Kampo Today: What does Tsumura hope to gain from the New York Office? Hideo Anzai: The office's basic mission is to develop the Kampo market in the U.S., where the environment for this type of product is now very favorable. Since we don't have a distribution network in the U.S. or experience in sales or marketing in this country, one of our key tasks is to identify appropriate partner companies that can help us penetrate the U.S. market. Market segments are very diverse in the U.S., and I imagine that, depending on the segment, we may need to work with multiple partners. KT: In Japan, Tsumura is known principally as leader in the prescription Kampo market and, to a lesser extent, in the OTC Kampo market. How do you expect to position your products in the U.S.? HA: We are primarily focusing on the dietary supplement market, which is expanding rapidly and where we have competitive strengths. At the same time, we are still considering the possibility of drug status for selected products. This would, of course, require carrying out clinical studies. We already have some experience with clinical studies in Europe and the U.S. In 1991, we received the first approval of an IND for an herbal medicine from the FDA and subsequently completed a successful first-phase clinical study for an herbal combination formula for arthritis (see Kampo Today [KT], vol. 1 , no. 3, March 1996). KT: What are the strengths that can help Tsumura win a place in the dietary supplement market? HA: Unlike the great majority of players in the market, we are able to offer standardized, pharmaceutical-grade products. In addition to our outstanding process technology and quality control capability, we put substantial laboratory and clinical science behind our products. Recently, for example, some of our products have passed double-blind reevaluation studies mandated by Japan's Ministry of Health & Welfare (see KT, vol.1, no. 2; vol. 2, no.1). KT: What obstacles do you see in your efforts to bring Kampo to the U.S. market? HA: Perhaps the principal one is that only very few people have any familiarity with Kampo. This means we have a major educational task. Kampo Today is, of course, playing a role in this. The Internet, where many people turn for health information of all kinds, is a great educational resource, and we intend to make full use of it. We have recently expanded the Kampo information available in English on Tsumura's website and are pleased with the response this has generated. Some good publications on Kampo have started to become available in English, and this will surely be helpful as well. KT: When do you expect to have products on the U.S. market? HA: We are now preparing products for the U.S. market and expect to have several ready by this coming spring. KT: Will the New York office be involved in any non-Kampo-related activities? HA: Herb-based new products are a promising area. We have an extensive library of active fractions and ingredients derived from medicinal herbs, which we have discovered or developed in the course of our intensive research on Kampo medicine. We believe they have great potential value for the U.S. market, not only as starting compounds for new drugs but also as possible new dietary supplements, food additives, etc. We would like to develop them in the U.S., perhaps in cooperation with American partners. |