John, I think that LGND is closer to infinity than you realize. With LLY on board, the clinicals will really crank up in the diabetes area. However, LGND has already made significant progress on its own. LGND chose Targretin to be its initial flagship product. Consequently, they initiated several clinical trials for cancer. Targretin has been in cancer patients for three years and Phase II/III trials for oral treatment of CTCL should be completed in about 6 months. Recently, LGND presented Phase I/II data which put oral Targretin approval in the slam dunk category. Virtually all patients responded (with complete remission, partial remission, or stabilization of disease), even among advanced or refractory patients. Thus it seems likely that oral Targretin will be on pharmacy shelves in 1999 (for CTCL).
Once the drug is availble, MDs can perscribe it for anything they deem appropriate. LGND began a Phase II diabetes trial in Europe last spring. The trial was small. It was designed to determine the optimal dose and to provide some initial clinical data to show LLY (or other interested pharmas). IR seems to be again indicating that the initial data will be released this year. I expect LLY to start US trials on Targretin in early 1998 and I also expect the second generation compound, LGD1268, to also enter the clinic then. By 1999, there will be a signicant amount of data on using Targretin to treat Type II diabetes. I expect it to work well in humans and to synergize with TZD's such as WLA's Rezulin or 2nd generation TZDs in SBH and Tekeda advanced trials.
Type II trials or Targretin will take awhile and approval may be a bit tougher for type II diabetes than for cancer. However, I do expect off label use to be significant, beginning in 1999. |
