Immunology and Oncology
   

The Immunology franchise is focused on expanding the market for Rapamune, AHP's novel immunosuppressant for organ transplantation. Rapamune, in its liquid form, was approved in the United States in 1999 for the prevention of organ rejection following kidney transplants and received a recommendation for approval in Europe in December 2000. In addition, AHP received approval for a tablet form of Rapamune in the United States in August 2000, which will improve ease of dosing.

Research projects in Immunology include expanded indications for Rapamune for other types of organ transplantation, including Phase II trials that are under way for therapy following liver transplants.

AHP is studying other innovative approaches to immunosuppression such as anti-B7 monoclonal antibodies, which potentially offer a more specific approach to the prevention of organ transplant rejection. In addition, Phase III clinical trials are under way for recombinant interleukin-11 for the treatment of Crohn's disease.

Mylotarg is the first oncology treatment that
directly targets leukemia cells using innovative
antibody-targeted chemotherapy.
The May 2000 approval of Mylotarg by the FDA marked a significant milestone for AHP's Oncology franchise. Mylotarg - a novel chemotherapy agent for relapsed acute myeloid leukemia in patients age 60 and over -is the first oncology treatment to directly target leukemic cells using innovative monoclonal antibody-targeted chemotherapy. Developed in collaboration with Celltech Group Plc., Mylotarg is unique because it delivers a powerful antitumor agent called calicheamicin directly to leukemic cells. AHP scientists developed technology linking calicheamicin to a humanized antibody that attaches to and destroys a specific type of cancer cell. This is dramatically different from standard chemotherapy, which kills both cancerous and healthy cells.

AHP is conducting trials to extend the use of Mylotarg to other forms of leukemia, as well as evaluating additional monoclonal antibodies in order to expand the use of this ground-breaking chemotherapy technology to breast cancer, lymphoma and prostate cancer.

Mylotarg joins Neumega in AHP's global Oncology franchise product portfolio. Clinical studies with Neumega-recombinant interleukin-11, approved for use in the United States as a platelet growth factor for chemotherapy-induced thrombocytopenia in nonmyeloid malignancies-are further defining its role in managing thrombocytopenia in myeloid malignancies and viral disease.

There currently are two other promising oncology research programs in Phase II clinical trials: CCI-779 and ERA-923. CCI-779 is designed to interrupt growth in a variety of tumors by inhibiting the action of a protein called mTOR, which appears to control a number of cell growth functions. It will be evaluated as a treatment for breast, prostate and renal cell cancers as well as soft tissue sarcoma. ERA-923 is a selective estrogen receptor modulator being developed as a treatment for breast cancer.

"After being on dialysis for four years because of kidney failure, I had a kidney transplant last November. My mother donated one of her kidneys to me. I've been taking Rapamune and other drugs since the operation, and everything is going well so far. I feel stronger than I have in years - almost like I'm a new person."

Irving Smith-Brooklyn, New York