been validated through the prior commercial and clinical development successes of the company’s scientific founder, Dr. Karl Thor. In addition to Dr. Thor’s successes, the Company’s senior management team has direct experience in the development of an aggregate of seven FDA-approved products and has been involved in the clinical development of over 20 investigational new drugs. Since mid-2002, Dynogen has filed or in-process 12 provisional patent applications.

What makes your product(s) and/or services unique vs. your competition? (Who is your competition, and what do they offer?) If you have no competition, why not?

Dynogen holds a leading position in the field of predictive modeling based on its proven abilities in the areas of NeuroUrology, drug development and clinical development. The Company believes these strengths will allow it to rapidly discover and develop unique therapies for unmet clinical needs in the areas of GU and GI disorders. Our competition comes from big pharma, which does not have the preclinical animal models or expertise in NeuroUrology.

Does your company already generate revenue?

Dynogen is a development-stage company, and therefore does not generate any revenues at this time.

What is your target market? What is the size of that market in terms of dollars? What share of that market do you believe you can win?

Our target market consists of individuals who are affected by overactive bladder, irritable bowel syndrome, and sexual dysfunction. Currently, the number of people suffering with these diseases are staggering: there are over 30 million people who are affected by overactive bladder and 20-40 million with irritable bowel syndrome. A novel therapy that provides greater efficacy or fewer side effects compared to currently marketed anticholinergics (the mainstay of bladder therapy) would generate peak annual sales of over $1 billion. Similarly, a well-tolerated and efficacious therapy for IBS or female sexual dysfunction would generate peak annual sales in the $1 billion range. A well-tolerated, efficacious treatment for premature ejaculation would generate sales of over $500 million.

What will you do with the invested funds? What is the timeline for product delivery? If you have existing products and services, how will additional funding help you expand your company, if that is the intention, or will you develop new products?

Dynogen will use invested funds to acquire attractive compounds and develop them to treat GU and GI disorders. The Company also seeks to develop proprietary compounds against Dynogen-validated novel targets for these disorders. Additional funding will also enable the Company to attract and enter into R&D collaborations as a strong and viable development partner.

What do you want from an investor other than money?

Dynogen has attracted and will continue to attract high-quality investors experienced in helping advance innovative biotechnology companies. Investors in Dynogen will not only provide financial support, but we will look to them to take a long-term view of the Company, and help management in achieving critical milestones. Networks in the biotech/pharmaceutical industry.are also very important for us.

Why will investors be impressed with your management team?

Dynogen has assembled a management team with extensive experience in the development and commercialization of pharmaceuticals. Combined, the entire team has brought seven products to market, four products to either NDA filing or current Phase III trials and filed over 20 INDs in the areas of urology, cancer, cardiovascular, gastrointestinal, inflammatory and infectious diseases.

What is the exit strategy for the investor from your company? Are there potential strategic alliances with larger companies? Do you wish to take the company public? Or do you wish to grow the company and either sell it or acquire other companies?

One of Dynogen’s strategic goals is to establish R&D collaborations with larger pharmaceutical and research companies. Recently, Dynogen announced a collaboration with Evotec OAI to utilize their chemistry and biology capabilities to identify and advance neurological compounds to treat genitourinary (GU) and gastrointestinal (GI) disorders.

The Company plans to grow and add value by executing on our key goals which we have discussed above. We plan to have 2 programs in development this year. It is also possible that the strategic acquisition of other companies can accelerate our growth and value creation and we remain alert to those possibilities.

Dynogen is always assessing its financing options. However, at this time the Company does not have any near-term plans for an IPO or being acquired by another company, but they are both viable options in the future.

Just the facts on Dynogen: www.localtechwire.com/article.cfm?u=3844