CEO Interview: Prospectus Pharmaceuticals (PVCT) Peter Culpepper
Provectus Pharmaceuticals, Inc. (PVCT), which targets the same markets as Dendreon Corporation (DNDN) and Merck & Co., Inc. (MRK), was recently profiled by The Wall Street Transcript, and the full transcript is available on Provectus Pharmaceutical’s web site at http://www.pvct.com/news/TWST_Provectus_2009-11-02.pdf.
Here is a brief synopsis of the interview available in full at the URL above:
PETER R. CULPEPPER, CFO and COO of Provectus, has spent 20 years in the financial field working for a wide range of companies and industries in the U.S. and abroad, especially high-growth startups. His experience with for-profit companies ranges from private startups to publicly traded, global conglomerates. He has also worked with large non-profits and a national CPA accounting firm. Mr. Culpepper led the national operating unit of a $1 billion publicly traded telecommunications company, as well as numerous operating units in Eastern Europe for a global telecommunications company. He handled the capital reporting process for a $5 billion global construction project and the formation of systems for a division that grew $150 million in revenue in two years. Previous employers include Neptec, Inc., a privately held optical networking component manufacturer, Metromedia Companies and PageNet, the largest wireless messaging company in the world. Mr. Culpepper taught undergraduate and graduate business courses for the University of Phoenix Online. He is also licensed as a Certified Public Accountant in Maryland and Tennessee. His professional affiliations include the American Institute of Certified Public Accountants, Financial Executives International and the Financial Executives Networking Group. Mr. Culpepper holds an MBA in finance from the University of Maryland, and he earned an AAS in accounting from the Northern Virginia Community College in Annandale, Va. Mr. Culpepper received a bachelor’s degree in philosophy from the College of William and Mary.
TWST: Let’s start with a brief history of Provectus and the concept behind your technological platform for drug development.
Mr. Culpepper: Provectus Pharmaceuticals (PVCT.OB) is a development-stage company that has been in existence since April 2002. Since that time, we have been developing drugs for two main therapeutic areas, oncology and dermatology. Our lead oncology agent, PV-10, is being developed as a therapy for several different types of cancers, but we are farthest along in our therapy for metastatic melanoma. And then we have another compound, PH-10, which is being developed for serious skin diseases like psoriasis and atopic dermatitis, which is more commonly known as eczema.
TWST: PH-10, your lead dermatology agent, is a topical treatment for plaque psoriasis. How does the FDA typically respond to topical treatments?
Mr. Culpepper: Well, that’s good a question. The FDA has been very accommodative in the sense that in our studies, we are allowed to apply the drug on a daily basis for 28 days. So the FDA knows, based on our Phase I data, which was very good, that the compound itself is very safe, as there’s a lot of good toxicity data. So the FDA allows the physicians to have their patients put it on once a day because it’s safe and there is not a concern of the drug going below the skin. So it’s very simple to use; it just needs to be applied. There’s not an injection as is the case with a number of other psoriasis drugs. And so, therefore, it’s straightforward and has more leeway from a clinical trial standpoint. If we did want to use it more than 28 days, which we might, the FDA would want us to do more extensive support data. We don’t expect a problem from this, but we will go through additional data just to support that you can use it more than 28 days. But our study for eczema, and we’ve already talked about the data, shows that it works applying it once a day for 28 days. And we expect the same thing from this psoriasis study, for which we just announced the completion of enrollment.
TWST: Now that the trials have gone well, will partnerships be a part of your developmental plans?
Mr. Culpepper: Yes, definitely. As soon as we have the data on the psoriasis trial completion that we recently announced, for which we expect interim data in the not-too-distant future, we plan to retain a financial adviser, assuming that it’s good data. We expect the psoriasis data to be good, just like we expected the atopic dermatitis data to be good, which we showed top-level at a conference just last month. So we expect the data to be good for both of our dermatology indications. On the basis of that Phase II data, we plan to enter into discussions for potentially licensing PH-10 to treat those two indications. Also we believe PH-10 could be applicable for a number of other dermatology issues, including wound care, MRSA and severe acne. So we would expect to enter into license discussions soon and are currently under NDA with a few derm players. So we are serious about licensing PH-10 on the basis of the Phase II data, and that’s of course assuming the data is as good or directionally positive for the psoriasis results as we already see with the eczema results. So yes, the answer is “yes” for dermatology. And for oncology, we plan to develop the drug further ourselves. And what I mean by that is we’re meeting with the FDA and talking to them about the regulatory pathway. We’re seeking accelerated approval for melanoma because it’s a deadly disease. Once you get melanoma, current protocol is to cut it out first. Then when it keeps on coming back, it’s judged to be recurrent and there are very high mortality rates. Your chance of living five years once you get recurrent melanoma is only 15%. So your odds of living a long time decrease dramatically once you get recurrent melanoma. Because of that, the FDA allows for accelerated approval, and we are seeking that. If we get that, then we don’t need to do a Phase III and can immediately pursue a New Drug Application and commercialize it even as soon as the end of next year in the best case scenario. Worst case, which is still tremendously good, is that we’ll have to do a Phase III. And at that point, we could even partner with a large company or take it ourselves to Phase III, since we have the capability to do that ourselves.
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