TWST: Please begin with a brief historical sketch of the company and a picture of the things you are doing at the present time.
Mr. Stewart: CollaGenex is a company that has transitioned from being a dental pharmaceutical company into a specialty dermatology company using proprietary technology that we have in-licensed from the State University of New York. Recent milestones include the approval of our first dermatology product, our flagship product Oracea, which is the first FDA-approved systemic treatment for rosacea, and the launch of that product was in July. We are also very focused on continuing to develop our pipeline of products, including incyclinide and a compound called COL-118 for indications that include acne, rosacea and erythema.
So our focus today is exclusively on dermatology. Our strategy is to leverage our pipeline and to commercialize the products ourselves through our own established sales force.
TWST: Would you tell us about rosacea?
Mr. Stewart: This is a topical condition that affects predominantly the face. It has three primary symptoms, inflammatory lesions like papules and pustules; erythema, which is a persistent but episodic redness; and telangiectasia, which are the spider veins that you often see on people's faces, around their nose, chin and cheeks. It's a condition for which there is no known cure, so we are really managing the symptoms. Onset is early to mid-40s; it's episodic, but it's with you for the rest of your life. There is no gender bias. Men and women are equally affected, and it is a progressive disease. It is not something that is purely cosmetic; it starts off as being itchy, painful, irritating and unsightly, and can move to be being painful and disfiguring.
TWST: What are the main things that the company expects to accomplish during the next two to three years?
Mr. Stewart: The first is to continue to build Oracea. The second is to complete the development of incyclinide, our follow-up compound. This is a chemically modified tetracycline, which has no antibacterial activities but is a pure play anti-inflammatory, and it's being targeted for the treatment of acne. That drug is finishing its Phase II dose-ranging study, and we would anticipate entering into Phase III studies in the middle of 2007. They will run until probably the middle of 2008 and we would file our NDA at the end of 2008. In addition to that, we also have a compound, which is undisclosed at the moment, but referred to as COL-118, that has been targeted for erythema (the redness that is associated with rosacea and acne). That drug will move from Phase I into Phase II during 2007. I think it's strategically very important for CollaGenex to continue to leverage our platform technologies to give us clearly differentiated products. All three of the products I have referred to are first in class. Oracea is the first systemic treatment labeled for the treatment of rosacea. Incyclinide will be the first significant new chemical entity, if we are successful in getting approval, in the treatment of acne since Accutane. COL-118 will also be a first as there is currently no product specifically and exclusively indicated for the treatment of redness associated with erythema.